National Health (Listing of Pharmaceutical Benefits) Amendment Instrument 2016 (No. 2) (PB 11 of 2016)
Sch 1Amendments
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Turn the raw legal text into a practical explanation grounded in National Health (Listing of Pharmaceutical Benefits) Amendment Instrument 2016 (No. 2) (PB 11 of 2016).
insert after the definition of “extemporaneously‑prepared pharmaceutical benefit”:
General Statement for drugs for the treatment of hepatitis C means the statement set out in Part 3 of Schedule 4;
[2] Schedule 1, entry for Aciclovir
substitute:
Aciclovir
Eye ointment 30 mg per g, 4.5 g
Application to the eye
AciVision
DZ
MP NP
C5965
1
0
1
AO
C5964
1
0
1
Zovirax
GK
MP NP
C5965
1
0
1
AO
C5964
1
0
1
Tablet 200 mg
Oral
a
Aciclovir Sandoz
HX
MP NP
C5936 C5942
P5936
50
0
25
a
Acyclo‑V 200
AF
MP NP
C5936 C5942
P5936
50
0
25
a
GenRx Aciclovir
GX
MP NP
C5936 C5942
P5936
50
0
50
a
Lovir
GN
MP NP
C5936 C5942
P5936
50
0
25
a
Zovirax 200 mg
GK
MP NP
C5936 C5942
P5936
50
0
25
a
Aciclovir 200
CR
MP NP
C5942
90
5
90
a
Aciclovir GH
GQ
MP NP
C5942
90
5
90
a
Aciclovir Sandoz
HX
MP NP
C5936 C5942
P5942
90
5
90
a
Acyclo‑V 200
AF
MP NP
C5936 C5942
P5942
90
5
90
a
Chem mart Aciclovir
CH
MP NP
C5942
90
5
90
a
GenRx Aciclovir
GX
MP NP
C5936 C5942
P5942
90
5
90
a
Lovir
GN
MP NP
C5936 C5942
P5942
90
5
90
a
Ozvir
RA
MP NP
C5942
90
5
90
a
Terry White Chemists Aciclovir
TW
MP NP
C5942
90
5
90
a
Zovirax 200 mg
GK
MP NP
C5936 C5942
P5942
90
5
90
Tablet 800 mg
Oral
a
Aciclovir 800
CR
MP NP
C5959 C5967
35
0
35
a
Aciclovir Sandoz
HX
MP NP
C5959 C5967
35
0
35
a
Acyclo‑V 800
AF
MP NP
C5946 C5959 C5967
P5959 P5967
35
0
35
a
GenRx Aciclovir
GX
MP NP
C5959 C5967
35
0
35
a
Zovirax 800 mg
GK
MP NP
C5959 C5967
35
0
35
Acyclo‑V 800
AF
MP NP
C5946 C5959 C5967
P5946
120
5
120
[3] Schedule 1, after entry for Amino acid formula with fat, carbohydrate, vitamins, minerals, and trace elements, without methionine and supplemented with docosahexanoic acid
insert:
Amino acid formula with fat, carbohydrate, vitamins, minerals and trace elements without phenylalanine
[4] Schedule 1, entry for Amino acid formula with fat, carbohydrate, vitamins, minerals, trace elements and medium chain triglycerides
insert in numerical order in the column headed “Circumstances”: C5945 C5974
[5] Schedule 1, entry for Amino acid synthetic formula supplemented with long chain polyunsaturated fatty acids and medium chain triglycerides in the form Oral powder 400 g (Alfamino)
insert in numerical order in the column headed “Circumstances”: C4415 C5945 C5974
[6] Schedule 1, entry for Amiodarone in the form Tablet containing amiodarone hydrochloride 200 mg
omit from the column headed “Responsible Person” for the brand “Rithmik 200”: QA substitute: RW
[7] Schedule 1, entry for Amisulpride in the form Tablet 400 mg
omit from the column headed “Responsible Person” for the brand “Amipride 400”: QA substitute: RW
[8] Schedule 1, entry for Amlodipine in each of the forms: Tablet 5 mg (as besylate); and Tablet 10 mg (as besylate)
omit:
Amlodipine‑DRLA
RZ
MP NP
30
5
30
[9] 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)
(a) omit:
a
Clamoxyl Duo
AL
PDP
C5833 C5894
10
0
10
(b) omit:
a
Clamoxyl Duo
AL
MP NP MW
C5832 C5893
10
1
10
[10] 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)
(a) omit:
a
Clamoxyl Duo forte
AL
PDP
C5833 C5894
10
0
10
(b) omit:
a
Clamoxyl Duo forte
AL
MP NP
C5832 C5893
10
1
10
[11] 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
(a) omit:
Clamoxyl
AL
PDP
C5833 C5894
1
0
1
(b) omit:
Clamoxyl
AL
