Schedule 4—Prescription only medicines and prescription animal remedies
Note 1: See sections 16, 28, 31 and 49, subsections 54(2) and 57(1) and section 60.
Note 2: Substances marked # are listed in Appendix D.
ABACAVIR.
ABALOPARATIDE.
ABATACEPT.
ABIRATERONE ACETATE.
ABCIXIMAB.
ABEMACICLIB.
ABROCITINIB.
ACALABRUTINIB.
ACAMPROSATE CALCIUM.
ACARBOSE.
ACEBUTOLOL.
ACEPROMAZINE.
ACETANILIDE and alkyl acetanilides (excluding when present as an excipient) for human therapeutic use.
ACETARSOL.
ACETAZOLAMIDE.
ACETOHEXAMIDE.
ACETYL ISOVALERYLTYLOSIN.
ACETYLCARBROMAL.
ACETYLCHOLINE.
ACETYLCYSTEINE except:
(b) in preparations for oral use when labelled with a recommended daily dose of 1 g or less of acetylcysteine.
ACETYLDIGITOXIN.
ACETYLMETHYLDIMETHYLOXIMIDOPHENYLHYDRAZINE.
ACETYLSTROPHANTHIDIN.
ACICLOVIR except in preparations containing 5% or less of aciclovir for the treatment of herpes labialis in packs containing 10 g or less.
ACIPIMOX.
ACITRETIN.
ACLIDINIUM BROMIDE.
ACOKANTHERA OUABAIO.
ACOKANTHERA SCHIMPERI.
ACONITUM spp. except:
(b) in preparations for oral use in adults in packs containing 0.02 mg or less of total alkaloids; or
(c) in preparations for dermal use in adults containing 0.02% or less of total alkaloids in packs containing 0.02 mg or less of total alkaloids.
ACRIVASTINE.
ADALIMUMAB.
ADAPALENE except when included in Schedule 3.
ADEFOVIR.
ADENOSINE for human therapeutic use in preparations for injection.
ADIPHENINE.
ADONIS VERNALIS.
ADRAFINIL.
ADRENALINE in:
(a) topical preparations for the treatment of wounds in humans; or
(b) all other preparations containing adrenaline except when included in or expressly excluded from Schedule 3.
ADRENOCORTICAL HORMONES except when separately specified in these Schedules.
AFAMELANOTIDE.
AFATINIB DIMALEATE.
AFLIBERCEPT.
AGALSIDASE.
AGLEPRISTONE.
AGOMELATINE.
ALANYLGLUTAMINE.
ALATROFLOXACIN MESILATE.
ALBENDAZOLE except:
(b) in intraruminal implants each containing 3.85 g or less of albendazole for the treatment of animals.
ALCLOFENAC.
ALCLOMETASONE except when included in Schedule 3.
ALCURONIUM.
ALDESLEUKIN.
ALDOSTERONE.
ALECTINIB.
ALEFACEPT.
ALEMTUZUMAB.
ALENDRONIC ACID.
ALFACALCIDOL.
ALFUZOSIN.
ALGLUCERASE.
ALGLUCOSIDASE.
ALIMEMAZINE except when included in Schedule 2 or 3.
ALIROCUMAB.
ALISKIREN.
ALKYL NITRITES except when separately specified in these Schedules.
ALLERGENS for therapeutic use.
ALLOPURINOL.
ALLYLESTRENOL.
ALOGLIPTIN.
ALOSETRON.
ALPELISIB.
ALPHA1‑PROTEINASE INHIBITOR (HUMAN).
ALPHADOLONE.
ALPHAXALONE.
ALPRENOLOL.
ALPROSTADIL.
ALSEROXYLON.
ALTEPLASE.
ALTRENOGEST.
ALTRETAMINE (hexamethylmelamine).
AMANTADINE.
AMBENONIUM CHLORIDE.
AMBRISENTAN.
AMBUCETAMIDE.
AMBUTONIUM BROMIDE.
AMCINONIDE.
AMIFAMPRIDINE.
AMIFOSTINE.
AMIKACIN.
AMILORIDE.
AMINOCAPROIC ACID.
AMINOGLUTETHIMIDE.
5‑AMINOLEVULINIC ACID.
AMINOMETRADINE.
AMINOPHENAZONE (amidopyrine) and derivatives for the treatment of animals.
AMINOPHYLLINE except when included in Schedule 3.
AMINOPTERIN.
4‑AMINOPYRIDINE for therapeutic use.
AMINOREX.
AMINOSALICYLIC ACID.
AMIODARONE.
AMIPHENAZOLE.
AMISOMETRADINE.
AMISULPRIDE.
AMITRIPTYLINE.
AMLODIPINE.
AMMI VISNAGA.
AMMONIUM BROMIDE for therapeutic use.
AMOBARBITAL when packed and labelled for injection.
AMODIAQUINE.
AMOROLFINE except:
AMOXAPINE.
AMOXICILLIN.
AMPHOMYCIN.
AMPHOTERICIN B.
AMPICILLIN.
AMPRENAVIR.
AMRINONE.
AMSACRINE.
AMYL NITRITE except when included in Schedule 3.
AMYLOCAINE.
ANABOLIC STEROIDAL AGENTS.
ANAGRELIDE.
ANAKINRA.
ANASTROZOLE.
ANCESTIM.
ANCROD and its immunoglobulin antidote.
ANDEXANET ALFA.
ANECORTAVE.
ANDROGENIC STEROIDAL AGENTS.
ANDROISOXAZOLE.
ANDROSTANOLONE.
ANDROSTENEDIOL.
ANDROSTENEDIONE.
ANGIOTENSIN AMIDE.
ANIDULAFUNGIN.
ANIMAL BLOOD PRODUCTS for veterinary use including:
(a) whole blood;
(b) blood components, including red cells, white cells, platelets, and plasma (including cryoprecipitate); and
(c) the following plasma-derived therapeutic proteins, and their equivalent recombinant alternatives:
(i) albumin;
(ii) anticoagulation complex;
(iii) C1 esterase inhibitors;
(iv) clotting factors;
(v) fibrinogen;
(vi) protein C;
(vii) prothrombin complex concentrate (PCC);
(viii) thrombin;
(ix) haemoglobin.
ANIRACETAM.
ANISTREPLASE.
ANTAZOLINE except when included in Schedule 2.
ANTIBIOTIC SUBSTANCES except:
(b) nisin.
ANTIGENS for human therapeutic use except when separately specified in this Schedule.
ANTIHISTAMINES except:
ANTIMONY for therapeutic use except when separately specified in these Schedules.
ANTISERA (immunosera) for human use by injection except when separately specified in these Schedules.
AOD‑9604 (CAS No. 221231‑10‑3).
APALUTAMIDE.
APIXABAN.
APOCYNUM spp.
APOMORPHINE.
APRACLONIDINE.
APRAMYCIN.
APREMILAST.
APREPITANT.
APROTININ.
ARBUTIN (BETA) in oral preparations except herbal preparations containing 500 mg or less beta‑arbutin per recommended daily dose.
ARECOLINE.
ARIPIPRAZOLE.
ARMODAFINIL.
ARSENIC for human therapeutic use except when separately specified in these Schedules.
ARTEMETHER.
ARTESUNATE.
ARTICAINE.
ASCIMINIB.
ASENAPINE.
ASFOTASE ALFA.
ASPARAGINASE.
ASPIRIN when:
(a) combined with caffeine, paracetamol or salicylamide; or
(b) combined with any derivative of the substances mentioned in paragraph (a); or
(c) for injection.
ASTEMIZOLE.
ASUNAPREVIR.
ATAMESTANE.
ATAZANAVIR.
ATENOLOL.
ATEZOLIZUMAB.
ATINVICITINIB.
ATIPAMEZOLE.
ATOMOXETINE.
ATORVASTATIN.
ATOSIBAN.
ATOVAQUONE.
ATRACURIUM BESILATE.
ATROPA BELLADONNA (belladonna) except when included in Schedule 2.
ATROPINE except when included in Schedule 2.
ATROPINE METHONITRATE.
AURANOFIN.
AUROTHIOMALATE SODIUM.
AVACOPAN.
AVATROMBOPAG.
AVELUMAB.
AVILAMYCIN except:
(a) in animal feed premixes containing 15% or less of avilamycin activity; or
(b) in animal feeds containing 50 mg/kg or less of avilamycin activity.
AVIPTADIL.
AXITINIB.
AVOPARCIN.
AZACITIDINE.
AZACYCLONOL.
AZAPERONE.
AZAPROPAZONE.
AZARIBINE.
AZATADINE except when included in Schedule 3.
AZATHIOPRINE.
AZELAIC ACID for therapeutic use except when included in Schedule 2.
AZELASTINE except when included in Schedule 2.
AZITHROMYCIN.
AZLOCILLIN.
AZTREONAM.
BACAMPICILLIN.
BACITRACIN.
BACLOFEN.
BALOXAVIR MARBOXIL.
BALSALAZIDE.
BAMBERMYCIN (flavophospholipol) except:
(b) in animal feeds for growth promotion containing 50 mg/kg or less of antibiotic substances.
BAMBUTEROL.
BAMETHAN.
BAMIPINE.
BARBITURATES except when separately specified in these Schedules.
BARICITINIB.
BASILIXIMAB.
BAZEDOXIFENE.
BECAPLERMIN.
BECLAMIDE.
BECLOMETASONE except when included in Schedule 2.
BELATACEPT.
BELIMUMAB.
BELUMOSUDIL.
BELZUTIFAN.
BEMEGRIDE.
BENACTYZINE.
BENAZEPRIL.
BENDAMUSTINE.
BENDROFLUAZIDE.
BENETHAMINE PENICILLIN.
BENORYLATE.
BENOXAPROFEN.
BENPERIDOL.
BENRALIZUMAB.
BENSERAZIDE.
BENZATHINE PENICILLIN.
BENZILONIUM.
BENZOCAINE except:
(b) in dermal preparations containing 2% or less of total local anaesthetic substances; or
(c) in lozenges containing 30 mg or less of total local anaesthetic substances per dosage unit.
BENZODIAZEPINE derivatives except when separately specified in these Schedules.
BENZOYL PEROXIDE in preparations for human therapeutic use except:
(b) in preparations for external use containing 5% or less of benzoyl peroxide.
BENZPHETAMINE.
BENZTHIAZIDE.
BENZATROPINE.
BENZYDAMINE except:
(b) in preparations for dermal use; or
(c) in divided topical oral preparations containing 3 mg or less of benzydamine; or
(d) in undivided topical oral preparations containing 0.3% or less of benzydamine in a primary pack containing not more than 50 mL.
BENZYLPENICILLIN.
BEPRIDIL.
BERACTANT.
BESIFLOXACIN.
BETAHISTINE.
BETAMETHASONE.
BETAXOLOL.
BETHANECHOL CHLORIDE.
BETHANIDINE.
BEVACIZUMAB.
BEVANTOLOL.
BEXAROTENE.
BEZAFIBRATE.
BEZLOTOXUMAB.
BIBROCATHOL.
BICALUTAMIDE.
BICTEGRAVIR.
BIFONAZOLE except:
(b) in preparations for dermal use containing 1% or less of bifonazole for the treatment of the scalp; or
(c) in preparations for dermal use for the treatment of tinea pedis.
BILASTINE except when included in Schedule 2 or 3.
BIMATOPROST.
BINIMETINIB.
BIPERIDEN.
BISMUTH COMPOUNDS for cosmetic use, except:
(a) bismuth citrate when incorporated in hair colourant preparations in concentrations of 0.5% or less; or
(b) bismuth oxychloride.
