National Health (Listing of Pharmaceutical Benefits) Amendment Instrument 2015 (No. 12) (No. PB 117 of 2015)
1National Health (Listing of Pharmaceutical Benefits) Amendment Instrument 2015 (No. 12) (No. PB 117 of 2015)
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National Health (Listing of Pharmaceutical Benefits) Amendment Instrument 2015
(No. 12)
National Health Act 1953
I, PENNY SHAKESPEARE, First Assistant Secretary, Pharmaceutical Benefits Division, Department of Health, delegate of the Minister for Health, make this Instrument under sections 84AF, 84AK, 85, 85A, 88 and 101 of the National Health Act 1953.
Dated 21 December 2015
PENNY SHAKESPEARE
First Assistant Secretary
Pharmaceutical Benefits Division
Department of Health
1 Name of Instrument
(1) This Instrument is the National Health (Listing of Pharmaceutical Benefits) Amendment Instrument 2015 (No. 12).
(2) This Instrument may also be cited as PB 117 of 2015.
2 Commencement
This Instrument commences on 1 January 2016.
3 Amendment of National Health (Listing of Pharmaceutical Benefits) Instrument 2012 (PB 71 of 2012)
Schedule 1 amends the National Health (Listing of Pharmaceutical Benefits) Instrument 2012 (PB 71 of 2012).
Schedule 1 Amendments
[1] Schedule 1, entry for Alendronic Acid
omit:
Ossmax 70mg
RA
MP NP
C4882 C4885 C4889
4
5
4
[2] Schedule 1, entry for Alendronic acid with colecalciferol in the form Tablet 70 mg (as alendronate sodium) with 70 micrograms colecalciferol
(a) omit:
APO-Alendronate Plus D3 70 mg/70 mcg
TX
MP NP
C4070 C4087 C4110
4
5
4
(b) omit:
Chem mart Alendronate Plus D3 70 mg/70 mcg
CH
MP NP
C4070 C4087 C4110
4
5
Section 1 - National Health (Listing of Pharmaceutical Benefits) Amendment Instrument 2015 (No. 12) (No. PB 117 of 2015) - National Health (Listing of Pharmaceutical Benefits) Amendment Instrument 2015 (No. 12) (No. PB 117 of 2015) | Zoe
4
(c) omit:
Terry White Chemists Alendronate Plus D3 70 mg/70 mcg
TW
MP NP
C4070 C4087 C4110
4
5
4
[3] Schedule 1, entry for Alendronic acid with colecalciferol in the form Tablet 70 mg (as alendronate sodium) with 140 micrograms colecalciferol
(a) omit:
APO-Alendronate Plus D3 70 mg/140 mcg
TX
MP NP
C4122 C4123 C4133
4
5
4
(b) omit:
Chem mart Alendronate Plus D3 70 mg/140 mcg
CH
MP NP
C4122 C4123 C4133
4
5
4
(c) omit:
Terry White Chemists Alendronate Plus D3 70 mg/140 mcg
TW
MP NP
C4122 C4123 C4133
4
5
4
[4] Schedule 1, entry for Alginic acid with calcium carbonate and sodium bicarbonate
insert in the column headed “Circumstances”: C5837
[5] Schedule 1, entry for Aluminium Hydroxide with Magnesium Hydroxide
insert in the column headed “Circumstances”: C5837
[6] Schedule 1, omit entry for Aluminium Hydroxide with Magnesium Trisilicate and Magnesium Hydroxide
[7] Schedule 1, entry for Amoxycillin in the form Tablet 1 g (as trihydrate)
omit from the column headed “Circumstances” (twice occurring): C1582 substitute: C5843
[8] Schedule 1, entry for Amoxycillin in the form Powder for paediatric oral drops 100 mg (as trihydrate) per mL, 20 mL [Maximum Quantity: 1; Number of Repeats: 1]
(a) omit from the column headed “Brand”: Amoxil
(b) omit from the column headed “Responsible Person”: AS
(c) insert in the column headed “Circumstances”: C5863
[9] Schedule 1, entry for Amoxycillin in the form Powder for oral suspension 125 mg (as trihydrate) per 5 mL, 100 mL
(a) omit:
GenRx Amoxycillin
GX
PDP
1
0
1
(b) omit:
GenRx Amoxycillin
GX
MP NP
1
1
1
[10] Schedule 1, entry for Amoxycillin in the form Powder for oral suspension 250 mg (as trihydrate) per 5 mL, 100 mL
(a) omit:
GenRx Amoxycillin
GX
PDP
1
0
1
(b) omit:
GenRx Amoxycillin
GX
MP NP
1
1
1
[11] Schedule 1, entry for Amoxycillin with Clavulanic Acid in the form Tablet containing 500 mg amoxycillin (as trihydrate) with 125 mg clavulanic acid (as potassium clavulanate) [Maximum Quantity: 10; Number of Repeats: 0]
(a) insert in the column headed “Schedule Equivalent” for all brands: a
(b) insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
a
AlphaClav Duo
AF
PDP
C5833 C5894
10
0
10
(c) omit from the column headed “Circumstances” (all instances): C1836 C1837 substitute: C5833 C5894
[12] Schedule 1, entry for Amoxycillin with Clavulanic Acid in the form Tablet containing 500 mg amoxycillin (as trihydrate) with 125 mg clavulanic acid (as potassium clavulanate) [Maximum Quantity: 10; Number of Repeats: 1]
(a) insert in the column headed “Schedule Equivalent” for all brands: a
(b) insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
a
AlphaClav Duo
AF
MP NP MW
C5832 C5893
10
1
10
(c) omit from the column headed “Circumstances” (all instances): C1836 C1837 substitute: C5832 C5893
[13] Schedule 1, entry for Amoxycillin with Clavulanic Acid in the form Tablet containing 875 mg amoxycillin (as trihydrate) with 125 mg clavulanic acid (as potassium clavulanate) [Maximum Quantity: 10; Number of Repeats: 0]
(a) insert in the column headed “Schedule Equivalent” for all brands: a