MP NP
C5832 C5893
1
1
1
[12] Schedule 1, entry for Amoxycillin with Clavulanic Acid in the form Powder for oral suspension containing 400 mg amoxycillin (as trihydrate) with 57 mg clavulanic acid (as potassium clavulanate) per 5 mL, 60 mL
(a) omit:
Clamoxyl Duo 400
AL
PDP
C5833 C5894
1
0
1
(b) omit:
Clamoxyl Duo 400
AL
MP NP
C5832 C5893
1
1
1
[13] Schedule 1, entry for Anastrozole
(a) omit:
Anastrozole‑DRLA
RZ
MP NP
C5464
30
5
30
(b) omit:
Pharmacy Choice Anastrozole
RI
MP NP
C5464
30
5
30
[14] Schedule 1, entry for Atenolol in the form Tablet 50 mg
omit from the column headed “Responsible Person” for the brand “Tensig”: QA substitute: RW
[15] Schedule 1, entry for Atorvastatin in each of the forms: Tablet 10 mg (as calcium); Tablet 20 mg (as calcium); Tablet 40 mg (as calcium); and Tablet 80 mg (as calcium)
omit from the column headed “Responsible Person” for the brands “Torvastat 10”, “Torvastat 20”, “Torvastat 40” and “Torvastat 80” respectively (all instances): QA substitute: RW
[16] Schedule 1, entry for Azathioprine in the form Tablet 50 mg
omit from the column headed “Responsible Person” for the brand “Azapin”: QA substitute: RW
[17] Schedule 1, entry for Cabergoline in the form Tablet 500 micrograms [Maximum Quantity: 2; Number of Repeats: 0]
(a) insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
a
APO-Cabergoline
TX
MP
C5136 C5137 C5357 C5172 C5398
P5172
2
0
2
NP
C5172
2
0
2
(b) insert in the column headed “Schedule Equivalent” for the brands “Dostan” and “Dostinex”: a
[18] Schedule 1, entry for Cabergoline in the form Tablet 500 micrograms [Maximum Quantity: 8; Number of Repeats: 5]
(a) insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
a
APO-Cabergoline
TX
MP
C5136 C5137 C5357 C5172 C5398
P5136 P5137 P5357 P5398
8
5
8
(b) insert in the column headed “Schedule Equivalent” for the brands “Dostan” and “Dostinex”: a
[19] Schedule 1, entry for Calcipotriol with betamethasone in the form Gel containing calcipotriol 50 micrograms with betamethasone 500 micrograms (as dipropionate) per g, 30 g
omit from the column headed “Circumstances”: C3827 substitute: C5955
[20] Schedule 1, entry for Calcipotriol with betamethasone in the form Gel containing calcipotriol 50 micrograms with betamethasone 500 micrograms (as dipropionate) per g, 60 g
omit from the column headed “Circumstances”: C5465 substitute: C5963
[21] Schedule 1, entry for Calcitriol
omit from the column headed “Responsible Person” for the brand “Kosteo”: QA substitute: RW
[22] Schedule 1, entry for Candesartan in each of the forms: Tablet containing candesartan cilexetil 4 mg; Tablet containing candesartan cilexetil 8 mg; Tablet containing candesartan cilexetil 16 mg; and Tablet containing candesartan cilexetil 32 mg
omit from the column headed “Responsible Person” for the brands “Candesartan Aspen 4”, “Candesartan Aspen 8”, “Candesartan Aspen 16” and “Candesartan Aspen 32” respectively:
QA substitute: RW
[23] Schedule 1, entry for Candesartan with Hydrochlorothiazide in each of the forms: Tablet containing candesartan cilexetil 16 mg with hydrochlorothiazide 12.5 mg; Tablet containing candesartan cilexetil 32 mg with hydrochlorothiazide 12.5 mg; and Tablet containing candesartan cilexetil 32 mg with hydrochlorothiazide 25 mg
omit from the column headed “Responsible Person” for the brands “Candesartan Combi Aspen 16/12.5”, “Candesartan Combi Aspen 32/12.5” and
“Candesartan Combi Aspen 32/25” respectively: QA substitute: RW
[24] Schedule 1, entry for Carmustine
omit from the column headed “Responsible Person”: OA substitute: EI
