In compliance with authority procedures set out in subparagraph 14 (d): | |
Patients undergoing percutaneous coronary balloon angioplasty | |
Patients undergoing percutaneous coronary atherectomy | |
Patients undergoing percutaneous coronary stent placement | |
Acamprosate Calcium | In compliance with authority procedures set out in subparagraph 14 (d): |
For use within a comprehensive treatment program for alcohol dependence with the goal of maintaining abstinence | |
Acarbose | — |
Acetazolamide | — |
Acetylcysteine Sodium | Bronchiectasis |
Cystic fibrosis | |
Aciclovir | In respect of the eye ointment 30 mg per g, 4.5 g: |
Herpes simplex keratitis | |
In respect of the tablet 200 mg: | |
In compliance with authority procedures set out in subparagraph 14 (d): | |
Moderate to severe initial genital herpes | |
Episodic treatment or suppressive therapy of moderate to severe recurrent genital herpes, where the diagnosis is confirmed microbiologically (by viral culture, antigen detection or nucleic acid amplification by polymerase chain reaction) but where commencement of treatment need not await confirmation of diagnosis | |
In respect of the tablet 800 mg: | |
In compliance with authority procedures set out in subparagraph 14 (d): | |
Treatment of patients with herpes zoster within 72 hours of the onset of the rash | |
Herpes zoster ophthalmicus | |
Patients with advanced human immunodeficiency virus disease (CD4 cell counts of less than 150 million per L) | |
Acitretin | In compliance with authority procedures set out in subparagraph 14 (d): |
Severe intractable psoriasis | |
Severe forms of disorders of keratinisation | |
Adalimumab | In compliance with authority procedures set out in subsubparagraph 14 (d)(i): |
Initial treatment in a biological disease modifying anti-rheumatic drug (bDMARD) treatment cycle, by a rheumatologist or by a clinical immunologist with expertise in the management of rheumatoid arthritis, of adults with severe active rheumatoid arthritis, and: (a) (i) who have not previously received treatment with a bDMARD for this condition subsidised under the Pharmaceutical Benefits Scheme (PBS); or (ii) who, where the patient has previously received PBS-subsidised bDMARD treatment, have received no PBS-subsidised treatment with a bDMARD for this condition for a period of 5 years or more starting from the date the last course of PBS-subsidised bDMARD therapy was approved; and (b) who have failed to achieve an adequate response to methotrexate at a dose of at least 20 mg weekly, have failed to achieve an adequate response to methotrexate (at a dose of at least 7.5 mg weekly) in combination with 2 other non-biological disease modifying anti-rheumatic drugs (DMARDs) for a minimum of 3 months, and have failed to achieve an adequate response following a minimum of 3 months' treatment with leflunomide alone or with leflunomide in combination with methotrexate or with cyclosporin alone, unless: (i) treatment with any of the above-mentioned drugs is contraindicated according to the relevant Therapeutic Goods Administration-approved Product Information, or intolerance of a severity necessitating permanent treatment withdrawal develops during the relevant period of use, in which case the patient is exempted from demonstrating an inadequate response to that particular agent (or agents) only; or | |
(ii) the patient has had a break in PBS-subsidised bDMARD treatment of at least 5 years, in which case the patient is required to demonstrate failure to achieve an adequate response to treatment with at least 1 non-biological DMARD, at an adequate dose, for a minimum of 3 months; and (c) who have signed a patient acknowledgement form declaring that they understand and acknowledge that, within a single bDMARD treatment cycle, PBS-subsidised treatment with any bDMARD will cease if they do not demonstrate the response to treatment required to support continuation of PBS-subsidised treatment at any assessment where a response must be demonstrated; and where bDMARD means a drug included in the following list of drugs: adalimumab, anakinra, etanercept or infliximab; and where a bDMARD treatment cycle is a period of treatment with successive bDMARDs which commences when an eligible patient (one who has not received PBS-subsidised treatment with a bDMARD for rheumatoid arthritis in at least the previous 5 years) receives an initial course of PBS-subsidised therapy with 1 bDMARD, and which continues until the patient has tried, and either failed or ceased to respond to, PBS-subsidised treatment with a maximum of 3 bDMARDs, at which point the patient is no longer eligible for treatment and the period of treatment ceases; and where the following conditions apply: failure to achieve an adequate response to the treatment regimens specified at (b) above is demonstrated by an elevated erythrocyte sedimentation rate (ESR) greater than 25 mm per hour or a C-reactive protein (CRP) level greater than 15 mg per L, and either a total active joint count of at least 20 active (swollen and tender) joints, or at least 4 active joints from the following list of major joints: — elbow, wrist, knee or ankle (assessed as active if swollen and tender); or — shoulder or hip (assessed as active if there is pain in passive movement and restriction of passive movement, and where pain and limitation of movement are due to active disease and not irreversible damage such as joint destruction or bony overgrowth); if the requirement to demonstrate an elevated ESR or CRP cannot be met, the authority application includes the reasons why this criterion cannot be satisfied; where the patient is exempted from demonstrating an inadequate response to a treatment regimen specified at (b) above on the basis of contraindication or intolerance, the authority application includes details of the contraindication or intolerance, including the degree of toxicity; the authority application includes a completed copy of the appropriate PBS Authority Application - Supporting Information Form which includes details of the patient's ESR and CRP measurements, and an assessment of the patient's active joint count, conducted no earlier than 1 month prior to the date of application, and a copy of the signed patient acknowledgment form; a course of treatment is limited to a maximum of 16 weeks of treatment at a dose that does not exceed 40 mg per fortnight In compliance with authority procedures set out in subsubparagraph 14 (d)(i) or 14(d)(ii): Continuation of initial treatment in a bDMARD treatment cycle, by a rheumatologist or by a clinical immunologist with expertise in the management of rheumatoid arthritis, of adults with severe active rheumatoid arthritis who have previously been issued with an authority prescription for initial treatment with this drug for a period of less than 16 weeks, and where approval of the application would enable the patient to complete a course of 16 weeks of treatment in total, at a dose that does not exceed 40 mg per fortnight; and where 'bDMARD' and 'bDMARD treatment cycle' have the meaning given above | |
In compliance with authority procedures set out in subsubparagraph 14 (d)(i): Initial treatment or recommencement of treatment within an ongoing bDMARD treatment cycle, by a rheumatologist or by a clinical immunologist with expertise in the management of rheumatoid arthritis, of adults with severe active rheumatoid arthritis who have received prior PBS-subsidised treatment with a bDMARD for this condition in this bDMARD treatment cycle and who are eligible to receive further bDMARD therapy within this treatment cycle; and where bDMARD means a drug included in the following list of drugs: adalimumab, anakinra, etanercept or infliximab; and where a bDMARD treatment cycle is a period of treatment with successive bDMARDs which commences when an eligible patient (one who has not received PBS-subsidised treatment with a bDMARD for rheumatoid arthritis in at least the previous 5 years) receives an initial course of PBS-subsidised therapy with 1 bDMARD, and which continues until the patient has tried, and either failed or ceased to respond to, PBS-subsidised treatment with a maximum of 3 bDMARDs, at which point the patient is no longer eligible for treatment and the period of treatment ceases; and where the following conditions apply: patients who commenced PBS-subsidised bDMARD treatment prior to 1 December 2004 are deemed to have commenced their first bDMARD treatment cycle with that therapy and any PBS-subsidised treatment received prior to 1 December 2004 is deemed to be treatment received as part of the patient's first bDMARD treatment cycle; patients are eligible to commence therapy with adalimumab within this bDMARD treatment cycle provided they have not already tried, and either failed or ceased to respond to, PBS-subsidised treatment with 3 bDMARDs within this treatment cycle, and provided they also meet the conditions applying to recommencement of adalimumab therapy specified below, if applicable; patients who have previously commenced, and subsequently ceased, PBS-subsidised treatment with adalimumab within this bDMARD treatment cycle are eligible to recommence therapy with this drug within this same cycle if: (i) they have demonstrated an adequate response to their most recent course of PBS-subsidised adalimumab treatment; and (ii) the response was assessed, and the assessment was provided to the Medicare Australia CEO, no later than 4 weeks from the date that course ceased; and (iii) the response was assessed following a minimum of 12 weeks of therapy when the most recent course of PBS-subsidised treatment was an initial 16 week course; and (iv) response to treatment was determined using the same indices of disease severity used to establish baseline at the commencement of treatment; an adequate response to treatment is defined as an erythrocyte sedimentation rate no greater than 25 mm per hour or a C-reactive protein level no greater than 15 mg per L or either marker reduced by at least 20% from baseline, and either a reduction in the total active (swollen and tender) joint count by at least 50% from baseline, where baseline is at least 20 active joints, or a reduction in the number of the following major joints which are active, from at least 4, by at least 50%: — elbow, wrist, knee or ankle (assessed as active if swollen and tender); or — shoulder or hip (assessed as active if there is pain in passive movement and restriction of passive movement, and where pain and limitation of movement are due to active disease and not irreversible damage such as joint destruction or bony overgrowth); the authority application includes a completed copy of the appropriate PBS Authority Application - Supporting Information Form and, where this is required, evidence of the patient's response to their most recent course of adalimumab therapy; a course of treatment is limited to a maximum of 16 weeks of treatment at a dose that does not exceed 40 mg per fortnight | |
In compliance with authority procedures set out in subsubparagraph 14 (d)(i) or 14(d)(ii): Continuation of initial treatment, or of a course which recommences treatment, within an ongoing bDMARD treatment cycle, by a rheumatologist or by a clinical immunologist with expertise in the management of rheumatoid arthritis, of adults with severe active rheumatoid arthritis who have previously been issued with an authority prescription for initial treatment or recommencement of treatment with this drug for a period of less than 16 weeks, and where approval of the application would enable the patient to complete a course of 16 weeks of treatment in total, at a dose that does not exceed 40mg per fortnight; and where ‘bDMARD’ and ‘bDMARD treatment cycle’ have the meaning given above In compliance with authority procedures set out in subsubparagraph 14 (d)(i): Commencement of adalimumab treatment in a bDMARD treatment cycle with an initial supply subsidised under the Pharmaceutical Benefits Scheme (PBS) for continuing treatment, by a rheumatologist or by a clinical immunologist with expertise in the management of rheumatoid arthritis, of adults with severe active rheumatoid arthritis who were receiving treatment with adalimumab prior to 1 November 2004, who failed to qualify for PBS-subsidised therapy after 1 May 2004 due to an inability to receive concomitant methotrexate, and who have demonstrated a response to adalimumab treatment as specified in the criteria for continuing PBS-subsidised treatment with adalimumab detailed below; and where bDMARD means a drug included in the following list of drugs: adalimumab, anakinra, etanercept or infliximab; and where a bDMARD treatment cycle is a period of treatment with successive bDMARDs which commences when an eligible patient (one who has not received PBS-subsidised treatment with a bDMARD for rheumatoid arthritis in at least the previous 5 years) receives an initial course of PBS-subsidised therapy with 1 bDMARD, and which continues until the patient has tried, and either failed or ceased to respond to, PBS-subsidised treatment with a maximum of 3 bDMARDs, at which point the patient is no longer eligible for treatment and the period of treatment ceases; and where the following conditions apply: the authority application includes sufficient information to determine the patient's eligibility for treatment and the date of assessment of the patient; the course of treatment is limited to a maximum of 24 weeks of treatment at a dose that does not exceed 40 mg per fortnight Commencement of adalimumab treatment in a bDMARD treatment cycle with an initial supply subsidised under the Pharmaceutical Benefits Scheme (PBS) for continuing treatment, by a rheumatologist or by a clinical immunologist with expertise in the management of rheumatoid arthritis, of adults with severe active rheumatoid arthritis who were receiving treatment with adalimumab prior to 1 March 2005, who failed to qualify for PBS-subsidised therapy after 1 May 2004 due to testing negative for rheumatoid factor, and who have demonstrated a response to adalimumab treatment as specified in the criteria for continuing PBS-subsidised treatment with adalimumab detailed below; and where bDMARD means a drug included in the following list of drugs: adalimumab, anakinra, etanercept or infliximab; and where a bDMARD treatment cycle is a period of treatment with successive bDMARDs which commences when an eligible patient (one who has not received PBS-subsidised treatment with a bDMARD for rheumatoid arthritis in at least the previous 5 years) receives an initial course of PBS-subsidised therapy with 1 bDMARD, and which continues until the patient has tried, and either failed or ceased to respond to, PBS-subsidised treatment with a maximum of 3 bDMARDs, at which point the patient is no longer eligible for treatment and the period of treatment ceases; and | |
where the following conditions apply: the authority application includes sufficient information to determine the patient's eligibility for treatment and the date of assessment of the patient; the course of treatment is limited to a maximum of 24 weeks of treatment at a dose that does not exceed 40 mg per fortnight Continuing treatment within an ongoing biological disease modifying anti-rheumatic drug (bDMARD) treatment cycle, by a rheumatologist or by a clinical immunologist with expertise in the management of rheumatoid arthritis, of adults with severe active rheumatoid arthritis, and: (a) who have demonstrated an adequate response to treatment with adalimumab; and (b) whose most recent course of bDMARD treatment subsidised under the Pharmaceutical Benefits Scheme (PBS) in this bDMARD treatment cycle was with adalimumab; and where bDMARD means a drug included in the following list of drugs: adalimumab, anakinra, etanercept or infliximab; and where a bDMARD treatment cycle is a period of treatment with successive bDMARDs which commences when an eligible patient (one who has not received PBS-subsidised treatment with a bDMARD for rheumatoid arthritis in at least the previous 5 years) receives an initial course of PBS-subsidised therapy with 1 bDMARD, and which continues until the patient has tried, and either failed or ceased to respond to, PBS-subsidised treatment with a maximum of 3 bDMARDs, at which point the patient is no longer eligible for treatment and the period of treatment ceases; and where the following conditions apply: patients who commenced PBS-subsidised bDMARD treatment prior to 1 December 2004 are deemed to have commenced their first bDMARD treatment cycle with that therapy and any PBS-subsidised treatment received prior to 1 December 2004 is deemed to be treatment received as part of the patient's first bDMARD treatment cycle; an adequate response to treatment is defined as an erythrocyte sedimentation rate no greater than 25 mm per hour or a C-reactive protein level no greater than 15 mg per L or either marker reduced by at least 20% from baseline, and either a reduction in the total active (swollen and tender) joint count by at least 50% from baseline, where baseline is at least 20 active joints, or a reduction in the number of the following major joints which are active, from at least 4, by at least 50%: — elbow, wrist, knee or ankle (assessed as active if swollen and tender); or — shoulder or hip (assessed as active if there is pain in passive movement and restriction of passive movement, and where pain and limitation of movement are due to active disease and not irreversible damage such as joint destruction or bony overgrowth); the same indices of disease severity used to establish baseline at the commencement of treatment are used to determine response; the authority application includes a completed copy of the appropriate PBS Authority Application - Supporting Information Form, and a measurement of response to the most recent prior course of therapy with adalimumab, where response is assessed, and this assessment is provided to the Medicare Australia CEO, no later than 4 weeks from the cessation of that treatment course; if the most recent course of adalimumab therapy was an initial 16 week course, the application for continuing treatment is accompanied by an assessment of response to a minimum of 12 weeks of treatment with that course; a course of treatment is limited to a maximum of 24 weeks of treatment at a dose that does not exceed 40 mg per fortnight | |
In compliance with authority procedures set out in subsubparagraph 14 (d)(i) or 14(d)(ii): Continuing treatment within an ongoing bDMARD treatment cycle, by a rheumatologist or by a clinical immunologist with expertise in the management of rheumatoid arthritis, of adults with severe active rheumatoid arthritis who have previously been issued with an authority prescription for continuing treatment with this drug for a period of less than 24 weeks, and where approval of the application would enable the patient to complete a course of 24 weeks of treatment in total, at a dose that does not exceed 40 mg per fortnight; and where 'bDMARD' and 'bDMARD treatment cycle' have the meaning given above | |
Adrenaline | In compliance with authority procedures set out in subparagraph 14 (d): |
Initial supply for anticipated emergency treatment of acute allergic reactions with anaphylaxis in a patient who has been assessed to be at significant risk of anaphylaxis by, or in consultation with, a clinical immunologist, allergist, paediatrician or respiratory physician, where the name of the specialist consulted is included in the authority application | |
Continuing supply for anticipated emergency treatment of acute allergic reactions with anaphylaxis, where the patient has previously been issued with an authority prescription for this drug | |
Adrenaline Acid Tartrate | — |
Albendazole | In respect of the tablet 200 mg: |
In compliance with authority procedures set out in subparagraph 14 (d): | |
Treatment of tapeworm infestation | |
In respect of the tablet 400 mg: | |
In compliance with authority procedures set out in subparagraph 14 (d): | |
For the treatment of hydatid disease in conjunction with surgery or when a surgical cure cannot be achieved or where surgery cannot be used | |
Alendronate Sodium | In respect of the tablet equivalent to 70 mg alendronic acid: |
In compliance with authority procedures set out in subparagraph 14 (d): | |
Initial treatment for established osteoporosis in patients with fracture due to minimal trauma, where the fracture has been demonstrated radiologically and the year of plain x-ray or computed tomography scan or magnetic resonance imaging scan is included in the authority application, provided that if the fracture is a vertebral fracture, there is a 20% or greater reduction in height of the anterior or mid portion of the affected vertebral body relative to the posterior height of that body, or, a 20% or greater reduction in any of these heights compared to the vertebral body above or below the affected vertebral body | |
Continuing treatment for established osteoporosis in patients with fracture due to minimal trauma, where the patient has previously been issued with an authority prescription for this drug | |
In respect of the tablet equivalent to 40 mg alendronic acid: | |
In compliance with authority procedures set out in subparagraph 14 (d): | |
Symptomatic Paget's disease of bone | |
\"Alfaré\" | In compliance with authority procedures set out in subparagraph 14 (d): |
Initial treatment, for up to 3 months, for intolerance (not infant colic) to both cows' milk protein and soy protein in children up to the age of 2 years, where intolerance is demonstrated when the child has failed to respond to a strict cows' milk protein free diet with a soy protein as the principal formula, and where the date of birth of the patient is included in the authority application | |
Continuing treatment for intolerance (not infant colic) to both cows' milk protein and soy protein in children up to the age of 2 years, where clinical improvement has been demonstrated with the protein hydrolysate formula with medium chain triglycerides, and where the date of birth of the patient is included in the authority application | |
Continuing treatment for intolerance (not infant colic) to both cows' milk protein and soy protein in children aged 2 years and over, where the child has been assessed by a suitably qualified allergist or paediatrician, and where the date of birth of the patient is included in the authority application | |
Biliary atresia | |
Chronic liver failure with fat malabsorption | |
Chylous ascites | |
Chylothorax | |
Cystic fibrosis | |
Enterokinase deficiency | |
Proven fat malabsorption | |
Severe diarrhoea of greater than 2 weeks' duration in infants under the age of 4 months, where the date of birth of the patient is included in the authority application | |
Severe intestinal malabsorption including short bowel syndrome | |
Allopurinol | — |
Alprazolam | In compliance with authority procedures set out in subparagraph 14 (d): |
Panic disorder where other treatments have failed or are inappropriate | |
Alteplase | Treatment of acute myocardial infarction within 12 hours of onset of attack |
Aluminium Hydroxide - Dried with Magnesium Hydroxide | — |
Aluminium Hydroxide - Dried with Magnesium Trisilicate and Magnesium Hydroxide | — |
Amantadine Hydrochloride | Parkinson's disease which is not drug induced |
Amiloride Hydrochloride | — |
Aminoglutethimide | — |
Amiodarone Hydrochloride | Severe cardiac arrhythmias |
Amisulpride | In compliance with authority procedures set out in subparagraph 14 (d): |
Schizophrenia | |
Amitriptyline Hydrochloride | — |
Amlodipine Besylate | — |
Amoxycillin Trihydrate | In respect of the tablet, chewable, equivalent to 250 mg amoxycillin, capsule equivalent to 250 mg amoxycillin, capsule equivalent to 500 mg amoxycillin and sachet containing oral powder equivalent to 3 g amoxycillin: |
— | |
In respect of the tablet equivalent to 1 g amoxycillin: | |
Acute exacerbations of chronic bronchitis | |
Amoxycillin Trihydrate with Potassium Clavulanate | Infections where resistance to amoxycillin trihydrate is suspected Infections where resistance to amoxycillin trihydrate is proven |
Amoxycillin Trihydrate with Potassium Clavulanate and Water - Purified BP | Infections where resistance to amoxycillin trihydrate is suspected Infections where resistance to amoxycillin trihydrate is proven |
Amoxycillin Trihydrate with Water - Purified BP | — |
Amphotericin | — |
Ampicillin Sodium | — |
Ampicillin Trihydrate | — |
Anakinra | In compliance with authority procedures set out in subsubparagraph 14 (d)(i): |
Initial treatment in a biological disease modifying anti-rheumatic drug (bDMARD) treatment cycle, by a rheumatologist or by a clinical immunologist with expertise in the management of rheumatoid arthritis, of adults with severe active rheumatoid arthritis, and: (a) (i) who have not previously received treatment with a bDMARD for this condition subsidised under the Pharmaceutical Benefits Scheme (PBS); or (ii) who, where the patient has previously received PBS-subsidised bDMARD treatment, have received no PBS-subsidised treatment with a bDMARD for this condition for a period of 5 years or more starting from the date the last course of PBS-subsidised bDMARD therapy was approved; and (b) who have failed to achieve an adequate response to methotrexate at a dose of at least 20 mg weekly, have failed to achieve an adequate response to methotrexate (at a dose of at least 7.5 mg weekly) in combination with 2 other non-biological disease modifying anti-rheumatic drugs (DMARDs) for a minimum of 3 months, and have failed to achieve an adequate response following a minimum of 3 months' treatment with leflunomide alone or with leflunomide in combination with methotrexate or with cyclosporin alone, unless: | |
(i) treatment with any of the above-mentioned drugs is contraindicated according to the relevant Therapeutic Goods Administration-approved Product Information, or intolerance of a severity necessitating permanent treatment withdrawal develops during the relevant period of use, in which case the patient is exempted from demonstrating an inadequate response to that particular agent (or agents) only; or (ii) the patient has had a break in PBS-subsidised bDMARD treatment of at least 5 years, in which case the patient is required to demonstrate failure to achieve an adequate response to treatment with at least 1 non-biological DMARD, at an adequate dose, for a minimum of 3 months; and (c) who have signed a patient acknowledgement form declaring that they understand and acknowledge that, within a single bDMARD treatment cycle, PBS-subsidised treatment with any bDMARD will cease if they do not demonstrate the response to treatment required to support continuation of PBS-subsidised treatment at any assessment where a response must be demonstrated; and where bDMARD means a drug included in the following list of drugs: adalimumab, anakinra, etanercept or infliximab; and where a bDMARD treatment cycle is a period of treatment with successive bDMARDs which commences when an eligible patient (one who has not received PBS-subsidised treatment with a bDMARD for rheumatoid arthritis in at least the previous 5 years) receives an initial course of PBS-subsidised therapy with 1 bDMARD, and which continues until the patient has tried, and either failed or ceased to respond to, PBS-subsidised treatment with a maximum of 3 bDMARDs, at which point the patient is no longer eligible for treatment and the period of treatment ceases; and where the following conditions apply: the patient receives concomitant treatment with methotrexate at a dose of at least 7.5 mg weekly; failure to achieve an adequate response to the treatment regimens specified at (b) above is demonstrated by an elevated erythrocyte sedimentation rate (ESR) greater than 25 mm per hour or a C-reactive protein (CRP) level greater than 15 mg per L, and either a total active joint count of at least 20 active (swollen and tender) joints, or at least 4 active joints from the following list of major joints: — elbow, wrist, knee or ankle (assessed as active if swollen and tender); or — shoulder or hip (assessed as active if there is pain in passive movement and restriction of passive movement, and where pain and limitation of movement are due to active disease and not irreversible damage such as joint destruction or bony overgrowth); if the requirement to demonstrate an elevated ESR or CRP cannot be met, the authority application includes the reasons why this criterion cannot be satisfied; where the patient is exempted from demonstrating an inadequate response to a treatment regimen specified at (b) above on the basis of contraindication or intolerance, the authority application includes details of the contraindication or intolerance, including the degree of toxicity; the authority application includes a completed copy of the appropriate PBS Authority Application - Supporting Information Form which includes details of the patient's ESR and CRP measurements, and an assessment of the patient's active joint count, conducted no earlier than 1 month prior to the date of application, and a copy of the signed patient acknowledgment form; a course of treatment is limited to a maximum of 16 weeks of treatment | |
In compliance with authority procedures set out in subsubparagraph 14 (d)(i) or 14(d)(ii): Continuation of initial treatment in a bDMARD treatment cycle, by a rheumatologist or by a clinical immunologist with expertise in the management of rheumatoid arthritis, of adults with severe active rheumatoid arthritis who are receiving concomitant treatment with methotrexate at a dose of at least 7.5 mg weekly and who have previously been issued with an authority prescription for initial treatment with this drug for a period of less than 16 weeks, and where approval of the application would enable the patient to complete a course of 16 weeks of treatment in total; and where 'bDMARD' and 'bDMARD treatment cycle' have the meaning given above | |
In compliance with authority procedures set out in subsubparagraph 14 (d)(i): Initial treatment or recommencement of treatment within an ongoing bDMARD treatment cycle, by a rheumatologist or by a clinical immunologist with expertise in the management of rheumatoid arthritis, of adults with severe active rheumatoid arthritis who have received prior PBS-subsidised treatment with a bDMARD for this condition in this bDMARD treatment cycle and who are eligible to receive further bDMARD therapy within this treatment cycle; and where bDMARD means a drug included in the following list of drugs: adalimumab, anakinra, etanercept or infliximab; and where a bDMARD treatment cycle is a period of treatment with successive bDMARDs which commences when an eligible patient (one who has not received PBS-subsidised treatment with a bDMARD for rheumatoid arthritis in at least the previous 5 years) receives an initial course of PBS-subsidised therapy with 1 bDMARD, and which continues until the patient has tried, and either failed or ceased to respond to, PBS-subsidised treatment with a maximum of 3 bDMARDs, at which point the patient is no longer eligible for treatment and the period of treatment ceases; and where the following conditions apply: the patient receives concomitant treatment with methotrexate at a dose of at least 7.5 mg weekly; patients who commenced PBS-subsidised bDMARD treatment prior to 1 December 2004 are deemed to have commenced their first bDMARD treatment cycle with that therapy and any PBS-subsidised treatment received prior to 1 December 2004 is deemed to be treatment received as part of the patient's first bDMARD treatment cycle; patients are eligible to commence therapy with anakinra within this bDMARD treatment cycle provided they have not already tried, and either failed or ceased to respond to, PBS-subsidised treatment with 3 bDMARDs within this treatment cycle, and provided they also meet the conditions applying to recommencement of anakinra therapy specified below, if applicable; unless this treatment cycle is the patient's first bDMARD treatment cycle and the patient has failed to demonstrate a response to PBS-subsidised treatment with adalimumab, etanercept and infliximab commenced prior to 1 December 2004, in which case the patient is eligible to commence therapy with anakinra in this first treatment cycle, despite having previously failed to respond to 3 bDMARDs; patients who have previously commenced, and subsequently ceased, PBS-subsidised treatment with anakinra within this bDMARD treatment cycle are eligible to recommence therapy with this drug within this same cycle if: (i) they have demonstrated an adequate response to their most recent course of PBS-subsidised anakinra treatment; and (ii) the response was assessed, and the assessment was provided to the Medicare Australia CEO, no later than 4 weeks from the date that course ceased; and (iii) the response was assessed following a minimum of 12 weeks of therapy when the most recent course of PBS-subsidised treatment was an initial 16 week course; and (iv) response to treatment was determined using the same indices of disease severity used to establish baseline at the commencement of treatment; | |
an adequate response to treatment is defined as an erythrocyte sedimentation rate no greater than 25 mm per hour or a C-reactive protein level no greater than 15 mg per L or either marker reduced by at least 20% from baseline, and either a reduction in the total active (swollen and tender) joint count by at least 50% from baseline, where baseline is at least 20 active joints, or a reduction in the number of the following major joints which are active, from at least 4, by at least 50%: — elbow, wrist, knee or ankle (assessed as active if swollen and tender); or — shoulder or hip (assessed as active if there is pain in passive movement and restriction of passive movement, and where pain and limitation of movement are due to active disease and not irreversible damage such as joint destruction or bony overgrowth); the authority application includes a completed copy of the appropriate PBS Authority Application - Supporting Information Form and, where this is required, evidence of the patient's response to their most recent course of anakinra therapy; a course of treatment is limited to a maximum of 16 weeks of treatment In compliance with authority procedures set out in subsubparagraph 14 (d)(i) or 14(d)(ii): Continuation of initial treatment, or of a course which recommences treatment, within an ongoing bDMARD treatment cycle, by a rheumatologist or by a clinical immunologist with expertise in the management of rheumatoid arthritis, of adults with severe active rheumatoid arthritis who are receiving concomitant treatment with methotrexate at a dose of at least 7.5 mg weekly and who have previously been issued with an authority prescription for initial treatment or recommencement of treatment with this drug for a period of less than 16 weeks, and where approval of the application would enable the patient to complete a course of 16 weeks of treatment in total; and where 'bDMARD' and 'bDMARD treatment cycle' have the meaning given above | |
In compliance with authority procedures set out in subsubparagraph 14 (d)(i): Commencement of anakinra treatment in a bDMARD treatment cycle with an initial supply subsidised under the Pharmaceutical Benefits Scheme (PBS) for continuing treatment, by a rheumatologist or by a clinical immunologist with expertise in the management of rheumatoid arthritis, of adults with severe active rheumatoid arthritis who were receiving treatment with anakinra prior to 1 July 2004 and who have demonstrated a response as specified in the criteria for continuing PBS-subsidised treatment with anakinra detailed below; and where bDMARD means a drug included in the following list of drugs: adalimumab, anakinra, etanercept or infliximab; and where a bDMARD treatment cycle is a period of treatment with successive bDMARDs which commences when an eligible patient (one who has not received PBS-subsidised treatment with a bDMARD for rheumatoid arthritis in at least the previous 5 years) receives an initial course of PBS-subsidised therapy with 1 bDMARD, and which continues until the patient has tried, and either failed or ceased to respond to, PBS-subsidised treatment with a maximum of 3 bDMARDs, at which point the patient is no longer eligible for treatment and the period of treatment ceases; and where the following conditions apply: the patient receives concomitant treatment with methotrexate at a dose of at least 7.5 mg weekly; the authority application includes sufficient information to determine the patient's eligibility for treatment and the date of assessment of the patient; the course of treatment is limited to a maximum of 24 weeks of treatment | |
Commencement of anakinra treatment in a bDMARD treatment cycle with an initial supply subsidised under the Pharmaceutical Benefits Scheme (PBS) for continuing treatment, by a rheumatologist or by a clinical immunologist with expertise in the management of rheumatoid arthritis, of adults with severe active rheumatoid arthritis who were receiving treatment with anakinra prior to 1 March 2005, who failed to qualify for PBS-subsidised therapy after 1 December 2004 due to testing negative for rheumatoid factor, and who have demonstrated a response as specified in the criteria for continuing PBS-subsidised treatment with anakinra detailed below; and where bDMARD means a drug included in the following list of drugs: adalimumab, anakinra, etanercept or infliximab; and where a bDMARD treatment cycle is a period of treatment with successive bDMARDs which commences when an eligible patient (one who has not received PBS-subsidised treatment with a bDMARD for rheumatoid arthritis in at least the previous 5 years) receives an initial course of PBS-subsidised therapy with 1 bDMARD, and which continues until the patient has tried, and either failed or ceased to respond to, PBS-subsidised treatment with a maximum of 3 bDMARDs, at which point the patient is no longer eligible for treatment and the period of treatment ceases; and where the following conditions apply: the patient receives concomitant treatment with methotrexate at a dose of at least 7.5 mg weekly; the authority application includes sufficient information to determine the patient's eligibility for treatment and the date of assessment of the patient; the course of treatment is limited to a maximum of 24 weeks of treatment | |
Continuing treatment within an ongoing biological disease modifying anti-rheumatic drug (bDMARD) treatment cycle, by a rheumatologist or by a clinical immunologist with expertise in the management of rheumatoid arthritis, of adults with severe active rheumatoid arthritis, and: (a) who have demonstrated an adequate response to treatment with anakinra; and (b) whose most recent course of bDMARD treatment subsidised under the Pharmaceutical Benefits Scheme (PBS) in this bDMARD treatment cycle was with anakinra; and where bDMARD means a drug included in the following list of drugs: where a bDMARD treatment cycle is a period of treatment with successive bDMARDs which commences when an eligible patient (one who has not received PBS-subsidised treatment with a bDMARD for rheumatoid arthritis in at least the previous 5 years) receives an initial course of PBS-subsidised therapy with 1 bDMARD, and which continues until the patient has tried, and either failed or ceased to respond to, PBS-subsidised treatment with a maximum of 3 bDMARDs, at which point the patient is no longer eligible for treatment and the period of treatment ceases; and where the following conditions apply: the patient receives concomitant treatment with methotrexate at a dose of at least 7.5 mg weekly; patients who commenced PBS-subsidised bDMARD treatment prior to 1 December 2004 are deemed to have commenced their first bDMARD treatment cycle with that therapy and any PBS-subsidised treatment received prior to 1 December 2004 is deemed to be treatment received as part of the patient's first bDMARD treatment cycle; if this treatment cycle is the patient's first bDMARD treatment cycle and the patient has failed to demonstrate a response to PBS-subsidised treatment with adalimumab, etanercept and infliximab commenced prior to 1 December 2004, the patient is eligible to continue PBS-subsidised therapy with anakinra in this first treatment cycle, despite having previously failed to respond to 3 bDMARDs; | |