BISMUTH COMPOUNDS for human therapeutic use, except bismuth formic iodide or bismuth subiodide in dusting powders containing 3% or less of bismuth.
BISOPROLOL.
BIVALIRUDIN.
BLEOMYCIN.
BLINATUMOMAB.
BOCEPREVIR.
BOLANDIOL.
BOLASTERONE.
BOLAZINE.
BOLDENONE (dehydrotestosterone).
BOLENOL.
BOLMANTALATE.
BORON, including boric acid and borax, for human therapeutic use except:
(a) in preparations for internal use containing 6 mg or less of boron per recommended daily dose; or
(b) in preparations for dermal use containing 0.35% or less of boron, which are not for paediatric or antifungal use; or
(c) when present as an excipient.
BORTEZOMIB.
BOSENTAN.
BOSUTINIB.
BOTULINUM TOXINS for human use except when separately specified in these Schedules.
BPC‑157.
BRENTUXIMAB VEDOTIN.
BRETYLIUM TOSILATE.
BREXPIPRAZOLE.
BRIGATINIB.
BRIMONIDINE except when included in Schedule 2.
BRINZOLAMIDE.
BRIVARACETAM.
BROMAZEPAM.
BROMIDES, inorganic, for therapeutic use except when separately specified in these Schedules.
BROMOCRIPTINE.
BROMOFORM for therapeutic use.
BROMPHENIRAMINE except when included in Schedule 2 or 3.
BROMVALETONE.
BRUGMANSIA spp.
BUCLIZINE except when included in Schedule 3.
BUDESONIDE except when included in Schedule 2.
BUFEXAMAC.
BULEVIRTIDE.
BUMETANIDE.
BUPHENINE.
BUPIVACAINE except when included in Schedule 5.
BUPROPION.
BUSERELIN.
BUSPIRONE.
BUSULPHAN.
BUTACAINE.
BUTAMBEN except in dermal preparations containing 2% or less of total local anaesthetic substances.
BUTOCONAZOLE except when included in Schedule 3.
BUTRACONAZOLE.
BUTYLCHLORAL HYDRATE.
BUTYL NITRITE.
CABAZITAXEL.
CABERGOLINE.
CABOTEGRAVIR.
CABOZANTINIB.
CADMIUM COMPOUNDS for human therapeutic use.
CAFFEINE for internal therapeutic use except:
(a) in divided preparations when labelled with a maximum recommended daily dose of no greater than 600 mg of total caffeine; or
(b) in undivided preparations with a concentration of less than 5% of caffeine and when labelled with a maximum recommended daily dose of no greater than 600 mg of total caffeine.
CALCIFEDIOL for human internal therapeutic use except in preparations containing 10 micrograms or less of calcifediol per recommended daily dose.
CALCIPOTRIOL.
CALCITONIN.
CALCITONIN SALMON.
CALCITRIOL.
CALCIUM CARBIMIDE for therapeutic use.
CALCIUM HYDROXYLAPATITE in preparations for injection or implantation:
CALCIUM POLYSTYRENE SULPHONATE.
CALOTROPIS GIGANTEA.
CALOTROPIS PROCERA.
CALUSTERONE.
CAMPHORATED OIL for therapeutic use.
CAMPHOTAMIDE.
CANAGLIFLOZIN.
CANAKINUMAB.
CANDESARTAN CILEXETIL.
CANDICIDIN.
CANINE TICK ANTI‑SERUM.
CANNABIDIOL in preparations for therapeutic use or analytical and scientific research where:
(a) cannabidiol comprises 98% or more of the total cannabinoid content of the preparation; and
(b) any cannabinoids, other than cannabidiol, must be only those naturally found in cannabis and comprise 2% or less of the total cannabinoid content of the preparation;
(c) included in Schedule 3; or
(d) in hemp seed oil at a concentration of 75 mg/kg or less.
CANTHARIDIN.
CAPECITABINE.
CAPIVASERTIB.
CAPREOMYCIN.
CAPROMORELIN.
CAPTODIAME.
CAPTOPRIL.
CAPURIDE.
CARAMIPHEN.
CARBACHOL.
CARBAMAZEPINE.
CARBARYL for human therapeutic use.
CARBAZOCHROME.
CARBENICILLIN.
CARBENOXOLONE for internal use.
CARBETOCIN.
CARBIDOPA.
CARBIMAZOLE.
CARBOCROMEN.
CARBOPLATIN.
CARBOPROST.
CARBROMAL.
CARBUTAMIDE.
CARBUTEROL.
CARFILZOMIB.
CARGLUMIC ACID (N‑carbamoyl‑L‑glutamic acid).
CARINDACILLIN.
CARIPRAZINE.
CARISOPRODOL.
CARMUSTINE.
CARNIDAZOLE.
CARPROFEN.
CARVEDILOL.
CASIRIVIMAB.
CASPOFUNGIN.
CATHINE.
CATUMAXOMAB.
CEDAZURIDINE.
CEFACETRILE.
CEFACLOR.
CEFADROXIL.
CEFALEXIN.
CEFALORIDINE.
CEFALOTIN.
CEFAMANDOLE.
CEFAPIRIN.
CEFAZOLIN.
CEFEPIME.
CEFETAMET.
CEFIDEROCOL.
CEFIXIME.
CEFODIZIME.
CEFONICID.
CEFOPERAZONE.
CEFOTAXIME.
CEFOTETAN.
CEFOTIAM.
CEFOVECIN for veterinary use.
CEFOXITIN.
CEFPIROME.
CEFPODOXIME.
CEFQUINOME.
CEFTAROLINE FOSAMIL.
CEFSULODIN.
CEFTAZIDIME.
CEFTIBUTEN.
CEFTIOFUR.
CEFTRIAXONE.
CEFUROXIME.
CELECOXIB except when included in Schedule 3.
CELIPROLOL.
CENEGERMIN.
CEPHAELIS ACUMINATA (ipecacuanha) except in preparations containing 0.2% or less of emetine.
CEPHAELIS IPECACUANHA except in preparations containing 0.2% or less of emetine.
CEPHALONIUM.
CEPHRADINE.
CERITINIB.
CERIVASTATIN.
CERLIPONASE ALFA.
CERTOLIZUMAB PEGOL.
CERULETIDE.
CETIRIZINE except
(b) in divided preparations for oral use for the treatment of seasonal allergic rhinitis in adults and children 6 years of age and over when:
(i) in a primary pack containing not more than 10 days’ supply; and
(ii) labelled with a recommended daily dose not exceeding 10 mg of cetirizine.
CETRORELIX.
CETUXIMAB.
CHENODEOXYCHOLIC ACID.
CHLORAL FORMAMIDE.
CHLORAL HYDRATE except in preparations for topical use containing 2% or less of chloral hydrate.
CHLORALOSE except when included in Schedule 6.
CHLORAMBUCIL.
CHLORAMPHENICOL except when included in Schedule 3.
CHLORPHENAMINE except when included in Schedule 2 or 3.
CHLORPHENTERMINE.
CHLORPROMAZINE.
CHLORPROPAMIDE.
CHLORPROTHIXENE.
CHLORQUINALDOL for human topical use.
CHLORTALIDONE.
CHLORTETRACYCLINE except when included in Schedule 5.
CHLORZOXAZONE.
CHOLERA VACCINE.
CHOLIC ACID.
CHYMOPAPAIN for human therapeutic use.
CICLACILLIN.
CICLESONIDE.
CICLOPIROX except:
CICLOSPORIN.
CIDOFOVIR.
CILASTATIN.
CILAZAPRIL.
CILGAVIMAB.
CILOSTAZOL.
CIMETIDINE except when included in Schedule 3.
CIMICOXIB.
CINACALCET.
CINCHOCAINE except when included in Schedule 2.
CINNARIZINE.
CINOXACIN.
CIPAGLUCOSIDASE ALFA.
CIPROFLOXACIN.
CISAPRIDE.
CISATRACURIUM BESILATE.
CISPLATIN.
CITALOPRAM.
CJC‑1295 (CAS No. 863288‑34‑0).
CLADRIBINE.
CLANOBUTIN.
CLARITHROMYCIN.
CLASCOTERONE.
CLAVULANIC ACID.
CLEMASTINE except when included in Schedule 3.
CLEMIZOLE.
CLENBUTEROL.
CLEVIDIPINE.
CLIDINIUM BROMIDE.
CLINDAMYCIN.
CLIOQUINOL and other halogenated derivatives of oxyquinoline for human topical use except when separately specified in this Schedule.
CLOBAZAM.
CLOBETASOL.
CLOBETASONE (clobetasone‑17‑butyrate) except when included in Schedule 3.
CLOCORTOLONE.
CLODRONIC ACID (includes sodium clodronate).
CLOFARABINE.
CLOFAZIMINE.
CLOFENAMIDE.
CLOFIBRATE.
CLOMIFENE.
CLOMIPRAMINE.
CLOMOCYCLINE.
CLONAZEPAM.
CLONIDINE.
CLOPAMIDE.
CLOPIDOGREL.
CLOPROSTENOL.
CLORAZEPATE.
CLOREXOLONE.
CLORPRENALINE.
CLOSTEBOL (4‑chlorotestosterone).
CLOTRIMAZOLE except:
CLOXACILLIN.
CLOZAPINE.
COBALT for human therapeutic use except as dicobalt edetate in preparations for the treatment of cyanide poisoning.
COBICISTAT.
COBIMETINIB.
CODEINE when compounded with one or more other therapeutically active substances:
(a) in divided preparations containing 30 mg or less of codeine per dosage unit; or
(b) in undivided preparations containing 1% or less of codeine.
CO‑DERGOCRINE.
COLCHICINE.
COLCHICUM AUTUMNALE.
COLESTIPOL.
COLESTYRAMINE for human therapeutic use.
COLFOSCERIL PALMITATE for human therapeutic use.
COLISTIN.
COLLAGEN in preparations for injection or implantation:
COLLAGENASE CLOSTRIDIUM HISTOLYTICUM.
COLURACETAM.
CONCIZUMAB.
CONVALLARIA KEISKI.
CONVALLARIA MAJALIS.
COPPER COMPOUNDS for human use except:
(b) in preparations for human internal use containing 5 mg or less of copper per recommended daily dose; or
(c) in other preparations containing 5% or less of copper compounds.
CORIFOLLITROPIN ALFA.
CORONILLA spp.
CORTICOSTERONE.
CORTICOTROPHIN.
CORTISONE.
CO‑TRIMOXAZOLE.
COUMARIN for therapeutic use (excluding when present as an excipient).
CRISABOROLE.
CRIZOTINIB.
CROFELEMER.
CUPRIMYXIN.
CURARE.
CYCLANDELATE.
CYCLIZINE except when included in Schedule 3.
CYCLOBENZAPRINE.
CYCLOFENIL.
CYCLOHEXIMIDE.
CYCLOPENTHIAZIDE.
CYCLOPENTOLATE.
CYCLOPHOSPHAMIDE.
CYCLOPROPANE for therapeutic use.
CYCLOSERINE.
CYCLOTHIAZIDE.
CYCRIMINE.
CYMARIN.
CYPROHEPTADINE except when included in Schedule 3.
CYPROTERONE.
CYTARABINE.
CYTISINE except when included in Schedule 3.
DABRAFENIB MESILATE.
DABIGATRAN.
DACARBAZINE.
DACLATASVIR.
DACLIZUMAB.
DACTINOMYCIN.
DALFOPRISTIN.
DALTEPARIN (includes dalteparin sodium).
DANAPAROID (includes danaparoid sodium).
DANAZOL.
DANICOPAN.
DANTHRON for human use.
DANTROLENE.
DAPAGLIFLOZIN.
DAPOXETINE.