(b) insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
a
AlphaClav Duo Forte
AF
PDP
C5833 C5894
10
0
10
(c) omit from the column headed “Circumstances” (all instances): C1836 C1837 substitute: C5833 C5894
[14] Schedule 1, entry for Amoxycillin with Clavulanic Acid in the form Tablet containing 875 mg amoxycillin (as trihydrate) with 125 mg clavulanic acid (as potassium clavulanate) [Maximum Quantity: 10; Number of Repeats: 1]
(a) insert in the column headed “Schedule Equivalent” for all brands: a
(b) insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
a
AlphaClav Duo Forte
AF
MP NP MW
C5832 C5893
10
1
10
(c) omit from the column headed “Circumstances” (all instances): C1836 C1837 substitute: C5832 C5893
[15] Schedule 1, entry for Amoxycillin with Clavulanic Acid in the form Powder for oral suspension containing 125 mg amoxycillin (as trihydrate) with 31.25 mg clavulanic acid (as potassium clavulanate) per 5 mL, 75 mL [Maximum Quantity: 1; Number of Repeats: 0]
omit from the column headed “Circumstances” (all instances): C1836 C1837 substitute: C5833 C5894
[16] Schedule 1, entry for Amoxycillin with Clavulanic Acid in the form Powder for oral suspension containing 125 mg amoxycillin (as trihydrate) with 31.25 mg clavulanic acid (as potassium clavulanate) per 5 mL, 75 mL [Maximum Quantity: 1; Number of Repeats: 1]
omit from the column headed “Circumstances” (all instances): C1836 C1837 substitute: C5832 C5893
[17] Schedule 1, entry for Amoxycillin with Clavulanic Acid in the forms: Powder for oral suspension containing 400 mg amoxycillin (as trihydrate) with 57 mg clavulanic acid (as potassium clavulanate) per 5 mL, 60 mL [Maximum Quantity: 1; Number of Repeats: 0]
omit from the column headed “Circumstances” (all instances): C1836 C1837 substitute: C5833 C5894
[18] Schedule 1, entry for Amoxycillin with Clavulanic Acid in the forms: Powder for oral suspension containing 400 mg amoxycillin (as trihydrate) with 57 mg clavulanic acid (as potassium clavulanate) per 5 mL, 60 mL [Maximum Quantity: 1; Number of Repeats: 1]
omit from the column headed “Circumstances” (all instances): C1836 C1837 substitute: C5832 C5893
[19] Schedule 1, entry for Aspirin in the form Tablet 100 mg
(a) omit:
Astrix
YN
MP NP
112
1
112
(b) omit:
Mayne Pharma Aspirin
YT
MP NP
112
1
112
(c) insert in the column headed “Circumstances” for the brand “Spren 100”: C5884
[20] Schedule 1, entry for Aspirin in the form Tablet, dispersible, 300 mg
(a) insert in the column headed “Circumstances” \[Authorised Prescriber PDP\]: C5870
(b) insert in the column headed “Circumstances” \[Authorised Prescriber MP NP\]: C5857
[21] Schedule 1, omit entry for Atorvastatin and ezetimibe
[22] Schedule 1, entry for Biperidin
omit from the column headed “Responsible Person”: LM substitute: ZC
[24] Schedule 1, entry for Buprenorphine in each of the forms: Tablet (sublingual) 400 micrograms (as hydrochloride); Tablet (sublingual) 2 mg (as hydrochloride); and Tablet (sublingual) 8 mg (as hydrochloride)
omit from the column headed “Responsible Person”: RC substitute: IR
[25] Schedule 1, entry for Buprenorphine with naloxone in each of the forms: Film (soluble) 2 mg (as hydrochloride)-0.5 mg (as hydrochloride); and Film (soluble) 8 mg (as hydrochloride)-2 mg (as hydrochloride)
omit from the column headed “Responsible Person”: RC substitute: IR
[26] Schedule 1, entry for Calcitriol
(a) insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
a
APO-Calcitriol
TX
MP NP
C5089 C5114 C5255 C5401 C5402
100
3
100
(b) insert in the column headed “Schedule Equivalent” for all brands: a
[27] Schedule 1, entry for Candesartan with Hydrochlorothiazide in the form Tablet containing candesartan cilexetil 16 mg with hydrochlorothiazide 12.5 mg
(a) insert in the column headed “Schedule Equivalent” for all brands: a
(b) insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
a
Asartan HCT 16/12.5
DO
MP NP
C4374
30
5
30
[28] Schedule 1, entry for Candesartan with Hydrochlorothiazide in the form Tablet containing candesartan cilexetil 32 mg with hydrochlorothiazide 12.5 mg
(a) insert in the column headed “Schedule Equivalent” for all brands: a
(b) insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
a
Asartan HCT 32/12.5
DO
MP NP
C4374
30
5
30
[29] Schedule 1, entry for Candesartan with Hydrochlorothiazide in the form Tablet containing candesartan cilexetil 32 mg with hydrochlorothiazide 25 mg
(a) insert in the column headed “Schedule Equivalent” for all brands: a
(b) insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
a
Asartan HCT 32/25
DO
MP NP
C4374
30
5
30
[30] Schedule 1, entry for Capecitabine in the form Tablet 150 mg
omit:
Xeloda
RO
MP
60
2
60
[31] Schedule 1, entry for Carbimazole
omit from the column headed “Responsible Person”: LM substitute: ZC
[32] Schedule 1, entry for Cefepime in each of the forms: Powder for injection 1 g (as hydrochloride); and Powder for injection 2 g (as hydrochloride)