an adequate response to treatment is defined as an erythrocyte sedimentation rate no greater than 25 mm per hour or a C-reactive protein level no greater than 15 mg per L or either marker reduced by at least 20% from baseline, and either a reduction in the total active (swollen and tender) joint count by at least 50% from baseline, where baseline is at least 20 active joints, or a reduction in the number of the following major joints which are active, from at least 4, by at least 50%: — elbow, wrist, knee or ankle (assessed as active if swollen and tender); or — shoulder or hip (assessed as active if there is pain in passive movement and restriction of passive movement, and where pain and limitation of movement are due to active disease and not irreversible damage such as joint destruction or bony overgrowth); the same indices of disease severity used to establish baseline at the commencement of treatment are used to determine response; the authority application includes a completed copy of the appropriate PBS Authority Application - Supporting Information Form, and a measurement of response to the most recent prior course of therapy with anakinra, where response is assessed, and this assessment is provided to the Medicare Australia CEO, no later than 4 weeks from the cessation of that treatment course; if the most recent course of anakinra therapy was an initial 16 week course, the application for continuing treatment is accompanied by an assessment of response to a minimum of 12 weeks of treatment with that course; a course of treatment is limited to a maximum of 24 weeks of treatment In compliance with authority procedures set out in subsubparagraph 14 (d)(i) or 14(d)(ii): Continuing treatment within an ongoing bDMARD treatment cycle, by a rheumatologist or by a clinical immunologist with expertise in the management of rheumatoid arthritis, of adults with severe active rheumatoid arthritis who are receiving concomitant treatment with methotrexate at a dose of at least 7.5 mg weekly and who have previously been issued with an authority prescription for continuing treatment with this drug for a period of less than 24 weeks, and where approval of the application would enable the patient to complete a course of 24 weeks of treatment in total; and where 'bDMARD' and 'bDMARD treatment cycle' have the meaning given above | |
Anastrozole | Treatment of hormone-dependent breast cancer in post- menopausal women |
Apraclonidine Hydrochloride | Short-term reduction of intra-ocular pressure in patients already on maximally tolerated anti-glaucoma therapy |
Aprepitant | In compliance with authority procedures set out in subparagraph 14 (d): |
Management of nausea and vomiting associated with cytotoxic chemotherapy being used to treat malignancy, when aprepitant is used in combination with a 5-hydroxytryptamine type 3 receptor antagonist and dexamethasone, where treatment with aprepitant is limited to an initial dose of 125 mg and 2 subsequent doses of 80 mg per cycle of cytotoxic chemotherapy, and where the cytotoxic chemotherapy to be administered to the patient includes any of the following agents: | |
Aripiprazole | In compliance with authority procedures set out in subparagraph 14 (d): |
Schizophrenia | |
Aspirin | — |
Atenolol | — |
Atorvastatin Calcium | For use in accordance with paragraph 16 |
Atovaquone | In compliance with authority procedures set out in subparagraph 14 (d): |
Treatment of mild to moderate Pneumocystis carinii pneumonia in adult patients who are intolerant of trimethoprim with sulfamethoxazole therapy | |
Atropine Sulfate | — |
Auranofin | — |
Azathioprine | — |
Azithromycin Dihydrate | Uncomplicated urethritis due to Chlamydia trachomatis |
Uncomplicated cervicitis due to Chlamydia trachomatis | |
Trachoma | |
Azithromycin Dihydrate with Water - Purified BP | Trachoma |
Baclofen | — |
Balsalazide Sodium | In compliance with authority procedures set out in subparagraph 14 (d): |
Mild to moderate ulcerative colitis where hypersensitivity to sulfonamides exists | |
Mild to moderate ulcerative colitis where intolerance to sulfasalazine exists | |
\"BCG Immunotherapeutic\" (Bacillus Calmette-Guérin/ Connaught strain) | Treatment of carcinoma in situ of the urinary bladder |
\"BCG-Tice\" (Bacillus Calmette-Guérin/ Tice strain) | Primary and relapsing superficial urothelial carcinoma of the bladder |
Beclomethasone Dipropionate | In respect of the pressurised inhalation 50 micrograms per dose, 200 doses (CFC-free formulation) and pressurised inhalation 100 micrograms per dose, 200 doses (CFC-free formulation): |
— | |
In respect of the pressurised inhalation in breath actuated device 50 micrograms per dose, 200 doses (CFC-free formulation) and pressurised inhalation in breath actuated device 100 micrograms per dose, 200 doses (CFC-free formulation): | |
Patients unable to achieve co-ordinated use of other metered dose inhalers containing this drug | |
Benzathine Penicillin | — |
Benzhexol Hydrochloride | — |
Benztropine Mesylate | — |
Benzydamine Hydrochloride | Radiation induced mucositis |
Benzyl Benzoate | — |
Benzylpenicillin Sodium | — |
Betamethasone Acetate with Betamethasone Sodium Phosphate | Alopecia areata For local intra-articular or peri-articular infiltration |
Granulomata, dermal | |
Keloid | |
Lichen planus hypertrophic | |
Lichen simplex chronicus | |
Lupus erythematosus, chronic discoid | |
Necrobiosis lipoidica | |
Uveitis | |
Betamethasone Dipropionate | Treatment of corticosteroid-responsive dermatoses |
Betamethasone Valerate | Treatment of corticosteroid-responsive dermatoses |
Betaxolol Hydrochloride | — |
Bethanechol Chloride | — |
Bicalutamide | In compliance with authority procedures set out in subparagraph 14 (d): |
Metastatic (equivalent to stage D) prostatic carcinoma, when used in combination with gonadotrophin-releasing hormone (luteinising hormone-releasing hormone) agonist therapy | |
Bimatoprost | — |
Biperiden Hydrochloride | — |
Bisacodyl | Paraplegic and quadriplegic patients and others with severe neurogenic impairment of bowel function |
Patients who are receiving long-term nursing care on account of age, infirmity or other condition in hospitals, nursing homes or residential facilities | |
For use by a patient who is receiving long-term nursing care and in respect of whom a Carer Allowance is payable as a disabled adult | |
Patients receiving palliative care | |
Terminal malignant neoplasia | |
Anorectal congenital abnormalities | |
Megacolon | |
Bisoprolol Fumarate | In compliance with authority procedures set out in subparagraph 14 (d): |
Moderate to severe heart failure in patients stabilised on conventional therapy which must include an angiotensin-converting enzyme inhibitor if tolerated | |
Bivalirudin Trifluoroacetate | In compliance with authority procedures set out in subparagraph 14 (d): |
Patients undergoing non-emergency percutaneous coronary intervention | |
Bleomycin Sulfate | Germ cell neoplasms |
Lymphoma | |
Brimonidine Tartrate | — |
Brimonidine Tartrate with Timolol Maleate | Reduction of elevated intra-ocular pressure in patients with open-angle glaucoma who are not adequately controlled with timolol maleate eye drops equivalent to 5 mg timolol per mL |
Reduction of elevated intra-ocular pressure in patients with ocular hypertension who are not adequately controlled with timolol maleate eye drops equivalent to 5 mg timolol per mL | |
Brinzolamide | — |
Bromocriptine Mesylate | In respect of the tablet equivalent to 2.5 mg bromocriptine: |
Prevention of the onset of lactation in the puerperium for medical reasons | |
Acromegaly | |
Parkinson's disease | |
Pathological hyperprolactinaemia where surgery is not indicated | |
Pathological hyperprolactinaemia where surgery has already been used with incomplete resolution | |
Pathological hyperprolactinaemia where radiotherapy is not indicated | |
Pathological hyperprolactinaemia where radiotherapy has already been used with incomplete resolution | |
In respect of the capsule equivalent to 5 mg bromocriptine and capsule equivalent to 10 mg bromocriptine: | |
Acromegaly | |
Parkinson's disease | |
Pathological hyperprolactinaemia where surgery is not indicated | |
Pathological hyperprolactinaemia where surgery has already been used with incomplete resolution | |
Pathological hyperprolactinaemia where radiotherapy is not indicated | |
Pathological hyperprolactinaemia where radiotherapy has already been used with incomplete resolution | |
Budesonide | In respect of the powder for oral inhalation in breath actuated device 100 micrograms per dose, 200 doses, powder for oral inhalation in breath actuated device 200 micrograms per dose, 200 doses and powder for oral inhalation in breath actuated device 400 micrograms per dose, 200 doses: |
— | |
In respect of the nebuliser suspension 500 micrograms in 2 mL single dose units, 30 and nebuliser suspension 1 mg in 2 mL single dose units, 30: | |
In compliance with authority procedures set out in subparagraph 14 (d): | |
Severe chronic asthma in patients who require long-term steroid therapy and who are unable to use other forms of inhaled steroid therapy | |
Budesonide with Eformoterol Fumarate Dihydrate | Patients who previously had frequent episodes of asthma while receiving treatment with oral corticosteroids and who have been stabilised on concomitant inhaled eformoterol fumarate dihydrate and budesonide |
Patients who previously had frequent episodes of asthma while receiving treatment with optimal doses of inhaled corticosteroids and who have been stabilised on concomitant inhaled eformoterol fumarate dihydrate and budesonide | |
Buprenorphine | Chronic severe disabling pain not responding to non-narcotic analgesics |
Bupropion Hydrochloride | In compliance with authority procedures set out in subparagraph 14 (d): |
Commencement of treatment as short-term adjunctive therapy for nicotine dependence to facilitate the goal of achieving abstinence in patients who have indicated that they are ready to cease smoking and who have entered a comprehensive support and counselling program, and where details of the program are specified in the authority application | |
Commencement of treatment as short-term adjunctive therapy for nicotine dependence to facilitate the goal of achieving abstinence in patients who have indicated that they are ready to cease smoking and who are entering a comprehensive support and counselling program during the same consultation at which the authority application is made, and where details of the program are specified in the authority application | |
Completion of treatment as short-term adjunctive therapy for nicotine dependence to facilitate the goal of achieving abstinence in patients who have indicated that they are ready to cease smoking and who have entered a comprehensive support and counselling program, and where the patient has previously been issued with an authority prescription for commencement of treatment with this drug | |
Busulfan | — |
Cabergoline | In respect of the tablet 500 micrograms: |
Prevention of the onset of lactation in the puerperium for medical reasons | |
In compliance with authority procedures set out in subparagraph 14 (d): | |
Pathological hyperprolactinaemia where surgery is not indicated | |
Pathological hyperprolactinaemia where surgery has already been used with incomplete resolution | |
Pathological hyperprolactinaemia where radiotherapy is not indicated | |
Pathological hyperprolactinaemia where radiotherapy has already been used with incomplete resolution | |
In respect of the tablet 1 mg, tablet 2 mg and tablet 4 mg: | |
Parkinson's disease | |
Calcipotriol | Chronic stable plaque type psoriasis vulgaris |
Calcitriol | In compliance with authority procedures set out in subparagraph 14 (d): |
Hypocalcaemia due to renal disease | |
Hypoparathyroidism | |
Hypophosphataemic rickets | |
Vitamin D-resistant rickets | |
Initial treatment for established osteoporosis in patients with fracture due to minimal trauma, where the fracture has been demonstrated radiologically and the year of plain x-ray or computed tomography scan or magnetic resonance imaging scan is included in the authority application, provided that if the fracture is a vertebral fracture, there is a 20% or greater reduction in height of the anterior or mid portion of the affected vertebral body relative to the posterior height of that body, or, a 20% or greater reduction in any of these heights compared to the vertebral body above or below the affected vertebral body | |
Continuing treatment for established osteoporosis in patients with fracture due to minimal trauma, where the patient has previously been issued with an authority prescription for this drug | |
Calcium Carbonate | In compliance with authority procedures set out in subparagraph 14 (d): |
Hyperphosphataemia associated with chronic renal failure | |
Calcium Citrate | In compliance with authority procedures set out in subparagraph 14 (d): |
Hyperphosphataemia associated with chronic renal failure | |
Calcium Folinate | In respect of the injection equivalent to 50 mg folinic acid in 5 mL and injection equivalent to 100 mg folinic acid in 10 mL: |
— | |
In respect of the tablet equivalent to 15 mg folinic acid: | |
Antidote to folic acid antagonists | |
Candesartan Cilexetil | — |
Candesartan Cilexetil with Hydrochlorothiazide | Hypertension in patients who are not adequately controlled with 16 mg candesartan cilexetil |
Capecitabine | In compliance with authority procedures set out in subparagraph 14 (d): |
Advanced breast cancer after failure of prior therapy which includes a taxane and an anthracycline | |
Advanced breast cancer where therapy with a taxane or an anthracycline is contraindicated | |
Advanced breast cancer in combination with docetaxel after failure of prior anthracycline-containing chemotherapy | |
Treatment of advanced or metastatic colorectal cancer | |
\"Caprilon\" | Chylous ascites |
Chylothorax | |
Fat malabsorption due to liver disease, short gut syndrome, cystic fibrosis or gastrointestinal disorders | |
Captopril | In respect of the tablet 12.5 mg, tablet 25 mg and tablet 50 mg: |
— | |
In respect of the oral solution 5 mg per mL, 95 mL: | |
For patients unable to take a solid dose form of an angiotensin-converting enzyme inhibitor | |
Carbachol | — |
Carbamazepine | — |
Carbimazole | — |
\"Carbohydrate Free Mixture\" | Patients with intractable seizures requiring treatment with a ketogenic diet |
Glucose transport protein defects | |
Pyruvate dehydrogenase deficiency | |
Infants and young children with glucose-galactose intolerance and multiple monosaccharide intolerance | |
Carbomer 974 | In compliance with authority procedures set out in subparagraph 14 (d): |
Severe dry eye syndrome in patients who are sensitive to preservatives in multi-dose eye drops | |
Carbomer 980 | In respect of the ocular lubricating gel 2 mg per g, 10 g: |
Severe dry eye syndrome, including Sjogren's syndrome | |
In respect of the eye drops 2 mg per g, single dose units 0.6 mL, 30: | |
In compliance with authority procedures set out in subparagraph 14 (d): | |
Severe dry eye syndrome in patients who are sensitive to preservatives in multi-dose eye drops | |
Carboplatin | — |
Carmellose Sodium | In respect of the eye drops 5 mg per mL, 15 mL and eye drops 10 mg per mL, 15 mL: |
Severe dry eye syndrome, including Sjogren's syndrome | |
In respect of the eye drops 2.5 mg per mL, single dose units 0.6 mL, 24, eye drops 5 mg per mL, single dose units 0.4 mL, 30, eye drops 10 mg per mL, single dose units 0.4 mL, 30 and ocular lubricating gel 10 mg per mL, single dose units 0.6 mL, 28: | |
In compliance with authority procedures set out in subparagraph 14 (d): | |
Severe dry eye syndrome in patients who are sensitive to preservatives in multi-dose eye drops | |
Carvedilol | In respect of the pack containing 30 tablets 3.125 mg, 30 tablets 6.25 mg and 10 tablets 12.5 mg: |
In compliance with authority procedures set out in subparagraph 14 (d): | |
Moderate to severe heart failure in patients stabilised on conventional therapy which must include an angiotensin-converting enzyme inhibitor if tolerated | |
In respect of the tablet 3.125 mg, tablet 6.25 mg, tablet 12.5 mg and tablet 25 mg: | |
In compliance with authority procedures set out in subparagraph 14 (d): | |
Moderate to severe heart failure in patients stabilised on conventional therapy which must include an angiotensin-converting enzyme inhibitor if tolerated | |
Patients receiving this drug as a pharmaceutical benefit prior to 1 August 2002 | |
Cefaclor Monohydrate | — |
Cefaclor Monohydrate with Water - Purified BP | — |
Cefepime Hydrochloride | In compliance with authority procedures set out in subparagraph 14 (d): |
Treatment of febrile neutropenia | |
Cefotaxime Sodium | Infections where positive bacteriological evidence confirms that this antibiotic is an appropriate therapeutic agent |
Septicaemia, suspected | |
Septicaemia, proven | |
Ceftriaxone Sodium | In respect of the powder for injection equivalent to 250 mg ceftriaxone: |
Gonorrhoea | |
Infections where positive bacteriological evidence confirms that this antibiotic is an appropriate therapeutic agent | |
Septicaemia, suspected | |
Septicaemia, proven | |
In respect of the powder for injection equivalent to 500 mg ceftriaxone, powder for injection equivalent to 1 g ceftriaxone and powder for injection equivalent to 2 g ceftriaxone: | |
Infections where positive bacteriological evidence confirms that this antibiotic is an appropriate therapeutic agent | |
Septicaemia, suspected | |
Septicaemia, proven | |
Cefuroxime Axetil | — |
Celecoxib | Symptomatic treatment of osteoarthritis |
Symptomatic treatment of rheumatoid arthritis | |
Cephalexin | — |
Cephalexin with Water - Purified BP | — |
Cephalothin Sodium | — |
Cephazolin Sodium | Infections where positive bacteriological evidence confirms that this antibiotic is an appropriate therapeutic agent |
Septicaemia, suspected | |
Septicaemia, proven | |
Chlorambucil | — |
Chloramphenicol | — |
Chlorpromazine Hydrochloride | — |
Chlorthalidone | — |
Cholestyramine | — |
Chorionic Gonadotrophin | In respect of the injection set containing 3 ampoules powder for injection 500 units and 3 ampoules solvent 1 mL: |
Anovulatory infertility | |
For the treatment of infertility in males due to hypogonadotrophic hypogonadism | |
For the treatment of infertility in males associated with isolated luteinising hormone deficiency | |
For the treatment of males who have combined deficiency of human growth hormone and gonadotrophins and in whom the absence of secondary sexual characteristics indicates a lag in maturation | |
For the treatment, for a period not exceeding 6 months, of males over the age of 16 years who show clinical evidence of hypogonadism or delayed puberty | |
Cryptorchism not due to organic obstruction in boys over 12 months of age | |
In respect of the injection set containing 3 ampoules powder for injection 1,500 units and 3 ampoules solvent 1 mL: | |
Anovulatory infertility | |
For the treatment of infertility in males due to hypogonadotrophic hypogonadism | |
For the treatment of infertility in males associated with isolated luteinising hormone deficiency | |
For the treatment of males who have combined deficiency of human growth hormone and gonadotrophins and in whom the absence of secondary sexual characteristics indicates a lag in maturation | |
For the treatment, for a period not exceeding 6 months, of males over the age of 16 years who show clinical evidence of hypogonadism or delayed puberty | |
Ciclesonide | — |
Cimetidine | — |
Cimetidine Hydrochloride | — |
Ciprofloxacin Hydrochloride | In respect of the tablet equivalent to 250 mg ciprofloxacin: |
Gonorrhoea | |
In compliance with authority procedures set out in subparagraph 14 (d): | |
Respiratory tract infection proven or suspected to be caused by Pseudomonas aeruginosa in severely immunocompromised patients | |
Bacterial gastroenteritis in severely immunocompromised patients | |
Treatment of infections proven to be due to Pseudomonas aeruginosa or other gram-negative bacteria resistant to all other oral antimicrobials | |
Treatment of joint and bone infections, epididymo-orchitis, prostatitis or perichondritis of the pinna, suspected or proven to be caused by gram-negative bacteria or gram-positive bacteria resistant to all other appropriate antimicrobials | |
In respect of the tablet equivalent to 500 mg ciprofloxacin and tablet equivalent to 750 mg ciprofloxacin: | |
In compliance with authority procedures set out in subparagraph 14 (d): | |
Respiratory tract infection proven or suspected to be caused by Pseudomonas aeruginosa in severely immunocompromised patients | |
Bacterial gastroenteritis in severely immunocompromised patients | |
Treatment of infections proven to be due to Pseudomonas aeruginosa or other gram-negative bacteria resistant to all other oral antimicrobials | |
Treatment of joint and bone infections, epididymo-orchitis, prostatitis or perichondritis of the pinna, suspected or proven to be caused by gram-negative bacteria or gram-positive bacteria resistant to all other appropriate antimicrobials | |
In respect of the eye drops equivalent to 3 mg ciprofloxacin per mL, 5 mL: | |
In compliance with authority procedures set out in subparagraph 14 (d): | |
Bacterial keratitis | |
Cisplatin | — |
Citalopram Hydrobromide | Major depressive disorders |
Cladribine | In compliance with authority procedures set out in subparagraph 14 (d): |
Hairy cell leukaemia | |
Clarithromycin | — |
Clindamycin Hydrochloride | Gram-positive coccal infections where these cannot be safely and effectively treated with a penicillin |
Clomiphene Citrate | Anovulatory infertility |
Patients undergoing in-vitro fertilisation | |
Clomipramine Hydrochloride | Cataplexy associated with narcolepsy |
Obsessive-compulsive disorder | |
Phobic disorders in adults | |
Clonazepam | In respect of the injection 1 mg in 2 mL (set containing solution 1 mg in 1 mL and 1 mL diluent): |
Epilepsy | |
In respect of the tablet 500 micrograms, tablet 2 mg and oral liquid 2.5 mg per mL, 10 mL: | |
In compliance with authority procedures set out in subparagraph 14 (d): | |
Neurologically proven epilepsy | |
Clonidine Hydrochloride | — |
Clopidogrel Hydrogen Sulfate | In compliance with authority procedures set out in subparagraph 14 (d): |
Prevention of recurrence of ischaemic stroke or transient cerebral ischaemic events: | |
in patients with a history of symptomatic cerebrovascular ischaemic episodes while on therapy with low-dose aspirin | |
in patients where low-dose aspirin poses an unacceptable risk of gastrointestinal bleeding | |
in patients where there is a history of anaphylaxis, urticaria or asthma within 4 hours of ingestion of aspirin, other salicylates, or non-steroidal anti-inflammatory drugs | |
Prevention of recurrence of myocardial infarction or unstable angina: | |
in patients with a history of symptomatic cardiac ischaemic events while on therapy with low-dose aspirin | |
in patients where low-dose aspirin poses an unacceptable risk of gastrointestinal bleeding | |
in patients where there is a history of anaphylaxis, urticaria or asthma within 4 hours of ingestion of aspirin, other salicylates, or non-steroidal anti-inflammatory drugs | |
Coal Tar - Prepared | — |
Codeine Phosphate | — |
Codeine Phosphate with Paracetamol | — |
Colchicine | — |
Colestipol Hydrochloride | — |
Copper Sulfate | — |
Cortisone Acetate | — |
Cyclophosphamide | — |
Cyclosporin | In compliance with authority procedures set out in subparagraph 14 (d): |
Maintenance therapy, following initiation and stabilisation of treatment with cyclosporin, of patients with organ or tissue transplants, where therapy remains under the supervision and direction of the transplant unit reviewing the patient and where the name of the specialised transplant unit reviewing treatment and the date of the latest review at the specialised transplant unit are included in the authority application | |
Maintenance therapy, following initiation and stabilisation of treatment with cyclosporin, of patients with severe atopic dermatitis for whom other systemic therapies are ineffective or inappropriate, where therapy remains under the supervision and direction of a dermatologist, clinical immunologist or specialised unit reviewing the patient and where the name of the dermatologist, clinical immunologist or specialised unit reviewing treatment and the date of the latest review are included in the authority application | |
Maintenance therapy, following initiation and stabilisation of treatment with cyclosporin, of patients with severe psoriasis for whom other systemic therapies are ineffective or inappropriate and in whom the disease has caused significant interference with quality of life, where therapy remains under the supervision and direction of a dermatologist or specialised unit reviewing the patient and where the name of the dermatologist or specialised unit reviewing treatment and the date of the latest review are included in the authority application | |
Maintenance therapy, following initiation and stabilisation of treatment with cyclosporin, of patients with nephrotic syndrome in whom steroids and cytostatic drugs have failed or are not tolerated or are considered inappropriate and in whom renal function is unimpaired, where therapy remains under the supervision and direction of a nephrologist or specialised unit reviewing the patient and where the name of the nephrologist or specialised unit reviewing treatment and the date of the latest review are included in the authority application | |
Maintenance therapy, following initiation and stabilisation of treatment with cyclosporin, of patients with severe active rheumatoid arthritis for whom classical slow-acting anti-rheumatic agents (including methotrexate) are ineffective or inappropriate, where therapy remains under the supervision and direction of a rheumatologist, clinical immunologist or specialised unit reviewing the patient and where the name of the rheumatologist, clinical immunologist or specialised unit reviewing treatment and the date of the latest review are included in the authority application | |
Cyproheptadine Hydrochloride | Prevention of migraine |
Cyproterone Acetate | In respect of the tablet 50 mg: |
In compliance with authority procedures set out in subparagraph 14 (d): | |
Moderate to severe androgenisation, of which acne alone is not a sufficient indication, in non-pregnant women | |
Advanced carcinoma of the prostate | |
To reduce drive in sexual deviations in males | |
In respect of the tablet 100 mg: | |
In compliance with authority procedures set out in subparagraph 14 (d): | |
Advanced carcinoma of the prostate | |
To reduce drive in sexual deviations in males | |
Cytarabine | — |
Dalteparin Sodium | — |
Danazol | In compliance with authority procedures set out in subparagraph 14 (d): |
Endometriosis, visually proven | |
Hereditary angio-oedema | |
Treatment, for up to 6 months, of intractable primary menorrhagia | |
Treatment, for up to 6 months, of severe benign (fibrocystic) breast disease or mastalgia associated with severe symptomatic benign breast disease in patients refractory to other treatments | |
Dantrolene Sodium | Treatment of chronic spasticity |
Dapsone | — |
Desmopressin Acetate | In respect of the intranasal solution 100 micrograms per mL, 2.5 mL dropper bottle: |
In compliance with authority procedures set out in subparagraph 14 (d): | |
Cranial diabetes insipidus | |
In respect of the tablet 200 micrograms and nasal spray (pump pack) 10 micrograms per actuation, 60 actuations, 6 mL: | |
In compliance with authority procedures set out in subparagraph 14 (d): | |
Primary nocturnal enuresis: | |
in patients aged 6 years or older who are refractory to an enuresis alarm, where, if the application is for the tablet presentation of this drug, a period of 6 months or more has elapsed since an application was last approved for the issue of an authority prescription to the patient for the tablet presentation of this drug for this purpose | |
in patients aged 6 years or older for whom an enuresis alarm is contraindicated, where the reason for the contraindication is included in the authority application, and where, if the application is for the tablet presentation of this drug, a period of 6 months or more has elapsed since an application was last approved for the issue of an authority prescription to the patient for the tablet presentation of this drug for this purpose | |
Cranial diabetes insipidus | |
Dexamethasone | — |
Dexamethasone Sodium Metasulfobenzoate with Framycetin Sulfate and Gramicidin | — |
Dexamethasone Sodium Phosphate | — |
Dexamphetamine Sulfate | In compliance with authority procedures set out in subparagraph 14 (d): |
Use in attention deficit hyperactivity disorder, in accordance with State/Territory law | |
Narcolepsy | |
\"Dialamine\" | Gyrate atrophy of the choroid and retina |
Urea cycle disorders | |
Diazepam | — |
Diclofenac Sodium | In respect of the suppository 100 mg: |
— | |
In respect of the tablet 25 mg (enteric coated) and tablet 50 mg (enteric coated): | |
Chronic arthropathies (including osteoarthritis) with an inflammatory component | |
Bone pain due to malignant disease | |
In respect of the eye drops 1 mg per mL, 5 mL: | |
Inhibition of intraoperative miosis | |
Dicloxacillin Sodium | In respect of the powder for injection equivalent to 500 mg dicloxacillin and powder for injection equivalent to 1 g dicloxacillin: |
— | |
In respect of the capsule equivalent to 250 mg dicloxacillin and capsule equivalent to 500 mg dicloxacillin: | |
Serious staphylococcal infections | |
Diflunisal | Chronic arthropathies (including osteoarthritis) with an inflammatory component |
Bone pain due to malignant disease | |
\"Digestelact\" | In compliance with authority procedures set out in subparagraph 14 (d): |
Acute lactose intolerance in children aged 1 year and over, where the date of birth of the patient is included in the authority application and where the patient has not previously been issued with an authority prescription for this medicinal preparation for this purpose | |
Proven chronic lactose intolerance in children aged 1 year and over who are significantly malnourished, where the date of birth of the patient is included in the authority application, and where lactose intolerance has been proven either by the relief of symptoms on supervised withdrawal of lactose from the diet for 3 or 4 days and subsequent re-emergence of symptoms on rechallenge with lactose containing formulae or milk or food, or by the presence of not less than 0.5% reducing substance in stool exudate tested with copper sulfate diagnostic compound tablet | |
Digoxin | — |
Dihydroergotamine Mesylate | — |
Diltiazem Hydrochloride | — |
Diphenoxylate Hydrochloride with Atropine Sulfate | — |
Diphtheria and Tetanus Vaccine - Adsorbed | — |
Diphtheria and Tetanus Vaccine - Adsorbed (Diluted) | — |
Dipivefrine Hydrochloride | — |
Dipyridamole | Prevention of recurrence of ischaemic stroke or transient cerebral ischaemic events: |
in patients receiving therapy with low-dose aspirin | |
in patients where low-dose aspirin poses an unacceptable risk of gastrointestinal bleeding | |
in patients where there is a history of anaphylaxis, urticaria or asthma within 4 hours of ingestion of aspirin, other salicylates, or non-steroidal anti-inflammatory drugs | |
Dipyridamole with Aspirin | Prevention of recurrence of ischaemic stroke or transient cerebral ischaemic events |
Disodium Etidronate | In compliance with authority procedures set out in subparagraph 14 (d): |
Symptomatic Paget's disease of bone when salcatonin has been found to be unsatisfactory due to lack of efficacy | |
Symptomatic Paget's disease of bone when salcatonin has been found to be unsatisfactory due to unacceptable side effects | |
Heterotopic ossification | |
Disodium Etidronate and Calcium Carbonate | In compliance with authority procedures set out in subparagraph 14 (d): |
Initial treatment for established osteoporosis in patients with fracture due to minimal trauma, where the fracture has been demonstrated radiologically and the year of plain x-ray or computed tomography scan or magnetic resonance imaging scan is included in the authority application, provided that if the fracture is a vertebral fracture, there is a 20% or greater reduction in height of the anterior or mid portion of the affected vertebral body relative to the posterior height of that body, or, a 20% or greater reduction in any of these heights compared to the vertebral body above or below the affected vertebral body | |
Continuing treatment for established osteoporosis in patients with fracture due to minimal trauma, where the patient has previously been issued with an authority prescription for this drug | |
Disodium Pamidronate | In compliance with authority procedures set out in subparagraph 14 (d): |
Symptomatic Paget's disease of bone | |
Disopyramide | — |
Docetaxel | In compliance with authority procedures set out in subparagraph 14 (d): |
Advanced breast cancer after failure of prior therapy which includes an anthracycline | |
Advanced metastatic ovarian cancer after failure of prior therapy which includes a platinum compound | |
Locally advanced or metastatic non-small cell lung cancer | |
Docusate Sodium with Bisacodyl | Paraplegic and quadriplegic patients and others with severe neurogenic impairment of bowel function |
Patients who are receiving long-term nursing care on account of age, infirmity or other condition in hospitals, nursing homes or residential facilities | |
For use by a patient who is receiving long-term nursing care and in respect of whom a Carer Allowance is payable as a disabled adult | |
Patients receiving palliative care | |
Terminal malignant neoplasia | |
Anorectal congenital abnormalities | |
Megacolon | |
Dolasetron Mesylate | Management of nausea and vomiting associated with cytotoxic chemotherapy being used to treat malignancy |
Domperidone | — |
Donepezil Hydrochloride | In compliance with authority procedures set out in subparagraph 14 (d): |
Initial treatment, for up to 2 months, of mild to moderately severe Alzheimer's disease in patients with a baseline Mini-Mental State Examination score of 10 or more, where the diagnosis is confirmed by a specialist or consultant physician, and where the result of the baseline Mini-Mental State Examination and, if this result is at least 25 points, the result of the baseline Alzheimer's Disease Assessment Scale, cognitive sub-scale, are included in the authority application In compliance with authority procedures set out in subsubparagraph 14 (d)(i): Continuation of initial treatment of mild to moderately severe Alzheimer's disease in patients with a baseline Mini-Mental State Examination score of 10 or more, where the patient has previously been issued with an authority prescription for initial treatment with this drug for a period of up to 2 months, where the application confirms the information which established the patient's eligibility for initial treatment, and where approval of the application would enable the patient to complete a period of initial treatment of not more than 6 months of uninterrupted therapy Initial treatment, for up to 6 months, of mild to moderately severe Alzheimer's disease in patients with a baseline Mini-Mental State Examination score of 10 or more, where the diagnosis is confirmed by a specialist or consultant physician, and where the result of the baseline Mini-Mental State Examination and, if this result is at least 25 points, the result of the baseline Alzheimer's Disease Assessment Scale, cognitive sub-scale, are included in the authority application | |
Continuing treatment of mild to moderately severe Alzheimer's disease in patients with a baseline Mini-Mental State Examination score of 10 or more who demonstrate improvement in cognitive function following initial therapy, as measured by an increase of at least 2 points from baseline on the Mini-Mental State Examination, or a decrease of at least 4 points from baseline on the Alzheimer's Disease Assessment Scale, cognitive sub-scale, for patients with a Mini-Mental State Examination baseline score of at least 25 points, where the relevant result from the Mini-Mental State Examination or the Alzheimer's Disease Assessment Scale, cognitive sub-scale, is included in the authority application for continuing treatment In compliance with authority procedures set out in subparagraph 14 (d): Continuing treatment of mild to moderately severe Alzheimer's disease in patients with a baseline Mini-Mental State Examination score of 10 or more and with demonstrated improvement in cognitive function following initial therapy, where the patient has previously been issued with an authority prescription for continuing treatment | |
Initial treatment, for up to 2 months, of mild to moderately severe Alzheimer's disease in patients with a baseline Mini-Mental State Examination score of 9 or less, who are unable to register a score of 10 or more for reasons other than their Alzheimer's disease as they are from 1 or more of the following groups, where the diagnosis is confirmed by a specialist or consultant physician, and where the authority application includes the result of the baseline Mini-Mental State Examination and specifies to which of the groups the patient belongs: Unable to communicate adequately because of lack of competence in English, in people of non-English speaking background; Limited education, as defined by less than 6 years of education, or who are illiterate or innumerate; Aboriginal or Torres Strait Islanders who, by virtue of cultural factors, are unable to complete a Mini-Mental State Examination test; Intellectual (developmental or acquired) disability; Significant sensory impairment despite best correction, which precludes completion of a Mini-Mental State Examination test; Prominent dysphasia, out of proportion to other cognitive and functional impairment In compliance with authority procedures set out in subsubparagraph 14 (d)(i): Continuation of initial treatment of mild to moderately severe Alzheimer's disease in patients with a baseline Mini-Mental State Examination score of 9 or less, who are unable to register a score of 10 or more for reasons other than their Alzheimer's disease, where the patient has previously been issued with an authority prescription for initial treatment with this drug for a period of up to 2 months, where the application confirms the information which established the patient's eligibility for initial treatment, and where approval of the application would enable the patient to complete a period of initial treatment of not more than 6 months of uninterrupted therapy Initial treatment, for up to 6 months, of mild to moderately severe Alzheimer's disease in patients with a baseline Mini-Mental State Examination score of 9 or less, who are unable to register a score of 10 or more for reasons other than their Alzheimer's disease as they are from 1 or more of the following groups, where the diagnosis is confirmed by a specialist or consultant physician, and where the authority application includes the result of the baseline Mini-Mental State Examination and specifies to which of the groups the patient belongs: Unable to communicate adequately because of lack of competence in English, in people of non-English speaking background; Limited education, as defined by less than 6 years of education, or who are illiterate or innumerate; Aboriginal or Torres Strait Islanders who, by virtue of cultural factors, are unable to complete a Mini-Mental State Examination test; Intellectual (developmental or acquired) disability; Significant sensory impairment despite best correction, which precludes completion of a Mini-Mental State Examination test; Prominent dysphasia, out of proportion to other cognitive and functional impairment | |