[25] Schedule 1, entry for Carvedilol in each of the forms: Tablet 3.125 mg; Tablet 6.25 mg; Tablet 12.5 mg; and Tablet 25 mg
omit from the column headed “Responsible Person” for the brands “Vedilol 3.125”, “Vedilol 6.25”, “Vedilol 12.5” and “Vedilol 25” respectively:
QA substitute: RW
[26] Schedule 1, entry for Celecoxib in each of the forms: Capsule 100 mg; and Capsule 200 mg
omit from the column headed “Responsible Person” for the brand “Celexi”: QA substitute: RW
[27] Schedule 1, entry for Ciprofloxacin in the form Tablet 250 mg (as hydrochloride)
omit:
Ciprofloxacin‑DRLA
RZ
MP NP
C5614 C5615 C5666 C5687 C5688 C5689 C5722 C5780
14
0
14
[28] Schedule 1, entry for Ciprofloxacin in each of the forms: Tablet 500 mg (as hydrochloride); and Tablet 750 mg (as hydrochloride)
omit:
Ciprofloxacin‑DRLA
RZ
MP NP
C5614 C5615 C5687 C5688 C5689 C5722 C5780
14
0
14
[29] Schedule 1, entry for Citalopram in each of the forms: Tablet 10 mg (as hydrobromide); and Tablet 40 mg (as hydrobromide)
omit from the column headed “Responsible Person” for the brand “Talam”: QA substitute: RW
[30] Schedule 1, entry for Clindamycin
omit from the column headed “Responsible Person” for the brand “Calindamin”: QA substitute: RW
[31] Schedule 1, entry for Clopidogrel in the form Tablet 75 mg (as besilate)
(a) omit from the column headed “Responsible Person” for the brand “Clovix 75”: QA substitute: RW
(b) omit from the column headed “Responsible Person” for the brand “Plidogrel”: FM substitute: RF
[32] Schedule 1, after entry for Dabrafenib in the form Capsule 75 mg (as mesilate)
insert:
Daclatasvir
Tablet 30 mg
Oral
Daklinza
BQ
MP
C5969 C5972
P5969
28
2
28
MP
C5969 C5972
P5972
28
5
28
MP
See Note 2
See Note 2
See Note 2
See Note 2
28
C(100)
Tablet 60 mg
Oral
Daklinza
BQ
MP
C5969 C5972
P5969
28
2
28
MP
C5969 C5972
P5972
28
5
28
MP
See Note 2
See Note 2
See Note 2
See Note 2
28
C(100)
[33] Schedule 1, entry for Diclofenac in each of the forms: Tablet (enteric coated) containing diclofenac sodium 25 mg; and Tablet (enteric coated) containing diclofenac sodium 50 mg
omit from the column headed “Responsible Person” for the brands “Clonac 25” and “Clonac 50” respectively: QA substitute: RW
[34] Schedule 1, entry for Dipyridamole with Aspirin
omit from the column headed “Responsible Person” for the brand “Diasp SR”: QA substitute: RW
[35] Schedule 1, entry for Doxorubicin – Pegylated Liposomal in each of the forms: Suspension for I.V. infusion containing pegylated liposomal doxorubicin hydrochloride 20 mg in 10 mL; and Suspension for I.V. infusion containing pegylated liposomal doxorubicin hydrochloride
50 mg in 25 mL
omit from the column headed “Responsible Person” for the brand “Liposomal Doxorubicin SUN”: ZF substitute: RA
[36] Schedule 1, entry for Doxycycline in the form Tablet 50 mg (as monohydrate)
omit from the column headed “Responsible Person” for the brand “Frakas”: QA substitute: RW
[37] Schedule 1, entry for Duloxetine in the form Capsule 30 mg (as hydrochloride)
(a) insert in the column headed “Schedule Equivalent” for all brands: a
(b) omit:
a
Duloxetine-DRLA
RZ
MP NP
C1211
28
0
28
(c) insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
a
Duloxetine Sandoz
HX
MP NP
C1211
28
0
28
[38] Schedule 1, entry for Duloxetine in the form Capsule 60 mg (as hydrochloride)
(a) insert in the column headed “Schedule Equivalent” for all brands: a
(b) omit:
a
Duloxetine-DRLA
RZ
MP NP
C1211
28
5
28
(c) insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
a
Duloxetine Sandoz
HX
MP NP
C1211
28
5