omit from the column headed “Circumstances” (all instances): C1427 substitute: C5842
[33] Schedule 1, entry for Cefotaxime in the form Powder for injection 1 g (as sodium)
(a) omit from the column headed “Circumstances” \[Authorised Prescriber MP NP\] (twice occurring): C1169 C1846 C1847
substitute: C5827 C5828 C5829
(b) omit from the column headed “Circumstances” \[Authorised Prescriber PDP\] (twice occurring): C1169 substitute: C5892
[34] Schedule 1, entry for Cefotaxime in the form Powder for injection 2 g (as sodium)
(a) omit:
Cefotaxime Sandoz
SZ
MP NP
C1169 C1846 C1847
10
0
1
PDP
C1169
10
0
1
(b) omit from the column headed “Circumstances” for the brand “Hospira Pty Limited” \[Authorised Prescriber MP NP\]: C1169 C1846 C1847
substitute: C5826 C5881 C5890
(c) omit from the column headed “Circumstances” for the brand “Hospira Pty Limited” \[Authorised Prescriber PDP\]: C1169 substitute: C5519
[35] Schedule 1, entry for Ceftriaxone in the form Powder for injection 500 mg (as sodium) [Maximum Quantity: 1; Number of Repeats: 0]
(a) omit from the column headed “Circumstances”: C1143 C1169 C1846 C1847 substitute: C5826 C5855 C5881 C5890
(b) omit from the column headed “Purposes”: P1143 substitute: P5855
[36] Schedule 1, entry for Ceftriaxone in the form Powder for injection 500 mg (as sodium) [Maximum Quantity: 5; Number of Repeats: 0]
(a) omit from the column headed “Circumstances”: C1143 C1169 C1846 C1847 substitute: C5826 C5855 C5881 C5890
(b) omit from the column headed “Purposes”: P1169 P1846 P1847 substitute: P5826 P5881 P5890
[37] Schedule 1, entry for Ceftriaxone in the form Powder for injection 1 g (as sodium)
omit from the column headed “Circumstances” (all instances): C1169 C1846 C1847 substitute: C5830 C5862 C5868
[38] Schedule 1, entry for Ceftriaxone in the form Powder for injection 2 g (as sodium)
omit from the column headed “Circumstances” (all instances): C1169 C1846 C1847 substitute: C5826 C5881 C5890
[39] Schedule 1, entry for Cephazolin in the form Powder for injection 500 mg (as sodium)
omit from the column headed “Circumstances”: C1169 C1846 C1847 C3132 substitute: C5826 C5867 C5881 C5890
[40] Schedule 1, entry for Cephazolin in the form Powder for injection 1 g (as sodium)
omit from the column headed “Circumstances” (all instances): C1169 C1846 C1847 C3132 substitute: C5861 C5882 C5883 C5891
[41] Schedule 1, entry for Cephazolin in the form Powder for injection 2 g (as sodium)
(a) omit:
Cefazolin Sandoz
SZ
MP NP
C1169 C1846 C1847 C3132
10
0
1
(b) omit from the column headed “Circumstances” for the brand “Cephazolin Alphapharm”: C1169 C1846 C1847 C3132
substitute: C5826 C5867 C5881 C5890
[42] Schedule 1, omit entry for Chloramphenicol
[43] Schedule 1, entry for Chlorthalidone
omit from the column headed “Responsible Person”: LM substitute: ZC
[44] Schedule 1, entry for Clarithromycin in the form Tablet 250 mg
omit:
Klacid
GO
MP
P1434 P3325
100 CN1434 CN3325
2CN1434 CN3325
100
C(100)
[45] Schedule 1, entry for Clarithromycin in the form Tablet 500 mg
(a) omit from the column headed “Brand”: Klacid substitute: APO-Clarithromycin
(b) omit from the column headed “Responsible Person”: GO substitute: TX
(c) omit from the column headed “Circumstances”: C1434 C3325 substitute: C5873 C5874
[46] Schedule 1, entry for Cyproheptadine
omit from the column headed “Circumstances”: C1288 substitute: C5858
[47] Schedule 1, entry for Electrolyte Replacement, Oral
(a) omit:
O.R.S.
AS
MP NP
1
0
1
(b) insert in the column headed “Circumstances” for the brands “Repalyte New Formulation” and “restore O.R.S.”: C5889
[48] Schedule 1, entry for Erythromycin in the form Tablet 400 mg (as ethyl succinate)
omit from the column headed “Responsible Person” for the brand “E.E.S. 400 Filmtab” (twice occurring): LM substitute: ZC
[49] Schedule 1, entry for Erythromycin in the form Powder for oral liquid 200 mg (as ethyl succinate) per 5 mL, 100 mL
omit from the column headed “Responsible Person” for the brand “E.E.S. 200” (twice occurring): LM substitute: ZC
[50] Schedule 1, entry for Erythromycin in the form Powder for oral liquid 400 mg (as ethyl succinate) per 5 mL, 100 mL
omit from the column headed “Responsible Person” for the brand “E.E.S. Granules” (twice occurring): LM substitute: ZC
[51] Schedule 1, entry for Erythromycin in the form Powder for I.V. infusion 1 g (as lactobionate)
omit from the column headed “Responsible Person”: LM substitute: ZC
[52] Schedule 1, entry for Famciclovir in the form Tablet 125 mg
(a) insert in the column headed “Schedule Equivalent” for all brands: a
(b) insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
a
Auro-Famciclovir 125
DO
MP NP
C3624
40
1
40
[53] Schedule 1, entry for Famciclovir in the form Tablet 500 mg [Maximum Quantity: 30; Number of Repeats: 0]
(a) insert in the column headed “Schedule Equivalent” for all brands: a
(b) insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