Continuing treatment of mild to moderately severe Alzheimer's disease in eligible patients with a baseline Mini-Mental State Examination score of 9 or less who are unable to register a score of 10 or more for reasons other than their Alzheimer's disease and who demonstrate improvement in function following initial therapy, based on a rating of very much improved or much improved on the Clinicians Interview Based Impression of Change scale, as assessed by the same clinician who initiated treatment, and where the improvement rating achieved on the Clinicians Interview Based Impression of Change scale is stated in the authority application for continuing treatment In compliance with authority procedures set out in subparagraph 14 (d): Continuing treatment of mild to moderately severe Alzheimer's disease in eligible patients with a baseline Mini-Mental State Examination score of 9 or less and with demonstrated improvement in function following initial therapy, where the patient has previously been issued with an authority prescription for continuing treatment | |
Dorzolamide Hydrochloride | — |
Dorzolamide Hydrochloride with Timolol Maleate | Reduction of elevated intra-ocular pressure in patients with open-angle glaucoma who are not adequately controlled with timolol maleate eye drops equivalent to 5 mg timolol per mL |
Reduction of elevated intra-ocular pressure in patients with ocular hypertension who are not adequately controlled with timolol maleate eye drops equivalent to 5 mg timolol per mL | |
Dothiepin Hydrochloride | — |
Doxepin Hydrochloride | — |
Doxorubicin Hydrochloride | — |
Doxorubicin Hydrochloride - Pegylated | In compliance with authority procedures set out in subparagraph 14 (d): |
Liposomal | Advanced epithelial ovarian cancer in women who have failed a first-line platinum-based chemotherapy regimen |
Metastatic breast cancer, as monotherapy, after failure of prior therapy which includes capecitabine and a taxane | |
Metastatic breast cancer, as monotherapy, where therapy with capecitabine or a taxane is contraindicated | |
Doxycycline Hydrochloride | In respect of the tablet equivalent to 100 mg doxycycline and capsule equivalent to 100 mg doxycycline (containing enteric coated pellets): |
— | |
In respect of the tablet equivalent to 50 mg doxycycline and capsule equivalent to 50 mg doxycycline (containing enteric coated pellets): | |
Bronchiectasis in patients aged 8 years or older | |
Chronic bronchitis in patients aged 8 years or older | |
Severe acne | |
Doxycycline Monohydrate | In respect of the tablet equivalent to 100 mg doxycycline: |
— | |
In respect of the tablet equivalent to 50 mg doxycycline: | |
Bronchiectasis in patients aged 8 years or older | |
Chronic bronchitis in patients aged 8 years or older | |
Severe acne | |
Drotrecogin Alfa (Activated) | In compliance with authority procedures set out in subparagraph 14 (d): |
Adult patients with severe sepsis who have a high risk of death as determined by acute dysfunction in at least 2 organs or modified Acute Physiology and Chronic Health Evaluation II score of at least 25, where acute organ dysfunction is defined as follows: | |
\"Duocal\" | Patients with proven inborn errors of protein metabolism who are unable to meet their energy requirements with permitted food and formulae |
Dydrogesterone | — |
\"Easiphen\" | Phenylketonuria |
Eformoterol Fumarate Dihydrate | Patients with frequent episodes of asthma who are currently receiving treatment with oral corticosteroids |
Patients with frequent episodes of asthma who are currently receiving treatment with optimal doses of inhaled corticosteroids | |
\"EleCare\" | In compliance with authority procedures set out in subparagraph 14 (d): |
Initial treatment, for up to 3 months, for combined intolerance (not infant colic) to cows' milk protein, soy protein and protein hydrolysate formulae in children up to the age of 2 years, where combined intolerance is demonstrated when the child has failed to respond to a strict cows' milk protein free and strict soy protein free diet with a protein hydrolysate (with or without medium chain triglycerides) as the principal formula, and where the date of birth of the patient is included in the authority application | |
Continuing treatment for combined intolerance (not infant colic) to cows' milk protein, soy protein and protein hydrolysate formulae in children up to the age of 2 years, where the child has been assessed by a suitably qualified allergist or paediatrician, and where the date of birth of the patient is included in the authority application | |
Treatment for combined intolerance (not infant colic) to cows' milk protein, soy protein and protein hydrolysate formulae in children aged 2 years and over, where the child is assessed by a suitably qualified allergist or paediatrician at intervals not greater than 6 months, and where the date of birth of the patient is included in the authority application | |
Severe intestinal malabsorption including short bowel syndrome where protein hydrolysate formulae have failed | |
Severe intestinal malabsorption including short bowel syndrome where the patient has been receiving parenteral nutrition | |
Enalapril Maleate | — |
Enalapril Maleate with Hydrochlorothiazide | Hypertension in patients who are not adequately controlled with 20 mg enalapril maleate |
\"Energivit\" | Patients with proven inborn errors of protein metabolism who are unable to meet their energy requirements with permitted food and formulae |
Enoxaparin Sodium | — |
Entacapone | In compliance with authority procedures set out in subparagraph 14 (d): |
Parkinson's disease as adjunctive therapy in patients being treated with levodopa—decarboxylase inhibitor combinations who are experiencing fluctuations in motor function due to end-of-dose effect | |
Epirubicin Hydrochloride | — |
Eprosartan Mesylate | — |
Eprosartan Mesylate with Hydrochlorothiazide | Hypertension in patients who are not adequately controlled with either hydrochlorothiazide or eprosartan mesylate monotherapy |
Eptifibatide Acetate | In compliance with authority procedures set out in subparagraph 14 (d): |
Patients undergoing non-urgent percutaneous intervention with intracoronary stenting | |
Erythromycin | — |
Erythromycin Ethyl Succinate | — |
Erythromycin Ethyl Succinate with Water - Purified BP | — |
Erythromycin Lactobionate | — |
Escitalopram Oxalate | Major depressive disorders |
In compliance with authority procedures set out in subparagraph 14 (d): | |
Major depressive disorders, where adverse events have occurred with other suitable drugs available under the Pharmaceutical Benefits Scheme | |
Major depressive disorders, where drug interactions have occurred with other suitable drugs available under the Pharmaceutical Benefits Scheme | |
Major depressive disorders, where drug interactions are expected to occur with other suitable drugs available under the Pharmaceutical Benefits Scheme | |
Major depressive disorders, where transfer to another suitable drug available under the Pharmaceutical Benefits Scheme would cause patient confusion resulting in problems with compliance | |
Major depressive disorders, where transfer to another suitable drug available under the Pharmaceutical Benefits Scheme is likely to result in adverse clinical consequences | |
Esomeprazole Magnesium Trihydrate | In respect of the tablet (enteric coated), equivalent to 40 mg esomeprazole: |
Healing of gastro-oesophageal reflux disease | |
In respect of the tablet (enteric coated), equivalent to 20 mg esomeprazole: | |
Maintenance of healed gastro-oesophageal reflux disease | |
Esomeprazole Magnesium Trihydrate and Clarithromycin and Amoxycillin Trihydrate | Eradication of Helicobacter pylori associated with peptic ulcer disease |
Etanercept | In respect of the injection set containing 4 vials powder for injection 25 mg and 4 pre-filled syringes solvent 1 mL: |
In compliance with authority procedures set out in subsubparagraph 14 (d)(i): | |
Initial treatment commencing a treatment cycle, by a rheumatologist, of adults with active ankylosing spondylitis who have radiographically (plain X-ray) confirmed Grade II bilateral sacroiliitis or Grade III unilateral sacroiliitis, and: (a) who have not received any treatment with either etanercept or infliximab subsidised under the Pharmaceutical Benefits Scheme (PBS), or, where the patient has previously received PBS-subsidised treatment with either of these drugs, have not received PBS-subsidised treatment with etanercept or infliximab for this condition for a period of 5 years or more starting from the date the last course of PBS-subsidised treatment was approved; and (b) who, where the patient has received non-PBS-subsidised treatment with etanercept or infliximab, have not received non-PBS-subsidised treatment with etanercept prior to 1 July 2004; and (c) who have at least 2 of the following: (i) low back pain and stiffness for 3 or more months that is relieved by exercise but not by rest; or (ii) limitation of motion of the lumbar spine in the sagittal and the frontal planes as determined by a score of at least 1 on each of the lumbar flexion and lumbar side flexion measurements of the Bath Ankylosing Spondylitis Metrology Index (BASMI); or (iii) limitation of chest expansion relative to normal values for age and gender; and (d) who have documented confirmation of human leucocyte antigen B27 (HLA-B27) positive status; and (e) who have failed to achieve an adequate response following treatment with at least 2 non-steroidal anti-inflammatory drugs (NSAIDs), in combination with an appropriate exercise program, for a total period of at least 3 months, unless. (i) treatment with NSAIDs is contraindicated according to the relevant Therapeutic Goods Administration (TGA)-approved Product Information, in which case the patient is exempt from the NSAID component of the combined NSAID and exercise treatment regimen specified above; or (ii) adverse events of a severity necessitating permanent treatment withdrawal develop during the relevant period of use of 2 NSAIDs, in which case the patient may be exempted from the NSAID component of the combined NSAID and exercise treatment regimen specified above; or (iii) the patient is unable to complete the minimum exercise program, in which case the patient is exempt from completing the exercise component of the combined NSAID and exercise treatment regimen specified above; or (iv) the patient has had a break in PBS-subsidised therapy with etanercept and infliximab of at least 5 years duration, in which case the patient is required to demonstrate failure to achieve an adequate response to treatment with at least 1 NSAID, at an adequate dose, for a minimum of 3 consecutive months, instead of the combined NSAID and exercise regimen specified above; and (f) who have signed a patient acknowledgment form declaring that they understand and acknowledge that PBS-subsidised treatment with etanercept and with infliximab for ankylosing spondylitis will cease if they do not demonstrate the response to treatment required to support continuation of PBS-subsidised treatment at any assessment where a response must be demonstrated; and | |
where a treatment cycle is a period of treatment which commences when an eligible patient (one who has not received PBS-subsidised treatment with etanercept or with infliximab for ankylosing spondylitis in at least the previous 5 years) receives an initial course of PBS-subsidised therapy with either etanercept or infliximab, and which continues until the patient has tried and either failed, or ceased to respond to, PBS-subsidised courses of treatment with one or other drug up to 3 times (but with the same drug no more than twice), at which point the patient is no longer eligible for treatment with etanercept or infliximab for ankylosing spondylitis and the period of treatment ceases; and where the following conditions apply: failure to achieve an adequate response is demonstrated by: (a) a Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) score of at least 4 on a 0-10 scale, where the BASDAI score is determined at the completion of the 3 month NSAID and exercise trial, but prior to ceasing NSAID treatment, and is no more than 1 month old at the time of application; and (b) an elevated erythrocyte sedimentation rate (ESR) greater than 25 mm per hour or a C-reactive protein (CRP) level greater than 10 mg per L; both ESR and CRP measurements are included in the authority application and are no more than 1 month old; if the requirement to demonstrate an elevated ESR or CRP cannot be met, the authority application includes the reasons why this criterion cannot be satisfied; the authority application includes details of the NSAIDs trialled, their doses and duration of treatment; if the NSAID dose is less than the maximum recommended dose in the relevant Therapeutic Goods Administration (TGA)-approved Product Information, the authority application includes the reasons why a higher dose cannot be used; where the patient is exempted from the minimum 3 months of treatment with at least 2 NSAIDs because treatment with NSAIDs is contraindicated, the authority application includes evidence supporting the contraindication; an appropriate minimum exercise program includes stretch and range of motion exercises 5 times per week, and either aerobic exercise of at least 20 minutes duration at least 3 times per week or a group exercise class at least once per week; if a patient is unable to complete the minimum exercise program, the authority application includes the clinical reasons for this and details what, if any, exercise program has been followed; the application for authorisation includes: (a) a completed copy of the appropriate PBS Authority Application - Supporting Information Form which includes the following: (i) a copy of the radiological report confirming Grade II bilateral sacroiliitis or Grade III unilateral sacroiliitis; and (ii) a copy of the pathology report from an Approved Pathology Authority confirming the presence of HLA-B27; and (iii) a copy of the completed BASDAI Assessment Form; and (iv) a copy of the signed patient acknowledgment form; and (v) a copy of the exercise program self-certification form detailing the program followed and the dates over which it was followed; and (b) confirmation by the prescribing doctor that, to the best of their knowledge, the patient has followed the exercise program detailed in the self-certification form; a course of initial treatment commencing a treatment cycle is limited to a maximum of 6 weeks of treatment | |
In compliance with authority procedures set out in subsubparagraph 14 (d)(i): Initial treatment, or recommencement of treatment, with etanercept within an ongoing treatment cycle, by a rheumatologist, of adults with active ankylosing spondylitis who have radiographically (plain X-ray) confirmed Grade II bilateral sacroiliitis or Grade III unilateral sacroiliitis and who, in this treatment cycle, have received prior PBS-subsidised treatment with etanercept or with infliximab for this condition as 'new' patients and have not failed PBS-subsidised therapy with etanercept more than once; and where a treatment cycle is a period of treatment which commences when an eligible patient (one who has not received PBS-subsidised treatment with etanercept or with infliximab for ankylosing spondylitis in at least the previous 5 years) receives an initial course of PBS-subsidised therapy with either etanercept or infliximab, and which continues until the patient has tried and either failed, or ceased to respond to, PBS-subsidised courses of treatment with one or other drug up to 3 times (but with the same drug no more than twice), at which point the patient is no longer eligible for treatment with etanercept or infliximab for ankylosing spondylitis and the period of treatment ceases; and where a 'new' patient is one who was not 'grandfathered' onto PBS-subsidised treatment with either etanercept or infliximab; and where to be 'grandfathered' onto PBS-subsidised treatment with infliximab or with etanercept means to be commenced on PBS-subsidised treatment under the eligibility criteria specified for the initiation of PBS-subsidised treatment in patients who commenced non-PBS-subsidised treatment with infliximab prior to 1 March 2004 (where the patient is 'grandfathered' onto infliximab) or with etanercept prior to 1 July 2004 (where the patient is 'grandfathered' onto etanercept); and where the following conditions apply: patients who commenced PBS-subsidised treatment of ankylosing spondylitis with etanercept or infliximab prior to 1 August 2005 are deemed to have commenced their first treatment cycle with that therapy and any PBS-subsidised treatment with either drug received prior to 1 August 2005 is deemed to be treatment received as part of the patient's first treatment cycle; the authority application includes a completed copy of the appropriate PBS Authority Application - Supporting Information Form which includes a copy of the completed BASDAI Assessment Form; the application is accompanied by the results of the patient's most recent course of PBS-subsidised etanercept or infliximab therapy, where: (i) the response assessment is provided to the Medicare Australia CEO no later than 4 weeks from the date that course was ceased; and (ii) if the most recent course of PBS-subsidised treatment is a 6 week course, the patient is assessed for response to that course no earlier than 4 weeks from the commencement of that course; a course of initial treatment within an ongoing treatment cycle is limited to a maximum of 6 weeks of treatment | |
In compliance with authority procedures set out in subsubparagraph 14 (d)(i): Continuing treatment within an ongoing treatment cycle, by a rheumatologist, of adults with active ankylosing spondylitis who have received 6 weeks or more of treatment with etanercept subsidised under the Pharmaceutical Benefits Scheme (PBS) as 'new' patients, who have demonstrated a response to treatment with etanercept, and whose most recent course of PBS-subsidised therapy in this treatment cycle was with etanercept; and where a treatment cycle is a period of treatment which commences when an eligible patient (one who has not received PBS-subsidised treatment with etanercept or with infliximab for ankylosing spondylitis in at least the previous 5 years) receives an initial course of PBS-subsidised therapy with either etanercept or infliximab, and which continues until the patient has tried and either failed, or ceased to respond to, PBS-subsidised courses of treatment with one or other drug up to 3 times (but with the same drug no more than twice), at which point the patient is no longer eligible for treatment with etanercept or infliximab for ankylosing spondylitis and the period of treatment ceases; and where a 'new' patient is one who was not 'grandfathered' onto PBS-subsidised treatment with either etanercept or infliximab; and where to be 'grandfathered' onto PBS-subsidised treatment with infliximab or with etanercept means to be commenced on PBS-subsidised treatment under the eligiblity criteria specified for the initiation of PBS-subsidised treatment in patients who commenced non-PBS-subsidised treatment with infliximab prior to 1 March 2004 (where the patient is 'grandfathered' onto infliximab) or with etanercept prior to 1 July 2004 (where the patient is 'grandfathered' onto etanercept); and where the following conditions apply: patients who commenced PBS-subsidised treatment with etanercept or infliximab prior to 1 August 2005 are deemed to have commenced their first treatment cycle with that therapy and any PBS-subsidised treatment with either drug received prior to 1 August 2005 is deemed to be treatment received as part of the patient's first treatment cycle; response is defined as an improvement from baseline of at least 2 in the patient's Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) score and 1 of the following: (a) an erythrocyte sedimentation rate (ESR) measurement no greater than 25 mm per hour; or (b) a C-reactive protein (CRP) measurement no greater than 10 mg per L; or (c) an ESR or CRP measurement reduced by at least 20% from baseline; all measurements provided are no more than 1 month old at the time of application; the same acute phase reactant used to establish baseline at the commencement of an initial treatment course is measured for all subsequent continuing treatment applications for the patient; patients will be deemed to have failed to respond to treatment with a course of PBS-subsidised therapy, despite demonstrating a response as defined above, unless: (i) the response assessment is provided to the Medicare Australia CEO no later than 4 weeks from the date that course of treatment ceased; and (ii) if the course of therapy is a 6 week initial course, the assessment of response is made no earlier than 4 weeks from the commencement of that course; the application for authorisation includes a completed copy of the appropriate PBS Authority Application - Supporting Information Form which includes a copy of the completed BASDAI Assessment Form, including certification by the prescriber and the patient that the patient did not have access to their baseline BASDAI at the time of their continuing treatment assessment; a course of continuing treatment within an ongoing treatment cycle is limited to a maximum of 24 weeks of treatment | |
In compliance with authority procedures set out in subsubparagraph 14 (d)(i) or 14(d)(ii): Continuing treatment within an ongoing treatment cycle, by a rheumatologist, of adults with active ankylosing spondylitis who, qualifying under the criteria specified above, have previously been issued with an authority prescription for continuing treatment with etanercept as 'new' patients for a period of less than 24 weeks (other than a prescription for the first 4 weeks of continuing treatment immediately following an initial treatment course), and where approval of the application would enable the patient to complete a course of 24 weeks of treatment in total In compliance with authority procedures set out in subsubparagraph 14(d)(ii): Continuing treatment, for up to 4 weeks, within an ongoing treatment cycle, by a rheumatologist, of adults with active ankylosing spondylitis who have received 6 weeks of initial PBS-subsidised treatment with etanercept as 'new' patients immediately prior to this course of therapy and who, at the time of application, meet the criteria for continuing treatment with etanercept as specified above, and where a completed copy of the appropriate PBS Authority Application - Supporting Information Form (which includes a copy of the completed BASDAI Assessment Form) is submitted to the Medicare Australia CEO by facsimile | |
In compliance with authority procedures set out in subsubparagraph 14 (d)(i): Initial treatment, or recommencement of treatment, with etanercept within an ongoing treatment cycle, by a rheumatologist, of adults with active ankylosing spondylitis who have radiographically (plain X-ray) confirmed Grade II bilateral sacroiliitis or Grade III unilateral sacroiliitis, who were 'grandfathered' onto PBS-subsidised treatment with etanercept or infliximab and who have not failed PBS-subsidised therapy with etanercept more than once; and where a treatment cycle is a period of treatment which commences when an eligible patient (one who has not received PBS-subsidised treatment with etanercept or with infliximab for ankylosing spondylitis in at least the previous 5 years) receives an initial course of PBS-subsidised therapy with either etanercept or infliximab, and which continues until the patient has tried and either failed, or ceased to respond to, PBS-subsidised courses of treatment with one or other drug up to 3 times (but with the same drug no more than twice), at which point the patient is no longer eligible for treatment with etanercept or infliximab for ankylosing spondylitis and the period of treatment ceases; and where to be 'grandfathered' onto PBS-subsidised treatment with infliximab or with etanercept means to be commenced on PBS-subsidised treatment under the eligibility criteria specified for the initiation of PBS-subsidised treatment in patients who commenced non-PBS-subsidised treatment with infliximab prior to 1 March 2004 (where the patient is 'grandfathered' onto infliximab) or with etanercept prior to 1 July 2004 (where the patient is 'grandfathered' onto etanercept); and where the following conditions apply: patients who commenced PBS-subsidised treatment of ankylosing spondylitis with etanercept or infliximab prior to 1 August 2005 are deemed to have commenced their first treatment cycle with that therapy and any PBS-subsidised treatment with either drug received prior to 1 August 2005 is deemed to be treatment received as part of the patient's first treatment cycle; the authority application includes a completed copy of the appropriate PBS Authority Application - Supporting Information Form which includes a copy of the completed BASDAI Assessment Form; the application is accompanied by the results of the patient's most recent course of PBS-subsidised etanercept or infliximab therapy, where: (i) the response assessment is provided to the Medicare Australia CEO no later than 4 weeks from the date that course was ceased; and (ii) if the most recent course of PBS-subsidised treatment is a 6 week course, the patient is assessed for response to that course no earlier than 4 weeks from the commencement of that course; a course of initial treatment within an ongoing treatment cycle is limited to a maximum of 6 weeks of treatment | |
In compliance with authority procedures set out in subsubparagraph 14 (d)(i): Commencement of a treatment cycle with an initial PBS-subsidised course of etanercept for continuing treatment, by a rheumatologist, of adults with active ankylosing spondylitis who have radiographically (plain X-ray) confirmed Grade II bilateral sacroiliitis or Grade III unilateral sacroiliitis, who were receiving treatment with etanercept prior to 1 July 2004; and (a) who are receiving treatment with etanercept at the time of application; and (b) who have not received prior PBS-subsidised treatment with infliximab; and (c) who have documented confirmation of human leucocyte antigen B27 (HLA-B27) positive status; and (d) whose Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) score is less than or equal to 5 on a 0-10 scale; and (e) who have: (i) an erythrocyte sedimentation rate (ESR) measurement no greater than 25 mm per hour; or (ii) a C-reactive protein (CRP) measurement no greater than 10 mg per L; or (iii) an ESR or CRP measurement reduced by at least 20% from pre-treatment baseline; and (f) who have signed a patient acknowledgment form declaring that they understand and acknowledge that PBS-subsidised treatment with etanercept and with infliximab for ankylosing spondylitis will cease if they do not demonstrate the response to treatment required to support continuation of PBS-subsidised treatment at any assessment where a response must be demonstrated; and where a treatment cycle is a period of treatment which commences when an eligible patient (one who has not received PBS-subsidised treatment with etanercept or with infliximab for ankylosing spondylitis in at least the previous 5 years) receives an initial course of PBS-subsidised therapy with either etanercept or infliximab, and which continues until the patient has tried and either failed, or ceased to respond to, PBS-subsidised courses of treatment with one or other drug up to 3 times (but with the same drug no more than twice), at which point the patient is no longer eligible for treatment with etanercept or infliximab for ankylosing spondylitis and the period of treatment ceases; and where the following conditions apply: the BASDAI assessment and the ESR and CRP measurements are no more than 1 month old at the time of application; the application for authorisation includes a completed copy of the appropriate PBS Authority Application - Supporting Information Form which includes the following: (i) a copy of the radiological report confirming Grade II bilateral sacroiliitis or Grade III unilateral sacroiliitis; and (ii) a copy of the pathology report from an Approved Pathology Authority confirming the presence of HLA-B27; and (iii) a copy of the completed BASDAI Assessment Form; and (iv) a copy of the signed patient acknowledgment form; the course of treatment is limited to a maximum of 24 weeks of treatment; patients are eligible for PBS-subsidised treatment under the above criteria once only In compliance with authority procedures set out in subsubparagraph 14(d)(i) or 14(d)(ii): Continuation of a course of initial PBS-subsidised treatment commencing a treatment cycle, by a rheumatologist, of adults with active ankylosing spondylitis who were receiving non-PBS-subsidised treatment with etanercept prior to 1 July 2004 and at the time of the initial application for PBS-subsidised therapy and who, qualifying under the criteria specified above, have previously been issued with an authority prescription for initial PBS-subsidised treatment with etanercept for a period of less than 24 weeks, and where approval of the application would enable the patient to complete a course of 24 weeks of treatment in total | |
In compliance with authority procedures set out in subsubparagraph 14 (d)(i): Continuing PBS-subsidised treatment within an ongoing treatment cycle, by a rheumatologist, of adults with active ankylosing spondylitis who were 'grandfathered' onto PBS-subsidised treatment with etanercept or infliximab, who have received 6 weeks or more of PBS-subsidised treatment with etanercept, who have demonstrated a response to treatment with etanercept, and whose most recent course of PBS-subsidised therapy in this treatment cycle was with etanercept; and where a treatment cycle is a period of treatment which commences when an eligible patient (one who has not received PBS-subsidised treatment with etanercept or with infliximab for ankylosing spondylitis in at least the previous 5 years) receives an initial course of PBS-subsidised therapy with either etanercept or infliximab, and which continues until the patient has tried and either failed, or ceased to respond to, PBS-subsidised courses of treatment with one or other drug up to 3 times (but with the same drug no more than twice), at which point the patient is no longer eligible for treatment with etanercept or infliximab for ankylosing spondylitis and the period of treatment ceases; and where to be 'grandfathered' onto PBS-subsidised treatment with infliximab or with etanercept means to be commenced on PBS-subsidised treatment under the eligiblity criteria specified for the initiation of PBS-subsidised treatment in patients who commenced non-PBS-subsidised treatment with infliximab prior to 1 March 2004 (where the patient is 'grandfathered' onto infliximab) or with etanercept prior to 1 July 2004 (where the patient is 'grandfathered' onto etanercept); and where the following conditions apply: patients who commenced PBS-subsidised treatment with etanercept or infliximab prior to 1 August 2005 are deemed to have commenced their first treatment cycle with that therapy and any PBS-subsidised treatment with either drug received prior to 1 August 2005 is deemed to be treatment received as part of the patient's first treatment cycle; response to treatment is defined as a Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) score no more than 20% greater than the score included in the initial application for PBS-subsidised treatment, and: (a) an erythrocyte sedimentation rate (ESR) measurement no greater than 25 mm per hour; or (b) a C-reactive protein (CRP) measurement no greater than 10 mg per L; or (c) an ESR or CRP measurement reduced by at least 20% from pre-treatment baseline; all measurements provided are no more than 1 month old at the time of application; the same acute phase reactant used to establish baseline at the commencement of an initial treatment course is measured for all subsequent continuing treatment applications for the patient; patients will be deemed to have failed to respond to treatment with a course of PBS-subsidised therapy, despite demonstrating a response as defined above, unless: (i) the response assessment is provided to the Medicare Australia CEO no later than 4 weeks from the date that course of treatment ceased; and (ii) if the course of therapy is a 6 week initial course, the assessment of response is made no earlier than 4 weeks from the commencement of that course; the application for authorisation includes a completed copy of the appropriate PBS Authority Application - Supporting Information Form which includes a copy of the completed BASDAI Assessment Form including certification by the prescriber and the patient that the patient did not have access to their baseline BASDAI at the time of their continuing treatment assessment; a course of continuing treatment within an ongoing treatment cycle is limited to a maximum of 24 weeks of treatment | |
In compliance with authority procedures set out in subsubparagraph 14 (d)(i) or 14(d)(ii): Continuing treatment within an ongoing treatment cycle, by a rheumatologist, of adults with active ankylosing spondylitis who were 'grandfathered' onto PBS-subsidised treatment with etanercept or infliximab and who, qualifying under the criteria specified above, have previously been issued with an authority prescription for continuing PBS-subsidised treatment with etanercept for a period of less than 24 weeks (other than a prescription for the first 4 weeks of continuing treatment immediately following an initial treatment course), and where approval of the application would enable the patient to complete a course of 24 weeks of treatment in total In compliance with authority procedures set out in subsubparagraph 14(d)(ii): Continuing treatment, for up to 4 weeks, within an ongoing treatment cycle, by a rheumatologist, of adults with active ankylosing spondylitis who have received 6 weeks or more of initial PBS-subsidised treatment with etanercept as 'grandfathered' patients immediately prior to this course of therapy and who, at the time of application, meet the criteria for continuing treatment with etanercept as specified above, and where a completed copy of the appropriate PBS Authority Application - Supporting Information Form (which includes a copy of the completed BASDAI Assessment Form) is submitted to the Medicare Australia CEO by facsimile In compliance with authority procedures set out in subsubparagraph 14 (d)(i): Initial treatment in a biological disease modifying anti-rheumatic drug (bDMARD) treatment cycle, by a rheumatologist or by a clinical immunologist with expertise in the management of rheumatoid arthritis, of adults with severe active rheumatoid arthritis, and: (a) (i) who have not previously received treatment with a bDMARD for this condition subsidised under the Pharmaceutical Benefits Scheme (PBS); or (ii) who, where the patient has previously received PBS-subsidised bDMARD treatment, have received no PBS-subsidised treatment with a bDMARD for this condition for a period of 5 years or more starting from the date the last course of PBS-subsidised bDMARD therapy was approved; and (b) who have failed to achieve an adequate response to methotrexate at a dose of at least 20 mg weekly, have failed to achieve an adequate response to methotrexate (at a dose of at least 7.5 mg weekly) in combination with 2 other non-biological disease modifying anti-rheumatic drugs (DMARDs) for a minimum of 3 months, and have failed to achieve an adequate response following a minimum of 3 months' treatment with leflunomide alone or with leflunomide in combination with methotrexate or with cyclosporin alone, unless: (i) treatment with any of the above-mentioned drugs is contraindicated according to the relevant Therapeutic Goods Administration-approved Product Information, or intolerance of a severity necessitating permanent treatment withdrawal develops during the relevant period of use, in which case the patient is exempted from demonstrating an inadequate response to that particular agent (or agents) only; or (ii) the patient has had a break in PBS-subsidised bDMARD treatment of at least 5 years, in which case the patient is required to demonstrate failure to achieve an adequate response to treatment with at least 1 non-biological DMARD, at an adequate dose, for a minimum of 3 months; and (c) who have signed a patient acknowledgement form declaring that they understand and acknowledge that, within a single bDMARD treatment cycle, PBS-subsidised treatment with any bDMARD will cease if they do not demonstrate the response to treatment required to support continuation of PBS-subsidised treatment at any assessment where a response must be demonstrated; and | |
where bDMARD means a drug included in the following list of drugs: where a bDMARD treatment cycle is a period of treatment with successive bDMARDs which commences when an eligible patient (one who has not received PBS-subsidised treatment with a bDMARD for rheumatoid arthritis in at least the previous 5 years) receives an initial course of PBS-subsidised therapy with 1 bDMARD, and which continues until the patient has tried, and either failed or ceased to respond to, PBS-subsidised treatment with a maximum of 3 bDMARDs, at which point the patient is no longer eligible for treatment and the period of treatment ceases; and where the following conditions apply: failure to achieve an adequate response to the treatment regimens specified at (b) above is demonstrated by an elevated erythrocyte sedimentation rate (ESR) greater than 25 mm per hour or a C-reactive protein (CRP) level greater than 15 mg per L, and either a total active joint count of at least 20 active (swollen and tender) joints, or at least 4 active joints from the following list of major joints: — elbow, wrist, knee or ankle (assessed as active if swollen and tender); or — shoulder or hip (assessed as active if there is pain in passive movement and restriction of passive movement, and where pain and limitation of movement are due to active disease and not irreversible damage such as joint destruction or bony overgrowth); if the requirement to demonstrate an elevated ESR or CRP cannot be met, the authority application includes the reasons why this criterion cannot be satisfied; where the patient is exempted from demonstrating an inadequate response to a treatment regimen specified at (b) above on the basis of contraindication or intolerance, the authority application includes details of the contraindication or intolerance, including the degree of toxicity; the authority application includes a completed copy of the appropriate PBS Authority Application - Supporting Information Form which includes details of the patient's ESR and CRP measurements, and an assessment of the patient's active joint count, conducted no earlier than 1 month prior to the date of application, and a copy of the signed patient acknowledgment form; a course of treatment is limited to a maximum of 16 weeks of treatment In compliance with authority procedures set out in subsubparagraph 14 (d)(i) or 14(d)(ii): Continuation of initial treatment in a bDMARD treatment cycle, by a rheumatologist or by a clinical immunologist with expertise in the management of rheumatoid arthritis, of adults with severe active rheumatoid arthritis who have previously been issued with an authority prescription for initial treatment with this drug for a period of less than 16 weeks, and where approval of the application would enable the patient to complete a course of 16 weeks of treatment in total; and where 'bDMARD' and 'bDMARD treatment cycle' have the meaning given above | |