28
[39] Schedule 1, entry for Empagliflozin in each of the forms: Tablet 10 mg; and Tablet 25 mg
omit from the column headed “Circumstances”: C4848 substitute: C4983 C4991 C5629
[40] Schedule 1, after entry for Empagliflozin in the form Tablet 25 mg
insert:
Empagliflozin with metformin
Tablet containing 5 mg empagliflozin with 1 g metformin hydrochloride
Oral
Jardiamet 5 mg/1000 mg
BY
MP
C5657 C5798 C5953 C5966
60
5
60
NP
C5657 C5798 C5966
60
5
60
Tablet containing 5 mg empagliflozin with 500 mg metformin hydrochloride
Oral
Jardiamet 5 mg/500 mg
BY
MP
C5657 C5798 C5953 C5966
60
5
60
NP
C5657 C5798 C5966
60
5
60
Tablet containing 12.5 mg empagliflozin with 1 g metformin hydrochloride
Oral
Jardiamet 12.5 mg/1000 mg
BY
MP
C5657 C5798 C5953 C5966
60
5
60
NP
C5657 C5798 C5966
60
5
60
Tablet containing 12.5 mg empagliflozin with 500 mg metformin hydrochloride
Oral
Jardiamet 12.5 mg/500 mg
BY
MP
C5657 C5798 C5953 C5966
60
5
60
NP
C5657 C5798 C5966
60
5
60
[41] Schedule 1, entry for Famciclovir
substitute:
Famciclovir
Tablet 125 mg
Oral
a
APO‑Famciclovir
TX
MP NP
C5937
40
1
40
a
Auro-Famciclovir 125
DO
MP NP
C5937
40
1
40
a
Ezovir
AF
MP NP
C5937
40
1
40
a
Famciclovir AN
EA
MP NP
C5937
40
1
40
a
Famciclovir‑GA
ED
MP NP
C5937
40
1
40
a
Famvir
NV
MP NP
C5937
40
1
40
a
Favic 125
QA
MP NP
C5937
40
1
40
Tablet 250 mg
Oral
a
APO‑Famciclovir
TX
MP NP
C5937 C5951 C5971
P5937
20
1
20
a
Ezovir
AF
MP NP
C5937 C5951 C5971
P5937
20
1
20
a
Famciclovir AN
EA
MP NP
C5937 C5951 C5971
P5937
20
1
20
a
Famciclovir‑GA
ED
MP NP
C5937 C5951 C5971
P5937
20
1
20
a
Famciclovir Sandoz
SZ
MP NP
C5937 C5951 C5971
P5937
20
1
20
a
Famvir
NV
MP NP
C5937 C5951 C5971
P5937
20
1
20
a
Favic 250
QA
MP NP
C5937 C5951 C5971
P5937
20
1
20
a
APO‑Famciclovir
TX
MP NP
C5937 C5951 C5971
P5951
21
0
21
a
Auro-Famciclovir 250
DO
MP NP
C5951 C5971
P5951
21
0
21
a
Ezovir
AF
MP NP
C5937 C5951 C5971
P5951
21
0
21
a
Famciclovir AN
EA
MP NP
C5937 C5951 C5971
P5951
21
0
21
a
Famciclovir‑GA
ED
MP NP
C5937 C5951 C5971
P5951
21
0
21
a
Famciclovir generichealth 250
GQ
MP NP
C5951 C5971
P5951
21
0
21
a
Famciclovir Sandoz
SZ
MP NP
C5937 C5951 C5971
P5951
21
0
21
a
Famciclovir SCP 250
CR
MP NP
C5951 C5971
P5951
21
0
21
a
Famlo
RA
MP NP
C5951 C5971
P5951
21
0
21
a
Famvir
NV
MP NP
C5937 C5951 C5971
P5951
21
0
21
a
Favic 250
QA
MP NP
C5937 C5951 C5971
P5951
21
0
21
a
APO‑Famciclovir
TX
MP NP
C5937 C5951 C5971
P5971
56
5
56
a
Auro-Famciclovir 250
DO
MP NP
C5951 C5971
P5971
56
5
56
a
Ezovir
AF
MP NP
C5937 C5951 C5971
P5971
56
5
56
a
Famciclovir AN
EA
MP NP
C5937 C5951 C5971
P5971
56
5
56
a
Famciclovir‑GA
ED
MP NP
C5937 C5951 C5971
P5971
56
5
56
a
Famciclovir generichealth 250
GQ
MP NP
C5951 C5971
P5971
56
5
56
a
Famciclovir Sandoz
SZ
MP NP
C5937 C5951 C5971
P5971
56
5
56
a
Famciclovir SCP 250
CR
MP NP
C5951 C5971
P5971
56
5
56
a
Famlo
RA
MP NP
C5951 C5971
P5971
56
5
56
a
Famvir
NV
MP NP
C5937 C5951 C5971
P5971
56
5
56
a
Favic 250
QA
MP NP
C5937 C5951 C5971
P5971
56
5
56
Tablet 500 mg
Oral
a
APO‑Famciclovir
TX
MP NP
C5943 C5947 C5948 C5949 C5954
P5943
30
0
30
a
Auro-Famciclovir 500
DO
MP NP
C5943 C5947 C5948 C5949 C5954
P5943
30
0
30
a
Chem mart Famciclovir
CH
MP NP
C5943 C5947 C5948 C5949 C5954
P5943
30
0
30
a
Famciclovir AN
EA
MP NP
C5943 C5947 C5948 C5949 C5954
P5943
30
0
30
a
Famciclovir Sandoz
SZ
MP NP
C5943 C5947 C5948 C5949 C5954
P5943
30
0
30
a
Famvir
NV
MP NP
C5943 C5947 C5948 C5949 C5954
P5943
30
0
30
a
Favic 500
QA
MP NP
C5943 C5947 C5948 C5949 C5954
P5943
30
0
30
a
Terry White Chemists Famciclovir
TW
MP NP
C5943 C5947 C5948 C5949 C5954
P5943