DAPSONE.
DAPTOMYCIN.
DARATUMUMAB.
DARBEPOETIN.
DARIFENACIN.
DAROLUTAMIDE.
DARUNAVIR.
DATOPOTAMAB DERUXTECAN.
DATURA spp. except:
DASABUVIR.
DASATINIB.
DATURA STRAMONIUM (stramonium) except:
(b) for smoking or burning.
DATURA TATULA (stramonium) except:
(b) for smoking or burning.
DAUNORUBICIN.
DEANOL for therapeutic use.
DEBRISOQUINE.
DECAMETHONIUM.
DECITABINE.
DEFERASIROX.
DEFERIPRONE.
DEFIBROTIDE.
DEFLAZACORT.
DEGARELIX.
DEHYDROCHLOROMETHYLTESTOSTERONE.
DEHYDROCORTICOSTERONE.
DELAVIRDINE MESILATE.
DELGOCITINIB.
DEMBREXINE except when included in Schedule 5.
DEMECARIUM.
DEMECLOCYCLINE.
DENGUE VACCINE.
DENOSUMAB.
DEOXYCHOLIC ACID.
DEOXYCORTONE.
DEOXYRIBONUCLEASE except:
(b) for external use.
DERACOXIB.
DERMATOPHAGOIDES PTERONYSSINUS AND DERMATOPHAGOIDES FARINAE EXTRACT.
DESFERRIOXAMINE.
DESFLURANE.
DESIPRAMINE.
DESIRUDIN.
DESLANOSIDE.
DESLORATADINE except:
(a) when included in Schedule 2; or
(b) in divided preparations for oral use for the treatment of seasonal allergic rhinitis in adults and children 6 years of age and over, when:
(i) in a primary pack containing 10 dosage units or less; and
(ii) labelled with a recommended daily dose not exceeding 5 mg of desloratadine.
DESLORELIN.
DESMOPRESSIN (D.D.A.V.P.).
DESOGESTREL.
DESONIDE.
DESOXYMETHASONE.
DESVENLAFAXINE.
DETOMIDINE.
DEUCRAVACITINIB.
DEUTETRABENAZINE.
DEXAMETHASONE.
DEXCHLORPHENAMINE except when included in Schedule 2 or 3.
DEXFENFLURAMINE.
DEXMEDETOMIDINE.
DEXRAZOXANE.
DEXTROMETHORPHAN (excluding its stereoisomers) except when included in Schedule 2.
DEXTROPROPOXYPHENE:
(a) in divided preparations containing 135 mg of dextropropoxyphene or less per dosage unit; or
(b) liquid preparations containing 2.5% or less of dextropropoxyphene.
DEXTRORPHAN (excluding its stereoisomers).
DIAMTHAZOLE.
DIAVERIDINE.
DIAZEPAM.
DIAZOXIDE.
DIBENZEPIN.
DIBOTERMIN.
DIBROMOPROPAMIDINE for therapeutic use except when included in Schedule 2.
DICHLORALPHENAZONE.
DICHLOROPHEN for human therapeutic use.
DICHLORPHENAMIDE.
DICLOFENAC except:
(b) in preparations for dermal use unless:
(i) for the treatment of solar keratosis; or
(ii) containing more than 4% of diclofenac.
DICLOXACILLIN.
DICYCLOMINE.
DIDANOSINE.
DIENESTROL.
DIENOGEST.
DIETHAZINE.
DIETHYLCARBAMAZINE for human therapeutic use.
DIETHYLPROPION.
DIFELIKEFALIN.
DIFENOXIN in preparations containing, per dosage unit, 0.5 mg or less of difenoxin and a quantity of atropine sulfate equivalent to at least 5% of the dose of difenoxin.
DIFLORASONE.
DIFLOXACIN.
DIFLUCORTOLONE.
DIFLUNISAL.
DIGITALIS LANATA.
DIGITALIS PURPUREA.
DIGITOXIN.
DIGOXIN.
DIGOXIN‑SPECIFIC ANTIBODY FRAGMENT F (Ab).
DIHYDRALAZINE.
DIHYDROCODEINE when compounded with one or more other therapeutically active substances:
(a) in divided preparations containing not more than 100 mg of dihydrocodeine per dosage unit; or
(b) in undivided preparations with a concentration of not more than 2.5% of dihydrocodeine;
except when included in Schedule 3.
DIHYDROERGOTOXINE.
DIHYDROLONE.
DIHYDROSTREPTOMYCIN.
DIHYDROTACHYSTEROL.
DIIODOHYDROXYQUINOLINE (iodoquinol) except:
(a) when included in Schedule 3; or
(b) for human internal use.
DIISOPROPYLAMINE DICHLOROACETATE.
DILTIAZEM.
DIMENHYDRINATE except when included in Schedule 2 or 3.
DIMERCAPROL.
DIMETHANDROSTANOLONE.
DIMETHAZINE.
DIMETHINDENE except when included in Schedule 3.
DIMETHOTHIAZINE.
DIMETHOXANATE.
DIMETHYL FUMARATE.
DIMETHYL SULFOXIDE (excluding dimethyl sulfone) for therapeutic use except:
(b) in in vitro test kits; or
(c) when used as a flavour component in compliance with the current Therapeutic Goods (Permissible Ingredients) determination for listed medicines.
DIMETRIDAZOLE.
DIMIRACETAM.
2,4‑DINITROCHLOROBENZENE for therapeutic use.
DINITROCRESOLS for therapeutic use except when separately specified in these Schedules.
DINITRONAPHTHOLS for therapeutic use except when separately specified in these Schedules.
DINITROPHENOLS for therapeutic use.
DINITROTHYMOLS for therapeutic use except when separately specified in these Schedules.
DINOPROST.
DINOPROSTONE.
DIPERODON.
DIPHEMANIL except in preparations for dermal use.
DIPHENHYDRAMINE except when included in Schedule 2 or 3.
DIPHENIDOL.
DIPHENOXYLATE in preparations containing, per dosage unit, 2.5 mg or less of diphenoxylate and a quantity of atropine sulfate equivalent to at least 1% of the dose of diphenoxylate except when included in Schedule 3.
DIPHENYLPYRALINE.
DIPHTHERIA TOXOID.
DIPIVEFRIN.
DIPYRIDAMOLE.
DIRITHROMYCIN.
DIRLOTAPIDE.
DIROXIMEL FUMARATE.
DISOPHENOL.
DISOPYRAMIDE.
DISTIGMINE.
DISULFIRAM for therapeutic use.
DISULPHAMIDE.
DITHIAZANINE except when included in Schedule 6.
DITIOCARB.
DOBUTAMINE.
DOCETAXEL.
DOFETILIDE.
DOLASETRON.
DOLUTEGRAVIR.
DOMPERIDONE.
DONEPEZIL.
DOPAMINE.
DOPEXAMINE.
DORAVIRINE.
DORIPENEM.
DORNASE.
DORZOLAMIDE.
DOSULEPIN.
DOXANTRAZOLE.
DOXAPRAM.
DOXAZOSIN.
DOXEPIN.
DOXORUBICIN.
DOXYCYCLINE.
DOXYLAMINE except when included in Schedule 2 or 3.
DRONEDARONE.
DROPERIDOL.
DROSPIRENONE.
DROSTANOLONE.
DROTRECOGIN.
DUBOISIA LEICHHARDTII except when included in Schedule 2.
DUBOISIA MYOPOROIDES except when included in Schedule 2.
DULAGLUTIDE.
DULOXETINE.
DUPILUMAB.
DURVALUMAB.
DUTASTERIDE.
DYDROGESTERONE.
ECONAZOLE except:
ECOTHIOPATE (includes ecothiopate iodide).
ECTYLUREA.
ECULIZUMAB.
EDARAVONE.
EDETIC ACID for human therapeutic use except:
(a) in preparations containing 0.25% or less of edetic acid; or
(b) as dicobalt edetate in preparations for the treatment of cyanide poisoning; or
(c) in contact lens preparations.
EDOXUDINE.
EDROPHONIUM.
EFALIZUMAB.
EFAVIRENZ.
EFGARTIGIMOD ALFA.
EFLORNITHINE.
ELACESTRANT DIHYDROCHLORIDE.
ELAFIBRANOR.
ELBASVIR.
ELETRIPTAN except when included in Schedule 3.
ELEXACAFTOR.
ELINZANETANT.
ELOSULFASE ALFA.
ELOTUZUMAB.
ELRANATAMAB.
ELTENAC.
ELTROMBOPAG.
ELUXADOLINE.
ELVITEGRAVIR.
EMEPRONIUM.
EMETINE except in preparations containing 0.2% or less of emetine.
EMPAGLIFLOZIN.
EMTRICITABINE.
ENALAPRIL.
ENASIDENIB.
ENCORAFENIB.
ENESTEBOL.
ENFLURANE for therapeutic use.
ENFORTUMAB VEDOTIN.
ENFUVIRTIDE.
ENOBOSARM.
ENOXACIN.
ENOXAPARIN.
ENOXIMONE.
ENPROSTIL.
ENROFLOXACIN.
ENTACAPONE.
ENTECAVIR.
ENTRECTINIB.
ENZALUTAMIDE.
EPHEDRA spp. except in preparations containing 0.001% or less of ephedrine.
EPHEDRINE.
EPICILLIN.
EPINASTINE.
EPIRUBICIN.
EPITIOSTANOL.
EPLERENONE.
EPOETINS.
EPOPROSTENOL.
EPROSARTAN.
EPTIFIBATIDE.
ERENUMAB.
ERGOMETRINE.
ERGOT.
ERGOTAMINE.
ERGOTOXINE.
ERIBULIN MESILATE.
ERLOTINIB.
ERTAPENEM.
ERTUGLIFLOZIN.
ERYSIMUM spp.
ERYTHROMYCIN.
ERYTHROPOIETIN.
ERYTHROPOIETINS except when separately specified in these Schedules.
ESCITALOPRAM.
ESLICARBAZEPINE ACETATE.
ESMOLOL.
ESOMEPRAZOLE except when included in Schedule 2.
ESTETROL MONOHYDRATE.
ESTRADIOL except when included in Schedule 5.
ESTRIOL.
ESTRAMUSTINE.
ESTROGENS except when separately specified in these Schedules.
ESTRONE.
ESTROPIPATE (piperazine estrone sulfate).
ETACRYNIC ACID.
ETANERCEPT.
ETHAMBUTOL.
ETHAMIVAN.
ETHCHLORVYNOL.
ETHER for use in anaesthesia.
ETHINAMATE.
ETHINYLESTRADIOL.
ETHIONAMIDE.
ETHISTERONE.
ETHOGLUCID.
ETHOHEPTAZINE.
ETHOPROPAZINE.
ETHOSUXIMIDE.
ETHOTOIN.
ETHOXZOLAMIDE.
ETHYL CHLORIDE for human therapeutic use.
ETHYLDIENOLONE.
ETHYLMORPHINE when compounded with one or more other therapeutically active substances:
(a) in divided preparations containing not more than 100 mg of ethylmorphine per dosage unit; or
(b) in undivided preparations with a concentration of not more than 2.5% of ethylmorphine.
ETHYLESTRENOL.
ETIDOCAINE.
ETIDRONIC ACID (includes etidronate disodium):
(b) in topical preparations except in preparations containing 1% or less of etidronic acid.
ETILEFRIN.
ETIPROSTON.
ETODOLAC.
ETOFENAMATE except when included in Schedule 2.
ETOMIDATE.
ETONOGESTREL.
ETOPOSIDE.
ETORICOXIB.
ETRANACOGENE DEZAPARVOVEC.
ETRASIMOD.
ETRAVIRINE.