In compliance with authority procedures set out in subsubparagraph 14 (d)(i): Initial treatment or recommencement of treatment within an ongoing bDMARD treatment cycle, by a rheumatologist or by a clinical immunologist with expertise in the management of rheumatoid arthritis, of adults with severe active rheumatoid arthritis who have received prior PBS-subsidised treatment with a bDMARD for this condition in this bDMARD treatment cycle and who are eligible to receive further bDMARD therapy within this treatment cycle; and where bDMARD means a drug included in the following list of drugs: | |
where a bDMARD treatment cycle is a period of treatment with successive bDMARDs which commences when an eligible patient (one who has not received PBS-subsidised treatment with a bDMARD for rheumatoid arthritis in at least the previous 5 years) receives an initial course of PBS-subsidised therapy with 1 bDMARD, and which continues until the patient has tried, and either failed or ceased to respond to, PBS-subsidised treatment with a maximum of 3 bDMARDs, at which point the patient is no longer eligible for treatment and the period of treatment ceases; and where the following conditions apply: patients who commenced PBS-subsidised bDMARD treatment prior to 1 December 2004 are deemed to have commenced their first bDMARD treatment cycle with that therapy and any PBS-subsidised treatment received prior to 1 December 2004 is deemed to be treatment received as part of the patient's first bDMARD treatment cycle; patients are eligible to commence therapy with etanercept within this bDMARD treatment cycle provided they have not already tried, and either failed or ceased to respond to, PBS-subsidised treatment with 3 bDMARDs within this treatment cycle, and provided they also meet the conditions applying to recommencement of etanercept therapy specified below, if applicable; patients who have previously commenced, and subsequently ceased, PBS-subsidised treatment with etanercept within this bDMARD treatment cycle are eligible to recommence therapy with this drug within this same cycle if: (i) they have demonstrated an adequate response to their most recent course of PBS-subsidised etanercept treatment; and (ii) the response was assessed, and the assessment was provided to the Medicare Australia CEO, no later than 4 weeks from the date that course ceased; and (iii) the response was assessed following a minimum of 12 weeks of therapy when the most recent course of PBS-subsidised treatment was an initial 16 week course; and (iv) response to treatment was determined using the same indices of disease severity used to establish baseline at the commencement of treatment; an adequate response to treatment is defined as an erythrocyte sedimentation rate no greater than 25 mm per hour or a C-reactive protein level no greater than 15 mg per L or either marker reduced by at least 20% from baseline, and either a reduction in the total active (swollen and tender) joint count by at least 50% from baseline, where baseline is at least 20 active joints, or a reduction in the number of the following major joints which are active, from at least 4, by at least 50%: — elbow, wrist, knee or ankle (assessed as active if swollen and tender); or — shoulder or hip (assessed as active if there is pain in passive movement and restriction of passive movement, and where pain and limitation of movement are due to active disease and not irreversible damage such as joint destruction or bony overgrowth); the authority application includes a completed copy of the appropriate PBS Authority Application - Supporting Information Form and, where this is required, evidence of the patient's response to their most recent course of etanercept therapy; a course of treatment is limited to a maximum of 16 weeks of treatment In compliance with authority procedures set out in subsubparagraph 14 (d)(i) or 14(d)(ii): Continuation of initial treatment, or of a course which recommences treatment, within an ongoing bDMARD treatment cycle, by a rheumatologist or by a clinical immunologist with expertise in the management of rheumatoid arthritis, of adults with severe active rheumatoid arthritis who have previously been issued with an authority prescription for initial treatment or recommencement of treatment with this drug for a period of less than 16 weeks, and where approval of the application would enable the patient to complete a course of 16 weeks of treatment in total; and where 'bDMARD' and 'bDMARD treatment cycle' have the meaning given above | |
In compliance with authority procedures set out in subsubparagraph 14 (d)(i): Initial treatment, for up to 4 months, by a rheumatologist or by a clinical immunologist with expertise in the management of rheumatoid arthritis, of patients aged 18 years or older with a documented history of severe active polyarticular course juvenile chronic arthritis with onset prior to the age of 18 years, and who have signed a patient agreement form indicating that they understand and acknowledge that PBS-subsidised treatment will cease if their response to treatment as assessed against the predetermined response criteria does not support continuation of PBS-subsidised treatment; and where the patient has failed to achieve an adequate response to methotrexate at a dose of at least 20 mg weekly, has failed to achieve an adequate response to methotrexate in combination with 2 other disease modifying anti-rheumatic drugs for a minimum of 3 months, and has subsequently failed to achieve an adequate response following a minimum of 3 months' treatment with leflunomide alone or leflunomide in combination with methotrexate or cyclosporin alone, unless treatment with any of the above-mentioned drugs is contraindicated according to the relevant Therapeutic Goods Administration-approved Product Information, or intolerance of a severity necessitating permanent treatment withdrawal develops during the relevant period of use, in which case the patient is exempted from demonstrating an inadequate response to the above treatment regimens; and where the following conditions apply: failure to achieve an adequate response is demonstrated by an elevated erythrocyte sedimentation rate greater than 25 mm per hour or a C-reactive protein level greater than 15 mg per L, and either an active joint count of at least 20 active (swollen and tender) joints or at least 4 active joints from the following list: — elbow, wrist, knee or ankle (assessed as swollen and tender); — shoulder, cervical spine or hip (assessed as pain in passive movement and restriction of passive movement, where pain and limitation of movement are due to active disease and not irreversible damage such as joint destruction or bony overgrowth); if the requirement to demonstrate an elevated erythrocyte sedimentation rate or C-reactive protein level cannot be met, the authority application includes the reasons why this criterion cannot be satisfied; the authority application includes sufficient information to determine the patient's eligibility according to the above criteria and the date of joint assessment; where the patient is exempted from demonstrating an inadequate response to the treatment regimens specified above, the authority application includes details of the contraindication or intolerance, including the degree of toxicity In compliance with authority procedures set out in subsubparagraph 14 (d)(i) or 14(d)(ii): Initial treatment, by a rheumatologist or by a clinical immunologist with expertise in the management of rheumatoid arthritis, of patients aged 18 years or older with a documented history of severe active polyarticular course juvenile chronic arthritis with onset prior to the age of 18 years, who have previously been issued with an authority prescription for initial treatment with this drug for a period of less than 4 months, and where approval of the application would enable the patient to complete a period of initial treatment of not more than 4 months of uninterrupted therapy | |
In compliance with authority procedures set out in subsubparagraph 14 (d)(i): Commencement of etanercept treatment in a bDMARD treatment cycle with an initial supply subsidised under the Pharmaceutical Benefits Scheme (PBS) for continuing treatment, by a rheumatologist or by a clinical immunologist with expertise in the management of rheumatoid arthritis, of adults with severe active rheumatoid arthritis who were receiving treatment with etanercept prior to 1 March 2005, who failed to qualify for PBS-subsidised therapy after 1 August 2003 due to testing negative for rheumatoid factor, and who have demonstrated a response to etanercept treatment as specified in the criteria for continuing PBS-subsidised treatment with etanercept detailed below; and where bDMARD means a drug included in the following list of drugs: where a bDMARD treatment cycle is a period of treatment with successive bDMARDs which commences when an eligible patient (one who has not received PBS-subsidised treatment with a bDMARD for rheumatoid arthritis in at least the previous 5 years) receives an initial course of PBS-subsidised therapy with 1 bDMARD, and which continues until the patient has tried, and either failed or ceased to respond to, PBS-subsidised treatment with a maximum of 3 bDMARDs, at which point the patient is no longer eligible for treatment and the period of treatment ceases; and where the following conditions apply: the authority application includes sufficient information to determine the patient's eligibility for treatment and the date of assessment of the patient; the course of treatment is limited to a maximum of 24 weeks of treatment | |
Continuing treatment within an ongoing biological disease modifying anti-rheumatic drug (bDMARD) treatment cycle, by a rheumatologist or by a clinical immunologist with expertise in the management of rheumatoid arthritis, of adults with severe active rheumatoid arthritis, and: (a) who have demonstrated an adequate response to treatment with etanercept; and (b) whose most recent course of bDMARD treatment subsidised under the Pharmaceutical Benefits Scheme (PBS) in this bDMARD treatment cycle was with etanercept; and where bDMARD means a drug included in the following list of drugs: where a bDMARD treatment cycle is a period of treatment with successive bDMARDs which commences when an eligible patient (one who has not received PBS-subsidised treatment with a bDMARD for rheumatoid arthritis in at least the previous 5 years) receives an initial course of PBS-subsidised therapy with 1 bDMARD, and which continues until the patient has tried, and either failed or ceased to respond to, PBS-subsidised treatment with a maximum of 3 bDMARDs, at which point the patient is no longer eligible for treatment and the period of treatment ceases; and where the following conditions apply: patients who commenced PBS-subsidised bDMARD treatment prior to 1 December 2004 are deemed to have commenced their first bDMARD treatment cycle with that therapy and any PBS-subsidised treatment received prior to 1 December 2004 is deemed to be treatment received as part of the patient's first bDMARD treatment cycle; | |
an adequate response to treatment is defined as an erythrocyte sedimentation rate no greater than 25 mm per hour or a C-reactive protein level no greater than 15 mg per L or either marker reduced by at least 20% from baseline, and either a reduction in the total active (swollen and tender) joint count by at least 50% from baseline, where baseline is at least 20 active joints, or a reduction in the number of the following major joints which are active, from at least 4, by at least 50%: — elbow, wrist, knee or ankle (assessed as active if swollen and tender); or — shoulder or hip (assessed as active if there is pain in passive movement and restriction of passive movement, and where pain and limitation of movement are due to active disease and not irreversible damage such as joint destruction or bony overgrowth); the same indices of disease severity used to establish baseline at the commencement of treatment are used to determine response; the authority application includes a completed copy of the appropriate PBS Authority Application - Supporting Information Form, and a measurement of response to the most recent prior course of therapy with etanercept, where response is assessed, and this assessment is provided to the Medicare Australia CEO no later than 4 weeks from the cessation of that treatment course; if the most recent course of etanercept therapy was an initial 16 week course, the application for continuing treatment is accompanied by an assessment of response to a minimum of 12 weeks of treatment with that course; a course of treatment is limited to a maximum of 24 weeks of treatment In compliance with authority procedures set out in subsubparagraph 14 (d)(i) or 14(d)(ii): Continuing treatment within an ongoing bDMARD treatment cycle, by a rheumatologist or by a clinical immunologist with expertise in the management of rheumatoid arthritis, of adults with severe active rheumatoid arthritis who have previously been issued with an authority prescription for continuing treatment with this drug for a period of less than 24 weeks, and where approval of the application would enable the patient to complete a course of 24 weeks of treatment in total; and where 'bDMARD' and 'bDMARD treatment cycle' have the meaning given above | |
In compliance with authority procedures set out in subsubparagraph 14 (d)(i): Initial PBS-subsidised supply for continuing treatment, by a rheumatologist or by a clinical immunologist with expertise in the management of rheumatoid arthritis, of patients aged 18 years or older with a documented history of severe active polyarticular course juvenile chronic arthritis with onset prior to the age of 18 years, who were receiving treatment with etanercept prior to 1 December 2002, who have signed a patient agreement form indicating that they understand and acknowledge that PBS-subsidised treatment will cease if their response to treatment as assessed against predetermined response criteria does not support continuation of PBS-subsidised treatment, and who have demonstrated a response as specified in the criteria for continuing PBS-subsidised treatment with etanercept; and where the authority application includes sufficient information to determine the patient's eligibility for treatment and the date of assessment of the patient | |
Continuing PBS-subsidised treatment, by a rheumatologist or by a clinical immunologist with expertise in the management of rheumatoid arthritis, of patients aged 18 years or older with a documented history of severe active polyarticular course juvenile chronic arthritis with onset prior to the age of 18 years, who, at the time of application, demonstrate an adequate response to treatment with etanercept as manifested by an erythrocyte sedimentation rate no greater than 25 mm per hour or a C-reactive protein level no greater than 15 mg per L or either marker reduced by at least 20% from baseline, and an active joint count of fewer than 10 active (swollen and tender) joints or a reduction in the active (swollen and tender) joint count by at least 50% from baseline or a reduction in the number of the following active joints, from at least 4, by at least 50%: — elbow, wrist, knee or ankle (assessed as swollen and tender); — shoulder, cervical spine or hip (assessed as pain in passive movement and restriction of passive movement, where pain and limitation of movement are due to active disease and not irreversible damage such as joint destruction or bony overgrowth); and where the following conditions apply: the authority application includes sufficient information to determine the patient's response to treatment with etanercept according to the above criteria and the date of assessment of the patient; patients who have previously ceased treatment with etanercept due to failure to demonstrate an adequate response to treatment are not eligible to recommence treatment until a period of 12 months has elapsed since cessation of the previous treatment; authority applications for re-treatment with etanercept following a break in PBS-subsidised treatment with the drug include the reason for and date of cessation of the previous treatment course | |
In respect of the injection set containing 4 vials powder for injection 50 mg and 4 pre-filled syringes solvent 1 mL: | |
In compliance with authority procedures set out in subsubparagraph 14 (d)(i): Initial treatment in a biological disease modifying anti-rheumatic drug (bDMARD) treatment cycle, by a rheumatologist or by a clinical immunologist with expertise in the management of rheumatoid arthritis, of adults with severe active rheumatoid arthritis, and: (a) (i) who have not previously received treatment with a bDMARD for this condition subsidised under the Pharmaceutical Benefits Scheme (PBS); or (ii) who, where the patient has previously received PBS-subsidised bDMARD treatment, have received no PBS-subsidised treatment with a bDMARD for this condition for a period of 5 years or more starting from the date the last course of PBS-subsidised bDMARD therapy was approved; and (b) who have failed to achieve an adequate response to methotrexate at a dose of at least 20 mg weekly, have failed to achieve an adequate response to methotrexate (at a dose of at least 7.5 mg weekly) in combination with 2 other non-biological disease modifying anti-rheumatic drugs (DMARDs) for a minimum of 3 months, and have failed to achieve an adequate response following a minimum of 3 months' treatment with leflunomide alone or with leflunomide in combination with methotrexate or with cyclosporin alone, unless: | |
(i) treatment with any of the above-mentioned drugs is contraindicated according to the relevant Therapeutic Goods Administration-approved Product Information, or intolerance of a severity necessitating permanent treatment withdrawal develops during the relevant period of use, in which case the patient is exempted from demonstrating an inadequate response to that particular agent (or agents) only; or (ii) the patient has had a break in PBS-subsidised bDMARD treatment of at least 5 years, in which case the patient is required to demonstrate failure to achieve an adequate response to treatment with at least 1 non-biological DMARD, at an adequate dose, for a minimum of 3 months; and (c) who have signed a patient acknowledgement form declaring that they understand and acknowledge that, within a single bDMARD treatment cycle, PBS-subsidised treatment with any bDMARD will cease if they do not demonstrate the response to treatment required to support continuation of PBS-subsidised treatment at any assessment where a response must be demonstrated; and | |
where bDMARD means a drug included in the following list of drugs: where a bDMARD treatment cycle is a period of treatment with successive bDMARDs which commences when an eligible patient (one who has not received PBS-subsidised treatment with a bDMARD for rheumatoid arthritis in at least the previous 5 years) receives an initial course of PBS-subsidised therapy with 1 bDMARD, and which continues until the patient has tried, and either failed or ceased to respond to, PBS-subsidised treatment with a maximum of 3 bDMARDs, at which point the patient is no longer eligible for treatment and the period of treatment ceases; and where the following conditions apply: failure to achieve an adequate response to the treatment regimens specified at (b) above is demonstrated by an elevated erythrocyte sedimentation rate (ESR) greater than 25 mm per hour or a C-reactive protein (CRP) level greater than 15 mg per L, and either a total active joint count of at least 20 active (swollen and tender) joints, or at least 4 active joints from the following list of major joints: — elbow, wrist, knee or ankle (assessed as active if swollen and tender); or — shoulder or hip (assessed as active if there is pain in passive movement and restriction of passive movement, and where pain and limitation of movement are due to active disease and not irreversible damage such as joint destruction or bony overgrowth); if the requirement to demonstrate an elevated ESR or CRP cannot be met, the authority application includes the reasons why this criterion cannot be satisfied; | |
where the patient is exempted from demonstrating an inadequate response to a treatment regimen specified at (b) above on the basis of contraindication or intolerance, the authority application includes details of the contraindication or intolerance, including the degree of toxicity; the authority application includes a completed copy of the appropriate PBS Authority Application - Supporting Information Form which includes details of the patient's ESR and CRP measurements, and an assessment of the patient's active joint count, conducted no earlier than 1 month prior to the date of application, and a copy of the signed patient acknowledgment form; a course of treatment is limited to a maximum of 16 weeks of treatment In compliance with authority procedures set out in subsubparagraph 14(d)(i) or 14(d)(ii): Continuation of initial treatment in a bDMARD treatment cycle, by a rheumatologist or by a clinical immunologist with expertise in the management of rheumatoid arthritis, of adults with severe active rheumatoid arthritis who have previously been issued with an authority prescription for initial treatment with this drug for a period of less than 16 weeks, and where approval of the application would enable the patient to complete a course of 16 weeks of treatment in total; and where 'bDMARD' and 'bDMARD treatment cycle' have the meaning given above | |
In compliance with authority procedures set out in subsubparagraph 14 (d)(i): Initial treatment or recommencement of treatment within an ongoing bDMARD treatment cycle, by a rheumatologist or by a clinical immunologist with expertise in the management of rheumatoid arthritis, of adults with severe active rheumatoid arthritis who have received prior PBS-subsidised treatment with a bDMARD for this condition in this bDMARD treatment cycle and who are eligible to receive further bDMARD therapy within this treatment cycle; and where bDMARD means a drug included in the following list of drugs: | |
where a bDMARD treatment cycle is a period of treatment with successive bDMARDs which commences when an eligible patient (one who has not received PBS-subsidised treatment with a bDMARD for rheumatoid arthritis in at least the previous 5 years) receives an initial course of PBS-subsidised therapy with 1 bDMARD, and which continues until the patient has tried, and either failed or ceased to respond to, PBS-subsidised treatment with a maximum of 3 bDMARDs, at which point the patient is no longer eligible for treatment and the period of treatment ceases; and where the following conditions apply: patients who commenced PBS-subsidised bDMARD treatment prior to 1 December 2004 are deemed to have commenced their first bDMARD treatment cycle with that therapy and any PBS-subsidised treatment received prior to 1 December 2004 is deemed to be treatment received as part of the patient's first bDMARD treatment cycle; patients are eligible to commence therapy with etanercept within this bDMARD treatment cycle provided they have not already tried, and either failed or ceased to respond to, PBS-subsidised treatment with 3 bDMARDs within this treatment cycle, and provided they also meet the conditions applying to recommencement of etanercept therapy specified below, if applicable; | |
patients who have previously commenced, and subsequently ceased, PBS-subsidised treatment with etanercept within this bDMARD treatment cycle are eligible to recommence therapy with this drug within this same cycle if: (i) they have demonstrated an adequate response to their most recent course of PBS-subsidised etanercept treatment; and (ii) the response was assessed, and the assessment was provided to the Medicare Australia CEO, no later than 4 weeks from the date that course ceased; and (iii) the response was assessed following a minimum of 12 weeks of therapy when the most recent course of PBS-subsidised treatment was an initial 16 week course; and (iv) response to treatment was determined using the same indices of disease severity used to establish baseline at the commencement of treatment; | |
an adequate response to treatment is defined as an erythrocyte sedimentation rate no greater than 25 mm per hour or a C-reactive protein level no greater than 15 mg per L or either marker reduced by at least 20% from baseline, and either a reduction in the total active (swollen and tender) joint count by at least 50% from baseline, where baseline is at least 20 active joints, or a reduction in the number of the following major joints which are active, from at least 4, by at least 50%: — elbow, wrist, knee or ankle (assessed as active if swollen and tender); or — shoulder or hip (assessed as active if there is pain in passive movement and restriction of passive movement, and where pain and limitation of movement are due to active disease and not irreversible damage such as joint destruction or bony overgrowth); the authority application includes a completed copy of the appropriate PBS Authority Application - Supporting Information Form and, where this is required, evidence of the patient's response to their most recent course of etanercept therapy; a course of treatment is limited to a maximum of 16 weeks of treatment | |
In compliance with authority procedures set out in subsubparagraph 14 (d)(i) or 14(d)(ii): Continuation of initial treatment, or of a course which recommences treatment, within an ongoing bDMARD treatment cycle, by a rheumatologist or by a clinical immunologist with expertise in the management of rheumatoid arthritis, of adults with severe active rheumatoid arthritis who have previously been issued with an authority prescription for initial treatment or recommencement of treatment with this drug for a period of less than 16 weeks, and where approval of the application would enable the patient to complete a course of 16 weeks of treatment in total; and where 'bDMARD' and 'bDMARD treatment cycle' have the meaning given above | |
In compliance with authority procedures set out in subsubparagraph 14 (d)(i): Initial treatment, for up to 4 months, by a rheumatologist or by a clinical immunologist with expertise in the management of rheumatoid arthritis, of patients aged 18 years or older with a documented history of severe active polyarticular course juvenile chronic arthritis with onset prior to the age of 18 years, and who have signed a patient agreement form indicating that they understand and acknowledge that PBS-subsidised treatment will cease if their response to treatment as assessed against the predetermined response criteria does not support continuation of PBS-subsidised treatment; and where the patient has failed to achieve an adequate response to methotrexate at a dose of at least 20 mg weekly, has failed to achieve an adequate response to methotrexate in combination with 2 other disease modifying anti-rheumatic drugs for a minimum of 3 months, and has subsequently failed to achieve an adequate response following a minimum of 3 months' treatment with leflunomide alone or leflunomide in combination with methotrexate or cyclosporin alone, unless treatment with any of the above-mentioned drugs is contraindicated according to the relevant Therapeutic Goods Administration-approved Product Information, or intolerance of a severity necessitating permanent treatment withdrawal develops during the relevant period of use, in which case the patient is exempted from demonstrating an inadequate response to the above treatment regimens; and | |
where the following conditions apply: failure to achieve an adequate response is demonstrated by an elevated erythrocyte sedimentation rate greater than 25 mm per hour or a C-reactive protein level greater than 15 mg per L, and either an active joint count of at least 20 active (swollen and tender) joints or at least 4 active joints from the following list: — elbow, wrist, knee or ankle (assessed as swollen and tender); — shoulder, cervical spine or hip (assessed as pain in passive movement and restriction of passive movement, where pain and limitation of movement are due to active disease and not irreversible damage such as joint destruction or bony overgrowth); if the requirement to demonstrate an elevated erythrocyte sedimentation rate or C-reactive protein level cannot be met, the authority application includes the reasons why this criterion cannot be satisfied; the authority application includes sufficient information to determine the patient's eligibility according to the above criteria and the date of joint assessment; where the patient is exempted from demonstrating an inadequate response to the treatment regimens specified above, the authority application includes details of the contraindication or intolerance, including the degree of toxicity | |
In compliance with authority procedures set out in subsubparagraph 14 (d)(i) or 14(d)(ii): Initial treatment, by a rheumatologist or by a clinical immunologist with expertise in the management of rheumatoid arthritis, of patients aged 18 years or older with a documented history of severe active polyarticular course juvenile chronic arthritis with onset prior to the age of 18 years, who have previously been issued with an authority prescription for initial treatment with this drug for a period of less than 4 months, and where approval of the application would enable the patient to complete a period of initial treatment of not more than 4 months of uninterrupted therapy | |
In compliance with authority procedures set out in subsubparagraph 14 (d)(i): Commencement of etanercept treatment in a bDMARD treatment cycle with an initial supply subsidised under the Pharmaceutical Benefits Scheme (PBS) for continuing treatment, by a rheumatologist or by a clinical immunologist with expertise in the management of rheumatoid arthritis, of adults with severe active rheumatoid arthritis who were receiving treatment with etanercept prior to 1 March 2005, who failed to qualify for PBS-subsidised therapy after 1 August 2003 due to testing negative for rheumatoid factor, and who have demonstrated a response to etanercept treatment as specified in the criteria for continuing PBS-subsidised treatment with etanercept detailed below; and where bDMARD means a drug included in the following list of drugs: where a bDMARD treatment cycle is a period of treatment with successive bDMARDs which commences when an eligible patient (one who has not received PBS-subsidised treatment with a bDMARD for rheumatoid arthritis in at least the previous 5 years) receives an initial course of PBS-subsidised therapy with 1 bDMARD, and which continues until the patient has tried, and either failed or ceased to respond to, PBS-subsidised treatment with a maximum of 3 bDMARDs, at which point the patient is no longer eligible for treatment and the period of treatment ceases; and where the following conditions apply: the authority application includes sufficient information to determine the patient's eligibility for treatment and the date of assessment of the patient; the course of treatment is limited to a maximum of 24 weeks of treatment | |
Continuing treatment within an ongoing biological disease modifying anti-rheumatic drug (bDMARD) treatment cycle, by a rheumatologist or by a clinical immunologist with expertise in the management of rheumatoid arthritis, of adults with severe active rheumatoid arthritis, and: (a) who have demonstrated an adequate response to treatment with etanercept; and (b) whose most recent course of bDMARD treatment subsidised under the Pharmaceutical Benefits Scheme (PBS) in this bDMARD treatment cycle was with etanercept; and where bDMARD means a drug included in the following list of drugs: where a bDMARD treatment cycle is a period of treatment with successive bDMARDs which commences when an eligible patient (one who has not received PBS-subsidised treatment with a bDMARD for rheumatoid arthritis in at least the previous 5 years) receives an initial course of PBS-subsidised therapy with 1 bDMARD, and which continues until the patient has tried, and either failed or ceased to respond to, PBS-subsidised treatment with a maximum of 3 bDMARDs, at which point the patient is no longer eligible for treatment and the period of treatment ceases; and where the following conditions apply: patients who commenced PBS-subsidised bDMARD treatment prior to 1 December 2004 are deemed to have commenced their first bDMARD treatment cycle with that therapy and any PBS-subsidised treatment received prior to 1 December 2004 is deemed to be treatment received as part of the patient's first bDMARD treatment cycle; | |
an adequate response to treatment is defined as an erythrocyte sedimentation rate no greater than 25 mm per hour or a C-reactive protein level no greater than 15 mg per L or either marker reduced by at least 20% from baseline, and either a reduction in the total active (swollen and tender) joint count by at least 50% from baseline, where baseline is at least 20 active joints, or a reduction in the number of the following major joints which are active, from at least 4, by at least 50%: — elbow, wrist, knee or ankle (assessed as active if swollen and tender); or — shoulder or hip (assessed as active if there is pain in passive movement and restriction of passive movement, and where pain and limitation of movement are due to active disease and not irreversible damage such as joint destruction or bony overgrowth); the same indices of disease severity used to establish baseline at the commencement of treatment are used to determine response; the authority application includes a completed copy of the appropriate PBS Authority Application - Supporting Information Form, and a measurement of response to the most recent prior course of therapy with etanercept, where response is assessed, and this assessment is provided to the Medicare Australia CEO no later than 4 weeks from the cessation of that treatment course; if the most recent course of etanercept therapy was an initial 16 week course, the application for continuing treatment is accompanied by an assessment of response to a minimum of 12 weeks of treatment with that course; a course of treatment is limited to a maximum of 24 weeks of treatment In compliance with authority procedures set out in subsubparagraph 14 (d)(i) or 14(d)(ii): Continuing treatment within an ongoing bDMARD treatment cycle, by a rheumatologist or by a clinical immunologist with expertise in the management of rheumatoid arthritis, of adults with severe active rheumatoid arthritis who have previously been issued with an authority prescription for continuing treatment with this drug for a period of less than 24 weeks, and where approval of the application would enable the patient to complete a course of 24 weeks of treatment in total; and where 'bDMARD' and 'bDMARD treatment cycle' have the meaning given above | |
In compliance with authority procedures set out in subsubparagraph 14 (d)(i): Initial PBS-subsidised supply for continuing treatment, by a rheumatologist or by a clinical immunologist with expertise in the management of rheumatoid arthritis, of patients aged 18 years or older with a documented history of severe active polyarticular course juvenile chronic arthritis with onset prior to the age of 18 years, who were receiving treatment with etanercept prior to 1 December 2002, who have signed a patient agreement form indicating that they understand and acknowledge that PBS-subsidised treatment will cease if their response to treatment as assessed against predetermined response criteria does not support continuation of PBS-subsidised treatment, and who have demonstrated a response as specified in the criteria for continuing PBS-subsidised treatment with etanercept; and where the authority application includes sufficient information to determine the patient's eligibility for treatment and the date of assessment of the patient | |
Continuing PBS-subsidised treatment, by a rheumatologist or by a clinical immunologist with expertise in the management of rheumatoid arthritis, of patients aged 18 years or older with a documented history of severe active polyarticular course juvenile chronic arthritis with onset prior to the age of 18 years, who, at the time of application, demonstrate an adequate response to treatment with etanercept as manifested by an erythrocyte sedimentation rate no greater than 25 mm per hour or a C-reactive protein level no greater than 15 mg per L or either marker reduced by at least 20% from baseline, and an active joint count of fewer than 10 active (swollen and tender) joints or a reduction in the active (swollen and tender) joint count by at least 50% from baseline or a reduction in the number of the following active joints, from at least 4, by at least 50%: — elbow, wrist, knee or ankle (assessed as swollen and tender); — shoulder, cervical spine or hip (assessed as pain in passive movement and restriction of passive movement, where pain and limitation of movement are due to active disease and not irreversible damage such as joint destruction or bony overgrowth); and where the following conditions apply: the authority application includes sufficient information to determine the patient's response to treatment with etanercept according to the above criteria and the date of assessment of the patient; patients who have previously ceased treatment with etanercept due to failure to demonstrate an adequate response to treatment are not eligible to recommence treatment until a period of 12 months has elapsed since cessation of the previous treatment; authority applications for re-treatment with etanercept following a break in PBS-subsidised treatment with the drug include the reason for and date of cessation of the previous treatment course | |
Ethacrynic Acid | Patients hypersensitive to other oral diuretics |
Ethosuximide | — |
Etonogestrel | — |
Etoposide | — |
Etoposide Phosphate | — |
Everolimus | In compliance with authority procedures set out in subparagraph 14 (d): |
Maintenance therapy of patients with renal transplants following initiation and stabilisation of treatment with everolimus, where therapy remains under the supervision and direction of the transplant unit reviewing that patient and where the name of the specialised transplant unit reviewing treatment and the date of the latest review at the specialised transplant unit are included in the authority application | |
Maintenance therapy of patients with cardiac transplants following initiation and stabilisation of treatment with everolimus, where therapy remains under the supervision and direction of the transplant unit reviewing that patient and where the name of the specialised transplant unit reviewing treatment and the date of the latest review at the specialised transplant unit are included in the authority application | |
Exemestane | Treatment of hormone-dependent advanced breast cancer in post-menopausal women with disease progression following treatment with tamoxifen citrate |
Ezetimibe | In compliance with authority procedures set out in subparagraph 14 (d): |