a
Auro-Famciclovir 500
DO
MP NP
C3625 C3626 C3627 C3628 C3629
P3625
30
0
30
[54] Schedule 1, entry for Famciclovir in the form Tablet 500 mg [Maximum Quantity: 56; Number of Repeats: 5]
(a) insert in the column headed “Schedule Equivalent” for all brands: a
(b) insert in numerical order in the column headed “Circumstances” for the brand “Auro-Famciclovir 500”: C3625
(c) insert in the column headed “Purposes” for the brand “Auro-Famciclovir 500”: P3626 P3627 P3628 P3629
[55] Schedule 1, omit entry for Ferrous fumarate
[56] Schedule 1, omit entry for Ferrous Fumarate with Folic Acid
[57] Schedule 1, entry for Folic Acid in the form Tablet 500 micrograms
insert in the column headed “Circumstances” for the brands “Foltabs 500” and “Megafol 0.5”: C5824
[58] Schedule 1, entry for Folic Acid Tablet 5 mg
insert in the column headed “Circumstances”: C5820
[59] Schedule 1, entry for Glucose and Ketone Indicator—Urine
substitute:
Glucose and Ketone Indicator—Urine
Test strips, 50 (Keto‑Diabur‑Test 5000)
For external use
Keto‑Diabur‑Test 5000
RD
MP NP
C5852
2
2
1
Test strips, 50 (Keto‑Diastix)
For external use
Keto‑Diastix
BN
MP NP
C5852
2
2
1
[60] Schedule 1, entry for Glucose Indicator—Blood
(a) omit:
Test strips, 51 (Accu‑Chek Integra)
For external use
Accu‑Chek Integra
RD
MP NP
2
5
1
MP
P4241
2
11
1
(b) omit:
Test strips, 100 (GoodLife)
For external use
GoodLife
JN
MP NP
1
5
1
MP
P4241
1
11
1
[61] Schedule 1, entry for Glucose Indicator—Urine
omit from the column headed “Circumstances” (all instances): C1589 C2044 substitute: C5856 C5869
[73] Schedule 1, entry for Paracetamol
substitute:
Paracetamol
Suppositories 500 mg, 24
Rectal
Panadol
GC
MP NP
C4940 C4950
P4950
4
0
1
MP NP
C4940 C4950
P4940
4
3
1
Oral liquid 120 mg per 5 mL, 100 mL
Oral
Panamax
SW
PDP
C5846
1
0
1
MP NP
C5835
1
2
1
Oral liquid 240 mg per 5 mL, 200 mL
Oral
Panamax 240 Elixir
SW
PDP
C5846
1
0
1
MP NP
C5835
1
2
1
Tablet 500 mg
Oral
a
APO-Paracetamol
TX
PDP
C5846 C5885
P5846
100
0
100
a
Febridol
EA
PDP
C5846 C5885
P5846
100
0
100
a
Generic Health Pty Ltd
GQ
PDP
C5846 C5885
P5846
100
0
100
a
Panamax
SW
PDP
C5846 C5885
P5846
100
0
100
a
Paracetamol (Sandoz)
SZ
PDP
C5846 C5885
P5846
100
0
100
a
Paralgin
FM
PDP
C5846 C5885
P5846
100
0
100
a
Parapane
AF
PDP
C5846 C5885
P5846
100
0
100
a
APO-Paracetamol
TX
MP NP
C5835 C5865
P5835
100
1
100
a
Febridol
EA
MP NP
C5835 C5865
P5835
100
1
100
a
Generic Health Pty Ltd
GQ
MP NP
C5835 C5865
P5835
100
1
100
a
Panamax
SW
MP NP
C5835 C5865
P5835
100
1
100
a
Paracetamol (Sandoz)
SZ
MP NP
C5835 C5865
P5835
100
1
100
a
Paralgin
FM
MP NP
C5835 C5865
P5835
100
1
100
a
Parapane
AF
MP NP
C5835 C5865
P5835
100
1
100
a
APO-Paracetamol
TX
PDP
C5846 C5885
P5885
300
0
100
a
Febridol
EA
PDP
C5846 C5885
P5885
300
0
100
a
Generic Health Pty Ltd
GQ
PDP
C5846 C5885
P5885
300
0
100
a
Panamax
SW
PDP
C5846 C5885
P5885
300
0
100
a
Paracetamol (Sandoz)
SZ
PDP
C5846 C5885
P5885
300
0
100
a
Paralgin
FM
PDP
C5846 C5885
P5885
300
0
100
a
Parapane
AF
PDP
C5846 C5885
P5885
300
0
100
a
APO-Paracetamol
TX
MP NP
C5835 C5865
P5865
300
4
100
a
Febridol
EA
MP NP
C5835 C5865
P5865
300
4
100
a
Generic Health Pty Ltd
GQ
MP NP
C5835 C5865
P5865
300
4
100
a
Panamax
SW
MP NP
C5835 C5865
P5865
300
4
100
a
Paracetamol (Sandoz)
SZ
MP NP
C5835 C5865
P5865
300
4
100
a
Paralgin
FM
MP NP
C5835 C5865
P5865
300
4
100
a
Parapane
AF
MP NP
C5835 C5865
P5865
300
4
100
Tablet 665 mg (modified release)
Oral
Osteomol 665 Paracetamol
CR
MP NP
C4940 C4950 C5847
P4950
192
0
96
MP NP
C4940 C4950 C5847
P4940
192
3
96
MP NP
C4940 C4950 C5847
P5847
192
5
96
[74] Schedule 1, entry for Pemetrexed in the form Powder for I.V. infusion 100 mg (as disodium heptahydrate)
(a) insert in the column headed “Schedule Equivalent” for the brand “Alimta”: a
(b) insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
a
Pemetrexed MYX
YN
MP
C4789 C4792
See Note 3
SeeNote 3
1
D(100)
[75] Schedule 1, entry for Pemetrexed in the form Powder for I.V. infusion 500 mg (as disodium heptahydrate)
(a) insert in the column headed “Schedule Equivalent” for the brand “Alimta”: a
(b) insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
a
Pemetrexed MYX
YN
MP
C4789 C4792
See Note 3
SeeNote 3
1
D(100)
(c) insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
a
Pemetrexed Sandoz
SZ
MP
C4789 C4792
See Note 3
SeeNote 3
1
D(100)
[76] Schedule 1, entry for Propranolol in each of the forms: Tablet containing propranolol hydrochloride 10 mg; and Tablet containing propranolol hydrochloride 40 mg
insert in the column headed “Schedule Equivalent” for all brands: a
[77] Schedule 1, entry for Rituximab
omit:
Solution for I.V. infusion 100 mg in 10 mL
Injection
Mabthera
RO
MP
C4674 C4677 C4678 C4686 C4701 C4706 C4726
See Note 3
See Note 3
SeeNote 3
2
D(100)
substitute:
Solution for I.V. infusion 100 mg in 10 mL
Injection
Mabthera
RO
MP
See Note 3
See Note 3
See Note 3
SeeNote 3
1
D(100)
MP
C4674 C4677 C4678 C4686 C4701 C4706 C4726
See Note 3