ETRETINATE.
ETYNODIOL.
EVEROLIMUS.
EXEMESTANE.
EXENATIDE.
EZETIMIBE.
FAMCICLOVIR except when included in Schedule 3.
FAMOTIDINE except when included in Schedule 2.
FARICIMAB.
FASORACETAM.
FEBUXOSTAT.
FEDRATINIB.
FELBINAC except when included in Schedule 2.
FELODIPINE.
FELYPRESSIN.
FENBENDAZOLE except when included in Schedule 5.
FENBUFEN.
FENCAMFAMIN.
FENCLOFENAC.
FENFLURAMINE.
FENOFIBRATE.
FENOLDOPAM.
FENOPROFEN.
FENOTEROL.
FENPIPRAMIDE.
FENPIPRANE.
FENPROPOREX.
FENPROSTALENE.
FERRIC DERISOMALTOSE.
FEXOFENADINE except:
(b) in divided preparations for the treatment of seasonal allergic rhinitis in adults and children 12 years of age and over when:
(ii) labelled with a recommended daily dose not exceeding 120 mg of fexofenadine; or
(c) for the treatment of seasonal allergic rhinitis in adults and children 12 years of age and over when:
(i) in a primary pack containing 10 dosage units or less and not more than 10 days’ supply; and
(ii) labelled with a recommended daily dose not exceeding 180 mg of fexofenadine; or
(d) for the treatment of seasonal allergic rhinitis and children 6 years of age and over when:
(ii) labelled with a recommended daily dose not exceeding 60 mg of fexofenadine.
FEZOLINETANT.
FIBRINOLYSIN except for external use.
FIBROBLAST GROWTH FACTORS.
FIDAXOMICIN.
FILGOTINIB.
FILGRASTIM.
FINASTERIDE.
FINERENONE.
FINGOLIMOD.
FIROCOXIB.
FLECAINIDE.
FLEROXACIN.
FLOCTAFENINE.
FLORFENICOL.
FLUANISONE.
FLUCLOROLONE.
FLUCLOXACILLIN.
FLUCONAZOLE except when included in Schedule 3.
FLUCYTOSINE.
FLUDARABINE.
FLUDROCORTISONE.
FLUFENAMIC ACID.
FLUMAZENIL.
FLUMETASONE.
FLUMETHIAZIDE.
FLUNISOLIDE.
FLUNIXIN MEGLUMINE.
FLUOCINOLONE.
FLUOCINONIDE.
FLUOCORTIN.
FLUOCORTOLONE.
FLUORESCEIN in preparations for injection.
FLUORIDES in preparations for human use except when included in or expressly excluded from Schedule 2 or 3.
FLUOROMETHOLONE.
FLUOROURACIL.
FLUOXETINE.
FLUOXYMESTERONE.
FLUPENTIXOL.
FLUPHENAZINE.
FLUPROSTENOL.
FLURALANER in injectable preparations for use in companion animals.
FLURANDRENOLONE.
FLURAZEPAM.
FLURBIPROFEN except when:
(a) included in Schedule 2; or
(b) in divided preparations for topical oral use that contain 10 mg or less of flurbiprofen per dosage unit and that are:
(i) in a primary pack containing not more than 16 dosage units; and
(ii) labelled only for the treatment of adults and children over 12 years; or
(c) in undivided preparations for topical oral use containing either:
(i) 0.25% or less of flurbiprofen per dose; or
(ii) 10 mg or less of flurbiprofen per dose; and
that are:
(iii) in a primary pack containing not more than 15 Ml; and
(iv) labelled only for the treatment of adults 18 years and over.
FLUROXENE for human therapeutic use.
FLUSPIRILENE.
FLUTAMIDE.
FLUTICASONE except when included in Schedule 2.
FLUVASTATIN.
FLUVOXAMINE.
FOLIC ACID in preparations for human use for injection.
FOLINIC ACID in preparations for human use for injection.
FOLLICLE‑STIMULATING HORMONE except when separately specified in this Schedule.
FOLLISTATIN.
FOLLITROPIN ALFA.
FOLLITROPIN BETA.
FOLLITROPIN DELTA.
FOMEPIZOLE.
FOMIVIRSEN.
FONDAPARINUX.
FORMEBOLONE.
FORMESTANE.
FORMOTEROL
FOSAMPRENAVIR.
FOSAPREPITANT.
FOSCARNET.
FOSFESTROL (diethylstilbestrol diphosphate).
FOSFOMYCIN.
FOSINOPRIL.
FOSNETUPITANT.
FOSPHENYTOIN.
FOSTEMSAVIR.
FOTEMUSTINE.
FRAMYCETIN.
FRUQUINTINIB.
FULVESTRANT.
FURALTADONE.
FURAZABOL.
FURAZOLIDONE.
FUROSEMIDE (frusemide).
FUSIDIC ACID.
FUTIBATINIB.
FUZAPLADIB SODIUM.
GABAPENTIN.
GALANTAMINE.
GALANTHUS spp.
GALCANEZUMAB.
GALLAMINE.
GALSULFASE.
GANCICLOVIR.
GANIRELIX.
GARADACIMAB.
GATIFLOXACIN.
GRAZOPREVIR.
GEFITINIB.
GEMCITABINE.
GEMEPROST.
GEMFIBROZIL.
GEMIFLOXACIN.
GEMTUZUMAB OZOGAMICIN.
GENTAMICIN.
GESTODENE.
GESTONORONE.
GESTRINONE.
GHRH INJECTABLE PLASMID.
GILTERITINIB.
GITALIN.
GIVOSIRAN.
GLATIRAMER ACETATE.
GLECAPREVIR.
GLIBENCLAMIDE.
GLIBORNURIDE.
GLICLAZIDE.
GLIMEPIRIDE.
GLIPIZIDE.
GLIPTINS except when separately specified in these Schedules.
GLISOXEPIDE.
GLOFITAMAB.
GLUTATHIONE for parenteral use.
GLUTETHIMIDE.
GLYCERYL TRINITRATE except when included in Schedule 3.
GLYCOPYRRONIUM.
GLYMIDINE.
GnRH VACCINE.
GOLIMUMAB.
GONADORELIN.
GONADOTROPHIC HORMONES except when separately specified in this Schedule.
GOSERELIN.
GRAMICIDIN.
GRANISETRON.
GRAPIPRANT.
GREPAFLOXACIN.
GRISEOFULVIN.
GROWTH HORMONE RELEASING HORMONES* (GHRHs).
GROWTH HORMONE RELEASING PEPTIDES (GHRPs).
GROWTH HORMONE RELEASING PEPTIDE‑6 (GHRP‑6).
GROWTH HORMONE SECRETAGOGUES* (GHSs).
GUAIFENESIN for human therapeutic use except:
(b) in oral liquid preparations containing 2% or less of guaifenesin; or
(c) in divided preparations containing 200 mg or less of guaifenesin per dosage unit.
GUANABENZ.
GUANACLINE.
GUANETHIDINE.
GUANFACINE.
GUANIDINE for therapeutic use.
GUSELKUMAB.
HACHIMYCIN.
HAEMATIN.
HAEMOPHILUS INFLUENZAE VACCINE.
HALCINONIDE.
HALOFANTRINE.
HALOFENATE.
HALOFUGINONE in preparations containing 0.1% or less of halofuginone for the treatment of animals.
HALOPERIDOL.
HALOTHANE for therapeutic use.
HEMEROCALLIS (Hemerocallis flava).
HEPARINS for internal use except when separately specified in this Schedule.
HEPATITIS A VACCINE.
HEPATITIS B VACCINE.
HETACILLIN.
HEXACHLOROPHENE:
(a) in preparations for use on infants; or
(b) in other preparations except:
(i) when included in Schedule 2 or 6; or
(ii) in preparations containing 0.75% or less of hexachlorophene.
HEXAMETHONIUM.
HEXARELIN.
HEXETIDINE for human internal use.
HEXOBENDINE.
HEXOCYCLIUM.
HEXOPRENALINE.
HEXYL AMINOLEVULINATE (AS HYDROCHLORIDE).
HISTAMINE for therapeutic use except in preparations containing 0.5% or less of histamine.
HMG‑CoA REDUCTASE INHIBITORS (including "statins") except when separately specified in these Schedules.
HOMATROPINE.
HUMAN CHORIONIC GONADOTROPHIN except in pregnancy test kits.
HUMAN PAPILLOMAVIRUS VACCINE.
HYALURONIC ACID AND ITS POLYMERS in preparations for injection or implantation.
HYDRALAZINE.
HYDRARGAPHEN.
HYDROCHLOROTHIAZIDE.
HYDROCORTISONE:
(a) for human use except when included in Schedule 2 or 3; or
(b) for the treatment of animals.
HYDROCYANIC ACID for therapeutic use except in preparations containing 10 mg/kg or less of hydrocyanic acid.
HYDROFLUMETHIAZIDE.
HYDROQUINONE (other than its alkyl ethers separately specified in this Schedule) in preparations for human therapeutic or cosmetic use except:
(b) in hair preparations containing 0.3% or less of hydroquinone; or
(c) in cosmetic nail preparations containing 0.02% or less of hydroquinone.
HYDROXYCARBAMIDE.
HYDROXYCHLOROQUINE.
HYDROXYEPHEDRINE.
HYDROXYPHENAMATE.
HYDROXYPROGESTERONE.
HYDROXYSTENOZOL.
HYDROXYZINE.
HYGROMYCIN.
HYOSCINE except when included in Schedule 2.
HYOSCYAMINE except when included in Schedule 2.
HYOSCINE BUTYLBROMIDE except when included in Schedule 2 or Schedule 3.
HYOSCYAMUS NIGER except:
(b) in a pack containing 0.03 mg or less of total solanaceous alkaloids.
HYPOTHALAMIC RELEASING FACTORS except when separately specified in this Schedule.
HYPROMELLOSE in preparations for injection.
IBAFLOXACIN for veterinary use.
IBANDRONIC ACID.
IBOGAINE.
IBRITUMOMAB.
IBRUTINIB.
IBUFENAC.
IBUPROFEN except when:
(a) included in Schedule 2 or 3; or
(b) in preparations for dermal use; or
(c) in preparations for oral use that are labelled with a recommended daily dose of 1200 mg or less of ibuprofen in divided preparations, each containing 200 mg or less of ibuprofen, in a pack containing not more than 100 dosage units when:
(i) ibuprofen is the only therapeutically active constituent, other than phenylephrine or when combined with an effervescent agent; and
(ii) packed in blister or strip packaging or in a container with a child-resistant closure; and
(v) not labelled for the treatment of children 6 years and under; and
(vi) if combined with phenylephrine—not labelled for the treatment of children under 12 years.
IBUTAMOREN.
IBUTEROL.
IBUTILIDE.
ICATIBANT.
IDARUBICIN.
IDARUCIZUMAB.
IDEBENONE.
IDOXURIDINE except in preparations containing 0.5% or less of idoxuridine for dermal use.
IDURSULFASE.
IFOSFAMIDE.
ILOPROST.
ILUNOCITINIB.
IMATINIB.
IMDEVIMAB.
IMEPITOIN.
IMIDAPRIL.
IMIGLUCERASE.
IMIPENEM.
IMIPRAMINE.
IMIQUIMOD.
IMLIFIDASE.
IMMUNOGLOBULINS for human parenteral use except when separately specified in these Schedules.
INAVOLISIB.
INCLISIRAN.
INDACATEROL.
INDAPAMIDE.
INDINAVIR.
INDOMETACIN except when included in Schedule 2.
INDOPROFEN.
INDORAMIN.
INEBILIZUMAB.
INFIGRATINIB.
INFLIXIMAB.