For use in accordance with paragraph 16 in patients where treatment with an HMG CoA reductase inhibitor (statin) is contraindicated | |
For use in accordance with paragraph 16 in patients where treatment with an HMG CoA reductase inhibitor (statin) is unsuitable because the patient developed a clinically important product-related adverse event during treatment with a statin and required discontinuation of all statin treatment, and where a clinically important product-related adverse event is defined as follows: | |
Homozygous sitosterolaemia | |
Treatment of patients with homozygous familial hypercholesterolaemia whose cholesterol level, after dietary therapy, is greater than 6.5 mmol per L or greater than 5.5 mmol per L in patients with a high density lipoprotein level of less than 1 mmol per L, when used in combination with an HMG CoA reductase inhibitor (statin) | |
Initial treatment, when co-administered with an HMG CoA reductase inhibitor (statin), of patients with coronary heart disease whose cholesterol levels are inadequately controlled with a statin, where inadequate control with a statin is defined as a cholesterol level greater than 4 mmol per L after at least 3 months of treatment with a statin at a daily dose of 40 mg or greater, where the cholesterol level after 3 months of treatment with a statin and the dose of the statin are included in the authority application and where the cholesterol level results provided are no more than 1 month old at the time of application | |
Initial treatment, when co-administered with an HMG CoA reductase inhibitor (statin), of patients with diabetes mellitus whose cholesterol levels are inadequately controlled with a statin, where inadequate control with a statin is defined as a cholesterol level greater than 6.5 mmol per L (or greater than 5.5 mmol per L in patients with a high density lipoprotein level less than 1 mmol per L) after at least 3 months of treatment with a statin at a daily dose of 40 mg or greater, where the cholesterol level after 3 months of treatment with a statin and the dose of the statin are included in the authority application and where the cholesterol level results provided are no more than 1 month old at the time of application | |
Continuing treatment, when co-administered with an HMG CoA reductase inhibitor (statin), of patients with coronary heart disease or diabetes mellitus whose cholesterol levels were inadequately controlled with a statin, where the patient has previously been issued with an authority prescription for this drug | |
Famciclovir | In respect of the tablet 125 mg: |
In compliance with authority procedures set out in subparagraph 14 (d): | |
Episodic treatment of moderate to severe recurrent genital herpes, where the diagnosis is confirmed microbiologically (by viral culture, antigen detection or nucleic acid amplification by polymerase chain reaction) but where commencement of treatment need not await confirmation of diagnosis | |
In respect of the tablet 250 mg: | |
In compliance with authority procedures set out in subparagraph 14 (d): | |
Treatment of patients with herpes zoster within 72 hours of the onset of the rash | |
Suppressive therapy of moderate to severe recurrent genital herpes, where the diagnosis is confirmed microbiologically (by viral culture, antigen detection or nucleic acid amplification by polymerase chain reaction) but where commencement of treatment need not await confirmation of diagnosis | |
Famotidine | — |
Felodipine | — |
Fenofibrate | For use in accordance with paragraph 16 |
Fentanyl | Chronic severe disabling pain which is associated with proven malignant neoplasia and which is unresponsive to non-narcotic analgesics |
Ferrous Sulfate | — |
Flecainide Acetate | Serious supra-ventricular cardiac arrhythmias |
Serious ventricular cardiac arrhythmias where treatment is initiated in a hospital (in-patient or out-patient) | |
Flucloxacillin Magnesium with Water - Purified BP | Serious staphylococcal infections |
Flucloxacillin Sodium | In respect of the powder for injection equivalent to 500 mg flucloxacillin and powder for injection equivalent to 1 g flucloxacillin: |
— | |
In respect of the capsule equivalent to 250 mg flucloxacillin and capsule equivalent to 500 mg flucloxacillin: | |
Serious staphylococcal infections | |
Fluconazole | In compliance with authority procedures set out in subparagraph 14 (d): |
Treatment of cryptococcal meningitis in patients unable to take or tolerate amphotericin | |
Maintenance therapy in patients with cryptococcal meningitis and immunosuppression | |
Treatment of oropharyngeal candidiasis in immunosuppressed patients | |
Treatment of oesophageal candidiasis in immunosuppressed patients | |
Secondary prophylaxis of oropharyngeal candidiasis in immunosuppressed patients | |
Treatment of serious and life-threatening candida infections in patients unable to tolerate amphotericin | |
Fludrocortisone Acetate | — |
Fluorometholone | — |
Fluorometholone Acetate | — |
Fluorouracil Sodium | — |
Fluoxetine Hydrochloride | Major depressive disorders |
Obsessive-compulsive disorder | |
Flupenthixol Decanoate | — |
Fluphenazine Decanoate | — |
Flurbiprofen Sodium | — |
Flutamide | In compliance with authority procedures set out in subparagraph 14 (d): |
Metastatic (equivalent to stage D) prostatic carcinoma, when used in combination with gonadotrophin-releasing hormone (luteinising hormone-releasing hormone) agonist therapy | |
Fluticasone Propionate | — |
Fluticasone Propionate with Salmeterol Xinafoate | Patients who previously had frequent episodes of asthma while receiving treatment with oral corticosteroids and who have been stabilised on concomitant inhaled salmeterol xinafoate and fluticasone propionate |
Patients who previously had frequent episodes of asthma while receiving treatment with optimal doses of inhaled corticosteroids and who have been stabilised on concomitant inhaled salmeterol xinafoate and fluticasone propionate | |
Fluvastatin Sodium | For use in accordance with paragraph 16 |
Fluvoxamine Maleate | Major depressive disorders |
Obsessive-compulsive disorder | |
Folic Acid | — |
Follitropin Alfa | In respect of the injection set containing 1 vial powder for injection 75 I.U. and 1 pre-filled syringe solvent 1 mL and the injection set containing 1 vial powder for injection 1,050 I.U. and 1 pre-filled syringe solvent 2 mL: |
Anovulatory infertility | |
In respect of the injection set containing 10 vials powder for injection 75 I.U. and 10 pre-filled syringes solvent 1 mL, injection 300 I.U. in 0.5 mL multi-dose cartridge, injection set containing 1 vial powder for injection 450 I.U. and 1 pre-filled syringe solvent 1 mL, injection 450 I.U. in 0.75 mL multi-dose cartridge and injection 900 I.U. in 1.5 mL multi-dose cartridge: | |
Anovulatory infertility | |
In combination with chorionic gonadotrophin, for the treatment of infertility in males due to hypogonadotrophic hypogonadism, following failure of 6 months' treatment with chorionic gonadotrophin to achieve adequate spermatogenesis | |
Follitropin Beta | In respect of the solution for injection 100 I.U. in 0.5 mL single use vial, solution for injection 150 I.U. in 0.5 mL single use vial, solution for injection 300 I.U in 0.36 mL multi-dose cartridge, solution for injection 600 I.U in 0.72 mL multi-dose cartridge and solution for injection 900 I.U in 1.08 mL multi-dose cartridge: |
Anovulatory infertility | |
In combination with chorionic gonadotrophin, for the treatment of infertility in males due to hypogonadotrophic hypogonadism, following failure of 6 months' treatment with chorionic gonadotrophin to achieve adequate spermatogenesis | |
In respect of the solution for injection 200 I.U. in 0.5 mL single use vial: | |
In combination with chorionic gonadotrophin, for the treatment of infertility in males due to hypogonadotrophic hypogonadism, following failure of 6 months' treatment with chorionic gonadotrophin to achieve adequate spermatogenesis | |
Fondaparinux Sodium | In compliance with authority procedures set out in subparagraph 14 (d): |
Prevention of venous thromboembolic events in patients undergoing major hip surgery | |
Prevention of venous thromboembolic events in patients undergoing total knee replacement | |
Fosinopril Sodium | — |
Fosinopril Sodium with Hydrochlorothiazide | Hypertension in patients who are not adequately controlled with either hydrochlorothiazide or fosinopril sodium monotherapy |
Fotemustine | In compliance with authority procedures set out in subparagraph 14 (d): |
Metastatic malignant melanoma | |
Framycetin Sulfate | — |
Frusemide | — |
Gabapentin | In compliance with authority procedures set out in subparagraph 14 (d): |
Treatment of partial epileptic seizures which are not controlled satisfactorily by other anti-epileptic drugs | |
Galantamine Hydrobromide | In compliance with authority procedures set out in subparagraph 14 (d): |
Initial treatment, for up to 2 months, of mild to moderately severe Alzheimer's disease in patients with a baseline Mini-Mental State Examination score of 10 or more, where the diagnosis is confirmed by a specialist or consultant physician, and where the result of the baseline Mini-Mental State Examination and, if this result is at least 25 points, the result of the baseline Alzheimer's Disease Assessment Scale, cognitive sub-scale, are included in the authority application In compliance with authority procedures set out in subsubparagraph 14 (d)(i): Continuation of initial treatment of mild to moderately severe Alzheimer's disease in patients with a baseline Mini-Mental State Examination score of 10 or more, where the patient has previously been issued with an authority prescription for initial treatment with this drug for a period of up to 2 months, where the application confirms the information which established the patient's eligibility for initial treatment, and where approval of the application would enable the patient to complete a period of initial treatment of not more than 6 months of uninterrupted therapy Initial treatment, for up to 6 months, of mild to moderately severe Alzheimer's disease in patients with a baseline Mini-Mental State Examination score of 10 or more, where the diagnosis is confirmed by a specialist or consultant physician, and where the result of the baseline Mini-Mental State Examination and, if this result is at least 25 points, the result of the baseline Alzheimer's Disease Assessment Scale, cognitive sub-scale, are included in the authority application | |
Continuing treatment of mild to moderately severe Alzheimer's disease in patients with a baseline Mini-Mental State Examination score of 10 or more who demonstrate improvement in cognitive function following initial therapy, as measured by an increase of at least 2 points from baseline on the Mini-Mental State Examination, or a decrease of at least 4 points from baseline on the Alzheimer's Disease Assessment Scale, cognitive sub-scale, for patients with a Mini-Mental State Examination baseline score of at least 25 points, where the relevant result from the Mini-Mental State Examination or the Alzheimer's Disease Assessment Scale, cognitive sub-scale, is included in the authority application for continuing treatment In compliance with authority procedures set out in subparagraph 14 (d): Continuing treatment of mild to moderately severe Alzheimer's disease in patients with a baseline Mini-Mental State Examination score of 10 or more and with demonstrated improvement in cognitive function following initial therapy, where the patient has previously been issued with an authority prescription for continuing treatment | |
Initial treatment, for up to 2 months, of mild to moderately severe Alzheimer's disease in patients with a baseline Mini-Mental State Examination score of 9 or less, who are unable to register a score of 10 or more for reasons other than their Alzheimer's disease as they are from 1 or more of the following groups, where the diagnosis is confirmed by a specialist or consultant physician, and where the authority application includes the result of the baseline Mini-Mental State Examination and specifies to which of the groups the patient belongs: Unable to communicate adequately because of lack of competence in English, in people of non-English speaking background; Limited education, as defined by less than 6 years of education, or who are illiterate or innumerate; Aboriginal or Torres Strait Islanders who, by virtue of cultural factors, are unable to complete a Mini-Mental State Examination test; Intellectual (developmental or acquired) disability; Significant sensory impairment despite best correction, which precludes completion of a Mini-Mental State Examination test; Prominent dysphasia, out of proportion to other cognitive and functional impairment In compliance with authority procedures set out in subsubparagraph 14 (d)(i): Continuation of initial treatment of mild to moderately severe Alzheimer's disease in patients with a baseline Mini-Mental State Examination score of 9 or less, who are unable to register a score of 10 or more for reasons other than their Alzheimer's disease, where the patient has previously been issued with an authority prescription for initial treatment with this drug for a period of up to 2 months, where the application confirms the information which established the patient's eligibility for initial treatment, and where approval of the application would enable the patient to complete a period of initial treatment of not more than 6 months of uninterrupted therapy Initial treatment, for up to 6 months, of mild to moderately severe Alzheimer's disease in patients with a baseline Mini-Mental State Examination score of 9 or less, who are unable to register a score of 10 or more for reasons other than their Alzheimer's disease as they are from 1 or more of the following groups, where the diagnosis is confirmed by a specialist or consultant physician, and where the authority application includes the result of the baseline Mini-Mental State Examination and specifies to which of the groups the patient belongs: Unable to communicate adequately because of lack of competence in English, in people of non-English speaking background; Limited education, as defined by less than 6 years of education, or who are illiterate or innumerate; Aboriginal or Torres Strait Islanders who, by virtue of cultural factors, are unable to complete a Mini-Mental State Examination test; Intellectual (developmental or acquired) disability; Significant sensory impairment despite best correction, which precludes completion of a Mini-Mental State Examination test; Prominent dysphasia, out of proportion to other cognitive and functional impairment | |
Continuing treatment of mild to moderately severe Alzheimer's disease in eligible patients with a baseline Mini-Mental State Examination score of 9 or less who are unable to register a score of 10 or more for reasons other than their Alzheimer's disease and who demonstrate improvement in function following initial therapy, based on a rating of very much improved or much improved on the Clinicians Interview Based Impression of Change scale, as assessed by the same clinician who initiated treatment, and where the improvement rating achieved on the Clinicians Interview Based Impression of Change scale is stated in the authority application for continuing treatment In compliance with authority procedures set out in subparagraph 14 (d): Continuing treatment of mild to moderately severe Alzheimer's disease in eligible patients with a baseline Mini-Mental State Examination score of 9 or less and with demonstrated improvement in function following initial therapy, where the patient has previously been issued with an authority prescription for continuing treatment | |
Gefitinib | In compliance with authority procedures set out in subsubparagraph 14 (d)(i): |
Initial treatment subsidised under the Pharmaceutical Benefits Scheme (PBS), as monotherapy, of locally advanced or metastatic non-small cell lung cancer in patients with a World Health Organisation (WHO) performance status of 2 or less, and: (b) where there is evidence that the patient has at least 1 activating mutation of the epidermal growth factor receptor (EGFR) gene in tumour material, unless: (i) the patient commenced treatment with gefitinib prior to 1 July 2004, in which case, although an attempt must be made to test for the presence of an activating mutation of the EGFR gene, the patient is exempt from meeting this requirement; or (ii) the patient commenced treatment with gefitinib between 1 July 2004 and 27 September 2004, in which case a test for the presence of an activating mutation of the EGFR gene with a negative result does not render the patient ineligible if a radiological assessment of the patient which is less than 1 month old at the date of the authority application demonstrates that disease progression has not occurred while the patient has been on gefitinib therapy; and where the following conditions apply: the presence of a mutation is demonstrated by analysis of the DNA sequence of the EGFR gene; the authority application includes the following: (i) a completed copy of the appropriate PBS Authority Application - Supporting Information Form; and (ii) details of the prior chemotherapy including the names of drugs and date of the most recent treatment cycle; and (iii) details of the patient's WHO performance status; and (iv) a copy of the pathology report from an Approved Pathology Authority providing the result of the test for the presence of an activating mutation, or mutations, of the EGFR gene; and (v) where the patient is claiming exemption from the requirement to test positive for the presence of an activating mutation of the EGFR gene on the basis that treatment with gefitinib commenced between 1 July 2004 and 27 September 2004 and a radiological assessment within the month prior to the application shows disease progression has not occurred while on gefitinib therapy, a copy of that radiological assessment | |
In compliance with authority procedures set out in subsubparagraph 14 (d)(i) or 14(d)(ii): Continuing treatment, as monotherapy, of locally advanced or metastatic non-small cell lung cancer in patients with a World Health Organisation performance status of 2 or less, where the patient has previously been issued with an authority prescription for gefitinib | |
Gelatin - Succinylated | — |
Gemcitabine Hydrochloride | In compliance with authority procedures set out in subparagraph 14 (d): |
Advanced breast cancer in combination with paclitaxel after failure of prior therapy which includes an anthracycline | |
Advanced epithelial ovarian cancer, in combination with carboplatin, in patients who relapse more than 6 months after platinum-based therapy | |
Locally advanced or metastatic non-small cell lung cancer | |
Locally advanced or metastatic adenocarcinoma of the pancreas | |
Locally advanced or metastatic bladder cancer, when used in combination with cisplatin | |
Gemfibrozil | For use in accordance with paragraph 16 |
Gentamicin Sulfate | In respect of the injection equivalent to 80 mg gentamicin in 2 mL ampoule: |
— | |
In respect of the eye drops equivalent to 3 mg gentamicin per mL, 5 mL: | |
Invasive ocular infection | |
Perioperative use in ophthalmic surgery | |
Suspected pseudomonal eye infection | |
Gestrinone | In compliance with authority procedures set out in subparagraph 14 (d): |
Treatment of visually proven endometriosis where the duration of treatment provided for by this prescription, in combination with any previous prescriptions, does not exceed 6 months' uninterrupted therapy | |
Glatiramer Acetate | In compliance with authority procedures set out in subparagraph 14 (d): |
Initial treatment of clinically definite relapsing-remitting multiple sclerosis in ambulatory (without assistance or support) patients who have experienced at least 2 documented attacks of neurological dysfunction, believed to be due to the multiple sclerosis, in the preceding 2 years, and where the diagnosis is confirmed by magnetic resonance imaging of the brain or spinal cord and the date of the scan is included in the authority application, or where the authority application is accompanied by written certification provided by a radiologist that a magnetic resonance imaging scan is contraindicated because of the risk of physical (not psychological) injury to the patient | |
Continuing treatment of clinically definite relapsing-remitting multiple sclerosis in patients previously issued with an authority prescription for this drug who do not show continuing progression of disability while on treatment with this drug and who have demonstrated compliance with, and an ability to tolerate, this therapy | |
Glibenclamide | — |
Gliclazide | — |
Glimepiride | — |
Glipizide | — |
Glucagon Hydrochloride | — |
Glucose | — |
Glucose and Ketone Indicator—Urine | — |
Glucose with Sodium Chloride, Potassium Chloride and Sodium Acid Citrate | — |
Glucose Indicator—Blood | In respect of the electrode strips, 50 (Advantage II), electrode strips, 50 (GlucoCare), electrode strips, 50 (GlucoCare Super Sensor), electrode strips, 50 (GlucoMen Sensor), electrode strips, 50 (Omnitest EZ), electrode strips, 50 (TrueTrack), discs containing electrode sensors, 10 sensors per disc, 5, electrode strips, 100 (Optium glucose), electrode strips, 100 (SofTact), electrode strips, 100 (TrueSense), reagent strips, 50 (Accu-Chek Active), reagent strips, 50 (Accu-Chek Go), reagent strips, 51 (Accu-Chek Integra), reagent strips, 50 (Betachek), reagent strips, 50 (Betachek MERIDIAN), reagent strips, 50 (CareSens), reagent strips, 50 (Glucoflex-R), reagent strips, 50 (Glucostix) and reagent strips, 50 (SensoCard): |
— | |
In respect of the electrode strips, 50 (Ascensia Elite) and electrode strips, 100 (Precision Plus): | |
In compliance with authority procedures set out in subparagraph 14 (d): | |
Patients who have previously received this product as a pharmaceutical benefit | |
Patients who have purchased a meter to be used with this product prior to 1 August 2003 | |
Glucose Indicator—Urine | — |
Glycerol | Paraplegic and quadriplegic patients and others with severe neurogenic impairment of bowel function |
Patients who are receiving long-term nursing care on account of age, infirmity or other condition in hospitals, nursing homes or residential facilities | |
For use by a patient who is receiving long-term nursing care and in respect of whom a Carer Allowance is payable as a disabled adult | |
Patients receiving palliative care | |
Terminal malignant neoplasia | |
Anorectal congenital abnormalities | |
Megacolon | |
Glyceryl Trinitrate | — |
Goserelin Acetate | In respect of the subcutaneous implant equivalent to 3.6 mg goserelin in pre-filled injection syringe: |
In compliance with authority procedures set out in subparagraph 14 (d): | |
Locally advanced (equivalent to stage C) or metastatic (equivalent to stage D) carcinoma of the prostate | |
Hormone-dependent locally advanced (equivalent to stage III) or metastatic (equivalent to stage IV) breast cancer in pre-menopausal women | |
Treatment of visually proven endometriosis where the duration of treatment provided for by this prescription, in combination with any previous prescriptions, does not exceed 6 months' uninterrupted therapy | |
In respect of the subcutaneous implant (long acting) equivalent to 10.8 mg goserelin in pre-filled injection syringe: | |
In compliance with authority procedures set out in subparagraph 14 (d): | |
Locally advanced (equivalent to stage C) or metastatic (equivalent to stage D) carcinoma of the prostate | |
Granisetron Hydrochloride | Management of nausea and vomiting associated with cytotoxic chemotherapy being used to treat malignancy |
In compliance with authority procedures set out in subparagraph 14 (d): | |
Management of nausea and vomiting associated with radiotherapy being used to treat malignancy | |
Griseofulvin | — |
Haloperidol | — |
Haloperidol Decanoate | — |
\"HCU express\" | Pyridoxine non-responsive homocystinuria |
\"HCU gel\" | Pyridoxine non-responsive homocystinuria |
Heparin Sodium | — |
Hexamine Hippurate | — |
Homatropine Hydrobromide | — |
Hydralazine Hydrochloride | — |
Hydrochlorothiazide | — |
Hydrochlorothiazide with Amiloride Hydrochloride | — |
Hydrochlorothiazide with Triamterene | — |
Hydrocortisone | In respect of the tablet 4 mg, tablet 20 mg, eye drops 5 mg per mL, 10 mL and eye drops 10 mg per mL, 10 mL: |
— | |
In respect of the cream 10 mg per g, 50 g: | |
Treatment of corticosteroid-responsive dermatoses | |
Hydrocortisone Acetate | In respect of the eye ointment 5 mg per g, 5 g and eye ointment 10 mg per g, 5 g: |
— | |
In respect of the cream 10 mg per g, 30 g, cream 10 mg per g, 50 g, ointment 10 mg per g, 30 g and ointment 10 mg per g, 50 g: | |
Treatment of corticosteroid-responsive dermatoses | |
In respect of the rectal foam 90 mg per applicatorful, 14 applications, aerosol 21.1 g: | |
Proctitis | |
Ulcerative colitis | |
Hydrocortisone Sodium Succinate | — |
Hydromorphone Hydrochloride | In respect of the injection 2 mg in 1 mL ampoule, injection 10 mg in 1 mL ampoule, injection 50 mg in 5 mL ampoule and injection 500 mg in 50 mL vial: |
— | |
In respect of the tablet 2 mg, tablet 4 mg, tablet 8 mg and oral liquid 1 mg per mL, 473 mL: | |
Severe disabling pain not responding to non-narcotic analgesics | |
Hydroxocobalamin | Pernicious anaemia |
Other proven vitamin B12 deficiencies | |
Prophylaxis after gastrectomy | |
Hydroxychloroquine Sulfate | — |
Hydroxypropylcellulose | Severe dry eye syndrome unresponsive to artificial tear solutions |
Hydroxyurea | — |
Hypromellose | Severe dry eye syndrome, including Sjogren's syndrome |
Hypromellose with Carbomer 980 | Severe dry eye syndrome, including Sjogren's syndrome |
Hypromellose 2900 with Dextran 70 | In compliance with authority procedures set out in subparagraph 14 (d): |
Severe dry eye syndrome in patients who are sensitive to preservatives in multi-dose eye drops | |
Hypromellose 4500 with Dextran 70 | Severe dry eye syndrome, including Sjogren's syndrome |
Ibuprofen | In respect of the tablets 400 mg, 20: |
— | |
In respect of the tablet 200 mg and tablet 400 mg: | |
Chronic arthropathies (including osteoarthritis) with an inflammatory component | |
Bone pain due to malignant disease | |
Idarubicin Hydrochloride | Acute myelogenous leukaemia |
Ifosfamide | Relapsed or refractory germ cell tumours following first-line chemotherapy |
Relapsed or refractory sarcomas following first-line chemotherapy | |
Imipramine Hydrochloride | — |
Indapamide Hemihydrate | — |
Indomethacin | In respect of the suppository 100 mg: |
— | |
In respect of the capsule 25 mg: | |
Chronic arthropathies (including osteoarthritis) with an inflammatory component | |
Bone pain due to malignant disease | |
Influenza Vaccine (Split Virion) - Inactivated | Persons at special risk of adverse consequences from infections of the lower respiratory tract |
Insect Allergen Extract—Honey Bee Venom | — |
Insect Allergen Extract—Paper Wasp Venom | — |
Insect Allergen Extract—Yellow Jacket Venom | — |
Insulin - Isophane | — |
Insulin - Neutral | — |
Insulin - Neutral with Insulin - Isophane | — |
Insulin Aspart | — |
Insulin Aspart with Insulin Aspart Protamine Suspension | — |
Insulin Lispro | — |
Insulin Lispro with Insulin Lispro Protamine Suspension | — |
Interferon Alfa-2a | In respect of the injection 3,000,000 I.U. in 0.5 mL single dose pre-filled syringe: |
In compliance with authority procedures set out in subparagraph 14 (d): | |
Hairy cell leukaemia | |
Myeloproliferative disease with excessive thrombocytosis | |
Low grade non-Hodgkin's lymphoma with clinical features suggestive of a poor prognosis, in combination with anthracycline-based chemotherapy | |
In respect of the injection 4,500,000 I.U. in 0.5 mL single dose pre-filled syringe, injection 6,000,000 I.U. in 0.5 mL single dose pre-filled syringe and injection 9,000,000 I.U. in 0.5 mL single dose pre-filled syringe: | |
In compliance with authority procedures set out in subparagraph 14 (d): | |
Myeloproliferative disease with excessive thrombocytosis | |
Low grade non-Hodgkin's lymphoma with clinical features suggestive of a poor prognosis, in combination with anthracycline-based chemotherapy | |
Interferon Alfa-2b | In respect of the solution for injection 18,000,000 I.U. in 1.2 mL multi-dose injection pen: |
In compliance with authority procedures set out in subparagraph 14 (d): | |
Hairy cell leukaemia | |
Maintenance treatment of multiple myeloma once remission has been achieved with chemotherapy | |
Low grade non-Hodgkin's lymphoma with clinical features suggestive of a poor prognosis, in combination with anthracycline-based chemotherapy | |
In respect of the solution for injection 30,000,000 I.U. in 1.2 mL multi-dose injection pen: | |
In compliance with authority procedures set out in subparagraph 14 (d): | |
Maintenance treatment of multiple myeloma once remission has been achieved with chemotherapy | |
Low grade non-Hodgkin's lymphoma with clinical features suggestive of a poor prognosis, in combination with anthracycline-based chemotherapy | |
Interferon Beta-1a | In compliance with authority procedures set out in subparagraph 14 (d): |
Initial treatment of clinically definite relapsing-remitting multiple sclerosis in ambulatory (without assistance or support) patients who have experienced at least 2 documented attacks of neurological dysfunction, believed to be due to the multiple sclerosis, in the preceding 2 years, and where the diagnosis is confirmed by magnetic resonance imaging of the brain or spinal cord and the date of the scan is included in the authority application, or where the authority application is accompanied by written certification provided by a radiologist that a magnetic resonance imaging scan is contraindicated because of the risk of physical (not psychological) injury to the patient | |
Continuing treatment of clinically definite relapsing-remitting multiple sclerosis in patients previously issued with an authority prescription for this drug who do not show continuing progression of disability while on treatment with this drug and who have demonstrated compliance with, and an ability to tolerate, this therapy | |
Interferon Beta-1b | In compliance with authority procedures set out in subparagraph 14 (d): |
Initial treatment of clinically definite relapsing-remitting multiple sclerosis in ambulatory (without assistance or support) patients who have experienced at least 2 documented attacks of neurological dysfunction, believed to be due to the multiple sclerosis, in the preceding 2 years, and where the diagnosis is confirmed by magnetic resonance imaging of the brain or spinal cord and the date of the scan is included in the authority application, or where the authority application is accompanied by written certification provided by a radiologist that a magnetic resonance imaging scan is contraindicated because of the risk of physical (not psychological) injury to the patient | |
Continuing treatment of clinically definite relapsing-remitting multiple sclerosis in patients previously issued with an authority prescription for this drug who do not show continuing progression of disability while on treatment with this drug and who have demonstrated compliance with, and an ability to tolerate, this therapy | |
Ipratropium Bromide | In respect of the pressurised inhalation 21 micrograms per dose, 200 doses (CFC-free formulation): |
— | |
In respect of the nebuliser solution 250 micrograms (anhydrous) in 1 mL single dose units, 30, nebuliser solution 500 micrograms (anhydrous) in 1 mL single dose units, 30 and nebuliser solution 250 micrograms (anhydrous) per mL, 20 mL: | |
Asthma in patients unable to use this drug delivered from an oral pressurised inhalation device via a spacer | |
Chronic obstructive pulmonary disease in patients unable to use this drug delivered from an oral pressurised inhalation device via a spacer | |
Irbesartan | — |
Irbesartan with Hydrochlorothiazide | Hypertension in patients who are not adequately controlled with either hydrochlorothiazide or irbesartan monotherapy |
Irinotecan Hydrochloride Trihydrate | In compliance with authority procedures set out in subparagraph 14 (d): |
Metastatic colorectal cancer in patients with a World Health Organisation performance status of 2 or less | |
Iron Polymaltose Complex | — |
Iron Sucrose | In compliance with authority procedures set out in subparagraph 14 (d): |
Iron deficiency anaemia, when used in combination with either epoetin alfa or darbepoetin alfa, in patients undergoing chronic haemodialysis who have had a documented hypersensitivity reaction to iron polymaltose and in whom continued intravenous iron therapy is appropriate | |
Isoniazid | — |
Isosorbide Dinitrate | — |
Isosorbide Mononitrate | — |
Isotretinoin | In compliance with authority procedures set out in subparagraph 14 (d): |
Severe cystic acne not responsive to other therapy | |
Itraconazole | In compliance with authority procedures set out in subparagraph 14 (d): |
Systemic aspergillosis | |
Systemic sporotrichosis | |
Systemic histoplasmosis | |
Treatment and maintenance therapy in patients with Acquired Immunodeficiency Syndrome who have disseminated pulmonary histoplasmosis infection | |
Treatment and maintenance therapy in patients with Acquired Immunodeficiency Syndrome who have chronic pulmonary histoplasmosis infection | |
Treatment of oropharyngeal candidiasis in immunosuppressed patients | |
Treatment of oesophageal candidiasis in immunosuppressed patients | |
Ivermectin | In compliance with authority procedures set out in subparagraph 14 (d): |
Onchocerciasis | |
Strongyloidiasis | |
\"Karicare De-Lact\" | In compliance with authority procedures set out in subparagraph 14 (d): |
Acute lactose intolerance in patients up to the age of 12 months, where the date of birth of the patient is included in the authority application and where the patient has not previously been issued with an authority prescription for this medicinal preparation for this purpose | |
Proven chronic lactose intolerance in patients up to the age of 12 months, where the date of birth of the patient is included in the authority application, and where lactose intolerance has been proven either by the relief of symptoms on supervised withdrawal of lactose from the diet for 3 or 4 days and subsequent re-emergence of symptoms on rechallenge with lactose containing formulae or milk or food, or by the presence of not less than 0.5% reducing substance in stool exudate tested with copper sulfate diagnostic compound tablet | |
Ketoconazole | In compliance with authority procedures set out in subparagraph 14 (d): |
Symptomatic genital candidiasis recurring after treatment of at least 2 episodes with topical therapy | |
Oral candidiasis in severely immunocompromised persons where topical therapy has failed | |
Systemic or deep mycoses where other forms of therapy have failed | |
\"Ketonex-1\" | Maple syrup urine disease |
\"Ketonex-2\" | Maple syrup urine disease |
Ketoprofen | In respect of the suppository 100 mg: |
— | |
In respect of the capsule 200 mg (sustained release): | |
Chronic arthropathies (including osteoarthritis) with an inflammatory component | |
\"Kindergen\" | In compliance with authority procedures set out in subparagraph 14 (d): |
Infants and young children with chronic renal failure requiring treatment with a low protein and a low phosphorus diet, or a low protein, a low phosphorus and a low potassium diet | |
Labetalol Hydrochloride | — |
Lactulose | Hepatic coma or precoma (chronic porto-systemic encephalopathy) |
Constipation in patients with malignant neoplasia | |
Lamotrigine | In compliance with authority procedures set out in subparagraph 14 (d): |
Treatment of epileptic seizures which are not controlled satisfactorily by other anti-epileptic drugs | |
Lansoprazole | In respect of the capsule 30 mg and sachet containing granules for oral suspension, 30 mg per sachet: |
Initial treatment of peptic ulcer | |
Gastro-oesophageal reflux disease | |
Scleroderma oesophagus | |
In respect of the capsule 15 mg: | |
Gastro-oesophageal reflux disease | |
Scleroderma oesophagus | |
Latanoprost | — |
Leflunomide | In respect of the pack containing 3 tablets leflunomide 100 mg and 30 tablets leflunomide 20 mg: |
In compliance with authority procedures set out in subparagraph 14 (d): | |
Initiation treatment of severe active rheumatoid arthritis in patients for whom other disease modifying anti-rheumatic drugs (including methotrexate) are inappropriate or ineffective and where the authority application is made by a consultant physician | |
In respect of the tablet 10 mg and tablet 20 mg: | |
In compliance with authority procedures set out in subparagraph 14 (d): | |
Initiation treatment of severe active rheumatoid arthritis in patients for whom other disease modifying anti-rheumatic drugs (including methotrexate) are inappropriate or ineffective and where the authority application is made by a consultant physician | |
Ongoing leflunomide therapy for severe active rheumatoid arthritis in patients for whom other disease modifying anti-rheumatic drugs (including methotrexate) are inappropriate or ineffective | |
Lercanidipine Hydrochloride | — |
Letrozole | Treatment of hormone-dependent advanced breast cancer in post-menopausal women |
Leuprorelin Acetate | In compliance with authority procedures set out in subparagraph 14 (d): |
Locally advanced (equivalent to stage C) or metastatic (equivalent to stage D) carcinoma of the prostate | |
Levetiracetam | In compliance with authority procedures set out in subparagraph 14 (d): |
Treatment of partial epileptic seizures which are not controlled satisfactorily by other anti-epileptic drugs | |
Treatment of partial epileptic seizures which are not controlled satisfactorily by other anti-epileptic drugs, and where adverse events have occurred with other suitable drugs available under the Pharmaceutical Benefits Scheme | |
Treatment of partial epileptic seizures which are not controlled satisfactorily by other anti-epileptic drugs, and where drug interactions have occurred with other suitable drugs available under the Pharmaceutical Benefits Scheme | |
Treatment of partial epileptic seizures which are not controlled satisfactorily by other anti-epileptic drugs, and where drug interactions are expected to occur with other suitable drugs available under the Pharmaceutical Benefits Scheme | |
Treatment of partial epileptic seizures which are not controlled satisfactorily by other anti-epileptic drugs, and where transfer to another suitable drug available under the Pharmaceutical Benefits Scheme would cause patient confusion resulting in problems with compliance | |
Treatment of partial epileptic seizures which are not controlled satisfactorily by other anti-epileptic drugs, and where transfer to another suitable drug available under the Pharmaceutical Benefits Scheme is likely to result in adverse clinical consequences | |
Levobunolol Hydrochloride | — |
Levodopa with Benserazide Hydrochloride | — |
Levodopa with Carbidopa | In respect of the tablet 100 mg-25 mg (anhydrous) and tablet 250 mg-25 mg (anhydrous): |
— | |
In respect of the tablet 200 mg-50 mg (anhydrous) (modified release): | |
In compliance with authority procedures set out in subparagraph 14 (d): | |
Parkinson's disease where fluctuations in motor function are not adequately controlled by frequent dosing with conventional formulations of levodopa with decarboxylase inhibitor | |
Levodopa with Carbidopa and Entacapone | In compliance with authority procedures set out in subparagraph 14 (d): |
Parkinson's disease in patients being treated with levodopa—decarboxylase inhibitor combinations who are experiencing fluctuations in motor function due to end-of-dose effect | |
Parkinson's disease in patients stabilised on concomitant treatment with levodopa—decarboxylase inhibitor combinations and entacapone | |