30
0
30
a
APO‑Famciclovir
TX
MP NP
C5943 C5947 C5948 C5949 C5954
P5947 P5948 P5949 P5954
56
5
56
a
Auro-Famciclovir 500
DO
MP NP
C5943 C5947 C5948 C5949 C5954
P5947 P5948 P5949 P5954
56
5
56
a
Chem mart Famciclovir
CH
MP NP
C5943 C5947 C5948 C5949 C5954
P5947 P5948 P5949 P5954
56
5
56
a
Ezovir
AF
MP NP
C5947 C5948 C5949 C5954
56
5
56
a
Famciclovir AN
EA
MP NP
C5943 C5947 C5948 C5949 C5954
P5947 P5948 P5949 P5954
56
5
56
a
Famciclovir‑GA
ED
MP NP
C5947 C5948 C5949 C5954
56
5
56
a
Famciclovir generichealth 500
GQ
MP NP
C5947 C5948 C5949 C5954
56
5
56
a
Famciclovir Sandoz
SZ
MP NP
C5943 C5947 C5948 C5949 C5954
P5947 P5948 P5949 P5954
56
5
56
a
Famvir
NV
MP NP
C5943 C5947 C5948 C5949 C5954
P5947 P5948 P5949 P5954
56
5
56
a
Favic 500
QA
MP NP
C5943 C5947 C5948 C5949 C5954
P5947 P5948 P5949 P5954
56
5
56
a
Terry White Chemists Famciclovir
TW
MP NP
C5943 C5947 C5948 C5949 C5954
P5947 P5948 P5949 P5954
56
5
56
[42] Schedule 1, entry for Fluvoxamine in each of the forms: Tablet containing fluvoxamine maleate 50 mg; and Tablet containing fluvoxamine maleate 100 mg
omit from the column headed “Responsible Person” for the brands “Faverin 50” and “Faverin 100” respectively: QA substitute: RW
[43] Schedule 1, entry for Folinic acid in the form Tablet containing calcium folinate equivalent to 15 mg folinic acid
substitute:
Tablet containing calcium folinate equivalent to 15 mg folinic acid
Oral
Leucovorin Calcium (Hospira Pty Limited)
HH
MP
C5938
10
0
10
MP
C5973
10
0
10
C(100)
[44] Schedule 1, entry for Galantamine in each of the forms: Capsule (prolonged release) 8 mg (as hydrobromide); Capsule (prolonged release) 16 mg (as hydrobromide); and Capsule (prolonged release) 24 mg (as hydrobromide)
omit from the column headed “Responsible Person” for the brand “Gamine XR”: QA substitute: RW
[45] Schedule 1, entry for Gemcitabine in each of the forms: Powder for I.V. infusion 200 mg (as hydrochloride); and Powder for I.V. infusion 1 g (as hydrochloride)
omit from the column headed “Responsible Person” for the brand “Gemcitabine Sun”: ZF substitute: RA
[46] Schedule 1, after entry for Glycomacropeptide and essential amino acids with vitamins and minerals in the form Sachets containing oral powder 49 g, 28 (Camino Pro Bettermilk)
insert in the columns in the order indicated:
Sachets containing oral powder 49 g, 30 (Camino Pro Bettermilk)
Oral
Camino Pro Bettermilk
QH
MP NP
C4295
4
5
1
[47] Schedule 1, entry for Irbesartan in each of the forms: Tablet 75 mg; Tablet 150 mg; and Tablet 300 mg
omit:
Irbesartan-DRLA
RZ
MP NP
30
5
30
[48] Schedule 1, entry for Irbesartan with Hydrochlorothiazide in each of the forms: Tablet 150 mg-12.5 mg; Tablet 300 mg-12.5 mg; and Tablet 300 mg-25 mg
omit from the column headed “Responsible Person” for the brands “KSART HCT 150/12.5”, “KSART HCT 300/12.5” and “KSART HCT 300/25” respectively: QA substitute: RW
[49] Schedule 1, entry for Lamotrigine in each of the forms: Tablet 5 mg; Tablet 25 mg; Tablet 50 mg; Tablet 100 mg; and Tablet 200 mg
omit:
Lamogine
AF
MP NP
C5138
56
5
56
[50] Schedule 1, after entry for Latanoprost with timolol [Brand: Xamalol 50/5]
insert:
Ledipasvir with sofosbuvir
Tablet containing 90 mg ledipasvir with 400 mg sofosbuvir
Oral
Harvoni
GI
MP
C5944 C5969 C5972
P5944
28
1
28
MP
C5944 C5969 C5972
P5969
28
2
28
MP
C5944 C5969 C5972
P5972
28
5
28
MP
See Note 2
See Note 2
See Note 2
See Note 2
28
C(100)
[51] Schedule 1, entry for Leflunomide in each of the forms: Tablet 10 mg; and Tablet 20 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