INFLUENZA AND CORYZA VACCINES:
(a) for parenteral use; or
(b) for nasal administration.
INGENOL MEBUTATE.
INOTUZUMAB OZOGAMICIN.
INSULIN DEGLUDEC.
INSULIN GLARGINE.
INSULIN‑LIKE GROWTH FACTOR I.
INSULIN‑LIKE GROWTH FACTORS except when separately specified in this Schedule.
INSULINS.
INTERFERONS.
INTERLEUKINS except when separately specified in these Schedules.
IODOTHIOURACIL.
IPAMORELIN.
IPILIMUMAB.
IPRATROPIUM except when included in Schedule 2.
IPRIFLAVONE.
IPRINDOLE.
IPRONIAZID.
IPTACOPAN.
IRBESARTAN.
IRINOTECAN.
IRON COMPOUNDS in injectable preparations for human use.
ISAVUCONAZOLE.
ISOAMINILE.
ISOAMYL NITRITE.
ISOBUTYL NITRITE.
ISOCARBOXAZID.
ISOCONAZOLE except when included in Schedule 2, 3 or 6.
ISOETARINE.
ISOFLURANE for therapeutic use.
ISOMETHEPTENE.
ISONIAZID.
ISOPRENALINE.
ISOPRINOSINE.
ISOPROPAMIDE except when included in Schedule 2.
ISOSORBIDE DINITRATE except when included in Schedule 3.
ISOSORBIDE MONONITRATE.
ISOTRETINOIN.
ISOXICAM.
ISOXSUPRINE.
ISRADIPINE.
ITRACONAZOLE.
IVABRADINE.
IVACAFTOR.
IVERMECTIN:
(a) for human use; or
(b) for the treatment of mange in dogs.
IVOSIDENIB.
IXABEPILONE.
IXAZOMIB.
IXEKIZUMAB.
JAPANESE ENCEPHALITIS VACCINE.
KANAMYCIN.
KETANSERIN except in topical veterinary preparations containing 0.5% or less of ketanserin.
KETAZOLAM.
KETOCONAZOLE except:
(b) in preparations for dermal use containing 1% or less of ketoconazole for the treatment of the scalp; or
(c) in preparations for dermal use for the treatment of tinea pedis.
KETOPROFEN except:
(a) in preparations for dermal use; or
(b) when included in Schedule 3.
KETOROLAC (includes ketorolac trometamol).
KETOTIFEN except when included in Schedule 2.
KHELLIN.
KITASAMYCIN except:
(b) in animal feeds for growth promotion containing 100 mg/kg or less of antibiotic substances.
LABETALOL.
LACIDIPINE.
LACOSAMIDE.
LAMIVUDINE.
LAMOTRIGINE.
LANADELUMAB.
LANATOSIDES.
LANDIOLOL.
LANREOTIDE.
LANSOPRAZOLE except when included in Schedule 2 or 3.
LANTHANUM for therapeutic use.
LAPATINIB.
LARONIDASE.
LAROPIPRANT.
LAROTRECTINIB.
LATAMOXEF.
LATANOPROST.
LAUDEXIUM.
LAUROMACROGOLS in preparations for injection except:
(a) when present as an excipient; or
LAZERTINIB.
LEBRIKIZUMAB.
LECANEMAB.
LEDIPASVIR.
LEFETAMINE.
LEFLUNOMIDE.
LEMBOREXANT.
LENACAPAVIR.
LENALIDOMIDE.
LENIOLISIB.
LENOGRASTIM.
LENVATINIB.
LEPIRUDIN.
LEPTAZOL.
LERCANIDIPINE.
LESINURAD.
LETERMOVIR.
LETROZOLE.
LEUPRORELIN.
LEVALLORPHAN.
LEVAMISOLE:
(b) in preparations for the prevention or treatment of heartworm in dogs.
LEVETIRACETAM.
LEVOBUNOLOL.
LEVOBUPIVACAINE.
LEVOCABASTINE except when included in Schedule 2.
LEVOCETIRIZINE except:
(b) in divided preparations for oral use for the treatment of seasonal allergic rhinitis in adults and children 12 years of age and over when:
(i) in a primary pack containing not more than 5 days’ supply; and
(ii) labelled with a recommended daily dose not exceeding 5 mg of levocetirizine.
LEVODOPA.
LEVOMEPROMAZINE.
LEVOMILNACIPRAN.
LEVONORGESTREL except when included in Schedule 3.
LEVOSIMENDAN.
LIDOCAINE except:
(a) when included in Schedules 2 or 5; or
(b) in dermal preparations containing 2% or less of total local anaesthetic substances per dosage unit; or
(c) in lozenges containing 30 mg or less of total anaesthetic substances per dosage unit.
LIDOFLAZINE.
LIFITEGRAST.
LINACLOTIDE.
LINAGLIPTIN.
LINCOMYCIN.
LINDANE for human therapeutic use except when included in Schedule 2.
LINEZOLID.
LIOTHYRONINE.
LIPEGFILGRASTIM.
LIRAGLUTIDE.
LISINOPRIL.
LISURIDE.
LITHIUM for therapeutic use except:
(b) when present as an excipient in preparations for dermal use containing 0.25% or less of lithium; or
(c) in preparations containing 0.01% or less of lithium.
LIXISENATIDE.
LODOXAMIDE except when included in Schedule 2.
LOFEXIDINE.
LOGIPARIN for internal use.
LOMEFLOXACIN.
LOMUSTINE.
LOPERAMIDE except:
(b) in divided oral preparations containing 2 mg or less of loperamide per dosage unit, in a primary pack containing 8 dosage units or less.
LOPINAVIR.
LOPRAZOLAM.
LORACARBEF.
LORATADINE except:
(b) in divided preparations for oral use for the treatment of seasonal allergic rhinitis in adults and children 6 years of age and over, when:
(i) in a primary pack containing 10 dosage units or less; and
(ii) labelled with a recommended daily dose not exceeding 10 mg of loratadine.
LORAZEPAM.
LORLATINIB.
LORMETAZEPAM.
LOSARTAN.
LOTEPREDNOL.
LOXAPINE.
LUMACAFTOR.
LUMASIRAN.
LUMEFANTRINE.
LUMIRACOXIB.
LURASIDONE.
LURBINECTEDIN.
LUSPATERCEPT.
LUTEINISING HORMONE except in ovulation test kits.
LYMECYCLINE.
MACITENTAN for human use.
MAFENIDE except when included in Schedule 6.
MANDRAGORA OFFICINARUM.
MANNOMUSTINE.
MAPROTILINE.
MARAVIROC.
MARBOFLOXACIN.
MARIBAVIR.
MAROPITANT.
MARSTACIMAB.
MAVACAMTEN.
MAVACOXIB.
MAZINDOL.
MEASLES VACCINE.
MEBANAZINE.
MEBEVERINE.
MEBHYDROLIN.
MEBOLAZINE.
MEBUTAMATE.
MECAMYLAMINE.
MECASERMIN.
MECILLINAM.
MECLOCYCLINE.
MECLOFENAMATE.
MECLOFENOXATE.
MECLOZINE except when included in Schedule 2.
MEDAZEPAM.
MEDETOMIDINE.
MEDIGOXIN (methyldigoxin).
MEDROXYPROGESTERONE.
MEDRYSONE.
MEFENAMIC ACID except when included in Schedule 2.
MEFENOREX.
MEFLOQUINE.
MEFRUSIDE.
MEGESTROL.
MELAGATRAN.
MELANOTAN II.
MELATONIN for human use except when included in Schedule 3.
MELENGESTROL except when included in Schedule 6.
MELOXICAM except when included in Schedule 6.
MELPHALAN.
MEMANTINE.
MENINGOCOCCAL VACCINE.
MENINGOCOCCAL GROUP B VACCINE.
MENOTROPHIN.
MEPACRINE.
MEPENZOLATE.
MEPHENESIN.
MEPHENTERMINE.
MEPINDOLOL.
MEPITIOSTANE.
MEPIVACAINE.
MEPROBAMATE.
MEPTAZINOL.
MEPYRAMINE except when included in Schedule 2 or 3.
MEQUITAZINE.
MERCAPTAMINE for human therapeutic use.
MERCAPTOMERIN.
MERCAPTOPURINE.
MERCUROCHROME except when included in Schedule 2 or 6.
MERCURY for cosmetic or therapeutic use except:
(b) in a sealed device which prevents access to the mercury.
MEROPENEM.
MERSALYL.
MESABOLONE.
MESALAZINE.
MESNA.
MESTANOLONE (androstalone).
MESTEROLONE.
MESTRANOL.
METANDIENONE.
METARAMINOL.
METENOLONE.
METERGOLINE.
METFORMIN.
METHACHOLINE.
METHACYCLINE.
METHALLENESTRIL.
METHANDRIOL.
METHANTHELINIUM.
METHAZOLAMIDE.
METHDILAZINE except when included in Schedule 3.
METHENOLONE.
METHICILLIN.
METHIMAZOLE.
METHISAZONE.
METHIXENE.
METHOCARBAMOL.
METHOHEXITONE.
METHOIN.
METHOTREXATE.
METHOXAMINE except:
(b) in preparations for external use containing 1% or less of methoxamine.
METHOXSALEN.
METHOXYFLURANE.
METHSUXIMIDE.
METHYCLOTHIAZIDE.
METHYL AMINOLEVULINATE.
#METHYLANDROSTANOLONE.
METHYLCLOSTEBOL.
METHYLDOPA.
METHYLENE BLUE in preparations for injection.
METHYLERGOMETRINE.
METHYLMERCURY for therapeutic use.
METHYLNALTREXONE.
METHYLPENTYNOL.
METHYLPHENOBARBITAL.
METHYLPHENYLPIRACETAM.
METHYLPREDNISOLONE.
METHYLROSANILINIUM CHLORIDE for human use except when used as a dermal marker.
METHYL SALICYLATE in preparations for internal therapeutic use.
METHYLTESTOSTERONE.
METHYLTHIOURACIL.
METHYLTRIENOLONE.
METHYPRYLONE.
METHYSERGIDE.
METOCLOPRAMIDE except when included in Schedule 3.
METOLAZONE.
METOPROLOL.
METRIBOLONE.
METRIFONATE (trichlorfon) for human therapeutic use.
METRONIDAZOLE.
METYRAPONE.
MEXILETINE.
MEZLOCILLIN.
MIANSERIN.
MIBEFRADIL.
MIBOLERONE.
MICAFUNGIN.
MICONAZOLE except:
MIDAZOLAM.
MIDOSTAURIN.
MIDODRINE.
MIFEPRISTONE.
MIGALASTAT.
MIGLITOL.
MIGLUSTAT.
MILBEMYCIN OXIME except when included in Schedule 5.
MILNACIPRAN.
MILRINONE.
MINOCYCLINE.
MINOXIDIL except when included in Schedule 2.
MIRABEGRON.
MIRIKIZUMAB.
MIRTAZAPINE.
MISOPROSTOL.
MITOBRONITOL.
MITOMYCIN.
MITOTANE.
MITOXANTRONE.
MITRATAPIDE.
MIVACURIUM CHLORIDE.
MOBOCERTINIB.
MOCLOBEMIDE.
MODAFINIL.
MOLGRAMOSTIM.
MOLIDUSTAT.
MOLINDONE.
MOLNUPIRAVIR.
MOMELOTINIB.
MOMETASONE except when included in Schedule 2 or Schedule 3.
MONENSIN except:
(b) in animal feeds containing 360 mg/kg or less of antibiotic substances.
MONOBENZONE and alkyl ethers of hydroquinone for human therapeutic use or cosmetic use except in cosmetic nail preparations containing 0.02% or less of monobenzone or alkyl ethers of hydroquinone.