See Note 3
SeeNote 3
2
D(100)
[78] Schedule 1, entry for Sapropterin
omit from the column headed “Responsible Person”: SG substitute: IO
[79] Schedule 1, entry for Tacrolimus in the form Capsule 0.5 mg
(a) omit:
TACROLIMUS APOTEX
TX
MP
100
3
100
(b) omit:
TACROLIMUS APOTEX
TX
MP
P5569 P5602
200CN5569 CN5602
5CN5569 CN5602
100
C(100)
[80] Schedule 1, entry for Tacrolimus in the form Capsule 1 mg
(a) omit:
TACROLIMUS APOTEX
TX
MP
100
3
100
(b) omit:
TACROLIMUS APOTEX
TX
MP
P5569 P5602
200CN5569 CN5602
5CN5569 CN5602
100
C(100)
[81] Schedule 1, entry for Tacrolimus in the form Capsule 5 mg
(a) omit:
TACROLIMUS APOTEX
TX
MP
50
3
50
(b) omit:
TACROLIMUS APOTEX
TX
MP
P5569 P5602
100CN5569 CN5602
5CN5569 CN5602
50
C(100)
[82] Schedule 1, entry for Ticarcillin with Clavulanic Acid
(a) omit from the column headed “Circumstances” \[Authorised Prescriber MP NP\]: C1169 C1846 C1847 substitute: C5826 C5881 C5890
(b) omit from the column headed “Circumstances” \[Authorised Prescriber PDP\]: C1169 substitute: C5831
[83] Schedule 1, entry for Tramadol in the form Capsule containing tramadol hydrochloride 50 mg [Maximum Quantity: 20;
Number of Repeats: 0]
(a) omit from the column headed “Circumstances” \[Authorised Prescriber MP NP\] (all instances): C1497 C1615 substitute: C5848 C5877
(b) omit from the column headed “Purposes” (all instances): P1497 substitute: P5877
(c) omit from the column headed “Circumstances” \[Authorised Prescriber PDP\] (all instances): C1497 C1615 substitute: C5875 C5876
[84] Schedule 1, entry for Tramadol in the form Capsule containing tramadol hydrochloride 50 mg [Maximum Quantity: 20;
Number of Repeats: 2]
(a) omit from the column headed “Circumstances” (all instances): C1497 C1615 substitute: C5848 C5877
(b) omit from the column headed “Purposes” (all instances): P1615 substitute: P5848
[85] Schedule 1, entry for Tramadol in each of the forms: Tablet (sustained release) containing tramadol hydrochloride 50 mg; Tablet (sustained release) containing tramadol hydrochloride 100 mg; Tablet (sustained release) containing tramadol hydrochloride 150 mg; and Tablet (sustained release) containing tramadol hydrochloride 200 mg
omit from the column headed “Circumstances” (all instances): C1537 substitute: C5822
[86] Schedule 1, entry for Tramadol
omit:
Oral drops containing tramadol hydrochloride 100 mg per mL, 10 mL
Oral
Tramal
CS
MP NP PDP
C1537
1
0
1
Injection containing tramadol hydrochloride 100 mg in 2 mL
Injection
Tramadol ACT
EA
MP NP PDP
C1378
5
0
5
Tramadol Sandoz
SZ
MP NP PDP
C1378
5
0
5
Tramal 100
CS
MP NP PDP
C1378
5
0
5
substitute:
Oral drops containing tramadol hydrochloride 100 mg per mL, 10 mL
Oral
Tramal
CS
MP NP
C5822
1
0
1
PDP
C5878
1
0
1
Injection containing tramadol hydrochloride 100 mg in 2 mL
Injection
Tramadol ACT
EA
MP NP
C5886
5
0
5
PDP
C5818
5
0
5
Tramadol Sandoz
SZ
MP NP
C5886
5
0
5
PDP
C5818
5
0
5
Tramal 100
CS
MP NP
C5886
5
0
5
PDP
C5818
5
0
5
[87] Schedule 1, entry for Trandolapril in each of the forms: Capsule 500 micrograms; Capsule 1 mg; Capsule 2 mg; and Capsule 4 mg
omit:
APO‑Trandolapril
TX
MP NP
28
5
28
[88] Schedule 1, entry for Trastuzumab in each of the forms: Powder for I.V. infusion 60 mg; and Powder for I.V. infusion 150 mg
insert in numerical order in the column headed “Circumstances”: C5825 C5834 C5844
[89] Schedule 1, entry for Triglycerides, medium chain in each of the forms: Oil 500 mL (MCT Oil); and Oral emulsion 250 mL (Liquigen)
(a) omit from the column headed “Circumstances”: C5616
(b) insert in numerical order: C5853 C5888
[90] Schedule 3, Responsible Person code GH
omit from the column headed “Responsible Person”: Mercury Pharma (Australia) Pty Limited
substitute: Amdipharm Mercury (Australia) Pty Limited
[91] Schedule 3, after details relevant to Responsible Person code IK
insert:
IO
BioMarin Pharmaceutical Australia Pty Ltd
69 159 743 496
[92] Schedule 3, after details relevant to Responsible Person code IQ
insert:
IR
Indivior Pty Ltd
22 169 280 102
[93] Schedule 3
omit:
JN
JNS Biomedical Pty Ltd
79 163 593 833
[94] Schedule 3, after details relevant to Responsible Person code YT
insert:
ZC
Anspec Pty Limited
13 056 263 239
[95] Schedule 4, Part 1, after entry for Alendronic acid with colecalciferol and calcium
insert:
Alginic acid with calcium carbonate and sodium bicarbonate
C5837
For treatment of a patient identifying as Aboriginal or Torres Strait Islander
[96] Schedule 4, Part 1, after entry for Alprazolam
insert:
Aluminium hydroxide with magnesium hydroxide
C5837
For treatment of a patient identifying as Aboriginal or Torres Strait Islander
[97] Schedule 4, Part 1, entry for Amoxycillin
substitute:
Amoxycillin
C5843
Chronic bronchitisPatient must have acute exacerbations of the condition.
C5863
Infection suspected or proven to be due to a susceptible organismThe treatment must be for patients who require a liquid formulation and in whom the syrup formulations are unsuitable.