Leflunomide APOTEX
GX
MP
C5681 C5766
30
5
30
[52] Schedule 1, entry for Lercanidipine in each of the forms: Tablet containing lercanidipine hydrochloride 10 mg; and Tablet containing lercanidipine hydrochloride 20 mg
omit from the column headed “Responsible Person” for the brand “Lercan”: QA substitute: RW
[53] Schedule 1, entry for Letrozole
(a) omit:
Letrozole‑DRLA
RZ
MP NP
C5464
30
5
30
(b) omit:
Pharmacy Choice Letrozole
RI
MP NP
C5464
30
5
30
[54] Schedule 1, after entry for Leuprorelin in the form I.M. injection (modified release), powder for injection containing leuprorelin acetate
30 mg with diluent in pre-filled dual-chamber syringe
insert in the columns in the order indicated:
I.M. injection (modified release), powder for injection containing leuprorelin acetate 45 mg with diluent in pre-filled dual-chamber syringe
Injection
Lucrin Depot 6-Month
VE
MP
C5646
1
0
1
[55] Schedule 1, entry for Levetiracetam in the form Tablet 250 mg
omit from the column headed “Responsible Person” for the brand “Levi 250”: FM substitute: RW
[56] Schedule 1, entry for Levetiracetam in the form Tablet 500 mg
(a) insert in the column headed “Schedule Equivalent” for all brands: a
(b) omit from the column headed “Brand”: Levetiracetam generichealth substitute: Levetiracetam GH
(c) omit from the column headed “Responsible Person” for the brand “Levi 500”: FM substitute: RW
[57] Schedule 1, entry for Levetiracetam in the form Tablet 1 g
omit from the column headed “Responsible Person” for the brand “Levi 1000”: FM substitute: RW
[58] Schedule 1, entry for Lisinopril in each of the forms: Tablet 5 mg; Tablet 10 mg; and Tablet 20 mg
omit:
Lisinopril‑DRLA
RZ
MP NP
30
5
30
[59] Schedule 1, entry for Macrogol 3350 in the form Sachets containing powder for oral solution 13.125 g with electrolytes, 30
(a) omit from the column headed “Responsible Person” for the brand “Chemists’ Own Macrogol with Electrolytes” (all instances):
FM substitute: RW
(b) omit from the column headed “Responsible Person” for the brand “Macrovic” (all instances): QA substitute: RF
[60] Schedule 1, entry for Memantine in the form Tablet containing memantine hydrochloride 10 mg
omit from the column headed “Responsible Person” for the brand “Memanxa”: QA substitute: RW
[61] Schedule 1, entry for Metformin in each of the forms: Tablet containing metformin hydrochloride 500 mg; and Tablet containing metformin hydrochloride 850 mg
omit from the column headed “Responsible Person” for the brands “Formet Aspen 500” and “Formet Aspen 850” respectively: AS substitute: RW
[62] Schedule 1, entry for Metoprolol in the form Tablet containing metoprolol tartrate 50 mg
(a) omit:
Metatar
FM
MP NP
100
5
100
(b) omit from the column headed “Responsible Person” for the brand “Metrol 50”: QA substitute: RW
(c) omit:
Metatar
FM
MP NP
60
5
60
[63] Schedule 1, entry for Metoprolol in the form Tablet containing metoprolol tartrate 100 mg
(a) omit:
Metatar
FM
MP NP
60
5
60
(b) omit from the column headed “Responsible Person” for the brand “Metrol 100”: QA substitute: RW
[64] Schedule 1, entry for Metoprolol succinate in each of the forms: Tablet 23.75 mg (controlled release); Tablet 47.5 mg (controlled release); Tablet 95 mg (controlled release); and Tablet 190 mg (controlled release)
omit from the column headed “Responsible Person” for the brands “Metrol-XL 23.75”, “Metrol-XL 47.5”, “Metrol-XL 95” and “Metrol-XL 190” respectively:
QA substitute: RW
[65] Schedule 1, entry for Mirtazapine in each of the forms: Tablet 30 mg; and Tablet 45 mg