MONOCLONAL ANTIBODIES for therapeutic use except:
(a) in diagnostic test kits; or
MONOETHANOLAMINE in preparations for injection.
MONTELUKAST.
MOPERONE.
MORAZONE.
MORICIZINE.
MOTRAZEPAM.
MOTRETINIDE.
MOXIDECTIN in preparations for injection containing 10% or less of moxidectin except when included in Schedule 5 or 6.
(b) in animal feeds containing 100 mg/kg or less of antibiotic substances.
NARATRIPTAN except when included in Schedule 3.
NATALIZUMAB.
NATAMYCIN except for use as a food additive.
NATEGLINIDE.
NEBACUMAB.
NEBIVOLOL.
NEBRACETAM.
NEDOCROMIL.
NEFAZODONE.
NEFIRACETAM.
NEFOPAM.
NELARABINE.
NELFINAVIR (includes nelfinavir mesilate).
NEOMYCIN.
NEOSTIGMINE.
NEPAFENAC.
NERATINIB.
NERIUM OLEANDER.
NESIRITIDE.
NETILMICIN.
NETUPITANT.
NEVIRAPINE.
NIALAMIDE.
NICARDIPINE.
NICERGOLINE.
NICOFURANOSE.
NICORANDIL.
NICOTINE in preparations for human use except:
(a) when included in Schedule 3; or
(b) in preparations for oromucosal or transdermal administration for human therapeutic use when included in the Register as an aid in withdrawal either from tobacco smoking or nicotine vaping; or
(c) in tobacco prepared and packed for smoking.
NICOTINIC ACID in preparations for:
(a) human therapeutic use except:
(i) when separately specified in these Schedules; or
(ii) in preparations containing 100 mg or less of nicotinic acid per dosage unit; or
(iii) nicotinamide; or
(b) animal therapeutic use when packed and labelled for injection.
NICOUMALONE.
NIFEDIPINE.
NIFENAZONE.
NIKETHAMIDE.
NILOTINIB.
NILUTAMIDE.
NIMESULIDE.
NIMODIPINE.
NIMORAZOLE.
NINTEDANIB.
NIRAPARIB.
NIRIDAZOLE.
NIRMATRELVIR.
NIRSEVIMAB.
NISOLDIPINE.
NITISINONE.
NITRAZEPAM.
NITRENDIPINE.
NITRIC OXIDE for human therapeutic use.
NITROFURANTOIN.
NITROFURAZONE.
NITROUS OXIDE for therapeutic use.
NITROXOLINE.
NIVOLUMAB.
NIZATIDINE except when included in Schedule 2.
NOMEGESTROL.
NOMIFENSINE.
NORADRENALINE.
19‑NORANDROSTENEDIOL.
19‑NORANDROSTENEDIONE.
NORANDROSTENOLONE.
NORBOLETHONE.
NORCLOSTEBOL.
NORELGESTROMIN.
NORETHANDROLONE.
NORETHISTERONE.
NORFLOXACIN.
NORGESTREL.
NORIBOGAINE.
NORMAL HUMAN IMMUNOGLOBULIN.
NORMETHANDRONE.
NORTRIPTYLINE.
NOVOBIOCIN.
NOXIPTYLINE.
NUSINERSEN.
NYSTATIN except when included in Schedule 2 or 3.
OBETICHOLIC ACID.
OCLACITINIB.
OCRELIZUMAB.
OCRIPLASMIN.
OCTAMYLAMINE.
OCTATROPINE.
OCTREOTIDE.
OCTYL NITRITE.
ODEVIXIBAT.
OFATUMUMAB.
OFLOXACIN.
OLANZAPINE.
OLAPARIB.
OLARATUMAB.
OLEANDOMYCIN except:
(b) in animal feeds for growth promotion containing 50 mg/kg or less of antibiotic substances.
OLEANDRIN.
OLIPUDASE ALFA.
OLMESARTAN.
OLODATEROL.
OLOPATADINE except when included in Schedule 2.
OLSALAZINE.
OMALIZUMAB.
OMBERACETAM.
OMBITASVIR.
OMEGA‑3‑ACID ETHYL ESTERS (excluding salts and derivatives) for human therapeutic use, for the treatment of post‑myocardial infarction and/or hypertriglyceridaemia.
OMEPRAZOLE except when included in Schedule 2 or 3.
ONASEMNOGENE ABEPARVOVEC.
ONDANSETRON.
OPICAPONE.
OPIPRAMOL.
ORBIFLOXACIN.
ORCIPRENALINE.
ORGANOPHOSPHORUS COMPOUNDS with anticholinesterase activity for human therapeutic use except:
(b) in preparations containing 2% or less of malathion for external use.
ORLISTAT except when included in Schedule 3.
ORNIDAZOLE.
ORNIPRESSIN.
ORPHENADRINE.
ORTHOPTERIN.
OSELTAMIVIR.
OSILODROSTAT.
OSIMERTINIB.
OUABAIN.
OVANDROTONE.
OXABOLONE.
OXACILLIN.
OXALIPLATIN.
OXANDROLONE.
OXAPROZIN.
OXAZEPAM.
OXCARBAZEPINE.
OXEDRINE for human internal use except in preparations labelled with a recommended daily dose of 30 mg or less of oxedrine.
OXETACAINE (oxethazaine) except when included in Schedule 2.
OXICONAZOLE except:
OXIRACETAM.
OXITROPIUM.
OXOLAMINE.
OXOLINIC ACID.
OXPRENOLOL.
OXYBUPROCAINE.
OXYBUTYNIN.
OXYMESTERONE.
OXYMETHOLONE.
OXYPHENBUTAZONE.
OXYPHENCYCLIMINE.
OXYPHENONIUM.
OXYTETRACYCLINE except when included in Schedule 5.
OXYTOCIN.
OZANIMOD.
PACLITAXEL.
PALBOCICLIB.
PALIFERMIN.
PALIPERIDONE.
PALIVIZUMAB.
PALONOSETRON.
PALOPEGTERIPARATIDE.
PALOVAROTENE.
PAMAQUIN.
PAMIDRONIC ACID (includes pamidronate disodium).
PANCREATIC ENZYMES except:
(a) in preparations containing 20,000 BP units or less of lipase activity per dosage unit; or
PANCURONIUM.
PANITUMUMAB.
PANOBINOSTAT.
PANTOPRAZOLE except when included in Schedule 2 or 3.
PAPAVERINE in preparations for injection.
PARACETAMOL:
(a) when combined with aspirin or salicylamide or any derivative of these substances except when separately specified in these Schedules; or
(b) when combined with ibuprofen in a primary pack containing more than 30 dosage units; or
(c) in modified release tablets or capsules containing more than 665 mg paracetamol; or
(d) in non‑modified release tablets or capsules containing more than 500 mg paracetamol; or
(e) in individually wrapped powders or sachets of granules each containing more than 1000 mg paracetamol; or
(f) in tablets or capsules enclosed in a primary pack containing more than 100 tablets or capsules except in Schedule 3; or
(g) in individually wrapped powders or sachets of granules enclosed in a primary pack containing more than 50 wrapped powders or sachets of granules except when included in Schedule 3; or
(h) for injection; or
(i) for the treatment of animals.
PARALDEHYDE.
PARAMETHADIONE.
PARAMETHASONE.
PARECOXIB.
PARICALCITOL.
PARITAPREVIR.
PAROMOMYCIN.
PAROXETINE.
PASIREOTIDE.
PATIROMER SORBITEX CALCIUM.
PATISIRAN.
PAZOPANIB.
PECAZINE.
PEFLOXACIN.
PEGAPTANIB.
PEGASPARGASE.
PEGCETACOPLAN.
PEGFILGRASTIM.
PEGINTERFERON.
PEGUNIGALSIDASE ALFA.
PEGVALIASE.
PEGVISOMANT.
PEMBROLIZUMAB.
PEMETREXED.
PEMIGATINIB.
PEMOLINE.
PEMPIDINE.
PENBUTOLOL.
PENCICLOVIR except in preparations containing 1% or less of penciclovir for the treatment of herpes labialis in packs containing 10 g or less.
PENETHAMATE.
PENICILLAMINE.
PENTAERYTHRITYL TETRANITRATE.
PENTAGASTRIN.
PENTAMETHONIUM.
PENTAMIDINE (includes pentamidine isetionate).
PENTHIENATE.
PENTOBARBITAL when packed and labelled for injection.
PENTOLINIUM.
PENTOSAN POLYSULFATE SODIUM.
PENTOXIFYLLINE.
PERAMIVIR.
PERAMPANEL.
PERGOLIDE.
PERHEXILINE.
PERICIAZINE.
PERINDOPRIL.
PERMETHRIN for human therapeutic use except in preparations containing 5% or less of permethrin.
PERPHENAZINE.
PERTUSSIS ANTIGEN.
PERTUZUMAB.
PHENACEMIDE.
PHENACETIN for therapeutic use (excluding when present as an excipient).
PHENAGLYCODOL.
PHENAZONE except when included in Schedule 2 or 5.
PHENAZOPYRIDINE.
PHENELZINE.
PHENETICILLIN.
PHENFORMIN.
PHENGLUTARIMIDE.
PHENINDIONE.
PHENIRAMINE except when included in Schedule 2 or 3.
PHENISATIN.
PHENOBARBITAL.
PHENOL in preparations for injection.
PHENOLPHTHALEIN for human therapeutic use.
PHENOXYBENZAMINE.
PHENOXYMETHYLPENICILLIN.
PHENSUXIMIDE.
PHENTERMINE.
PHENTHIMENTONIUM.
PHENTOLAMINE.
PHENYLBUTAZONE.
PHENYLEPHRINE:
(a) in preparations for injection; or
(b) in preparations for human ophthalmic use containing 5% or more of phenylephrine.
(a) in divided preparations containing 100 mg or less of pholcodine per dosage unit; or
(b) in undivided preparations containing 2.5% or less of pholcodine;
except when included in Schedule 2.
PHOSPHODIESTERASE TYPE 5 INHIBITORS except:
(b) when present as an unmodified, naturally occurring substance.
PHTHALYLSULFATHIAZOLE.
PHYSOSTIGMINE.
PIBRENTASVIR.
PICROTOXIN.
PILOCARPINE except in preparations containing 0.025% or less of pilocarpine.
PIMECROLIMUS.
PIMOBENDAN.
PIMOZIDE.
PINACIDIL.
PINAVERIUM BROMIDE.
PINDOLOL.
PIOGLITAZONE.
PIPECURONIUM.
PIPEMIDIC ACID.
PIPENZOLATE.
PIPER METHYSTICUM (kava) in preparations for human use except when included on the Register in preparations:
(a) for oral use when present in tablet, capsule or teabag form that is labelled with a recommended maximum daily dose of 250 mg or less of kavalactones and:
(i) the tablet or capsule form contains 125 mg or less of kavalactones per tablet or capsule; or
(ii) the amount of dried whole or peeled rhizome and/or root in the teabag does not exceed 3 g;
and, where containing more than 25 mg of kavalactones per dose, compliant with the requirements of the required advisory statements for medicine labels; or
(b) in topical preparations for use on the rectum, vagina or throat containing dried whole or peeled rhizome and/or root or containing aqueous dispersions or aqueous extracts of whole or peeled rhizome and/or root; or
(c) in dermal preparations.
PIPERACILLIN.
PIPERIDINE.
PIPERIDOLATE.
PIPOBROMAN.
PIPOTHIAZINE.
PIPRADROL.
PIRACETAM.
PIRBUTEROL.
PIRENOXINE (catalin).
PIRENZEPINE.