Levonorgestrel | In respect of the tablets 30 micrograms, 28: |
— | |
In respect of the intrauterine drug delivery system 52 mg: | |
Contraception | |
Levonorgestrel with Ethinyloestradiol | — |
Lignocaine Hydrochloride | — |
Lincomycin Hydrochloride | — |
Liothyronine Sodium | In compliance with authority procedures set out in subparagraph 14 (d): |
Management of patients with thyroid cancer | |
Replacement therapy for hypothyroid patients who have documented intolerance to thyroxine sodium | |
Replacement therapy for hypothyroid patients who have documented resistance to thyroxine sodium | |
Initiation of thyroid therapy in severely hypothyroid patients | |
Lisinopril | — |
Lithium Carbonate | — |
\"Locasol\" | In compliance with authority procedures set out in subparagraph 14 (d): |
Hypercalcaemia in children under the age of 4 years | |
Lodoxamide Trometamol | In compliance with authority procedures set out in subparagraph 14 (d): |
Vernal kerato-conjunctivitis | |
Loperamide Hydrochloride | — |
\"Lophlex\" | Phenylketonuria |
Macrogol 3350 with Sodium Chloride, Sodium Bicarbonate and Potassium Chloride | Constipation in patients with malignant neoplasia |
\"Mapleflex\" | Maple syrup urine disease |
Medroxyprogesterone Acetate | In respect of the tablet 5 mg, tablet 10 mg, injection 50 mg in 1 mL vial and injection 150 mg in 1 mL vial: |
— | |
In respect of the tablet 500 mg: | |
Hormone-dependent advanced breast cancer | |
In respect of the tablet 100 mg, tablet 200 mg and tablet 250 mg: | |
Hormone-dependent breast cancer | |
Endometrial cancer | |
Mefenamic Acid | Dysmenorrhoea |
Menorrhagia | |
Megestrol Acetate | Hormone-dependent advanced breast cancer |
Meloxicam | Symptomatic treatment of osteoarthritis |
Melphalan | — |
Mercaptopurine | — |
Mesalazine | In respect of the suppositories 1 g, 28: |
Acute episode of mild to moderate ulcerative proctitis | |
In respect of the tablet 250 mg: | |
In compliance with authority procedures set out in subparagraph 14 (d): | |
Colitis (including ulcerative colitis and Crohn's disease) where hypersensitivity to sulfonamides exists | |
Colitis (including ulcerative colitis and Crohn's disease) where intolerance to sulfasalazine exists | |
In respect of the tablet 500 mg (enteric coated): | |
In compliance with authority procedures set out in subparagraph 14 (d): | |
Colitis and Crohn's disease where hypersensitivity to sulfonamides exists | |
Colitis and Crohn's disease where intolerance to sulfasalazine exists | |
In respect of the sachet containing granules, 500 mg per sachet and sachet containing granules, 1 g per sachet: | |
In compliance with authority procedures set out in subparagraph 14 (d): | |
Mild to moderate ulcerative colitis where hypersensitivity to sulfonamides exists | |
Mild to moderate ulcerative colitis where intolerance to sulfasalazine exists | |
In respect of the enemas 2 g in 60 mL, 7, enemas 4 g in 60 mL, 7 and rectal foam 1 g per applicatorful, 14 applications, aerosol 80 g: | |
In compliance with authority procedures set out in subparagraph 14 (d): | |
Acute episode of mild to moderate ulcerative colitis | |
In respect of the enemas 1 g in 100 mL, 7: | |
In compliance with authority procedures set out in subparagraph 14 (d): | |
Acute episode of mild to moderate ulcerative proctosigmoiditis | |
Mesna | Adjunctive therapy for use with ifosfamide or high dose cyclophosphamide |
\"Metabolic Mineral Mixture\" | Metabolic disorders |
Metformin Hydrochloride | — |
Metformin Hydrochloride with Glibenclamide | — |
Methadone Hydrochloride | Severe disabling pain not responding to non-narcotic analgesics |
Methotrexate | — |
Methyldopa | — |
Methylphenidate Hydrochloride | In compliance with authority procedures set out in subparagraph 14 (d): |
Use in attention deficit hyperactivity disorder, in accordance with State/Territory law | |
Methylprednisolone Aceponate | In respect of the cream 1 mg per g, 15 g, ointment 1 mg per g, 15 g and fatty ointment 1 mg per g, 15 g: |
Treatment of corticosteroid-responsive dermatoses | |
In respect of the lotion 1 mg per g, 20 g: | |
Eczema | |
Methylprednisolone Acetate | For local intra-articular or peri-articular infiltration |
Methylprednisolone Sodium Succinate | — |
Methysergide Maleate | — |
Metoclopramide Hydrochloride | — |
Metoprolol Succinate | In compliance with authority procedures set out in subparagraph 14 (d): |
Moderate to severe heart failure in patients stabilised on conventional therapy which must include an angiotensin-converting enzyme inhibitor if tolerated | |
Metoprolol Tartrate | — |
Metronidazole | In respect of the tablet 200 mg, tablet 400 mg and suppositories 500 mg, 10: |
— | |
In respect of the I.V. infusion 500 mg in 100 mL: | |
Prophylaxis in large bowel surgery | |
Treatment, in a hospital, of acute anaerobic sepsis | |
Metronidazole Benzoate | — |
Mexiletine Hydrochloride | — |
Mianserin Hydrochloride | Severe depression |
\"Minaphlex\" | Phenylketonuria |
Minocycline Hydrochloride | In respect of the capsule equivalent to 100 mg minocycline: |
— | |
In respect of the tablet equivalent to 50 mg minocycline: | |
Severe acne not responding to other tetracyclines | |
Minoxidil | In compliance with authority procedures set out in subparagraph 14 (d): |
Severe refractory hypertension where treatment with minoxidil was initiated in a hospital (in-patient or out-patient) | |
Mirtazapine | Major depressive disorders |
Misoprostol | In compliance with authority procedures set out in subparagraph 14 (d): |
Reduction in the incidence of gastrointestinal complications in patients who have a history of peptic ulcer disease and in whom non-steroidal anti-inflammatory drug therapy is essential | |
Duodenal ulcer (including pyloric and stomal ulcers), proven by current or prior x-ray, endoscopy or surgery, where the date on which, and the method by which, the ulcer was proven are included in the authority application | |
Gastric ulcer, proven by x-ray, endoscopy or surgery within the previous 2 years, where the date on which, and the method by which, the ulcer was proven are included in the authority application | |
Mitozantrone Hydrochloride | — |
Moclobemide | Major depressive disorders |
Modafinil | In compliance with authority procedures set out in subsubparagraph 14 (d)(i): |
Initial treatment, by a qualified sleep medicine practitioner, of patients with narcolepsy where: (i) intolerance to dexamphetamine sulfate of a severity necessitating permanent treatment withdrawal develops; or (ii) therapy with dexamphetamine sulfate poses an unacceptable medical risk, as indicated by the presence of any 1 of the following: | |
where the patient meets the following criteria diagnostic of narcolepsy: (i) a definite history of cataplexy and a Multiple Sleep Latency Test (MSLT), conducted following at least 6 hours of sleep, with a mean sleep latency less than 8 minutes; or (ii) a MSLT, conducted following at least 6 hours of sleep, with a mean sleep latency less than 8 minutes and 2 or more sleep onset rapid eye movement (REM) periods; and | |
where the following conditions apply: the MSLT is preceded by nocturnal polysomnography; the polysomnography test and the MSLT are conducted by, or under the supervision of, a qualified sleep medicine practitioner; polygraph records and sleep reports are available for audit by the Medicare Australia CEO; the authority application includes the following: (d) details of the contraindication or intolerance to dexamphetamine sulfate; the results of the polysomnography test and the MSLT which are included in the authority application are no more than 5 years old at the time of application | |
In compliance with authority procedures set out in subsubparagraph 14 (d)(i) or 14(d)(ii): Continuing treatment of narcolepsy, where the patient has previously been issued with an authority prescription for this drug | |
Mometasone Furoate | Treatment of corticosteroid-responsive dermatoses |
\"Monogen\" | Chylous ascites |
Chylothorax | |
Fat malabsorption due to liver disease, short gut syndrome, cystic fibrosis or gastrointestinal disorders | |
Hyperlipoproteinaemia type 1 | |
Long chain fatty acid oxidation disorders | |
Montelukast Sodium | In respect of the tablet, chewable, equivalent to 4 mg montelukast: |
In compliance with authority procedures set out in subparagraph 14 (d): | |
First-line preventer medication, as the single preventer agent for children aged from 2 to less than 6 years with frequent episodic or mild persistent asthma, as an alternative to sodium cromoglycate or nedocromil sodium | |
In respect of the tablet, chewable, equivalent to 5 mg montelukast: | |
In compliance with authority procedures set out in subparagraph 14 (d): | |
First-line preventer medication, as the single preventer agent for children aged from 6 to less than 15 years with frequent episodic or mild persistent asthma, as an alternative to sodium cromoglycate or nedocromil sodium | |
Morphine Hydrochloride | Severe disabling pain not responding to non-narcotic analgesics |
Morphine Sulfate | In respect of the injection 10 mg in 1 mL ampoule, injection 15 mg in 1 mL ampoule and injection 30 mg in 1 mL ampoule: |
— | |
In respect of the tablet 10 mg and tablet 20 mg: | |
Severe disabling pain due to cancer not responding to non-narcotic analgesics | |
In respect of the tablet 30 mg: | |
Severe disabling pain not responding to non-narcotic analgesics | |
In respect of the tablet 5 mg (controlled release), tablet 10 mg (controlled release), tablet 15 mg (controlled release), tablet 30 mg (controlled release), tablet 60 mg (controlled release), tablet 100 mg (controlled release), capsule 10 mg (containing sustained release pellets), capsule 20 mg (containing sustained release pellets), capsule 30 mg (controlled release), capsule 50 mg (containing sustained release pellets), capsule 60 mg (controlled release), capsule 90 mg (controlled release), capsule 100 mg (containing sustained release pellets), capsule 120 mg (controlled release), sachet containing controlled release granules for oral suspension, 20 mg per sachet, sachet containing controlled release granules for oral suspension, 30 mg per sachet, sachet containing controlled release granules for oral suspension, 60 mg per sachet and sachet containing controlled release granules for oral suspension, 100 mg per sachet: | |
Chronic severe disabling pain not responding to non-narcotic analgesics | |
In respect of the tablet 200 mg (controlled release) and sachet containing controlled release granules for oral suspension, 200 mg per sachet: | |
In compliance with authority procedures set out in subparagraph 14 (d): | |
Chronic severe disabling pain due to cancer | |
Morphine Tartrate | — |
Moxifloxacin Hydrochloride | In respect of the solution for I.V. infusion equivalent to 400 mg moxifloxacin in 250 mL: |
In compliance with authority procedures set out in subparagraph 14 (d): | |
Initial treatment of radiologically-confirmed, severe community-acquired pneumonia, requiring admission to an intensive care or high dependency unit, in patients greater than 12 years old with a history of hypersensitivity to penicillin | |
In respect of the tablet equivalent to 400 mg moxifloxacin: | |
In compliance with authority procedures set out in subparagraph 14 (d): | |
Oral treatment, following initial intravenous treatment with moxifloxacin hydrochloride, of radiologically-confirmed, severe community-acquired pneumonia, requiring admission to an intensive care or high dependency unit, in patients greater than 12 years old with a history of hypersensitivity to penicillin | |
Radiologically-confirmed, severe community-acquired pneumonia requiring hospitalisation, in patients greater than 12 years old with a history of hypersensitivity to penicillin | |
Radiologically-confirmed, community-acquired pneumonia in patients greater than 12 years old with a history of immediate hypersensitivity to penicillin (as defined by urticaria, angioedema, bronchospasm or anaphylaxis within 1 hour of drug administration) | |
\"MSUD AID III\" | Maple syrup urine disease |
\"MSUD Analog\" | Maple syrup urine disease |
\"MSUD Express\" | Maple syrup urine disease |
\"MSUD Maxamaid\" | Maple syrup urine disease |
\"MSUD Maxamum\" | Maple syrup urine disease |
\"MSUD-gel\" | Maple syrup urine disease |
Mycophenolate Mofetil | In compliance with authority procedures set out in subparagraph 14 (d): |
Maintenance therapy of patients with renal transplants following initiation and stabilisation of treatment with mycophenolate mofetil, where therapy remains under the supervision and direction of the transplant unit reviewing that patient and where the name of the specialised transplant unit reviewing treatment and the date of the latest review at the specialised transplant unit are included in the authority application | |
Maintenance therapy of patients with cardiac transplants following initiation and stabilisation of treatment with mycophenolate mofetil, where therapy remains under the supervision and direction of the transplant unit reviewing that patient and where the name of the specialised transplant unit reviewing treatment and the date of the latest review at the specialised transplant unit are included in the authority application | |
Mycophenolate Mofetil with Water - Purified BP | In compliance with authority procedures set out in subparagraph 14 (d): Maintenance therapy of patients with renal transplants following initiation and stabilisation of treatment with mycophenolate mofetil, where therapy remains under the supervision and direction of the transplant unit reviewing that patient and where the name of the specialised transplant unit reviewing treatment and the date of the latest review at the specialised transplant unit are included in the authority application |
Maintenance therapy of patients with cardiac transplants following initiation and stabilisation of treatment with mycophenolate mofetil, where therapy remains under the supervision and direction of the transplant unit reviewing that patient and where the name of the specialised transplant unit reviewing treatment and the date of the latest review at the specialised transplant unit are included in the authority application | |
Mycophenolate Sodium | In compliance with authority procedures set out in subparagraph 14 (d): |
Maintenance therapy of patients with renal transplants following initiation and stabilisation of treatment with mycophenolate sodium, where therapy remains under the supervision and direction of the transplant unit reviewing that patient and where the name of the specialised transplant unit reviewing treatment and the date of the latest review at the specialised transplant unit are included in the authority application | |
Nafarelin Acetate | In compliance with authority procedures set out in subparagraph 14 (d): |
Initial treatment, for up to 6 months, of visually proven endometriosis | |
Subsequent treatment, for up to 6 months, of visually proven endometriosis, where 2 years or more have elapsed since the end of the previous course and where a recent bone density assessment has been made and where the date of the assessment is included in the authority application | |
Naloxone Hydrochloride | — |
Naltrexone Hydrochloride | In compliance with authority procedures set out in subparagraph 14 (d): |
For use within a comprehensive treatment program for alcohol dependence with the goal of maintaining abstinence | |
Nandrolone Decanoate | In compliance with authority procedures set out in subparagraph 14 (d): |
Monotherapy for osteoporosis where other treatment has failed, where monotherapy does not preclude concomitant calcium supplementation, and where, if the authority application is the initial authority application for this purpose for the patient, specialist advice has been obtained confirming that this drug is the only suitable treatment option for the patient | |
Monotherapy for osteoporosis where other treatment is not tolerated, where monotherapy does not preclude concomitant calcium supplementation, and where, if the authority application is the initial authority application for this purpose for the patient, specialist advice has been obtained confirming that this drug is the only suitable treatment option for the patient | |
Monotherapy for osteoporosis where other treatment is contraindicated, where monotherapy does not preclude concomitant calcium supplementation, and where, if the authority application is the initial authority application for this purpose for the patient, specialist advice has been obtained confirming that this drug is the only suitable treatment option for the patient | |
Patients receiving PBS-subsidised therapy with this drug for osteoporosis prior to 1 February 2004 | |
Patients on long-term treatment with corticosteroids | |
Naproxen | Chronic arthropathies (including osteoarthritis) with an inflammatory component |
Bone pain due to malignant disease | |
Naproxen Sodium | Chronic arthropathies (including osteoarthritis) with an inflammatory component |
Bone pain due to malignant disease | |
Naratriptan Hydrochloride | In compliance with authority procedures set out in subparagraph 14 (d): |
Migraine attacks in patients receiving, or who have failed a reasonable trial of, prophylactic medication and where attacks in the past have usually failed to respond to oral therapy with ergotamine and other appropriate agents, or in whom these agents are contraindicated | |
Nedocromil Sodium | — |
\"Neocate\" | In compliance with authority procedures set out in subparagraph 14 (d): |
Initial treatment, for up to 3 months, for combined intolerance (not infant colic) to cows' milk protein, soy protein and protein hydrolysate formulae in children up to the age of 2 years, where combined intolerance is demonstrated when the child has failed to respond to a strict cows' milk protein free and strict soy protein free diet with a protein hydrolysate (with or without medium chain triglycerides) as the principal formula, and where the date of birth of the patient is included in the authority application | |
Continuing treatment for combined intolerance (not infant colic) to cows' milk protein, soy protein and protein hydrolysate formulae in children up to the age of 2 years, where the child has been assessed by a suitably qualified allergist or paediatrician, and where the date of birth of the patient is included in the authority application | |
Treatment for combined intolerance (not infant colic) to cows' milk protein, soy protein and protein hydrolysate formulae in children aged 2 years and over, where the child is assessed by a suitably qualified allergist or paediatrician at intervals not greater than 6 months, and where the date of birth of the patient is included in the authority application | |
Severe intestinal malabsorption including short bowel syndrome where protein hydrolysate formulae have failed | |
Severe intestinal malabsorption including short bowel syndrome where the patient has been receiving parenteral nutrition | |
\"Neocate Advance\" | In compliance with authority procedures set out in subparagraph 14 (d): |
Initial treatment, for up to 3 months, for combined intolerance (not infant colic) to cows' milk protein, soy protein and protein hydrolysate formulae in children up to the age of 2 years, where combined intolerance is demonstrated when the child has failed to respond to a strict cows' milk protein free and strict soy protein free diet with a protein hydrolysate (with or without medium chain triglycerides) as the principal formula, and where the date of birth of the patient is included in the authority application | |
Continuing treatment for combined intolerance (not infant colic) to cows' milk protein, soy protein and protein hydrolysate formulae in children up to the age of 2 years, where the child has been assessed by a suitably qualified allergist or paediatrician, and where the date of birth of the patient is included in the authority application | |
Treatment for combined intolerance (not infant colic) to cows' milk protein, soy protein and protein hydrolysate formulae in children aged 2 years and over, where the child is assessed by a suitably qualified allergist or paediatrician at intervals not greater than 6 months, and where the date of birth of the patient is included in the authority application | |
Severe intestinal malabsorption including short bowel syndrome where protein hydrolysate formulae have failed | |
Severe intestinal malabsorption including short bowel syndrome where the patient has been receiving parenteral nutrition | |
Neomycin Sulfate | — |
Neomycin Undecenoate with Bacitracin Zinc | — |
Nicorandil | — |
Nifedipine | — |
Nilutamide | In compliance with authority procedures set out in subparagraph 14 (d): |
Locally advanced (equivalent to stage C) or metastatic (equivalent to stage D) prostatic carcinoma, when used in combination with gonadotrophin-releasing hormone (luteinising hormone-releasing hormone) agonist therapy | |
Locally advanced (equivalent to stage C) or metastatic (equivalent to stage D) prostatic carcinoma, when used in conjunction with surgical orchidectomy | |
Nitrazepam | — |
Nitrofurantoin | — |
Nizatidine | — |
Norethisterone | — |
Norethisterone with Ethinyloestradiol | — |
Norethisterone with Mestranol | — |
Norfloxacin | In compliance with authority procedures set out in subparagraph 14 (d): |
Acute bacterial enterocolitis | |
Complicated urinary tract infection | |
Nortriptyline Hydrochloride | Major depression where other antidepressant therapy has failed |
Major depression where other antidepressant therapy is contraindicated | |
Nystatin | — |
Oestradiol | In respect of the tablet 2 mg and vaginal tablets 25 micrograms, 15: |
— | |
In respect of the transdermal patches 390 micrograms, 8, transdermal patches 2 mg, 4, transdermal patches 2 mg, 8 (Dermestril 25), transdermal patches 2 mg, 8 (Estraderm 25), transdermal patches 585 micrograms, 8, transdermal patches 3.28 mg, 8, transdermal patches 780 micrograms, 8, transdermal patches 3.8 mg, 4, transdermal patches 4 mg, 8 (Dermestril 50), transdermal patches 4 mg, 8 (Estraderm 50), transdermal patches 4.33 mg, 8, transdermal patches 1.17 mg, 8, transdermal patches 5.7 mg, 4, transdermal patches 6.57 mg, 8, transdermal patches 1.56 mg, 8, transdermal patches 7.6 mg, 4, transdermal patches 8 mg, 8 (Dermestril 100), transdermal patches 8 mg, 8 (Estraderm 100) and transdermal patches 8.66 mg, 8: | |
For use for post-menopausal symptoms where a trial of peri- or post-menopausal low-dose oestrogen therapy has demonstrated intolerance to oral oestrogens | |
Oestradiol and Oestradiol with Dydrogesterone | — |
Oestradiol and Oestradiol with Norethisterone Acetate | In respect of the pack containing 12 tablets oestradiol 2 mg, 10 tablets oestradiol 2 mg with norethisterone acetate 1 mg and 6 tablets oestradiol 1 mg: |
— | |
In respect of the pack containing 4 transdermal patches oestradiol 4 mg and 4 transdermal patches oestradiol 10 mg with norethisterone acetate 30 mg: | |
For use for post-menopausal symptoms where a trial of peri- or post-menopausal low-dose oestrogen therapy has demonstrated intolerance to oral oestrogens | |
Oestradiol Hemihydrate | For use for post-menopausal symptoms where a trial of peri- or post-menopausal low-dose oestrogen therapy has demonstrated intolerance to oral oestrogens |
Oestradiol Hemihydrate and Oestradiol Hemihydrate with Norethisterone Acetate | For use for post-menopausal symptoms where a trial of peri- or post-menopausal low-dose oestrogen therapy has demonstrated intolerance to oral oestrogens |
Oestradiol Hemihydrate with Norethisterone Acetate | In respect of the tablets equivalent to 1 mg oestradiol with 500 micrograms norethisterone acetate, 28 and tablets equivalent to 2 mg oestradiol with 1 mg norethisterone acetate, 28: |
— | |
In respect of the transdermal patches equivalent to 620 micrograms oestradiol with 2.7 mg norethisterone acetate, 8 and transdermal patches equivalent to 510 micrograms oestradiol with 4.8 mg norethisterone acetate, 8: | |
For use for post-menopausal symptoms where a trial of peri- or post-menopausal low-dose oestrogen therapy has demonstrated intolerance to oral oestrogens | |
Oestradiol Valerate | — |
Oestradiol Valerate and Oestradiol Valerate with Cyproterone Acetate | — |
Oestriol | — |
Oestrogens—Conjugated | — |
Oestrogens—Conjugated with Medroxyprogesterone Acetate | — |
Ofloxacin | In compliance with authority procedures set out in subparagraph 14 (d): |
Bacterial keratitis | |
Olanzapine | In compliance with authority procedures set out in subparagraph 14 (d): |
Schizophrenia | |
Maintenance treatment of bipolar I disorder | |
Olsalazine Sodium | In compliance with authority procedures set out in subparagraph 14 (d): |
Ulcerative colitis where hypersensitivity to sulfonamides exists | |
Ulcerative colitis where intolerance to sulfasalazine exists | |
Omeprazole | Initial treatment of peptic ulcer |
Gastro-oesophageal reflux disease | |
Scleroderma oesophagus | |
Zollinger-Ellison syndrome | |
Omeprazole and Clarithromycin and Amoxycillin Trihydrate | Eradication of Helicobacter pylori associated with peptic ulcer disease |
Omeprazole Magnesium | In respect of the tablet equivalent to 20 mg omeprazole: |
Initial treatment of peptic ulcer | |
Gastro-oesophageal reflux disease | |
Scleroderma oesophagus | |
Zollinger-Ellison syndrome | |
In respect of the tablet equivalent to 10 mg omeprazole: | |
Gastro-oesophageal reflux disease | |
Scleroderma oesophagus | |
Zollinger-Ellison syndrome | |
Ondansetron | Management of nausea and vomiting associated with cytotoxic chemotherapy being used to treat malignancy |
In compliance with authority procedures set out in subparagraph 14 (d): | |
Management of nausea and vomiting associated with radiotherapy being used to treat malignancy | |
Ondansetron Hydrochloride Dihydrate | In respect of the tablet equivalent to 4 mg ondansetron, tablet equivalent to 8 mg ondansetron, I.V. injection equivalent to 4 mg ondansetron in 2 mL ampoule and I.V. injection equivalent to 8 mg ondansetron in 4 mL ampoule: |
Management of nausea and vomiting associated with cytotoxic chemotherapy being used to treat malignancy | |
In compliance with authority procedures set out in subparagraph 14 (d): | |
Management of nausea and vomiting associated with radiotherapy being used to treat malignancy | |
In respect of the syrup equivalent to 4 mg ondansetron per 5 mL, 50 mL: | |
In compliance with authority procedures set out in subparagraph 14 (d): | |
Management of nausea and vomiting associated with radiotherapy being used to treat malignancy | |
Oxaliplatin | In compliance with authority procedures set out in subparagraph 14 (d): |
Metastatic colorectal cancer in patients with a World Health Organisation performance status of 2 or less, when used in combination with fluorouracil sodium and calcium folinate | |
Adjuvant treatment of stage III (Dukes C) colon cancer, in combination with fluorouracil sodium and calcium folinate, following complete resection of the primary tumour | |
Oxandrolone | In compliance with authority procedures set out in subparagraph 14 (d): |
Promotion of growth in girls with Turner syndrome where the date of confirmation of diagnosis is included in the authority application | |
Promotion of growth in boys of short stature with delayed bone maturation where the date of confirmation of diagnosis is included in the authority application | |
Oxazepam | — |
Oxcarbazepine | In compliance with authority procedures set out in subparagraph 14 (d): |
Treatment of partial epileptic seizures and primary generalised tonic-clonic seizures, which are not controlled satisfactorily by other anti-epileptic drugs | |
Oxprenolol Hydrochloride | — |
Oxybutynin Hydrochloride | Detrusor overactivity where propantheline bromide has failed |
Oxycodone Hydrochloride | In respect of the tablet 5 mg, capsule 5 mg, capsule 10 mg, capsule 20 mg and oral solution 5 mg per 5 mL, 250 mL: |
Severe disabling pain not responding to non-narcotic analgesics | |
In respect of the tablet 5 mg (controlled release), tablet 10 mg (controlled release), tablet 20 mg (controlled release), tablet 40 mg (controlled release) and tablet 80 mg (controlled release): | |
Chronic severe disabling pain not responding to non-narcotic analgesics | |
Oxycodone Pectinate | Severe disabling pain not responding to non-narcotic analgesics |
Paclitaxel | In compliance with authority procedures set out in subparagraph 14 (d): |
Adjuvant treatment of node-positive, oestrogen receptor negative, breast cancer administered sequentially to doxorubicin hydrochloride and cyclophosphamide | |
Advanced breast cancer after failure of prior therapy which includes an anthracycline | |
Advanced metastatic ovarian cancer after failure of prior therapy which includes a platinum compound | |
Primary treatment of ovarian cancer in combination with a platinum compound | |
Locally advanced or metastatic non-small cell lung cancer | |
Pancreatic Extract | — |
Pancrelipase | — |
Pantoprazole Sodium Sesquihydrate | In respect of the tablet (enteric coated), equivalent to 40 mg pantoprazole: |
Initial treatment of peptic ulcer | |
Gastro-oesophageal reflux disease | |
Scleroderma oesophagus | |
Zollinger-Ellison syndrome | |
In respect of the tablet (enteric coated), equivalent to 20 mg pantoprazole: | |
Gastro-oesophageal reflux disease | |
Paracetamol | In respect of the tablet 500 mg, oral liquid 120 mg per 5 mL, 100 mL and oral liquid 240 mg per 5 mL, 200 mL: |
— | |
In respect of the tablet 665 mg (modified release): | |
Relief of persistent pain associated with osteoarthritis | |
Paraffin - Soft White with Paraffin - Liquid | — |
Paroxetine Hydrochloride | Major depressive disorders |
Obsessive-compulsive disorder | |
Panic disorder | |
Pemetrexed Disodium Heptahydrate | In compliance with authority procedures set out in subparagraph 14 (d): |
Locally advanced or metastatic non-small cell lung cancer, after prior platinum-based chemotherapy | |
Locally advanced or metastatic non-small cell lung cancer, after prior platinum-based chemotherapy, where treatment with paclitaxel or docetaxel is contraindicated | |
Locally advanced or metastatic non-small cell lung cancer, after prior platinum-based chemotherapy, where intolerance to treatment with either docetaxel or paclitaxel has developed | |
Locally advanced or metastatic non-small cell lung cancer, after prior platinum-based chemotherapy, where treatment with either docetaxel or paclitaxel has been unsuccessful | |
Locally advanced or metastatic non-small cell lung cancer, after prior platinum-based chemotherapy, where transfer to docetaxel or paclitaxel is likely to result in adverse clinical consequences | |
Penicillamine | — |
\"Pepti-Junior\" | In compliance with authority procedures set out in subparagraph 14 (d): |
Initial treatment, for up to 3 months, for intolerance (not infant colic) to both cows' milk protein and soy protein in children up to the age of 2 years, where intolerance is demonstrated when the child has failed to respond to a strict cows' milk protein free diet with a soy protein as the principal formula, and where the date of birth of the patient is included in the authority application | |
Continuing treatment for intolerance (not infant colic) to both cows' milk protein and soy protein in children up to the age of 2 years, where clinical improvement has been demonstrated with the protein hydrolysate formula with medium chain triglycerides, and where the date of birth of the patient is included in the authority application | |
Continuing treatment for intolerance (not infant colic) to both cows' milk protein and soy protein in children aged 2 years and over, where the child has been assessed by a suitably qualified allergist or paediatrician, and where the date of birth of the patient is included in the authority application | |
Biliary atresia | |
Chronic liver failure with fat malabsorption | |
Chylous ascites | |
Cystic fibrosis | |
Enterokinase deficiency | |
Proven fat malabsorption | |
Severe diarrhoea of greater than 2 weeks' duration in infants under the age of 4 months, where the date of birth of the patient is included in the authority application | |
Severe intestinal malabsorption including short bowel syndrome | |
Pergolide Mesylate | Parkinson's disease as adjunctive therapy in patients being treated with levodopa—decarboxylase inhibitor combinations |
Perhexiline Maleate | In compliance with authority procedures set out in subparagraph 14 (d): |
Angina not responding to other therapy | |
Pericyazine | — |
Perindopril Erbumine | — |
Perindopril Erbumine with Indapamide Hemihydrate | Hypertension in patients who are not adequately controlled with either indapamide hemihydrate or perindopril erbumine monotherapy |
Permethrin | — |
Pethidine Hydrochloride | Short-term treatment of acute pain |
Phenelzine Sulfate | Depression where all other anti-depressant therapy has failed or is inappropriate |
\"Phenex-1\" | Phenylketonuria |
\"Phenex-2\" | Phenylketonuria |
Phenobarbitone | Epilepsy |
Phenobarbitone Sodium | Epilepsy |
Phenoxybenzamine Hydrochloride | Phaeochromocytoma |
Neurogenic urinary retention | |
Phenoxymethylpenicillin Benzathine | — |
Phenoxymethylpenicillin Potassium | — |
Phenytoin | — |
Phenytoin Sodium | — |
\"Phlexy-10\" | Phenylketonuria |
\"Phlexy-10 Drink Mix\" | Phenylketonuria |
Pilocarpine Hydrochloride | — |
Pimecrolimus | In compliance with authority procedures set out in subparagraph 14 (d): |
Treatment of facial or eyelid atopic dermatitis in patients aged between 3 months and 18 years who have 1 or more of the following contraindications to topical corticosteroids: | |
Short-term (up to 3 weeks) intermittent treatment of atopic dermatitis of the face or eyelids in patients aged between 3 months and 18 years who fail to achieve satisfactory disease control with intermittent topical corticosteroid therapy and where more than 3 months have passed since the initial diagnosis of atopic dermatitis; and | |
Pindolol | — |
Pioglitazone Hydrochloride | In compliance with authority procedures set out in subparagraph 14 (d): |
Initiation of therapy, in combination with either metformin hydrochloride or a sulfonylurea, in type 2 diabetic patients whose blood glucose concentrations are inadequately controlled and in whom therapy with metformin hydrochloride and a sulfonylurea in combination is contraindicated or not tolerated, where inadequate control of blood glucose is defined as glycosylated haemoglobin (Hb A1c) greater than 7% despite diet, exercise and maximally tolerated doses of metformin hydrochloride or a sulfonylurea, and where the authority application includes the patient's Hb A1c level determined by a measurement performed no earlier than 4 months prior to the date of the application, and the date of that measurement | |
Initiation of therapy, in combination with either metformin hydrochloride or a sulfonylurea, in type 2 diabetic patients whose blood glucose concentrations are inadequately controlled by therapy with metformin hydrochloride and a sulfonylurea in combination and which therapy the patient has continued to receive despite having developed intolerance or a contraindication to either agent, where inadequate control of blood glucose is defined as glycosylated haemoglobin (Hb A1c) greater than 7% despite diet, exercise and maximally tolerated doses of metformin hydrochloride or a sulfonylurea, and where the authority application includes the patient's Hb A1c level determined by a measurement performed no earlier than 4 months prior to the date of the application, and the date of that measurement | |
Continuation of therapy, in combination with either metformin hydrochloride or a sulfonylurea, in type 2 diabetic patients who have previously been issued with an authority prescription for pioglitazone hydrochloride or rosiglitazone maleate | |
Initiation of therapy, in combination with insulin, in insulin-treated type 2 diabetic patients whose blood glucose concentrations are inadequately controlled, where inadequate control of blood glucose is defined as glycosylated haemoglobin (Hb A1c) greater than 7% despite concomitant use of insulin and 1 or more oral anti-diabetic agents or despite use of insulin alone in patients where metformin hydrochloride would have been added to their treatment regimen had its use not been contraindicated, and where the authority application includes the patient's Hb A1c level determined by a measurement performed no earlier than 4 months prior to the date of the application, and the date of that measurement | |
Continuation of therapy, in combination with insulin, in type 2 diabetic patients who have previously been issued with an authority prescription for pioglitazone hydrochloride or rosiglitazone maleate Continuation of therapy, in combination with insulin and 1 or more other oral anti-diabetic agents, in type 2 diabetic patients who commenced treatment with pioglitazone hydrochloride prior to 1 November 2003 and who have previously been issued with an authority prescription for pioglitazone hydrochloride to be used in combination with insulin and 1 or more other oral anti-diabetic agents | |
Piperazine Oestrone Sulfate | — |
Piroxicam | Chronic arthropathies (including osteoarthritis) with an inflammatory component |
Pizotifen Malate | — |
\"PK AID II\" | Phenylketonuria |
\"PK Max\" | Phenylketonuria |
\"PKU Express Liquid\" | Phenylketonuria |
\"PKU-gel\" | Phenylketonuria |
\"PKU-Express\" | Phenylketonuria |
Pneumococcal Vaccine - Polyvalent | Splenectomised persons over 2 years of age |
Persons with Hodgkin's disease | |
Persons at high risk of pneumococcal infections | |
Polyethylene Glycol 400 with Propylene Glycol | Severe dry eye syndrome, including Sjogren's syndrome |
Polygeline | — |
Polymyxin B Sulfate with Bacitracin Zinc and Neomycin Sulfate | — |
Polyvinyl Alcohol | Severe dry eye syndrome, including Sjogren's syndrome |
Potassium Chloride | — |
Potassium Chloride with Potassium Bicarbonate | — |
Pravastatin Sodium | For use in accordance with paragraph 16 |
Prazosin Hydrochloride | — |
Prednisolone | — |
Prednisolone Acetate with Phenylephrine Hydrochloride | Corneal grafts Uveitis |
Prednisolone Sodium Phosphate | In respect of the oral solution equivalent to 5 mg prednisolone per mL, 30 mL and enema, retention, equivalent to 20 mg prednisolone in 100 mL: |
— | |
In respect of the suppositories equivalent to 5 mg prednisolone, 10: | |
Proctitis | |
Ulcerative colitis | |
Prednisone | — |
Primidone | — |
\"Pro-Phree\" | Patients with proven inborn errors of protein metabolism who are unable to meet their energy requirements with permitted food and formulae |
Probenecid | — |
Procaine Penicillin | — |
Prochlorperazine | — |
Prochlorperazine Maleate | — |
Prochlorperazine Mesylate | — |
Promethazine Hydrochloride | — |
Propantheline Bromide | Detrusor overactivity |
Propranolol Hydrochloride | — |
Propylthiouracil | — |
Pyrantel Embonate | — |
Pyridostigmine Bromide | — |
Pyrimethamine | — |
Quetiapine Fumarate | In compliance with authority procedures set out in subparagraph 14 (d): |
Schizophrenia | |
Quinagolide Hydrochloride | In compliance with authority procedures set out in subparagraph 14 (d): |
Pathological hyperprolactinaemia where surgery is not indicated | |
Pathological hyperprolactinaemia where surgery has already been used with incomplete resolution | |
Pathological hyperprolactinaemia where radiotherapy is not indicated | |
Pathological hyperprolactinaemia where radiotherapy has already been used with incomplete resolution | |
Quinapril Hydrochloride | — |
Quinapril Hydrochloride with Hydrochlorothiazide | Hypertension in patients who are not adequately controlled with either hydrochlorothiazide or quinapril hydrochloride monotherapy |
Quinidine Bisulfate | — |