omit from the column headed “Responsible Person” for the brand “Mirtazon”: QA substitute: RW
[66] Schedule 1, entry for Montelukast in each of the forms: Tablet, chewable, 4 mg (as sodium); and Tablet, chewable, 5 mg (as sodium)
omit from the column headed “Responsible Person” for the brands “Respikast 4” and “Respikast 5” respectively:
QA substitute: RW
[67] Schedule 1, entry for Morphine in each of the forms: Tablet containing morphine sulfate 10 mg (controlled release); Tablet containing morphine sulfate 30 mg (controlled release); Tablet containing morphine sulfate 60 mg (controlled release); and Tablet containing morphine sulfate 100 mg (controlled release)
omit from the column headed “Responsible Person” for the brands “Momex SR 10”, “Momex SR 30”, “Momex SR 60” and “Momex SR 100” respectively:
QA substitute: RW
[68] Schedule 1, entry for Nifedipine in each of the forms: Tablet 30 mg (controlled release); and Tablet 60 mg (controlled release)
omit from the column headed “Responsible Person” for the brands “Addos XR 30” and “Addos XR 60” respectively: QA substitute: RW
[69] Schedule 1, entry for Nitrazepam
omit:
Alodorm
AF
MP NP
P5661 P5684 P5770 P5771
50CN5661 CN5684 CN5770 CN5771
5CN5661 CN5684 CN5770 CN5771
25
Mogadon
IA
MP NP
P5661 P5684 P5770 P5771
50CN5661 CN5684 CN5770 CN5771
5CN5661 CN5684 CN5770 CN5771
25
substitute:
a
Alodorm
AF
MP NP
P5661 P5771 P5941 P5950
50CN5661 CN5771 CN5941 CN5950
5CN5661 CN5771 CN5941 CN5950
25
a
Mogadon
IA
MP NP
P5661 P5771 P5941 P5950
50CN5661 CN5771 CN5941 CN5950
5CN5661 CN5771 CN5941 CN5950
25
[70] Schedule 1, entry for Octreotide in each of the forms: Injection 50 micrograms (as acetate) in 1 mL; Injection 100 micrograms (as acetate) in 1 mL; and Injection 500 micrograms (as acetate) in 1 mL
omit from the column headed “Responsible Person” for the brand “Octreotide (SUN)”: ZF substitute: RA
[71] Schedule 1, entry for Olanzapine in the form Tablet 2.5 mg
(a) insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
Olanzacor 2.5
CR
MP NP
C5856 C5869
28
5
28
(b) omit:
Pharmacor Olanzapine 2.5
CR
MP NP
C5856 C5869
28
5
28
(c) omit:
Pharmacy Choice Olanzapine
RI
MP NP
C5856 C5869
28
5
28
[72] Schedule 1, entry for Olanzapine in the form Tablet 5 mg
(a) insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
Olanzacor 5
CR
MP NP
C5856 C5869
28
5
28
(b) omit:
Pharmacor Olanzapine 5
CR
MP NP
C5856 C5869
28
5
28
(c) omit:
Pharmacy Choice Olanzapine
RI
MP NP
C5856 C5869
28
5
28
[73] Schedule 1, entry for Olanzapine in the form Tablet 7.5 mg
(a) insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
Olanzacor 7.5
CR
MP NP
C5856 C5869
28
5
28
(b) omit:
Pharmacor Olanzapine 7.5
CR
MP NP
C5856 C5869
28
5
28
(c) omit:
Pharmacy Choice Olanzapine
RI
MP NP
C5856 C5869
28
5
28
[74] Schedule 1, entry for Olanzapine in the form Tablet 10 mg
(a) insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
Olanzacor 10
CR
MP NP
C5856 C5869
28
5
28
(b) omit:
Pharmacor Olanzapine 10
CR
MP NP
C5856 C5869
28
5
28
(c) omit:
Pharmacy Choice Olanzapine
RI
MP NP
C5856 C5869
28
5
28
[75] Schedule 1, entry for Olanzapine in each of the forms: Tablet 5 mg (orally disintegrating); and Tablet 10 mg (orally disintegrating)
omit:
Pharmacy Choice Olanzapine ODT
RI
MP NP
C5856 C5869
28
5
28
[76] Schedule 1, entry for Omeprazole in the form Capsule 20 mg
omit from the column headed “Responsible Person” for the brand “Pemzo” (twice occurring): QA substitute: RW
[77] Schedule 1, entry for Oxaliplatin in the form Solution concentrate for I.V. infusion 50 mg in 10 mL