Compliance with Authority Required procedures
[98] Schedule 4, Part 1, entry for Amoxycillin with Clavulanic Acid
substitute:
Amoxycillin with clavulanic acid
C5832
Infections where resistance to amoxycillin is proven
C5833
Infection where resistance to amoxycillin is suspected
C5893
Infection where resistance to amoxycillin is suspected
C5894
Infections where resistance to amoxycillin is proven
[99] Schedule 4, Part 1, after entry for Asenapine
insert:
Aspirin
C5857
For treatment of a patient identifying as Aboriginal or Torres Strait Islander
C5870
For treatment of a patient identifying as Aboriginal or Torres Strait Islander
C5884
For treatment of a patient identifying as Aboriginal or Torres Strait Islander
[100] Schedule 4, Part 1, omit entry for Atorvastatin and ezetimibe
[101] Schedule 4, Part 1, entry for Bisacodyl
insert in numerical order:
C5819
P5819
ConstipationPatient must be receiving long-term nursing care and in respect of whom a Carer Allowance is payable as a disabled adult.Patient must identify as Aboriginal or Torres Strait Islander.
C5823
P5823
Anorectal congenital abnormalitiesPatient must identify as Aboriginal or Torres Strait Islander.
C5851
P5851
Terminal malignant neoplasiaPatient must identify as Aboriginal or Torres Strait Islander.
C5866
P5866
MegacolonPatient must identify as Aboriginal or Torres Strait Islander.
C5879
P5879
ConstipationPatient must be receiving long-term nursing care on account of age, infirmity or other condition in a hospital, nursing home or residential facility.Patient must identify as Aboriginal or Torres Strait Islander.
[102] Schedule 4, Part 1, entry for Buprenorphine [Circumstances Code C4951]
omit from the column headed “Circumstances and Purposes”: non-narcotic analgesics substitute: non-opioid analgesics
[103] Schedule 4, Part 1, entry for Cefepime
substitute:
Cefepime
C5842
Febrile neutropenia
Compliance with Authority Required procedures
[104] Schedule 4, Part 1, entry for Cefotaxime
substitute:
Cefotaxime
C5519
Infection where positive bacteriological evidence confirms that this antibiotic is an appropriate therapeutic agent
C5826
Septicaemia, suspected
C5827
Infection where positive bacteriological evidence confirms that this antibiotic is an appropriate therapeutic agent
C5828
Septicaemia, suspected
C5829
Septicaemia, proven
C5881
Infection where positive bacteriological evidence confirms that this antibiotic is an appropriate therapeutic agent
C5890
Septicaemia, proven
C5892
Infection where positive bacteriological evidence confirms that this antibiotic is an appropriate therapeutic agent
[105] Schedule 4, Part 1, entry for Ceftriaxone
substitute:
Ceftriaxone
C5826
P5826
Septicaemia, suspected
C5830
Infection where positive bacteriological evidence confirms that this antibiotic is an appropriate therapeutic agent
C5855
P5855
Gonorrhoea
C5862
Septicaemia, proven
C5868
Septicaemia, suspected
C5881
P5881
Infection where positive bacteriological evidence confirms that this antibiotic is an appropriate therapeutic agent
C5890
P5890
Septicaemia, proven
[106] Schedule 4, Part 1, entry for Cephazolin
substitute:
Cephazolin
C5826
Septicaemia, suspected
C5861
Septicaemia, suspected
C5867
Cellulitis
C5881
Infection where positive bacteriological evidence confirms that this antibiotic is an appropriate therapeutic agent
C5882
Septicaemia, proven
C5883
Cellulitis
C5890
Septicaemia, proven
C5891
Infection where positive bacteriological evidence confirms that this antibiotic is an appropriate therapeutic agent
[107] Schedule 4, Part 1, entry for Clarithromycin
(a) omit:
C1434
Where the patient is receiving treatment at/from a private hospitalTreatment of Mycobacterium avium complex infections
Compliance with Written or Telephone Authority Required procedures
(b) omit:
C3325
Where the patient is receiving treatment at/from a public hospitalTreatment of Mycobacterium avium complex infections
Compliance with Written or Telephone Authority Required procedures – Streamlined Authority Code 3325
(c) insert in numerical order after existing text
C5873
Where the patient is receiving treatment at/from a private hospitalMycobacterium avium complex infection
Compliance with Written or Telephone Authority Required procedures
C5874
Where the patient is receiving treatment at/from a public hospitalMycobacterium avium complex infection
Compliance with Written or Telephone Authority Required procedures - Streamlined Authority Code 5874
[108] Schedule 4, Part 1, entry for Codeine with paracetamol [Purposes Code P4903]
omit from the column headed “Circumstances and Purposes”: non-narcotic analgesics substitute: non-opioid analgesics
[109] Schedule 4, Part 1, entry for Cyproheptadine
substitute:
Cyproheptadine
C5858
Prevention of migraine
[110] Schedule 4, Part 1, after entry for Eformoterol
insert:
Electrolyte replacement, oral
C5889
For treatment of a patient identifying as Aboriginal or Torres Strait Islander
[111] Schedule 4, Part 1, entry for Fentanyl [Circumstances Code C4952]
omit from the column headed “Circumstances and Purposes”: non-narcotic analgesics substitute: non-opioid analgesics
[112] Schedule 4, Part 1, after entry for Fluvoxamine
insert:
Folic acid
C5820
For treatment of a patient identifying as Aboriginal or Torres Strait Islander
C5824
For treatment of a patient identifying as Aboriginal or Torres Strait Islander
[113] Schedule 4, Part 1, entry for Glucose and Ketone Indicator—Urine
substitute:
Glucose and ketone indicator—urine
C5852
For treatment of a patient identifying as Aboriginal or Torres Strait Islander
[114] Schedule 4, Part 1, entry for Glucose Indicator—Urine
substitute:
Glucose indicator—urine
C5852
For treatment of a patient identifying as Aboriginal or Torres Strait Islander
[115] Schedule 4, Part 1, entry for Glycerol
(a) omit:
C5613
P5613
ConstipationPatient must be receiving long-term nursing care and in respect of whom a Carer Allowance is payable as a disabled adult.