Quinine Bisulfate | In compliance with authority procedures set out in subparagraph 14 (d): |
Malaria | |
Quinine Sulfate | In compliance with authority procedures set out in subparagraph 14 (d): |
Malaria | |
Rabeprazole Sodium | In respect of the tablet 20 mg (enteric coated): |
Initial treatment of peptic ulcer | |
Gastro-oesophageal reflux disease | |
Scleroderma oesophagus | |
In respect of the tablet 10 mg (enteric coated): | |
Gastro-oesophageal reflux disease | |
Scleroderma oesophagus | |
Raloxifene Hydrochloride | In compliance with authority procedures set out in subparagraph 14 (d): |
Initial treatment for established post-menopausal osteoporosis in patients with fracture due to minimal trauma, where the fracture has been demonstrated radiologically and the year of plain x-ray or computed tomography scan or magnetic resonance imaging scan is included in the authority application, provided that if the fracture is a vertebral fracture, there is a 20% or greater reduction in height of the anterior or mid portion of the affected vertebral body relative to the posterior height of that body, or, a 20% or greater reduction in any of these heights compared to the vertebral body above or below the affected vertebral body | |
Continuing treatment for established post-menopausal osteoporosis in patients with fracture due to minimal trauma, where the patient has previously been issued with an authority prescription for this drug | |
Raltitrexed | In compliance with authority procedures set out in subparagraph 14 (d): |
For use as a single agent in the treatment of advanced colorectal cancer | |
Ramipril | — |
Ranitidine Hydrochloride | — |
\"RCF\" | Patients with intractable seizures requiring treatment with a ketogenic diet |
Glucose transport protein defects | |
Pyruvate dehydrogenase deficiency | |
Infants and young children with glucose-galactose intolerance and multiple monosaccharide intolerance | |
Reboxetine Mesilate | Major depressive disorders |
Reteplase | Treatment of acute myocardial infarction within 6 hours of onset of attack |
Rifampicin | In respect of the capsule 150 mg and capsule 300 mg: |
Prophylaxis of meningococcal disease in close contacts and carriers | |
Prophylactic treatment of contacts of patients with Haemophilus influenzae type B | |
In compliance with authority procedures set out in subparagraph 14 (d): | |
Leprosy in adults | |
In respect of the syrup 100 mg per 5 mL, 60 mL: | |
Prophylaxis of meningococcal disease in close contacts and carriers | |
Prophylactic treatment of contacts of patients with Haemophilus influenzae type B | |
Riluzole | In compliance with authority procedures set out in subparagraph 14 (d): |
Initial treatment of amyotrophic lateral sclerosis, as diagnosed by a neurologist, in patients aged 75 years or less with disease duration of 2 years or less who have at least 60 percent of predicted forced vital capacity within 2 months prior to commencing riluzole therapy, and who have not undergone tracheostomy, have not experienced respiratory failure and, if not ambulatory, are either able to use upper limbs or able to swallow, and where the date of diagnosis and the date and results of spirometry (in terms of percent of predicted forced vital capacity) are included in the authority application | |
Initial PBS-subsidised treatment of amyotrophic lateral sclerosis for patients receiving treatment with riluzole prior to 1 March 2003 who would have qualified under the initial treatment criteria for PBS subsidy and where the date of diagnosis, date of commencement of riluzole treatment and the date and results of spirometry (in terms of percent of predicted forced vital capacity) are included in the authority application | |
Continuing treatment of amyotrophic lateral sclerosis in patients who have previously been issued with an authority prescription for this drug and who have not undergone tracheostomy, have not experienced respiratory failure and, if not ambulatory, are either able to use upper limbs or able to swallow | |
Risedronate Sodium | In respect of the tablet 5 mg and tablet 35 mg: |
In compliance with authority procedures set out in subparagraph 14 (d): | |
Initial treatment for established osteoporosis in patients with fracture due to minimal trauma, where the fracture has been demonstrated radiologically and the year of plain x-ray or computed tomography scan or magnetic resonance imaging scan is included in the authority application, provided that if the fracture is a vertebral fracture, there is a 20% or greater reduction in height of the anterior or mid portion of the affected vertebral body relative to the posterior height of that body, or, a 20% or greater reduction in any of these heights compared to the vertebral body above or below the affected vertebral body | |
Continuing treatment for established osteoporosis in patients with fracture due to minimal trauma, where the patient has previously been issued with an authority prescription for this drug | |
In respect of the tablet 30 mg: | |
In compliance with authority procedures set out in subparagraph 14 (d): | |
Symptomatic Paget's disease of bone | |
Risperidone | In respect of the tablet 0.5 mg, tablet 0.5 mg (orally disintegrating), tablet 1 mg and tablet 1 mg (orally disintegrating): |
In compliance with authority procedures set out in subparagraph 14 (d): | |
Behavioural disturbances characterised by psychotic symptoms and aggression in patients with dementia where non-pharmacological methods have been unsuccessful | |
Schizophrenia | |
In respect of the oral solution 1 mg per mL, 30 mL: | |
In compliance with authority procedures set out in subparagraph 14 (d): | |
Behavioural disturbances characterised by psychotic symptoms and aggression in patients with dementia where non-pharmacological methods have been unsuccessful | |
In respect of the tablet 2 mg, tablet 2 mg (orally disintegrating), tablet 3 mg, tablet 4 mg, oral solution 1 mg per mL, 100 mL, I.M. injection (modified release), set containing 1 vial powder for injection 25 mg, 1 pre-filled syringe diluent 2 mL and 3 needles, I.M. injection (modified release), set containing 1 vial powder for injection 37.5 mg, 1 pre-filled syringe diluent 2 mL and 3 needles and I.M. injection (modified release), set containing 1 vial powder for injection 50 mg, 1 pre-filled syringe diluent 2 mL and 3 needles: | |
In compliance with authority procedures set out in subparagraph 14 (d): | |
Schizophrenia | |
Rituximab | In compliance with authority procedures set out in subparagraph 14 (d): |
Relapsed or refractory low-grade B-cell non-Hodgkin's lymphoma | |
Relapsed or refractory follicular B-cell non-Hodgkin's lymphoma | |
Treatment of previously untreated, CD20 positive, diffuse large B-cell non-Hodgkin's lymphoma, in combination with chemotherapy | |
Rivastigmine Hydrogen Tartrate | In compliance with authority procedures set out in subparagraph 14 (d): |
Initial treatment, for up to 2 months, of mild to moderately severe Alzheimer's disease in patients with a baseline Mini-Mental State Examination score of 10 or more, where the diagnosis is confirmed by a specialist or consultant physician, and where the result of the baseline Mini-Mental State Examination and, if this result is at least 25 points, the result of the baseline Alzheimer's Disease Assessment Scale, cognitive sub-scale, are included in the authority application In compliance with authority procedures set out in subsubparagraph 14 (d)(i): Continuation of initial treatment of mild to moderately severe Alzheimer's disease in patients with a baseline Mini-Mental State Examination score of 10 or more, where the patient has previously been issued with an authority prescription for initial treatment with this drug for a period of up to 2 months, where the application confirms the information which established the patient's eligibility for initial treatment, and where approval of the application would enable the patient to complete a period of initial treatment of not more than 6 months of uninterrupted therapy Initial treatment, for up to 6 months, of mild to moderately severe Alzheimer's disease in patients with a baseline Mini-Mental State Examination score of 10 or more, where the diagnosis is confirmed by a specialist or consultant physician, and where the result of the baseline Mini-Mental State Examination and, if this result is at least 25 points, the result of the baseline Alzheimer's Disease Assessment Scale, cognitive sub-scale, are included in the authority application | |
Continuing treatment of mild to moderately severe Alzheimer's disease in patients with a baseline Mini-Mental State Examination score of 10 or more who demonstrate improvement in cognitive function following initial therapy, as measured by an increase of at least 2 points from baseline on the Mini-Mental State Examination, or a decrease of at least 4 points from baseline on the Alzheimer's Disease Assessment Scale, cognitive sub-scale, for patients with a Mini-Mental State Examination baseline score of at least 25 points, where the relevant result from the Mini-Mental State Examination or the Alzheimer's Disease Assessment Scale, cognitive sub-scale, is included in the authority application for continuing treatment In compliance with authority procedures set out in subparagraph 14 (d): Continuing treatment of mild to moderately severe Alzheimer's disease in patients with a baseline Mini-Mental State Examination score of 10 or more and with demonstrated improvement in cognitive function following initial therapy, where the patient has previously been issued with an authority prescription for continuing treatment | |
Initial treatment, for up to 2 months, of mild to moderately severe Alzheimer's disease in patients with a baseline Mini-Mental State Examination score of 9 or less, who are unable to register a score of 10 or more for reasons other than their Alzheimer's disease as they are from 1 or more of the following groups, where the diagnosis is confirmed by a specialist or consultant physician, and where the authority application includes the result of the baseline Mini-Mental State Examination and specifies to which of the groups the patient belongs: Unable to communicate adequately because of lack of competence in English, in people of non-English speaking background Limited education, as defined by less than 6 years of education, or who are illiterate or innumerate; Aboriginal or Torres Strait Islanders who, by virtue of cultural factors, are unable to complete a Mini-Mental State Examination test; Intellectual (developmental or acquired) disability; Significant sensory impairment despite best correction, which precludes completion of a Mini-Mental State Examination test; Prominent dysphasia, out of proportion to other cognitive and functional impairment In compliance with authority procedures set out in subsubparagraph 14 (d)(i): Continuation of initial treatment of mild to moderately severe Alzheimer's disease in patients with a baseline Mini-Mental State Examination score of 9 or less, who are unable to register a score of 10 or more for reasons other than their Alzheimer's disease, where the patient has previously been issued with an authority prescription for initial treatment with this drug for a period of up to 2 months, where the application confirms the information which established the patient's eligibility for initial treatment, and where approval of the application would enable the patient to complete a period of initial treatment of not more than 6 months of uninterrupted therapy Initial treatment, for up to 6 months, of mild to moderately severe Alzheimer's disease in patients with a baseline Mini-Mental State Examination score of 9 or less, who are unable to register a score of 10 or more for reasons other than their Alzheimer's disease as they are from 1 or more of the following groups, where the diagnosis is confirmed by a specialist or consultant physician, and where the authority application includes the result of the baseline Mini-Mental State Examination and specifies to which of the groups the patient belongs: Unable to communicate adequately because of lack of competence in English, in people of non-English speaking background; Limited education, as defined by less than 6 years of education, or who are illiterate or innumerate; Aboriginal or Torres Strait Islanders who, by virtue of cultural factors, are unable to complete a Mini-Mental State Examination test; Intellectual (developmental or acquired) disability; Significant sensory impairment despite best correction, which precludes completion of a Mini-Mental State Examination test; Prominent dysphasia, out of proportion to other cognitive and functional impairment | |
Continuing treatment of mild to moderately severe Alzheimer's disease in eligible patients with a baseline Mini-Mental State Examination score of 9 or less who are unable to register a score of 10 or more for reasons other than their Alzheimer's disease and who demonstrate improvement in function following initial therapy, based on a rating of very much improved or much improved on the Clinicians Interview Based Impression of Change scale, as assessed by the same clinician who initiated treatment, and where the improvement rating achieved on the Clinicians Interview Based Impression of Change scale is stated in the authority application for continuing treatment In compliance with authority procedures set out in subparagraph 14 (d): Continuing treatment of mild to moderately severe Alzheimer's disease in eligible patients with a baseline Mini-Mental State Examination score of 9 or less and with demonstrated improvement in function following initial therapy, where the patient has previously been issued with an authority prescription for continuing treatment | |
Rosiglitazone Maleate | In compliance with authority procedures set out in subparagraph 14 (d): |
Initiation of therapy, in combination with 1 or more oral hypoglycaemic agents, in type 2 diabetic patients: | |
Continuing therapy, in combination with 1 or more oral hypoglycaemic agents, in type 2 diabetic patients who have previously been issued with an authority prescription for rosiglitazone maleate or pioglitazone hydrochloride | |
Initiation of therapy, in combination with insulin, in insulin-treated type 2 diabetic patients whose blood glucose concentrations are inadequately controlled, where inadequate control of blood glucose is defined as glycosylated haemoglobin (Hb A1c) greater than 7% despite concomitant use of insulin and 1 or more oral anti-diabetic agents or despite use of insulin alone in patients where metformin hydrochloride would have been added to their treatment regimen had its use not been contraindicated, and where the authority application includes the patient's Hb A1c level determined by a measurement performed no earlier than 4 months prior to the date of the application, and the date of that measurement | |
Continuation of therapy, in combination with insulin, in type 2 diabetic patients who have previously been issued with an authority prescription for rosiglitazone maleate or pioglitazone hydrochloride | |
Roxithromycin | — |
\"S-26 LF\" | In compliance with authority procedures set out in subparagraph 14 (d): |
Acute lactose intolerance in patients up to the age of 12 months, where the date of birth of the patient is included in the authority application and where the patient has not previously been issued with an authority prescription for this medicinal preparation for this purpose | |
Proven chronic lactose intolerance in patients up to the age of 12 months, where the date of birth of the patient is included in the authority application, and where lactose intolerance has been proven either by the relief of symptoms on supervised withdrawal of lactose from the diet for 3 or 4 days and subsequent re-emergence of symptoms on rechallenge with lactose containing formulae or milk or food, or by the presence of not less than 0.5% reducing substance in stool exudate tested with copper sulfate diagnostic compound tablet | |
Salbutamol Sulfate | In respect of the oral solution equivalent to 2 mg salbutamol per 5 mL, 150 mL, capsule containing powder for oral inhalation equivalent to 200 micrograms salbutamol (for use in Ventolin Rotahaler) and pressurised inhalation equivalent to 100 micrograms salbutamol per dose, 200 doses (CFC-free formulation): |
— | |
In respect of the pressurised inhalation in breath actuated device equivalent to 100 micrograms salbutamol per dose, 200 doses (CFC-free formulation): | |
Patients unable to achieve co-ordinated use of other metered dose inhalers containing this drug | |
In respect of the nebuliser solution equivalent to 2.5 mg salbutamol in 2.5 mL single dose units, 30, nebuliser solution equivalent to 5 mg salbutamol in 2.5 mL single dose units, 30 and nebuliser solution equivalent to 5 mg salbutamol per mL, 30 mL: | |
Asthma in patients unable to use this drug delivered from an oral pressurised inhalation device via a spacer | |
Chronic obstructive pulmonary disease in patients unable to use this drug delivered from an oral pressurised inhalation device via a spacer | |
Salcatonin | In compliance with authority procedures set out in subparagraph 14 (d): |
Symptomatic Paget's disease of bone | |
Treatment initiated in a hospital (in-patient or out-patient) of hypercalcaemia | |
Salmeterol Xinafoate | Patients with frequent episodes of asthma who are currently receiving treatment with oral corticosteroids |
Patients with frequent episodes of asthma who are currently receiving treatment with optimal doses of inhaled corticosteroids | |
Selegiline Hydrochloride | Late stage Parkinson's disease as adjunctive therapy in patients being treated with levodopa—decarboxylase inhibitor combinations |
Sertraline Hydrochloride | Major depressive disorders |
Obsessive-compulsive disorder | |
Panic disorder where other treatments have failed or are inappropriate | |
Silver Sulfadiazine with Chlorhexidine Gluconate | Prevention and treatment of infection in partial or full skin thickness loss due to burns |
Prevention and treatment of infection in partial or full skin thickness loss due to epidermolysis bullosa | |
Stasis ulcers | |
Simvastatin | For use in accordance with paragraph 16 |
Sirolimus | In compliance with authority procedures set out in subparagraph 14 (d): |
Maintenance therapy of patients with renal transplants following initiation and stabilisation of treatment with sirolimus, where therapy remains under the supervision and direction of the transplant unit reviewing that patient and where the name of the specialised transplant unit reviewing treatment and the date of the latest review at the specialised transplant unit are included in the authority application | |
Sodium Acid Phosphate | In compliance with authority procedures set out in subparagraph 14 (d): |
Familial hypophosphataemia | |
Hypercalcaemia | |
Hypophosphataemic rickets | |
Vitamin D-resistant rickets | |
Sodium Alginate with Calcium Carbonate and Sodium Bicarbonate | — |
Sodium Aurothiomalate | — |
Sodium Chloride | — |
Sodium Chloride with Glucose | — |
Sodium Chloride with Potassium Chloride and Calcium Chloride | — |
Sodium Chloride with Sodium Acetate, Sodium Gluconate, Potassium Chloride and Magnesium Chloride | — |
Sodium Clodronate Tetrahydrate | Maintenance treatment of hypercalcaemia of malignancy refractory to anti-neoplastic therapy |
Multiple myeloma | |
Bone metastases from breast cancer | |
Sodium Cromoglycate | In respect of the capsule containing powder for oral inhalation 20 mg (for use in Intal Spinhaler or Intal Halermatic), solution for inhalation 20 mg in 2 mL ampoule, pressurised inhalation 1 mg per dose, 200 doses, pressurised inhalation 1 mg per dose, 200 doses (CFC-free formulation) and pressurised inhalation 5 mg per dose, 112 doses (CFC-free formulation): |
— | |
In respect of the eye drops 20 mg per mL, 10 mL: | |
In compliance with authority procedures set out in subparagraph 14 (d): | |
Vernal kerato-conjunctivitis | |
Sodium Fusidate | For use in combination with another antibiotic in the treatment of proven serious staphylococcal infections |
Sodium Lactate with Sodium Chloride, Potassium Chloride and Calcium Chloride | — |
Sodium Valproate | — |
Sorbitol with Sodium Citrate and Sodium Lauryl Sulfoacetate | Paraplegic and quadriplegic patients and others with severe neurogenic impairment of bowel function |
Patients who are receiving long-term nursing care on account of age, infirmity or other condition in hospitals, nursing homes or residential facilities | |
For use by a patient who is receiving long-term nursing care and in respect of whom a Carer Allowance is payable as a disabled adult | |
Patients receiving palliative care | |
Terminal malignant neoplasia | |
Anorectal congenital abnormalities | |
Megacolon | |
Sotalol Hydrochloride | Severe cardiac arrhythmias |
Spironolactone | Hyperaldosteronism, including refractory cardiac failure |
Female hirsutism | |
Sterculia with Frangula Bark | Paraplegic and quadriplegic patients and others with severe neurogenic impairment of bowel function |
Patients who are receiving long-term nursing care on account of age, infirmity or other condition in hospitals, nursing homes or residential facilities | |
For use by a patient who is receiving long-term nursing care and in respect of whom a Carer Allowance is payable as a disabled adult | |
Patients receiving palliative care | |
Terminal malignant neoplasia | |
Anorectal congenital abnormalities | |
Megacolon | |
Sucralfate | — |
Sulfacetamide Sodium | — |
Sulfasalazine | — |
Sulindac | Chronic arthropathies (including osteoarthritis) with an inflammatory component |
Bone pain due to malignant disease | |
Sulthiame | — |
Sumatriptan | In compliance with authority procedures set out in subparagraph 14 (d): |
Migraine attacks in patients receiving, or who have failed a reasonable trial of, prophylactic medication and where attacks in the past have usually failed to respond to oral therapy with ergotamine and other appropriate agents, or in whom these agents are contraindicated | |
Sumatriptan Succinate | In compliance with authority procedures set out in subparagraph 14 (d): |
Migraine attacks in patients receiving, or who have failed a reasonable trial of, prophylactic medication and where attacks in the past have usually failed to respond to oral therapy with ergotamine and other appropriate agents, or in whom these agents are contraindicated | |
Tacrolimus | In compliance with authority procedures set out in subparagraph 14 (d): |
Maintenance therapy of patients with liver transplants following initiation and stabilisation of treatment with tacrolimus, where therapy remains under the supervision and direction of the transplant unit reviewing that patient and where the name of the specialised transplant unit reviewing treatment and the date of the latest review at the specialised transplant unit are included in the authority application | |
Maintenance therapy of patients with renal transplants following initiation and stabilisation of treatment with tacrolimus, where therapy remains under the supervision and direction of the transplant unit reviewing that patient and where the name of the specialised transplant unit reviewing treatment and the date of the latest review at the specialised transplant unit are included in the authority application | |
Tamoxifen Citrate | Treatment of hormone-dependent breast cancer |
Telmisartan | — |
Telmisartan with Hydrochlorothiazide | Hypertension in patients who are not adequately controlled with either hydrochlorothiazide or telmisartan monotherapy |
Temazepam | — |
Temozolomide | In respect of the capsule 5 mg, capsule 20 mg and capsule 100 mg: |
In compliance with authority procedures set out in subparagraph 14 (d): | |
Glioblastoma multiforme concomitantly with radiotherapy | |
Recurrence of anaplastic astrocytoma following standard therapy | |
Recurrence of glioblastoma multiforme following standard therapy | |
Glioblastoma multiforme following radiotherapy | |
In respect of the capsule 250 mg: | |
In compliance with authority procedures set out in subparagraph 14 (d): | |
Recurrence of anaplastic astrocytoma following standard therapy | |
Recurrence of glioblastoma multiforme following standard therapy | |
Glioblastoma multiforme following radiotherapy | |
Tenecteplase | Treatment of acute myocardial infarction within 12 hours of onset of attack |
Terbinafine Hydrochloride | In compliance with authority procedures set out in subparagraph 14 (d): |
Proximal or extensive (greater than 80% nail involvement) onychomycosis due to dermatophyte infection where topical treatment has failed, where the infection is proven by microscopy or culture and confirmed by an Approved Pathology Authority not more than 12 months prior to the date of the authority application and where the date of the pathology report is included in the authority application | |
Terbutaline Sulfate | In respect of the injection 500 micrograms in 1 mL ampoule and powder for oral inhalation in breath actuated device 500 micrograms per dose, 200 doses: |
— | |
In respect of the nebuliser solution 5 mg in 2 mL single dose units, 30: | |
Asthma in patients unable to use this drug delivered from a breath actuated device | |
Chronic obstructive pulmonary disease in patients unable to use this drug delivered from a breath actuated device | |
Testosterone | In compliance with authority procedures set out in subparagraph 14 (d): |
Androgen deficiency in males with established pituitary or testicular disorders | |
Androgen deficiency in males 40 years and older who do not have established pituitary or testicular disorders other than aging, confirmed by at least 2 morning blood samples taken on different mornings, where androgen deficiency is confirmed by testosterone less than 8 nmol per L, or from 8 to 15 nmol per L with luteinising hormone greater than 1.5 times the upper limit of the eugonadal reference range for young men | |
Micropenis, pubertal induction, or constitutional delay of growth or puberty, in males under 18 years of age | |
Testosterone Enanthate | In compliance with authority procedures set out in subparagraph 14 (d): |
Androgen deficiency in males with established pituitary or testicular disorders | |
Androgen deficiency in males 40 years and older who do not have established pituitary or testicular disorders other than aging, confirmed by at least 2 morning blood samples taken on different mornings, where androgen deficiency is confirmed by testosterone less than 8 nmol per L, or from 8 to 15 nmol per L with luteinising hormone greater than 1.5 times the upper limit of the eugonadal reference range for young men | |
Micropenis, pubertal induction, or constitutional delay of growth or puberty, in males under 18 years of age | |
Testosterone Propionate with Testosterone Phenylpropionate and Testosterone Isocaproate | In compliance with authority procedures set out in subparagraph 14 (d): Androgen deficiency in males with established pituitary or testicular disorders |
Androgen deficiency in males 40 years and older who do not have established pituitary or testicular disorders other than aging, confirmed by at least 2 morning blood samples taken on different mornings, where androgen deficiency is confirmed by testosterone less than 8 nmol per L, or from 8 to 15 nmol per L with luteinising hormone greater than 1.5 times the upper limit of the eugonadal reference range for young men | |
Micropenis, pubertal induction, or constitutional delay of growth or puberty, in males under 18 years of age | |
Testosterone Propionate with Testosterone Phenylpropionate, Testosterone Isocaproate and Testosterone Decanoate | In compliance with authority procedures set out in subparagraph 14 (d): Androgen deficiency in males with established pituitary or testicular disorders |
Androgen deficiency in males 40 years and older who do not have established pituitary or testicular disorders other than aging, confirmed by at least 2 morning blood samples taken on different mornings, where androgen deficiency is confirmed by testosterone less than 8 nmol per L, or from 8 to 15 nmol per L with luteinising hormone greater than 1.5 times the upper limit of the eugonadal reference range for young men | |
Micropenis, pubertal induction, or constitutional delay of growth or puberty, in males under 18 years of age | |
Testosterone Undecanoate | In compliance with authority procedures set out in subparagraph 14 (d): |
Androgen deficiency in males with established pituitary or testicular disorders | |
Androgen deficiency in males 40 years and older who do not have established pituitary or testicular disorders other than aging, confirmed by at least 2 morning blood samples taken on different mornings, where androgen deficiency is confirmed by testosterone less than 8 nmol per L, or from 8 to 15 nmol per L with luteinising hormone greater than 1.5 times the upper limit of the eugonadal reference range for young men | |
Micropenis, pubertal induction, or constitutional delay of growth or puberty, in males under 18 years of age | |
Tetanus Vaccine - Adsorbed | — |
Tetrabenazine | In compliance with authority procedures set out in subparagraph 14 (d): |
Hyperkinetic extrapyramidal disorders | |
Tetracosactrin | — |
Theophylline | — |
Thioguanine | — |
Thioridazine Hydrochloride | In compliance with authority procedures set out in subparagraph 14 (d): |
Management of patients with schizophrenia who have failed to respond adequately to treatment with appropriate courses of at least 2 other antipsychotic drugs, at an adequate dose and for an adequate duration, because of insufficient effectiveness | |
Management of patients with schizophrenia who have failed to respond adequately to treatment with appropriate courses of at least 2 other antipsychotic drugs, at an adequate dose and for an adequate duration, because of the inability to achieve an effective dose due to intolerable adverse effects from those drugs | |
Thiotepa | — |
Thyroxine Sodium | — |
Tiagabine Hydrochloride | In compliance with authority procedures set out in subparagraph 14 (d): |
Treatment of partial epileptic seizures which are not controlled satisfactorily by other anti-epileptic drugs | |
Tiaprofenic Acid | Chronic arthropathies (including osteoarthritis) with an inflammatory component |
Ticarcillin Sodium with Potassium Clavulanate | Infections where positive bacteriological evidence confirms that this antibiotic is an appropriate therapeutic agent |
Septicaemia, suspected | |
Septicaemia, proven | |
Ticlopidine Hydrochloride | In compliance with authority procedures set out in subparagraph 14 (d): |
Prevention of recurrence of ischaemic stroke or transient cerebral ischaemic events: | |
in patients with a history of symptomatic cerebrovascular ischaemic episodes while on therapy with low-dose aspirin | |
in patients where low-dose aspirin poses an unacceptable risk of gastrointestinal bleeding | |
in patients where there is a history of anaphylaxis, urticaria or asthma within 4 hours of ingestion of aspirin, other salicylates, or non-steroidal anti-inflammatory drugs | |
Patients established on this drug as a pharmaceutical benefit prior to 1 November 1999 | |
Tiludronate Disodium | In compliance with authority procedures set out in subparagraph 14 (d): |
Symptomatic Paget's disease of bone | |
Timolol Maleate | — |
Tinidazole | — |
Tiotropium Bromide Monohydrate | For the long-term maintenance treatment of bronchospasm and dyspnoea associated with chronic obstructive pulmonary disease |
Tirofiban Hydrochloride | In compliance with authority procedures set out in subparagraph 14 (d): |
Patients with high risk unstable angina who have new transient or persistent ST-T ischaemic changes and anginal pain lasting longer than 20 minutes | |
Patients with high risk unstable angina who have new transient or persistent ST-T ischaemic changes and repetitive episodes of angina at rest or during minimal exercise in the previous 12 hours | |
Patients with non-Q-wave myocardial infarction | |
Tobramycin | Invasive ocular infection |
Perioperative use in ophthalmic surgery | |
Suspected pseudomonal eye infection | |
Tobramycin Sulfate | Infections where positive bacteriological evidence confirms that this antibiotic is an appropriate therapeutic agent |
Septicaemia, suspected | |
Septicaemia, proven | |
Topiramate | In compliance with authority procedures set out in subparagraph 14 (d): |
Treatment of partial epileptic seizures, primary generalised tonic-clonic epileptic seizures and seizures of the Lennox-Gastaut syndrome, which are not controlled satisfactorily by other anti-epileptic drugs | |
Treatment of partial epileptic seizures, primary generalised tonic-clonic epileptic seizures and seizures of the Lennox-Gastaut syndrome, which are not controlled satisfactorily by other anti-epileptic drugs, and where adverse events have occurred with other suitable drugs available under the Pharmaceutical Benefits Scheme | |
Treatment of partial epileptic seizures, primary generalised tonic-clonic epileptic seizures and seizures of the Lennox-Gastaut syndrome, which are not controlled satisfactorily by other anti-epileptic drugs, and where drug interactions have occurred with other suitable drugs available under the Pharmaceutical Benefits Scheme | |
Treatment of partial epileptic seizures, primary generalised tonic-clonic epileptic seizures and seizures of the Lennox-Gastaut syndrome, which are not controlled satisfactorily by other anti-epileptic drugs, and where drug interactions are expected to occur with other suitable drugs available under the Pharmaceutical Benefits Scheme | |
Treatment of partial epileptic seizures, primary generalised tonic-clonic epileptic seizures and seizures of the Lennox-Gastaut syndrome, which are not controlled satisfactorily by other anti-epileptic drugs, and where transfer to another suitable drug available under the Pharmaceutical Benefits Scheme would cause patient confusion resulting in problems with compliance | |
Treatment of partial epileptic seizures, primary generalised tonic-clonic epileptic seizures and seizures of the Lennox-Gastaut syndrome, which are not controlled satisfactorily by other anti-epileptic drugs, and where transfer to another suitable drug available under the Pharmaceutical Benefits Scheme is likely to result in adverse clinical consequences | |
Topotecan Hydrochloride | In compliance with authority procedures set out in subparagraph 14 (d): |
Advanced metastatic ovarian cancer after failure of prior therapy which includes a platinum compound | |
Toremifene Citrate | Treatment of hormone-dependent metastatic breast cancer in post-menopausal patients |
Tramadol Hydrochloride | In respect of the capsule 50 mg: |
For acute pain where aspirin or paracetamol alone is inappropriate or has failed | |
For dosage titration in chronic pain where aspirin or paracetamol alone is inappropriate or has failed | |
In respect of the tablet 100 mg (sustained release), tablet 150 mg (sustained release), tablet 200 mg (sustained release) and oral drops 100 mg per mL, 10 mL: | |
For pain where aspirin or paracetamol alone is inappropriate or has failed | |
In respect of the injection 100 mg in 2 mL ampoule: | |
Short-term treatment of acute pain | |
Trandolapril | — |
Tranexamic Acid | — |
Tranylcypromine Sulfate | — |
Travoprost | — |
Triamcinolone Acetonide | In respect of the injection 10 mg in 1 mL ampoule: |
Alopecia areata | |
For local intra-articular or peri-articular infiltration | |
Granulomata, dermal | |
Keloid | |
Lichen planus hypertrophic | |
Lichen simplex chronicus | |
Lupus erythematosus, chronic discoid | |
Necrobiosis lipoidica | |
Psoriasis | |
In respect of the cream 200 micrograms per g, 100 g and ointment 200 micrograms per g, 100 g: | |
Treatment of corticosteroid-responsive dermatoses | |
Triamcinolone Acetonide with Neomycin Sulfate, Gramicidin and Nystatin | — |
Trifluoperazine Hydrochloride | — |
Triglycerides Oil - Medium Chain | In compliance with authority procedures set out in subparagraph 14 (d): |
Chylous ascites | |
Chylothorax | |
Fat malabsorption due to liver disease, short gut syndrome, cystic fibrosis or gastrointestinal disorders | |
Hyperlipoproteinaemia type 1 | |
Intractable childhood epilepsy or cerebrospinal fluid glucose transporter defect, requiring a ketogenic diet | |
Long chain fatty acid oxidation disorders | |
Trimethoprim | — |
Trimethoprim with Sulfamethoxazole | — |
Tropisetron Hydrochloride | Management of nausea and vomiting associated with cytotoxic chemotherapy being used to treat malignancy |
\"TYR gel\" | Tyrosinaemia |
\"TYR Express\" | Tyrosinaemia |
Ursodeoxycholic Acid | In compliance with authority procedures set out in subparagraph 14 (d): |
Primary biliary cirrhosis | |
Valaciclovir Hydrochloride | In compliance with authority procedures set out in subparagraph 14 (d): |
Moderate to severe initial genital herpes | |
Episodic treatment or suppressive therapy of moderate to severe recurrent genital herpes, where the diagnosis is confirmed microbiologically (by viral culture, antigen detection or nucleic acid amplification by polymerase chain reaction) but where commencement of treatment need not await confirmation of diagnosis | |
Treatment of patients with herpes zoster within 72 hours of the onset of the rash | |
Herpes zoster ophthalmicus | |
Vancomycin Hydrochloride | In respect of the powder for injection equivalent to 500 mg (500,000 I.U.) vancomycin activity: |
Prophylaxis of endocarditis in patients hypersensitive to penicillin | |
Endophthalmitis | |
Use initiated in a hospital for infections where vancomycin hydrochloride is an appropriate antibiotic | |
In respect of the capsule equivalent to 125 mg (125,000 I.U.) vancomycin activity and capsule equivalent to 250 mg (250,000 I.U.) vancomycin activity: | |
In compliance with authority procedures set out in subparagraph 14 (d): | |
Antibiotic associated pseudomembranous colitis due to Clostridium difficile which is unresponsive to metronidazole | |
Antibiotic associated pseudomembranous colitis due to Clostridium difficile where there is intolerance to metronidazole | |
Venlafaxine Hydrochloride | Major depressive disorders |
Verapamil Hydrochloride | — |
Vigabatrin | In compliance with authority procedures set out in subparagraph 14 (d): |
Treatment of epileptic seizures which are not controlled satisfactorily by other anti-epileptic drugs | |
Vinblastine Sulfate | — |
Vincristine Sulfate | — |
Vinorelbine Tartrate | In compliance with authority procedures set out in subparagraph 14 (d): |
Advanced breast cancer after failure of prior therapy which includes an anthracycline | |
Locally advanced or metastatic non-small cell lung cancer | |
Warfarin Sodium | — |
\"XMET Analog\" | For infants and very young children with pyridoxine non-responsive homocystinuria |
\"XMET Maxamaid\" | Pyridoxine non-responsive homocystinuria |
\"XMET Maxamum\" | Pyridoxine non-responsive homocystinuria |
\"XMTVI Analog\" | Methylmalonic acidaemia |
Propionic acidaemia | |
\"XMTVI Asadon\" | Methylmalonic acidaemia |
Propionic acidaemia | |
\"XMTVI Maxamaid\" | Methylmalonic acidaemia |
Propionic acidaemia | |
\"XMTVI Maxamum\" | Methylmalonic acidaemia |
Propionic acidaemia | |
\"XP Analog\" | Phenylketonuria |
\"XP Analog LCP\" | Phenylketonuria |
\"XP Maxamaid\" | Phenylketonuria |
\"XP Maxamum\" | Phenylketonuria |
\"XPhen, Tyr Analog\" | Tyrosinaemia |
\"XPhen, Tyr Maxamaid\" | Tyrosinaemia |
\"XPhen, Tyr Maxamum\" | Tyrosinaemia |
\"XPTM Tyrosidon\" | Tyrosinaemia |
Zolmitriptan | In compliance with authority procedures set out in subparagraph 14 (d): |
Migraine attacks in patients receiving, or who have failed a reasonable trial of, prophylactic medication and where attacks in the past have usually failed to respond to oral therapy with ergotamine and other appropriate agents, or in whom these agents are contraindicated | |