PIRETANIDE.
PIRFENIDONE.
PIROXICAM except in preparations for dermal use.
PIRPROFEN.
PITAVASTATIN.
PITUITARY HORMONES except when separately specified in these Schedules.
PIVAMPICILLIN.
PIZOTIFEN.
PLICAMYCIN.
PLITIDEPSIN.
PLERIXAFOR.
PNEUMOCOCCAL VACCINE.
PODOPHYLLOTOXIN for human use:
PODOPHYLLUM EMODI (podophyllin) for human use:
PODOPHYLLUM PELTATUM (podophyllin) for human use:
POLIDEXIDE.
POLIOMYELITIS VACCINE.
POLYACRYLAMIDE in preparations for injection or implantation:
(b) for cosmetic use; or
(c) for veterinary use.
POLYCAPROLACTONE in preparations for injection or implantation:
POLYESTRADIOL.
POLYLACTIC ACID in preparations for injection or implantation:
POLYMYXIN.
POLYSULFATED GLYCOSAMINOGLYCANS in preparations for injection, except when separately specified in these Schedules.
POLYTHIAZIDE.
POMALIDOMIDE.
PONATINIB.
PONESIMOD.
PORACTANT.
POSACONAZOLE.
POTASSIUM BROMIDE for therapeutic use.
POTASSIUM CHLORIDE in oral preparations for human therapeutic use except:
(a) when containing less than 550 mg of potassium chloride per dosage unit; or
(b) in preparations for oral rehydration therapy; or
(c) in preparations for oral use for bowel cleansing prior to diagnostic medical and surgical procedures; or
PROCHLORPERAZINE except when included in Schedule 3.
PROCYCLIDINE except when included in Schedule 2.
PROGESTERONE except when included in Schedule 5.
PROGESTOGENS except when separately specified in these Schedules.
PROGLUMIDE.
PROGUANIL.
PROLINTANE.
PROMAZINE.
PROMETHAZINE except when included in Schedule 2 or 3.
PROMOXOLANE.
PROPAFENONE.
PROPAMIDINE for therapeutic use except when included in Schedule 2.
PROPANIDID.
PROPANTHELINE.
PROPENTOFYLLINE.
PROPETANDROL.
PROPIONIBACTERIUM ACNES for therapeutic use.
PROPOFOL.
PROPRANOLOL.
PROPYLHEXEDRINE.
PROPYLTHIOURACIL.
PROPYPHENAZONE.
PROQUAZONE.
PROSCILLARIDIN.
PROSTAGLANDINS except when separately specified in this Schedule.
PROSTIANOL.
PROTAMINE.
PROTHIONAMIDE.
PROTHIPENDYL.
PROTIRELIN.
PROTOVERATRINES.
PROTRIPTYLINE.
PROXYMETACAINE.
PRUCALOPRIDE.
PSEUDOEPHEDRINE except when included in Schedule 3.
PYRAZINAMIDE.
PYRIDINOLCARBAMATE.
PYRIDOSTIGMINE.
PYRIDOXINE, PYRIDOXAL OR PYRIDOXAMINE for human therapeutic use except:
(a) in oral preparations containing 200 mg or less but more than 50 mg of pyridoxine, pyridoxal or pyridoxamine per recommended daily dose when compliant with the requirements of the required advisory statements for medicine labels; or
(b) in oral preparations containing 50 mg or less of pyridoxine, pyridoxal or pyridoxamine per recommended daily dose.
PYRIMETHAMINE.
PYROVALERONE.
PYRVINIUM.
QUAZEPAM.
QUETIAPINE.
QUINAGOLIDE.
QUINAPRIL.
QUINBOLONE.
QUINETHAZONE.
QUINIDINE.
QUININE for human therapeutic use except when the maximum recommended daily dose is 50 mg or less of quinine.
QUINISOCAINE (dimethisoquin).
QUINUPRISTIN.
RABEPRAZOLE except when included in Schedule 2 or 3.
RABIES VACCINE.
RACETAMS except when separately specified in these Schedules.
RACTOPAMINE except when included in Schedule 5.
RALOXIFENE.
RALTEGRAVIR.
RALTITREXED.
RAMIPRIL.
RAMUCIRUMAB.
RANIBIZUMAB.
RANITIDINE except:
(b) in divided preparations for oral use containing 150mg or less of ranitidine per dosage unit when supplied in the manufacturer’s original pack containing not more than 14 dosage units; or
(c) in divided preparations for oral use containing 300mg or less of ranitidine per dosage unit in the manufacturer’s original pack containing not more than 7 dosage units.
RANOLAZINE.
RAPACURONIUM.
RASAGILINE.
RASBURICASE.
RAUWOLFIA SERPENTINA.
RAUWOLFIA VOMITORIA.
RAZOXANE.
REBOXETINE.
RED YEAST RICE for human therapeutic use.
REMDESIVIR.
REGDANVIMAB.
REGORAFENIB.
RELUGOLIX.
REMOXIPRIDE.
REPAGLINIDE.
REPOTRECTINIB.
RESERPINE.
RESLIZUMAB.
RETAPAMULIN.
RETEPLASE.
RETIGABINE.
RIBAVIRIN.
RIBOCICLIB.
RIDAFOROLIMUS.
RIFABUTIN.
RIFAMPICIN.
RIFAMYCIN.
RIFAPENTINE.
RIFAXIMIN.
RILPIVIRINE.
RILUZOLE.
RIMEGEPANT.
RIMEXOLONE.
RIMITEROL.
RIMONABANT.
RIOCIGUAT.
RIPRETINIB.
RISANKIZUMAB.
RISDIPLAM.
RISEDRONIC ACID.
RISPERIDONE.
RITLECITINIB.
RITODRINE.
RITONAVIR.
RITUXIMAB.
RIVAROXABAN.
RIVASTIGMINE.
RIZATRIPTAN except when included in Schedule 3.
ROBENACOXIB.
ROCURONIUM.
ROFECOXIB.
ROFLUMILAST.
ROLITETRACYCLINE.
ROLZIRACETAM.
ROMIDEPSIN.
ROMIFIDINE.
ROMIPLOSTIM.
ROMOSOZUMAB.
RONIDAZOLE.
ROPINIROLE.
ROPIVACAINE.
ROSIGLITAZONE.
ROSOXACIN.
ROSUVASTATIN.
ROTIGOTINE.
ROXIBOLONE.
ROXITHROMYCIN.
ROZANOLIXIZUMAB.
RUBELLA VACCINE.
RUBOXISTAURIN.
RUFINAMIDE.
RUPATADINE.
RUXOLITINIB.
SACITUZUMAB GOVITECAN.
SACUBITRIL.
SAFINAMIDE.
SALBUTAMOL except when included in Schedule 3.
SALICYLAMIDE when combined with aspirin, caffeine or paracetamol or any derivative of these substances.
SALINOMYCIN except:
(b) in animal feeds containing 60 mg/kg or less of antibiotic substances.
SALMETEROL.
SAPROPTERIN.
SAQUINAVIR.
SARILUMAB.
SARS‑COV‑2 (COVID‑19) VACCINE.
SAXAGLIPTIN.
SCHOENOCAULON OFFICINALE (sabadilla) except in preparations containing 10 mg/kg or 10 mg/L or less of total alkaloids of Schoenocaulon officinale.
SCOPOLIA CARNIOLICA for therapeutic use.
SEBELIPASE ALFA.
SEBETRALSTAT.
SECUKINUMAB.
SELADELPAR.
SELECTIVE ANDROGEN RECEPTOR MODULATORS (SARM).
SELEGILINE.
SELENIUM:
(a) for human oral use with a recommended daily dose of more than 300 micrograms; or
(b) for the treatment of animals except:
(i) when included in Schedule 6 or 7; or
(ii) in solid, slow release bolus preparations containing 300 mg or less of selenium per dosage unit; or
(iii) in other divided preparations containing 30 micrograms or less of selenium per dosage unit; or
(iv) as elemental selenium, in pellets containing 100 g/kg or less of selenium; or
(v) in feeds containing 1 g/tonne or less of selenium.
SELETRACETAM.
SELEXIPAG.
SELINEXOR.
SELPERCATINIB.
SELUMETINIB.
SEMAGLUTIDE.
SEPIAPTERIN.
SERELAXIN.
SERMORELIN.
SERTINDOLE.
SERTRALINE.
SEVELAMER.
SEVOFLURANE.
SEX HORMONES and all substances having sex hormonal activity except when separately specified in these Schedules.
SIBUTRAMINE.
SILANDRONE.
SILDENAFIL.
SILICONES for intra‑ocular use.
SILODOSIN.
SILTUXIMAB.
SILVER SULFADIAZINE.
SIMEPREVIR.
SIMVASTATIN.
SIPONIMOD.
SIROLIMUS.
SISOMICIN (sisomycin).
SITAGLIPTIN.
SITAXENTAN.
SODIUM BROMIDE for therapeutic use.
SODIUM CELLULOSE PHOSPHATE for human internal use.
SODIUM CITRATE DIHYDRATE for therapeutic use in dialysis, diafiltration, or total plasma exchange.
SODIUM CROMOGLYCATE except when included in Schedule 2.
SODIUM GLYCEROPHOSPHATE HYDRATE.
SODIUM MORRHUATE in preparations for injection.
SODIUM NITROPRUSSIDE for human therapeutic use.
SODIUM PHENYLBUTYRATE.
SODIUM PHOSPHATE in preparations for oral laxative use.
SODIUM POLYSTYRENE SULPHONATE for human therapeutic use.
SODIUM SALICYLATE in preparations for internal use for the treatment of animals.
SODIUM TETRADECYLSULFATE in preparations for injection.
SODIUM ZIRCONIUM CYCLOSILICATE.
SOFOSBUVIR.
SOLASODINE.
SOLIFENACIN.
SOMAPACITAN.
SOMATOSTATIN.
SOMATOTROPIN EQUINE.
SOMATROPIN (human growth hormone).
SONIDEGIB.
SONTOQUINE.
SORAFENIB.
SOTALOL.
SOTATERCEPT.
SOTORASIB.
SOTROVIMAB.
SPARFLOXACIN.
SPARTEINE.
SPECTINOMYCIN.
SPESOLIMAB.
SPIRAMYCIN.
SPIRAPRIL.
SPIRONOLACTONE.
STANOLONE.
STANOZOLOL.
STAVUDINE.
STENABOLIC (SR9009) and other synthetic REV‑ERB agonists.
STENBOLONE.
STEROID HORMONES except when separately specified in these Schedules.
STILBESTROL (diethylstilbestrol).
STIRIPENTOL.
STREPTODORNASE.
STREPTOKINASE.
STREPTOMYCIN.
STRONTIUM RANELATE.
STROPHANTHINS.
STROPHANTHUS spp.
STRYCHNINE in preparations containing 1.5% or less of strychnine for the treatment of animals.
STRYCHNOS spp. except in preparations containing 1 mg or less per litre or per kilogram of strychnine.
STYRAMATE.
SUCCIMER.
SUCROFERRIC OXYHYDROXIDE.
SUGAMMADEX.
SULBACTAM.
SULCONAZOLE except when included in Schedule 2.
SULFACETAMIDE except when included in Schedule 3 or 5.
SULFADIAZINE except when included in Schedule 5.
SULFADIMETHOXINE.
SULFADIMIDINE except when included in Schedule 5.
SULFADOXINE.
SULFAFURAZOLE.
SULFAGUANIDINE.
SULFAMERAZINE except when included in Schedule 5.
SULFAMETHIZOLE.
SULFAMETHOXAZOLE.
SULFAMETHOXYDIAZINE.
SULFAMETHOXYPYRIDAZINE.