(b) omit:
C5685
P5685
Anorectal congenital abnormalities
C5720
P5720
ConstipationPatient must be receiving long-term nursing care on account of age, infirmity or other condition in a hospital, nursing home or residential facility.
(c) omit:
C5776
P5776
Terminal malignant neoplasia
C5804
P5804
Megacolon
(d) insert in numerical order after existing text:
C5819
P5819
ConstipationPatient must be receiving long-term nursing care and in respect of whom a Carer Allowance is payable as a disabled adult.Patient must identify as Aboriginal or Torres Strait Islander.
C5823
P5823
Anorectal congenital abnormalitiesPatient must identify as Aboriginal or Torres Strait Islander.
C5851
P5851
Terminal malignant neoplasiaPatient must identify as Aboriginal or Torres Strait Islander.
C5866
P5866
MegacolonPatient must identify as Aboriginal or Torres Strait Islander.
C5879
P5879
ConstipationPatient must be receiving long-term nursing care on account of age, infirmity or other condition in a hospital, nursing home or residential facility.Patient must identify as Aboriginal or Torres Strait Islander.
[116] Schedule 4, Part 1, entry for Hydromorphone [Circumstances Codes: C4556; C4926; and C4959]
omit from the column headed “Circumstances and Purposes”: non-narcotic analgesics substitute: non-opioid analgesics
[117] Schedule 4, Part 1, entry for Hydroxocobalamin
substitute:
Hydroxocobalamin
C5840
Pernicious anaemiaPatient must identify as Aboriginal or Torres Strait Islander.
C5841
Anaemias associated with vitamin B12 deficiencyPatient must have had a gastrectomy; ANDThe treatment must be for prophylaxis.Patient must identify as Aboriginal or Torres Strait Islander.
C5854
Proven vitamin B12 deficiencies other than pernicious anaemiaPatient must identify as Aboriginal or Torres Strait Islander.
[118] Schedule 4, Part 1, entry for Methadone [Circumstances Codes: C4902; C4941; and C4953]
omit from the column headed “Circumstances and Purposes”: non-narcotic analgesics substitute: non-opioid analgesics
[119] Schedule 4, Part 1, entry for Morphine [Circumstances Codes: C4556; C4900; C4911; C4926; C4927; C4935; C4948; C4959; and C4960]
omit from the column headed “Circumstances and Purposes”: non-narcotic analgesics substitute: non-opioid analgesics
[120] Schedule 4, Part 1, entry for Naratriptan
(a) omit:
C3281
Migraine attack in a patient where attacks in the past have usually failed to respond to analgesics, and where adverse events have occurred with other suitable PBS‑listed drugs
Compliance with Authority Required procedures
C3282
Migraine attack in a patient where attacks in the past have usually failed to respond to analgesics, and where drug interactions have occurred with other suitable PBS‑listed drugs
Compliance with Authority Required procedures
C3283
Migraine attack in a patient where attacks in the past have usually failed to respond to analgesics, and where drug interactions are expected to occur with other suitable PBS‑listed drugs
Compliance with Authority Required procedures
C3284
Migraine attack in a patient where attacks in the past have usually failed to respond to analgesics, and where transfer to another suitable PBS‑listed drug would cause patient confusion resulting in problems with compliance
Compliance with Authority Required procedures
C3285
Migraine attack in a patient where attacks in the past have usually failed to respond to analgesics, and where transfer to another suitable PBS‑listed drug is likely to result in adverse clinical consequences
Compliance with Authority Required procedures
(b) insert in numerical order after existing text:
C5849
Migraine attackThe condition must have usually failed to respond to analgesics in the past; ANDPatient must be one in whom transfer to another suitable PBS-listed drug would cause patient confusion resulting in problems with compliance.
Compliance with Authority Required procedures
C5850
Migraine attackThe condition must have usually failed to respond to analgesics in the past; ANDPatient must be one in whom transfer to another suitable PBS-listed drug is likely to result in adverse clinical consequences.
Compliance with Authority Required procedures
C5859
Migraine attackThe condition must have usually failed to respond to analgesics in the past; ANDPatient must be one in whom adverse events have occurred with other suitable PBS-listed drugs.
Compliance with Authority Required procedures
C5860
Migraine attackThe condition must have usually failed to respond to analgesics in the past; ANDPatient must be one in whom drug interactions are expected to occur with other suitable PBS-listed drugs.
Compliance with Authority Required procedures
C5887
Migraine attackThe condition must have usually failed to respond to analgesics in the past; ANDPatient must be one in whom drug interactions have occurred with other suitable PBS-listed drugs.
Compliance with Authority Required procedures
[121] Schedule 4, Part 1, entry for Olanzapine
(a) omit:
C1589
Schizophrenia
Compliance with Authority Required procedures – Streamlined Authority Code 1589
C2044
Maintenance treatment of bipolar I disorder
Compliance with Authority Required procedures – Streamlined Authority Code 2044
(b) insert in numerical order after existing text:
C5856
Schizophrenia
Compliance with Authority Required procedures - Streamlined Authority Code 5856
C5869
Bipolar I disorderThe treatment must be maintenance therapy.
Compliance with Authority Required procedures - Streamlined Authority Code 5869
[122] Schedule 4, Part 1, entry for Oxycodone [Circumstances Codes: C4583; C4926; and C4959]
omit from the column headed “Circumstances and Purposes”: non-narcotic analgesics substitute: non-opioid analgesics
[123] Schedule 4, Part 1, entry for Oxycodone with naloxone [Circumstances Code C4951]
omit from the column headed “Circumstances and Purposes”: non-narcotic analgesics substitute: non-opioid analgesics
[124] Schedule 4, Part 1, entry for Paracetamol
(a) omit:
P4913
Chronic arthropathies
(b) omit:
C4969
P4969
Persistent painThe condition must be associated with osteoarthritis
(c) insert in numerical order after existing text:
C5835
P5835
For treatment of a patient identifying as Aboriginal or Torres Strait Islander
C5846
P5846
For treatment of a patient identifying as Aboriginal or Torres Strait Islander
C5847
P5847
Persistent painThe condition must be associated with osteoarthritis.Patient must identify as Aboriginal or Torres Strait Islander.