Zuclopenthixol Decanoate | — |
In compliance with authority procedures set out in subparagraph 14 (d): | |
Continuing supply for palliative care patients where constipation is a problem, and where a palliative care patient is a patient with an active, progressive, far-advanced disease and for whom the prognosis is limited and the focus of care is the quality of life | |
Initial supply, for up to 4 months, for palliative care patients where constipation is a problem, and where a palliative care patient is a patient with an active, progressive, far-advanced disease and for whom the prognosis is limited and the focus of care is the quality of life | |
Continuing supply for palliative care patients where constipation is a problem, where consultation with a palliative care specialist or service has occurred, and where a palliative care patient is a patient with an active, progressive, far-advanced disease and for whom the prognosis is limited and the focus of care is the quality of life | |
Carmellose Sodium | In compliance with authority procedures set out in subparagraph 14 (d): |
Continuing supply for palliative care patients where dry mouth is a symptom, and where a palliative care patient is a patient with an active, progressive, far-advanced disease and for whom the prognosis is limited and the focus of care is the quality of life | |
Initial supply, for up to 4 months, for palliative care patients where dry mouth is a symptom, and where a palliative care patient is a patient with an active, progressive, far-advanced disease and for whom the prognosis is limited and the focus of care is the quality of life | |
Continuing supply for palliative care patients where dry mouth is a symptom, where consultation with a palliative care specialist or service has occurred, and where a palliative care patient is a patient with an active, progressive, far-advanced disease and for whom the prognosis is limited and the focus of care is the quality of life | |
Clonazepam | In compliance with authority procedures set out in subparagraph 14 (d): |
Continuing supply for palliative care patients for the prevention of epilepsy, and where a palliative care patient is a patient with an active, progressive, far-advanced disease and for whom the prognosis is limited and the focus of care is the quality of life | |
Initial supply, for up to 4 months, for palliative care patients for the prevention of epilepsy, and where a palliative care patient is a patient with an active, progressive, far-advanced disease and for whom the prognosis is limited and the focus of care is the quality of life | |
Continuing supply for palliative care patients for the prevention of epilepsy, where consultation with a palliative care specialist or service has occurred, and where a palliative care patient is a patient with an active, progressive, far-advanced disease and for whom the prognosis is limited and the focus of care is the quality of life | |
Diazepam | In compliance with authority procedures set out in subparagraph 14 (d): |
Continuing supply for palliative care patients where anxiety is a problem, and where a palliative care patient is a patient with an active, progressive, far-advanced disease and for whom the prognosis is limited and the focus of care is the quality of life | |
Initial supply, for up to 4 months, for palliative care patients where anxiety is a problem, and where a palliative care patient is a patient with an active, progressive, far-advanced disease and for whom the prognosis is limited and the focus of care is the quality of life | |
Continuing supply for palliative care patients where anxiety is a problem, where consultation with a palliative care specialist or service has occurred, and where a palliative care patient is a patient with an active, progressive, far-advanced disease and for whom the prognosis is limited and the focus of care is the quality of life | |
Diclofenac Sodium | In compliance with authority procedures set out in subparagraph 14 (d): |
Continuing supply for palliative care patients where severe pain is a problem, and where a palliative care patient is a patient with an active, progressive, far-advanced disease and for whom the prognosis is limited and the focus of care is the quality of life | |
Initial supply, for up to 4 months, for palliative care patients where severe pain is a problem, and where a palliative care patient is a patient with an active, progressive, far-advanced disease and for whom the prognosis is limited and the focus of care is the quality of life | |
Continuing supply for palliative care patients where severe pain is a problem, where consultation with a palliative care specialist or service has occurred, and where a palliative care patient is a patient with an active, progressive, far-advanced disease and for whom the prognosis is limited and the focus of care is the quality of life | |
Docusate Sodium with Bisacodyl | In compliance with authority procedures set out in subparagraph 14 (d): |
Continuing supply for palliative care patients where constipation is a problem, and where a palliative care patient is a patient with an active, progressive, far-advanced disease and for whom the prognosis is limited and the focus of care is the quality of life | |
Initial supply, for up to 4 months, for palliative care patients where constipation is a problem, and where a palliative care patient is a patient with an active, progressive, far-advanced disease and for whom the prognosis is limited and the focus of care is the quality of life | |
Continuing supply for palliative care patients where constipation is a problem, where consultation with a palliative care specialist or service has occurred, and where a palliative care patient is a patient with an active, progressive, far-advanced disease and for whom the prognosis is limited and the focus of care is the quality of life | |
Glycerol | In compliance with authority procedures set out in subparagraph 14 (d): |
Continuing supply for palliative care patients where constipation is a problem, and where a palliative care patient is a patient with an active, progressive, far-advanced disease and for whom the prognosis is limited and the focus of care is the quality of life | |
Initial supply, for up to 4 months, for palliative care patients where constipation is a problem, and where a palliative care patient is a patient with an active, progressive, far-advanced disease and for whom the prognosis is limited and the focus of care is the quality of life | |
Continuing supply for palliative care patients where constipation is a problem, where consultation with a palliative care specialist or service has occurred, and where a palliative care patient is a patient with an active, progressive, far-advanced disease and for whom the prognosis is limited and the focus of care is the quality of life | |
Hyoscine Butylbromide | In compliance with authority procedures set out in subparagraph 14 (d): |
Continuing supply for palliative care patients where colicky pain is a symptom, and where a palliative care patient is a patient with an active, progressive, far-advanced disease and for whom the prognosis is limited and the focus of care is the quality of life | |
Initial supply, for up to 4 months, for palliative care patients where colicky pain is a symptom, and where a palliative care patient is a patient with an active, progressive, far-advanced disease and for whom the prognosis is limited and the focus of care is the quality of life | |
Continuing supply for palliative care patients where colicky pain is a symptom, where consultation with a palliative care specialist or service has occurred, and where a palliative care patient is a patient with an active, progressive, far-advanced disease and for whom the prognosis is limited and the focus of care is the quality of life | |
Ibuprofen | In compliance with authority procedures set out in subparagraph 14 (d): |
Continuing supply for palliative care patients where severe pain is a problem, and where a palliative care patient is a patient with an active, progressive, far-advanced disease and for whom the prognosis is limited and the focus of care is the quality of life | |
Initial supply, for up to 4 months, for palliative care patients where severe pain is a problem, and where a palliative care patient is a patient with an active, progressive, far-advanced disease and for whom the prognosis is limited and the focus of care is the quality of life | |
Continuing supply for palliative care patients where severe pain is a problem, where consultation with a palliative care specialist or service has occurred, and where a palliative care patient is a patient with an active, progressive, far-advanced disease and for whom the prognosis is limited and the focus of care is the quality of life | |
Indomethacin | In compliance with authority procedures set out in subparagraph 14 (d): |
Continuing supply for palliative care patients where severe pain is a problem, and where a palliative care patient is a patient with an active, progressive, far-advanced disease and for whom the prognosis is limited and the focus of care is the quality of life | |
Initial supply, for up to 4 months, for palliative care patients where severe pain is a problem, and where a palliative care patient is a patient with an active, progressive, far-advanced disease and for whom the prognosis is limited and the focus of care is the quality of life | |
Continuing supply for palliative care patients where severe pain is a problem, where consultation with a palliative care specialist or service has occurred, and where a palliative care patient is a patient with an active, progressive, far-advanced disease and for whom the prognosis is limited and the focus of care is the quality of life | |
Naproxen | In compliance with authority procedures set out in subparagraph 14 (d): |
Continuing supply for palliative care patients where severe pain is a problem, and where a palliative care patient is a patient with an active, progressive, far-advanced disease and for whom the prognosis is limited and the focus of care is the quality of life | |
Initial supply, for up to 4 months, for palliative care patients where severe pain is a problem, and where a palliative care patient is a patient with an active, progressive, far-advanced disease and for whom the prognosis is limited and the focus of care is the quality of life | |
Continuing supply for palliative care patients where severe pain is a problem, where consultation with a palliative care specialist or service has occurred, and where a palliative care patient is a patient with an active, progressive, far-advanced disease and for whom the prognosis is limited and the focus of care is the quality of life | |
Naproxen Sodium | In compliance with authority procedures set out in subparagraph 14 (d): |
Continuing supply for palliative care patients where severe pain is a problem, and where a palliative care patient is a patient with an active, progressive, far-advanced disease and for whom the prognosis is limited and the focus of care is the quality of life | |
Initial supply, for up to 4 months, for palliative care patients where severe pain is a problem, and where a palliative care patient is a patient with an active, progressive, far-advanced disease and for whom the prognosis is limited and the focus of care is the quality of life | |
Continuing supply for palliative care patients where severe pain is a problem, where consultation with a palliative care specialist or service has occurred, and where a palliative care patient is a patient with an active, progressive, far-advanced disease and for whom the prognosis is limited and the focus of care is the quality of life | |
Nitrazepam | In compliance with authority procedures set out in subparagraph 14 (d): |
Continuing supply for palliative care patients where insomnia is a problem, and where a palliative care patient is a patient with an active, progressive, far-advanced disease and for whom the prognosis is limited and the focus of care is the quality of life | |
Initial supply, for up to 4 months, for palliative care patients where insomnia is a problem, and where a palliative care patient is a patient with an active, progressive, far-advanced disease and for whom the prognosis is limited and the focus of care is the quality of life | |
Continuing supply for palliative care patients where insomnia is a problem, where consultation with a palliative care specialist or service has occurred, and where a palliative care patient is a patient with an active, progressive, far-advanced disease and for whom the prognosis is limited and the focus of care is the quality of life | |
Oxazepam | In compliance with authority procedures set out in subparagraph 14 (d): |
Continuing supply for palliative care patients where anxiety is a problem, and where a palliative care patient is a patient with an active, progressive, far-advanced disease and for whom the prognosis is limited and the focus of care is the quality of life | |
Initial supply, for up to 4 months, for palliative care patients where anxiety is a problem, and where a palliative care patient is a patient with an active, progressive, far-advanced disease and for whom the prognosis is limited and the focus of care is the quality of life | |
Continuing supply for palliative care patients where anxiety is a problem, where consultation with a palliative care specialist or service has occurred, and where a palliative care patient is a patient with an active, progressive, far-advanced disease and for whom the prognosis is limited and the focus of care is the quality of life | |
Paracetamol | In compliance with authority procedures set out in subparagraph 14 (d): |
Continuing supply for palliative care patients for analgesia or fever where alternative therapy cannot be tolerated, and where a palliative care patient is a patient with an active, progressive, far-advanced disease and for whom the prognosis is limited and the focus of care is the quality of life | |
Initial supply, for up to 4 months, for palliative care patients for analgesia or fever where alternative therapy cannot be tolerated, and where a palliative care patient is a patient with an active, progressive, far-advanced disease and for whom the prognosis is limited and the focus of care is the quality of life | |
Continuing supply for palliative care patients for analgesia or fever where alternative therapy cannot be tolerated, where consultation with a palliative care specialist or service has occurred, and where a palliative care patient is a patient with an active, progressive, far-advanced disease and for whom the prognosis is limited and the focus of care is the quality of life | |
Promethazine Hydrochloride | In compliance with authority procedures set out in subparagraph 14 (d): |
Continuing supply for palliative care patients where nausea or vomiting is a problem, and where a palliative care patient is a patient with an active, progressive, far-advanced disease and for whom the prognosis is limited and the focus of care is the quality of life | |
Initial supply, for up to 4 months, for palliative care patients where nausea or vomiting is a problem, and where a palliative care patient is a patient with an active, progressive, far-advanced disease and for whom the prognosis is limited and the focus of care is the quality of life | |
Continuing supply for palliative care patients where nausea or vomiting is a problem, where consultation with a palliative care specialist or service has occurred, and where a palliative care patient is a patient with an active, progressive, far-advanced disease and for whom the prognosis is limited and the focus of care is the quality of life | |
Sorbitol with Sodium Citrate and Sodium Lauryl Sulfoacetate | In compliance with authority procedures set out in subparagraph 14 (d): Continuing supply for palliative care patients where constipation is a problem, and where a palliative care patient is a patient with an active, progressive, far-advanced disease and for whom the prognosis is limited and the focus of care is the quality of life |
Initial supply, for up to 4 months, for palliative care patients where constipation is a problem, and where a palliative care patient is a patient with an active, progressive, far-advanced disease and for whom the prognosis is limited and the focus of care is the quality of life | |
Continuing supply for palliative care patients where constipation is a problem, where consultation with a palliative care specialist or service has occurred, and where a palliative care patient is a patient with an active, progressive, far-advanced disease and for whom the prognosis is limited and the focus of care is the quality of life | |
Sterculia with Frangula Bark | In compliance with authority procedures set out in subparagraph 14 (d): |
Continuing supply for palliative care patients where constipation is a problem, and where a palliative care patient is a patient with an active, progressive, far-advanced disease and for whom the prognosis is limited and the focus of care is the quality of life | |
Initial supply, for up to 4 months, for palliative care patients where constipation is a problem, and where a palliative care patient is a patient with an active, progressive, far-advanced disease and for whom the prognosis is limited and the focus of care is the quality of life | |
Continuing supply for palliative care patients where constipation is a problem, where consultation with a palliative care specialist or service has occurred, and where a palliative care patient is a patient with an active, progressive, far-advanced disease and for whom the prognosis is limited and the focus of care is the quality of life | |
Sulindac | In compliance with authority procedures set out in subparagraph 14 (d): |
Continuing supply for palliative care patients where severe pain is a problem, and where a palliative care patient is a patient with an active, progressive, far-advanced disease and for whom the prognosis is limited and the focus of care is the quality of life | |
Initial supply, for up to 4 months, for palliative care patients where severe pain is a problem, and where a palliative care patient is a patient with an active, progressive, far-advanced disease and for whom the prognosis is limited and the focus of care is the quality of life | |
Continuing supply for palliative care patients where severe pain is a problem, where consultation with a palliative care specialist or service has occurred, and where a palliative care patient is a patient with an active, progressive, far-advanced disease and for whom the prognosis is limited and the focus of care is the quality of life | |
Temazepam | In compliance with authority procedures set out in subparagraph 14 (d): |
Continuing supply for palliative care patients where insomnia is a problem, and where a palliative care patient is a patient with an active, progressive, far-advanced disease and for whom the prognosis is limited and the focus of care is the quality of life | |
Initial supply, for up to 4 months, for palliative care patients where insomnia is a problem, and where a palliative care patient is a patient with an active, progressive, far-advanced disease and for whom the prognosis is limited and the focus of care is the quality of life | |
Continuing supply for palliative care patients where insomnia is a problem, where consultation with a palliative care specialist or service has occurred, and where a palliative care patient is a patient with an active, progressive, far-advanced disease and for whom the prognosis is limited and the focus of care is the quality of life | |
— | |
Amoxycillin Trihydrate | — |
Amoxycillin Trihydrate with Potassium Clavulanate | Infections where resistance to amoxycillin trihydrate is suspected Infections where resistance to amoxycillin trihydrate is proven |
Amoxycillin Trihydrate with Potassium Clavulanate and Water - Purified BP | Infections where resistance to amoxycillin trihydrate is suspected Infections where resistance to amoxycillin trihydrate is proven |
Amoxycillin Trihydrate with Water - Purified BP | — |
Amphotericin | — |
Ampicillin Sodium | — |
Ampicillin Trihydrate | — |
Aspirin | — |
Atropine Sulfate | — |
Benzathine Penicillin | — |
Benztropine Mesylate | — |
Benzydamine Hydrochloride | Radiation induced mucositis |
Benzylpenicillin Sodium | — |
Betamethasone Acetate with Betamethasone Sodium Phosphate | For local intra-articular or peri-articular infiltration Keloid |
Lichen planus hypertrophic | |
Carbamazepine | — |
Cefaclor Monohydrate | — |
Cefaclor Monohydrate with Water - Purified BP | — |
Cefotaxime Sodium | Infections where positive bacteriological evidence confirms that this antibiotic is an appropriate therapeutic agent |
Cefuroxime Axetil | — |
Cephalexin | — |
Cephalexin with Water - Purified BP | — |
Cephalothin Sodium | — |
Chloramphenicol | — |
Clindamycin Hydrochloride | Gram-positive coccal infections where these cannot be safely and effectively treated with a penicillin |
Codeine Phosphate | — |
Codeine Phosphate with Paracetamol | — |
Diazepam | — |
Diclofenac Sodium | In respect of the suppository 100 mg: |
— | |
In respect of the tablet 25 mg (enteric coated) and tablet 50 mg (enteric coated): | |
Chronic arthropathies (including osteoarthritis) with an inflammatory component | |
Bone pain due to malignant disease | |
Dicloxacillin Sodium | In respect of the powder for injection equivalent to 500 mg dicloxacillin and powder for injection equivalent to 1 g dicloxacillin: |
— | |
In respect of the capsule equivalent to 250 mg dicloxacillin and capsule equivalent to 500 mg dicloxacillin: | |
Serious staphylococcal infections | |
Diflunisal | Chronic arthropathies (including osteoarthritis) with an inflammatory component |
Bone pain due to malignant disease | |
Doxycycline Hydrochloride | — |
Doxycycline Monohydrate | — |
Erythromycin | — |
Erythromycin Ethyl Succinate | — |
Erythromycin Ethyl Succinate with Water - Purified BP | — |
Erythromycin Lactobionate | — |
Flucloxacillin Magnesium with Water - Purified BP | Serious staphylococcal infections |
Flucloxacillin Sodium | In respect of the powder for injection equivalent to 500 mg flucloxacillin and powder for injection equivalent to 1 g flucloxacillin: |
— | |
In respect of the capsule equivalent to 250 mg flucloxacillin and capsule equivalent to 500 mg flucloxacillin: | |
Serious staphylococcal infections | |
Glucagon Hydrochloride | — |
Glucose | — |
Glyceryl Trinitrate | — |
Hydrocortisone Acetate | Treatment of corticosteroid-responsive dermatoses |
Hydrocortisone Sodium Succinate | For use in a hospital |
Hydromorphone Hydrochloride | In respect of the injection 2 mg in 1 mL ampoule, injection 10 mg in 1 mL ampoule and injection 50 mg in 5 mL ampoule: |
— | |
In respect of the tablet 2 mg, tablet 4 mg, tablet 8 mg and oral liquid 1 mg per mL, 473 mL: | |
Severe disabling pain not responding to non-narcotic analgesics | |
Ibuprofen | In respect of the tablets 400 mg, 20: |
— | |
In respect of the tablet 200 mg and tablet 400 mg: | |
Chronic arthropathies (including osteoarthritis) with an inflammatory component | |
Bone pain due to malignant disease | |
Indomethacin | In respect of the suppository 100 mg: |
— | |
In respect of the capsule 25 mg: | |
Chronic arthropathies (including osteoarthritis) with an inflammatory component | |
Bone pain due to malignant disease | |
Ketoprofen | In respect of the suppository 100 mg: |
— | |
In respect of the capsule 200 mg (sustained release): | |
Chronic arthropathies (including osteoarthritis) with an inflammatory component | |
Lignocaine Hydrochloride | — |
Lincomycin Hydrochloride | — |
Methylprednisolone Acetate | For local intra-articular or peri-articular infiltration |
Metoclopramide Hydrochloride | — |
Metronidazole | In respect of the tablet 200 mg, tablet 400 mg and suppositories 500 mg, 10: |
— | |
In respect of the I.V. infusion 500 mg in 100 mL: | |
Treatment, in a hospital, of acute anaerobic sepsis | |
Metronidazole Benzoate | — |
Morphine Hydrochloride | Severe disabling pain not responding to non-narcotic analgesics |
Morphine Sulfate | In respect of the injection 10 mg in 1 mL ampoule, injection 15 mg in 1 mL ampoule and injection 30 mg in 1 mL ampoule: |
— | |
In respect of the tablet 30 mg: | |
Severe disabling pain not responding to non-narcotic analgesics | |
In respect of the tablet 5 mg (controlled release), tablet 10 mg (controlled release), tablet 15 mg (controlled release), tablet 30 mg (controlled release), tablet 60 mg (controlled release), tablet 100 mg (controlled release), capsule 10 mg (containing sustained release pellets), capsule 20 mg (containing sustained release pellets), capsule 30 mg (controlled release), capsule 50 mg (containing sustained release pellets), capsule 60 mg (controlled release), capsule 90 mg (controlled release), capsule 100 mg (containing sustained release pellets), capsule 120 mg (controlled release), sachet containing controlled release granules for oral suspension, 20 mg per sachet, sachet containing controlled release granules for oral suspension, 30 mg per sachet, sachet containing controlled release granules for oral suspension, 60 mg per sachet and sachet containing controlled release granules for oral suspension, 100 mg per sachet: | |
Chronic severe disabling pain not responding to non-narcotic analgesics | |
Naloxone Hydrochloride | — |
Naproxen | Chronic arthropathies (including osteoarthritis) with an inflammatory component |
Bone pain due to malignant disease | |
Naproxen Sodium | Chronic arthropathies (including osteoarthritis) with an inflammatory component |
Bone pain due to malignant disease | |
Nitrazepam | — |
Nystatin | — |
Oxazepam | — |
Oxycodone Hydrochloride | In respect of the tablet 5 mg, capsule 5 mg, capsule 10 mg, capsule 20 mg and oral solution 5 mg per 5 mL, 250 mL: |
Severe disabling pain not responding to non-narcotic analgesics | |
In respect of the tablet 5 mg (controlled release), tablet 10 mg (controlled release), tablet 20 mg (controlled release), tablet 40 mg (controlled release) and tablet 80 mg (controlled release): | |
Chronic severe disabling pain not responding to non-narcotic analgesics | |
Oxycodone Pectinate | Severe disabling pain not responding to non-narcotic analgesics |
Paracetamol | — |
Pethidine Hydrochloride | Short-term treatment of acute pain |
Phenoxymethylpenicillin Benzathine | — |
Phenoxymethylpenicillin Potassium | — |
Piroxicam | Chronic arthropathies (including osteoarthritis) with an inflammatory component |
Procaine Penicillin | — |
Prochlorperazine | — |
Prochlorperazine Maleate | — |
Prochlorperazine Mesylate | — |
Promethazine Hydrochloride | — |
Sodium Chloride | — |
Sodium Chloride with Glucose | — |
Sulindac | Chronic arthropathies (including osteoarthritis) with an inflammatory component |
Bone pain due to malignant disease | |
Temazepam | — |
Tetanus Vaccine - Adsorbed | — |
Ticarcillin Sodium with Potassium Clavulanate | Infections where positive bacteriological evidence confirms that this antibiotic is an appropriate therapeutic agent |
Tramadol Hydrochloride | In respect of the capsule 50 mg: |
For acute pain where aspirin or paracetamol alone is inappropriate or has failed | |
For dosage titration in chronic pain where aspirin or paracetamol alone is inappropriate or has failed | |
In respect of the tablet 100 mg (sustained release), tablet 150 mg (sustained release), tablet 200 mg (sustained release) and oral drops 100 mg per mL, 10 mL: | |
For pain where aspirin or paracetamol alone is inappropriate or has failed | |
In respect of the injection 100 mg in 2 mL ampoule: | |
Short-term treatment of acute pain | |
Triamcinolone Acetonide | For local intra-articular or peri-articular infiltration |
Keloid | |
Lichen planus hypertrophic | |
Trimethoprim with Sulfamethoxazole | — |
Vancomycin Hydrochloride | Prophylaxis of endocarditis in patients hypersensitive to penicillin |
Abacavir Sulfate with Lamivudine | |
Abacavir Sulfate with Lamivudine and Zidovudine | |
Aluminium Hydroxide - Dried | Aluminium Hydroxide - Dried with Magnesium Hydroxide |
Aluminium Hydroxide - Dried with Magnesium Trisilicate and Magnesium Hydroxide | |
Amiloride Hydrochloride | Hydrochlorothiazide with Amiloride Hydrochloride |
Amoxycillin Trihydrate | Amoxycillin Trihydrate with Potassium Clavulanate |
Amoxycillin Trihydrate with Potassium Clavulanate and Water - Purified BP | |
Amoxycillin Trihydrate with Water - Purified BP | |
Aspirin | Dipyridamole with Aspirin |
Atropine Sulfate | Diphenoxylate Hydrochloride with Atropine Sulfate |
Azithromycin Dihydrate | Azithromycin Dihydrate with Water - Purified BP |
Bacitracin Zinc | Neomycin Undecenoate with Bacitracin Zinc |
Polymyxin B Sulfate with Bacitracin Zinc and Neomycin Sulfate | |
Benserazide Hydrochloride | Levodopa with Benserazide Hydrochloride |
Betamethasone Acetate | Betamethasone Acetate with Betamethasone Sodium Phosphate |
Betamethasone Sodium Phosphate | Betamethasone Acetate with Betamethasone Sodium Phosphate |
Bisacodyl | Docusate Sodium with Bisacodyl |
Brimonidine Tartrate | Brimonidine Tartrate with Timolol Maleate |
Budesonide | Budesonide with Eformoterol Fumarate Dihydrate |
Calcium Carbonate | Sodium Alginate with Calcium Carbonate and Sodium Bicarbonate |
Calcium Chloride | Sodium Chloride with Potassium Chloride and Calcium Chloride |
Sodium Lactate with Sodium Chloride, Potassium Chloride and Calcium Chloride | |
Candesartan Cilexetil | Candesartan Cilexetil with Hydrochlorothiazide |
Carbidopa | Levodopa with Carbidopa |
Levodopa with Carbidopa and Entacapone | |
Carbomer 980 | Hypromellose with Carbomer 980 |
Cefaclor Monohydrate | Cefaclor Monohydrate with Water - Purified BP |
Cephalexin | Cephalexin with Water - Purified BP |
Chlorhexidine Gluconate | Silver Sulfadiazine with Chlorhexidine Gluconate |
Codeine Phosphate | Codeine Phosphate with Paracetamol |
Cyproterone Acetate | Oestradiol Valerate with Cyproterone Acetate |
Dexamethasone Sodium Metasulfobenzoate | Dexamethasone Sodium Metasulfobenzoate with Framycetin Sulfate and Gramicidin |
Dextran 70 | Hypromellose 2900 with Dextran 70 |
Hypromellose 4500 with Dextran 70 | |
Diphenoxylate Hydrochloride | Diphenoxylate Hydrochloride with Atropine Sulfate |
Dipyridamole | Dipyridamole with Aspirin |
Docusate Sodium | Docusate Sodium with Bisacodyl |
Dorzolamide Hydrochloride | Dorzolamide Hydrochloride with Timolol Maleate |
Dydrogesterone | Oestradiol with Dydrogesterone |
Eformoterol Fumarate Dihydrate | Budesonide with Eformoterol Fumarate Dihydrate |
Enalapril Maleate | Enalapril Maleate with Hydrochlorothiazide |
Entacapone | Levodopa with Carbidopa and Entacapone |
Eprosartan Mesylate | Eprosartan Mesylate with Hydrochlorothiazide |
Erythromycin Ethyl Succinate | Erythromycin Ethyl Succinate with Water - Purified BP |
Ethinyloestradiol | Levonorgestrel with Ethinyloestradiol |
Norethisterone with Ethinyloestradiol | |
Flucloxacillin Magnesium | Flucloxacillin Magnesium with Water - Purified BP |
Fluticasone Propionate | Fluticasone Propionate with Salmeterol Xinafoate |
Fosinopril Sodium | Fosinopril Sodium with Hydrochlorothiazide |
Framycetin Sulfate | Dexamethasone Sodium Metasulfobenzoate with Framycetin Sulfate and Gramicidin |
Frangula Bark | Sterculia with Frangula Bark |
Glibenclamide | Metformin Hydrochloride with Glibenclamide |
Glucose | Glucose with Sodium Chloride, Potassium Chloride and Sodium Acid Citrate |
Sodium Chloride with Glucose | |
Gramicidin | Dexamethasone Sodium Metasulfobenzoate with Framycetin Sulfate and Gramicidin |
Triamcinolone Acetonide with Neomycin Sulfate, Gramicidin and Nystatin | |
Hydrochlorothiazide | Candesartan Cilexetil with Hydrochlorothiazide |
Enalapril Maleate with Hydrochlorothiazide | |
Eprosartan Mesylate with Hydrochlorothiazide | |
Fosinopril Sodium with Hydrochlorothiazide | |
Hydrochlorothiazide with Amiloride Hydrochloride | |
Hydrochlorothiazide with Triamterene | |
Irbesartan with Hydrochlorothiazide | |
Quinapril Hydrochloride with Hydrochlorothiazide | |
Telmisartan with Hydrochlorothiazide | |
Hypromellose | Hypromellose with Carbomer 980 |
Hypromellose 2900 | Hypromellose 2900 with Dextran 70 |
Hypromellose 4500 | Hypromellose 4500 with Dextran 70 |
Indapamide Hemihydrate | Perindopril Erbumine with Indapamide Hemihydrate |
Insulin - Isophane | Insulin - Neutral with Insulin - Isophane |
Insulin - Neutral | Insulin - Neutral with Insulin - Isophane |
Insulin Aspart | Insulin Aspart with Insulin Aspart Protamine Suspension |
Insulin Aspart Protamine Suspension | Insulin Aspart with Insulin Aspart Protamine Suspension |
Insulin Lispro | Insulin Lispro with Insulin Lispro Protamine Suspension |
Insulin Lispro Protamine Suspension | Insulin Lispro with Insulin Lispro Protamine Suspension |
Irbesartan | Irbesartan with Hydrochlorothiazide |
Lamivudine | Abacavir Sulfate with Lamivudine |
Abacavir Sulfate with Lamivudine and Zidovudine | |
Lamivudine with Zidovudine | |
Levodopa | Levodopa with Benserazide Hydrochloride |
Levodopa with Carbidopa | |
Levodopa with Carbidopa and Entacapone | |
Levonorgestrel | Levonorgestrel with Ethinyloestradiol |
Lopinavir | Lopinavir with Ritonavir |
Macrogol 3350 | Macrogol 3350 with Sodium Chloride, Sodium Bicarbonate and Potassium Chloride |
Magnesium Chloride | Sodium Chloride with Sodium Acetate, Sodium Gluconate, Potassium Chloride and Magnesium Chloride |
Magnesium Hydroxide | Aluminium Hydroxide - Dried with Magnesium Hydroxide |
Aluminium Hydroxide - Dried with Magnesium Trisilicate and Magnesium Hydroxide | |
Magnesium Trisilicate | Aluminium Hydroxide - Dried with Magnesium Trisilicate and Magnesium Hydroxide |
Medroxyprogesterone Acetate | Oestrogens—Conjugated with Medroxyprogesterone Acetate |
Mestranol | Norethisterone with Mestranol |
Metformin Hydrochloride | Metformin Hydrochloride with Glibenclamide |
Mycophenolate Mofetil | Mycophenolate Mofetil with Water - Purified BP |
Neomycin Sulfate | Polymyxin B Sulfate with Bacitracin Zinc and Neomycin Sulfate |
Triamcinolone Acetonide with Neomycin Sulfate, Gramicidin and Nystatin | |
Neomycin Undecenoate | Neomycin Undecenoate with Bacitracin Zinc |
Norethisterone | Norethisterone with Ethinyloestradiol |
Norethisterone with Mestranol | |
Norethisterone Acetate | Oestradiol with Norethisterone Acetate |
Oestradiol Hemihydrate with Norethisterone Acetate | |
Nystatin | Triamcinolone Acetonide with Neomycin Sulfate, Gramicidin and Nystatin |
Oestradiol | Oestradiol with Dydrogesterone |
Oestradiol with Norethisterone Acetate | |
Oestradiol Hemihydrate | Oestradiol Hemihydrate with Norethisterone Acetate |
Oestradiol Valerate | Oestradiol Valerate with Cyproterone Acetate |
Oestrogens—Conjugated | Oestrogens—Conjugated with Medroxyprogesterone Acetate |
Paracetamol | Codeine Phosphate with Paracetamol |
Paraffin - Liquid | Paraffin - Soft White with Paraffin - Liquid |
Paraffin - Soft White | Paraffin - Soft White with Paraffin - Liquid |
Perindopril Erbumine | Perindopril Erbumine with Indapamide Hemihydrate |
Phenylephrine Hydrochloride | Prednisolone Acetate with Phenylephrine Hydrochloride |
Polyethylene Glycol 400 | Polyethylene Glycol 400 with Propylene Glycol |
Polymyxin B Sulfate | Polymyxin B Sulfate with Bacitracin Zinc and Neomycin Sulfate |
Potassium Bicarbonate | Potassium Chloride with Potassium Bicarbonate |
Potassium Chloride | Glucose with Sodium Chloride, Potassium Chloride and Sodium Acid Citrate |
Macrogol 3350 with Sodium Chloride, Sodium Bicarbonate and Potassium Chloride | |
Potassium Chloride with Potassium Bicarbonate | |
Sodium Chloride with Potassium Chloride and Calcium Chloride | |
Sodium Chloride with Sodium Acetate, Sodium Gluconate, Potassium Chloride and Magnesium Chloride | |
Sodium Lactate with Sodium Chloride, Potassium Chloride and Calcium Chloride | |
Potassium Clavulanate | Amoxycillin Trihydrate with Potassium Clavulanate |
Amoxycillin Trihydrate with Potassium Clavulanate and Water - Purified BP | |
Ticarcillin Sodium with Potassium Clavulanate | |
Prednisolone Acetate | Prednisolone Acetate with Phenylephrine Hydrochloride |
Propylene Glycol | Polyethylene Glycol 400 with Propylene Glycol |
Quinapril Hydrochloride | Quinapril Hydrochloride with Hydrochlorothiazide |
Ritonavir | Lopinavir with Ritonavir |
Salmeterol Xinafoate | Fluticasone Propionate with Salmeterol Xinafoate |
Silver Sulfadiazine | Silver Sulfadiazine with Chlorhexidine Gluconate |
Sodium Acetate | Sodium Chloride with Sodium Acetate, Sodium Gluconate, Potassium Chloride and Magnesium Chloride |
Sodium Acid Citrate | Glucose with Sodium Chloride, Potassium Chloride and Sodium Acid Citrate |
Sodium Alginate | Sodium Alginate with Calcium Carbonate and Sodium Bicarbonate |
Sodium Bicarbonate | Macrogol 3350 with Sodium Chloride, Sodium Bicarbonate and Potassium Chloride |
Sodium Alginate with Calcium Carbonate and Sodium Bicarbonate | |
Sodium Chloride | Glucose with Sodium Chloride, Potassium Chloride and Sodium Acid Citrate |
Macrogol 3350 with Sodium Chloride, Sodium Bicarbonate and Potassium Chloride | |
Sodium Chloride with Glucose | |
Sodium Chloride with Potassium Chloride and Calcium Chloride | |
Sodium Chloride with Sodium Acetate, Sodium Gluconate, Potassium Chloride and Magnesium Chloride | |
Sodium Lactate with Sodium Chloride, Potassium Chloride and Calcium Chloride | |
Sodium Citrate | Sorbitol with Sodium Citrate and Sodium Lauryl Sulfoacetate |
Sodium Gluconate | Sodium Chloride with Sodium Acetate, Sodium Gluconate, Potassium Chloride and Magnesium Chloride |
Sodium Lactate | Sodium Lactate with Sodium Chloride, Potassium Chloride and Calcium Chloride |
Sodium Lauryl Sulfoacetate | Sorbitol with Sodium Citrate and Sodium Lauryl Sulfoacetate |
Sorbitol | Sorbitol with Sodium Citrate and Sodium Lauryl Sulfoacetate |
Stavudine | Stavudine with Water - Purified BP |
Sterculia | Sterculia with Frangula Bark |
Sulfamethoxazole | Trimethoprim with Sulfamethoxazole |
Telmisartan | Telmisartan with Hydrochlorothiazide |
Testosterone Decanoate | Testosterone Propionate with Testosterone Phenylpropionate, Testosterone Isocaproate and Testosterone Decanoate |
Testosterone Isocaproate | Testosterone Propionate with Testosterone Phenylpropionate and Testosterone Isocaproate |
Testosterone Propionate with Testosterone Phenylpropionate, Testosterone Isocaproate and Testosterone Decanoate | |
Testosterone Phenylpropionate | Testosterone Propionate with Testosterone Phenylpropionate and Testosterone Isocaproate |
Testosterone Propionate with Testosterone Phenylpropionate, Testosterone Isocaproate and Testosterone Decanoate | |
Testosterone Propionate | Testosterone Propionate with Testosterone Phenylpropionate and Testosterone Isocaproate |
Testosterone Propionate with Testosterone Phenylpropionate, Testosterone Isocaproate and Testosterone Decanoate | |
Ticarcillin Sodium | Ticarcillin Sodium with Potassium Clavulanate |
Timolol Maleate | Brimonidine Tartrate with Timolol Maleate |
Dorzolamide Hydrochloride with Timolol Maleate | |
Triamcinolone Acetonide | Triamcinolone Acetonide with Neomycin Sulfate, Gramicidin and Nystatin |
Triamterene | Hydrochlorothiazide with Triamterene |
Trimethoprim | Trimethoprim with Sulfamethoxazole |
Water - Purified BP | Amoxycillin Trihydrate with Potassium Clavulanate and Water - Purified BP |
Amoxycillin Trihydrate with Water - Purified BP | |
Azithromycin Dihydrate with Water - Purified BP | |
Cefaclor Monohydrate with Water - Purified BP | |
Cephalexin with Water - Purified BP | |
Erythromycin Ethyl Succinate with Water - Purified BP | |
Flucloxacillin Magnesium with Water - Purified BP | |
Mycophenolate Mofetil with Water - Purified BP | |
Stavudine with Water - Purified BP | |
Zidovudine | Abacavir Sulfate with Lamivudine and Zidovudine |
Lamivudine with Zidovudine | |