SULFAMETROLE.
SULFAMONOMETHOXINE.
SULFAMOXOLE.
SULFAPHENAZOLE.
SULFAPYRIDINE.
SULFAQUINOXALINE.
SULFASALAZINE.
SULFATHIAZOLE except when included in Schedule 5.
SULFATROXAZOLE.
SULFINPYRAZONE.
SULFOMYXIN.
SULFONAMIDE ANTIBIOTICS except when separately specified in these Schedules.
SULFONMETHANE (sulfonal) and alkyl sulfonals.
SULINDAC.
SULTAMICILLIN.
SULTHIAME.
SUMATRIPTAN except when included in Schedule 3.
SUNIFIRAM.
SUNITINIB.
SUPROFEN.
SUTILAINS.
SUXAMETHONIUM.
SUXETHONIUM.
SUVOREXANT.
TACRINE.
TACROLIMUS.
TADALAFIL.
TAFAMIDIS.
TAFASITAMAB.
TAFENOQUINE SUCCINATE.
TAFLUPROST.
TAGRAXOFUSP.
TALAZOPARIB.
TALIGLUCERASE ALFA.
TALIMOGENE LAHERPAREPVEC.
TAMOXIFEN.
TAMSULOSIN.
TANACETUM VULGARE except in preparations containing 0.8% or less of oil of tansy.
TASIPIMIDINE SULFATE.
TASONERMIN.
TAZAROTENE.
TAZOBACTAM.
TB‑500.
T‑CELL RECEPTOR ANTIBODY.
TEBENTAFUSP.
TECLISTAMAB.
TEDUGLUTIDE.
TEGAFUR.
TEGASEROD.
TELAPREVIR.
TELITHROMYCIN.
TEICOPLANIN.
TELBIVUDINE.
TELMISARTAN.
TELOTRISTAT ETHYL.
TEMAZEPAM.
TEMOZOLOMIDE.
TEMSIROLIMUS.
TENECTEPLASE.
TENIPOSIDE.
TENOFOVIR.
TENOXICAM.
TEPOTINIB.
TEPOXALIN.
TEPROTUMUMAB.
TERAZOSIN.
TERBINAFINE except:
TERBUTALINE except when included in Schedule 3.
TERFENADINE.
TERIFLUNOMIDE.
TERIPARATIDE.
TERLIPRESSIN.
TERODILINE.
TEROPTERIN.
TESTOLACTONE.
TESTOSTERONE except when included in Schedule 6.
TETANUS ANTITOXIN except when used for short‑term protection or treatment of tetanus in animals.
TETANUS TOXOID for human use.
TETRABENAZINE.
TETRACAINE except:
(b) in dermal preparations containing 2% or less of total local anaesthetic substances.
TETRACOSACTIDE.
TETRACYCLINE except when included in Schedule 5.
TETRAETHYLAMMONIUM.
TETROXOPRIM.
TEZACAFTOR.
TEZEPELUMAB.
THALIDOMIDE.
THENYLDIAMINE.
THEOPHYLLINE except when included in Schedule 3.
THEVETIA PERUVIANA.
THEVETIN.
THIACETARSAMIDE in preparations for the prevention or treatment of heartworm in dogs.
THIAMBUTOSINE.
THIAZOSULFONE.
THIETHYLPERAZINE.
THIOACETAZONE.
THIOCARLIDE.
THIOMESTERONE (tiomesterone).
THIOPENTAL.
THIOPROPAZATE.
THIOPROPERAZINE.
THIORIDAZINE.
THIOSTREPTON.
THIOTEPA.
THIOTHIXENE.
THIOURACIL.
THIOUREA for therapeutic use except in preparations containing 0.1% or less of thiourea.
THYMOSIN BETA 4 (THYMOSIN β4).
THYMOXAMINE (includes thymoxamine hydrochloride).
THYROID except when separately specified in this Schedule.
THYROTROPHIN.
THYROXINE (includes thyroxine sodium).
TIAGABINE.
TIAMULIN.
TIANEPTINE.
TIAPROFENIC ACID.
TIARAMIDE.
TIBOLONE.
TICAGRELOR.
TICARCILLIN.
TICLOPIDINE.
TIEMONIUM.
TIENILIC ACID.
TIGECYCLINE.
TIGILANOL TIGLATE.
TIGLOIDINE.
TILDIPIROSIN.
TILETAMINE.
TILMANOCEPT.
TILMICOSIN.
TILUDRONIC ACID (includes disodium tiludronate).
TIMOLOL.
TINIDAZOLE.
TINZAPARIN (includes tinzaparin sodium).
TIOCONAZOLE except:
TIOGUANINE.
TIOTROPIUM.
TIPEPIDINE.
TIPIRACIL.
TIPRANAVIR.
TIRBANIBULIN.
TIRILAZAD.
TIROFIBAN.
TIRZEPATIDE.
TISLELIZUMAB.
TIXAGEVIMAB.
TOBRAMYCIN.
TOCAINIDE.
TOCERANIB.
TOCILIZUMAB.
TOFACITINIB.
TOLAZAMIDE.
TOLAZOLINE.
TOLBUTAMIDE.
TOLCAPONE.
TOLFENAMIC ACID.
TOLMETIN.
TOLONIUM.
TOLPROPAMINE.
TOLRESTAT.
TOLTERODINE.
TOLVAPTAN.
TOPIRAMATE.
TOPOTECAN.
TORASEMIDE.
TOREMIFENE.
TOXOIDS for human parenteral use except when separately specified in these Schedules.
TRABECTEDIN.
TRAMADOL.
TRANDOLAPRIL.
TRAMETINIB DIMETHYL SULFOXIDE.
TRANEXAMIC ACID except in preparations containing 3% or less of tranexamic acid for dermal cosmetic use.
TRANYLCYPROMINE.
TRASTUZUMAB.
TRASTUZUMAB DERUXTECAN.
TRASTUZUMAB EMTANSINE.
TRAVOPROST.
TRAZODONE.
TRENBOLONE (trienbolone, trienolone) except when included in Schedule 5.
TREOSULPHAN.
TREPROSTINIL.
TRESTOLONE.
TRETAMINE.
TRETINOIN except the ester hydroxypinacolone retinoate in preparations for dermal use containing 0.5% or less of hydroxypinacolone retinoate.
TRIACETYLOLEANDOMYCIN.
TRIAMCINOLONE except when included in Schedule 2 or 3.
TRIAMTERENE.
TRIAZIQUONE.
TRIAZOLAM.
TRICHLORMETHIAZIDE.
TRICHLOROACETIC ACID for human dermal use except when in preparations containing 12.5% or less of trichloroacetic acid for the treatment of warts other than anogenital warts.
TRICHLOROETHYLENE for therapeutic use.
TRICLOFOS.
TRICYCLAMOL.
TRIDIHEXETHYL.
TRIENTINE.
TRIFAROTENE.
TRIFLUOPERAZINE.
TRIFLUPERIDOL.
TRIFLUPROMAZINE.
TRIFLURIDINE.
TRIHEXYPHENIDYL.
TRILOSTANE.
TRIMETAPHAN.
TRIMETHOPRIM.
TRIMIPRAMINE.
TRIMUSTINE.
TRINITROPHENOL (excluding its derivatives) in preparations for human therapeutic use.
TRIOXYSALEN.
TRIPELENNAMINE.
TRIPROLIDINE except when included in Schedule 2 or 3.
TRIPTORELIN.
TROGLITAZONE.
TROLAMINE when in preparations for tattoo removal.
TROMETAMOL in preparations for injection except in preparations containing 3% or less of trometamol.
TROPICAMIDE.
TROPISETRON.
TROVAFLOXACIN.
TROXIDONE.
TRYPTOPHAN for human therapeutic use except in preparations labelled with a recommended daily dose of 100 mg or less of tryptophan.
TUBERCULIN.
TUBOCURARINE.
TUCATINIB.
TULATHROMYCIN.
TULOBUTEROL.
TYLOSIN.
TYPHOID VACCINE.
ULIPRISTAL except when included in Schedule 3.
UMECLIDINIUM.
UNIFIRAM.
UNOPROSTONE.
UPADACITINIB.
URACIL.
URAPIDIL.
URETHANE (excluding its derivatives) for therapeutic use.
UROFOLLITROPIN.
UROKINASE.
URSODEOXYCHOLIC ACID.
USTEKINUMAB.
VACCINES for human therapeutic use except when separately specified in this Schedule.
VACCINES for veterinary live virus except:
(a) poultry vaccines; or
(b) pigeon pox vaccine; or
(c) scabby mouth vaccine; or
(d) bovine ephemeral fever vaccine; or
(e) bovine herpesvirus‑1 vaccine.
VACCINES – PLASMID DNA for animal use except when separately specified in these Schedules.
VACCINIA VIRUS VACCINE.
VADADUSTAT.
VALACICLOVIR.
VALDECOXIB.
VALGANCICLOVIR.
VALNOCTAMIDE.
VALPROIC ACID.
VALSARTAN.
VANCOMYCIN.
VANDETANIB.
VARDENAFIL.
VARENICLINE.
VARICELLA VACCINE.
RECOMBINANT VARICELLA ZOSTER VIRUS GLYCOPROTEIN E ANTIGEN.
VASOPRESSIN.
VATINOXAN HYDROCHLORIDE.
VECURONIUM.
VEDAPROFEN.
VEDOLIZUMAB.
VELAGLIFLOZIN.
VELAGLUCERASE ALFA.
VELMANASE ALFA.
VELPATASVIR.
VEMURAFENIB.
VENETOCLAX.
VENLAFAXINE.
VERAPAMIL.
VERATRUM spp. except when separately specified in this Schedule.
VERDINEXOR.
VERICIGUAT.
VERNAKALANT.
VERTEPORFIN.
VIDARABINE.
VIGABATRIN.
VILANTEROL.
VILDAGLIPTIN.
VILOXAZINE.
VINBLASTINE.
VINCAMINE.
VINCRISTINE.
VINDESINE.
VINFLUNINE.
VINORELBINE.
VINYL ETHER for therapeutic use.
VIRGINIAMYCIN except when included in Schedule 5.
VISMODEGIB.
VISNADINE.
VITAMIN A for human therapeutic or cosmetic use except:
(a) in preparations for topical use containing 1% or less of Vitamin A; or
(b) in preparations for internal use containing 3000 micrograms retinol equivalents or less of Vitamin A per daily dose; or
(c) in preparations for parenteral nutrition replacement.
VITAMIN D for human internal therapeutic use except:
(a) in preparations containing 25 micrograms or less of vitamin D per recommended daily dose ; or
(b) when included in Schedule 3.
VORAPAXAR.
VORASIDENIB.
VORETIGENE NEPARVOVEC.
VORICONAZOLE.
VORINOSTAT.
VORTIOXETINE.
VOSORITIDE.
VOXILAPREVIR.
VUTRISIRAN.
WARFARIN for therapeutic use.
XAMOTEROL.
XANTHINOL NICOTINATE.
XIMELAGATRAN.
XIPAMIDE.
XYLAZINE.
YOHIMBINE.
ZAFIRLUKAST.
ZALCITABINE.
ZALEPLON.
ZANAMIVIR.
ZANUBRUTINIB.
ZERANOL except when included in Schedule 6.
ZIDOVUDINE.
ZILPATEROL.
ZILUCOPLAN.
ZIMELDINE.
ZINC COMPOUNDS for human internal use except:
(a) in preparations with a recommended daily dose of 25 mg or less of zinc; or
(b) in preparations with a recommended daily dose of more than 25 mg but not more than 50 mg of zinc when compliant with the requirements of the required advisory statements for medicine labels.