C5865
P5865
Chronic arthropathiesPatient must identify as Aboriginal or Torres Strait Islander.
C5885
P5885
Chronic arthropathiesPatient must identify as Aboriginal or Torres Strait Islander.
[125] Schedule 4, Part 1, entry for Tapentadol [Circumstances Code C4556]
omit from the column headed “Circumstances and Purposes”: non-narcotic analgesics substitute: non-opioid analgesics
[126] Schedule 4, Part 1, entry for Ticarcillin with Clavulanic Acid
substitute:
Ticarcillin with clavulanic acid
C5826
Septicaemia, suspected
C5831
Infection where positive bacteriological evidence confirms that this antibiotic is an appropriate therapeutic agent
C5881
Infection where positive bacteriological evidence confirms that this antibiotic is an appropriate therapeutic agent
C5890
Septicaemia, proven
[127] Schedule 4, Part 1, entry for Tramadol
substitute:
Tramadol
C5818
Acute painThe treatment must be for the short-term.
C5822
PainThe condition must be one in which aspirin and/or paracetamol alone are inappropriate or have failed.
C5848
P5848
Chronic painDose titrationThe condition must be one in which aspirin and/or paracetamol alone are inappropriate or have failed.
C5875
Acute painThe condition must be one in which aspirin and/or paracetamol alone are inappropriate or have failed.
C5876
Chronic painDose titrationThe condition must be one in which aspirin and/or paracetamol alone are inappropriate or have failed.
C5877
P5877
Acute painThe condition must be one in which aspirin and/or paracetamol alone are inappropriate or have failed.
C5878
PainThe condition must be one in which aspirin and/or paracetamol alone are inappropriate or have failed.
C5886
Acute painThe treatment must be for the short-term.
[128] Schedule 4, Part 1, entry for Trastuzumab
insert in numerical order:
C5825
Metastatic (Stage IV) HER2 positive adenocarcinoma of the stomach or gastro-oesophageal junctionInitial PBS-subsidised treatment (Grandfather patient)Patient must have evidence of human epidermal growth factor receptor 2 (HER2) positivity; ANDPatient must have been treated with this drug for this condition prior to 1 January 2016; ANDThe treatment must not be used in a patient with a left ventricular ejection fraction (LVEF) of less than 45% and/or with symptomatic heart failure.Cardiac function must be tested by echocardiography (ECHO) or multigated acquisition (MUGA), at 3 monthly intervals during treatment.Authority applications for initial treatment must be made in writing and must include:(a) a completed authority prescription form; and(b) a completed Metastatic (Stage IV) HER2 positive adenocarcinoma of stomach or gastro-oesophageal junction authority application form which includes confirmation that the patient has Stage IV disease and a copy of the pathology report from an Approved Pathology Authority confirming evidence of human epidermal growth factor receptor 2 (HER2) positivity.
Compliance with Written Authority Required procedures
C5834
Metastatic (Stage IV) HER2 positive adenocarcinoma of the stomach or gastro-oesophageal junctionContinuing treatmentPatient must have previously been issued with an authority prescription for this drug for this condition; ANDPatient must not have progressive disease; ANDThe treatment must not be used in a patient with a left ventricular ejection fraction (LVEF) of less than 45% and/or with symptomatic heart failure.Cardiac function must be tested by echocardiography (ECHO) or multigated acquisition (MUGA), at 3 monthly intervals during treatment.
Compliance with Written or Telephone Authority Required procedures
C5844
Metastatic (Stage IV) HER2 positive adenocarcinoma of the stomach or gastro-oesophageal junctionInitial treatmentPatient must have evidence of human epidermal growth factor receptor 2 (HER2) positivity as demonstrated by immunohistochemistry 2+ or more in tumour material; ANDPatient must have evidence of HER2 gene amplification as demonstrated by in situ hybridisation results based on more than 6 copies of HER2 in the same tumour tissue sample; ANDPatient must have evidence of HER2 gene amplification as demonstrated by in situ hybridisation results based on the ratio of HER2 to chromosome 17 being more than 2 in the same tumour tissue sample; ANDPatient must commence treatment in combination with cisplatin and capecitabine; ORPatient must commence treatment in combination with cisplatin and 5 fluorouracil; ANDPatient must not have previously received this drug for this condition; ANDPatient must not have received prior chemotherapy for this condition; ANDPatient must have a WHO performance status of 2 or less; ANDThe treatment must not be used in a patient with a left ventricular ejection fraction (LVEF) of less than 45% and/or with symptomatic heart failure.Authority applications for initial treatment must be made in writing and must include:(a) a completed authority prescription form; and(b) a completed Metastatic (Stage IV) HER2 positive adenocarcinoma of stomach or gastro-oesophageal junction authority application form which includes confirmation that the patient has Stage IV disease and a copy of the pathology report from an Approved Pathology Authority confirming evidence of human epidermal growth factor receptor 2 (HER2) gene amplification as demonstrated in tumour material by both (i) immunohistochemistry (IHC) 2+ or IHC 3+ AND (ii) in situ hybridisation (ISH) results based on both more than 6 copies of HER2 AND the ratio of HER2: chromosome 17 being more than 2 in the same tumour tissue sampleCardiac function must be tested by echocardiography (ECHO) or multigated acquisition (MUGA), prior to seeking the initial authority approval and then at 3 monthly intervals during treatment.
Compliance with Written Authority Required procedures
[129] Schedule 4, Part 1, entry for Triglycerides, medium chain
(a) omit:
C5616
Intractable childhood epilepsyPatient must require a ketogenic diet.Cerebrospinal fluid glucose transporter defectPatient must require a ketogenic diet.
Compliance with Authority Required procedures
(b) insert in numerical order after existing text:
C5853
Intractable childhood epilepsyPatient must require a ketogenic diet.
Compliance with Authority Required procedures
C5888
Cerebrospinal fluid glucose transporter defectPatient must require a ketogenic diet.