omit from the column headed “Responsible Person” for the brand “Oxaliplatin SUN”: ZF substitute: RA
[78] Schedule 1, entry for Oxaliplatin in the form Solution concentrate for I.V. infusion 100 mg in 20 mL
(a) omit:
Oxaliplatin MYX
YN
MP
See Note 3
SeeNote 3
1
D(100)
(b) omit from the column headed “Responsible Person” for the brand “Oxaliplatin SUN”: ZF substitute: RA
[79] Schedule 1, entry for Oxaliplatin in the form Solution concentrate for I.V. infusion 200 mg in 40 mL
omit from the column headed “Responsible Person” for the brand “Oxaliplatin SUN”: ZF substitute: RA:
[80] Schedule 1, entry for Perindopril in the form Tablet containing perindopril erbumine 2 mg
omit:
Indopril 2
QA
MP NP
30
5
30
[81] Schedule 1, entry for Perindopril in the form Tablet containing perindopril erbumine 4 mg
omit:
Indopril 4
QA
MP NP
30
5
30
[82] Schedule 1, entry for Perindopril in the form Tablet containing perindopril erbumine 8 mg
omit:
Indopril 8
QA
MP NP
30
5
30
[83] Schedule 1, entry for Phenoxybenzamine in the form Capsules containing phenoxybenzamine hydrochloride 10 mg, 30
omit from the column headed “Brand”: Dibenyline substitute: Amdipharm Mercury (Australia) Pty Limited
(a) insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
a
APO-Pramipexole ER
TX
MP NP
C5131
30
5
30
(b) insert in the column headed “Schedule Equivalent” for the brand “Sifrol ER” (all instances): a
[85] Schedule 1, after entry for Propylthiouracil
insert:
Protein formula with amino acids, carbohydrates, vitamins and minerals without phenylalanine, and supplemented with docosahexaenoic acid
Oral liquid 130 mL, 30 (PKU Easy)
Oral
PKU Easy
OH
MP NP
C5970
4
5
1
[86] Schedule 1, entry for Quetiapine in the form Tablet 25 mg (as fumarate)
(a) omit:
Pharmacy Choice Quetiapine
RI
MP NP
C4385 C4391 C4396
60
0
60
(b) omit from the column headed “Responsible Person” for the brand “Quetia 25”: FM substitute: RW
(c) omit from the column headed “Responsible Person” for the brand “Seronia 25”: QA substitute: RF
[87] Schedule 1, entry for Quetiapine in the form Tablet 100 mg (as fumarate)
(a) omit:
Pharmacy Choice Quetiapine
RI
MP NP
C4246 C5611 C5639
90
5
90
(b) omit from the column headed “Responsible Person” for the brand “Quetia 100”: FM substitute: RW
[88] Schedule 1, entry for Quetiapine in each of the forms: Tablet 200 mg (as fumarate); and Tablet 300 mg (as fumarate)
(a) omit:
Pharmacy Choice Quetiapine
RI
MP NP
C4246 C5611 C5639
60
5
60
(b) omit from the column headed “Responsible Person” for the brands “Quetia 200” and “Quetia 300” respectively: FM substitute: RW
[89] Schedule 1, entry for Rabeprazole in each of the forms: Tablet containing rabeprazole sodium 10 mg (enteric coated); and Tablet containing rabeprazole sodium 20 mg (enteric coated)
omit from the column headed “Responsible Person” for the brand “Parbezol”: QA substitute: RW
[90] Schedule 1, entry for Ramipril in each of the forms: Tablet 2.5 mg; Tablet 5 mg; and Capsule 10 mg
omit from the column headed “Responsible Person” for the brands “Prilace 2.5”, “Prilace 5” and “Prilace 10” respectively: QA substitute: RW
[91] Schedule 1, after entry for Reteplase
insert:
Ribavirin
Tablet 400 mg
Oral
Ibavyr
IX
MP
C5957 C5958
P5957
28
2
28
MP
C5957 C5958
P5958
28
5
28
MP
See Note 2
See Note 2
See Note 2
See Note 2
28
C(100)
Tablet 600 mg
Oral
Ibavyr
IX
MP
C5957 C5958
P5957
28
2
28
MP
C5957 C5958
P5958
28
5
28
MP
See Note 2
See Note 2
See Note 2
See Note 2
28
C(100)
[92] Schedule 1, entry for Ribavirin and Peginterferon Alfa-2a
[93] Schedule 1, entry for Risperidone in the form Tablet 0.5 mg
(a) omit:
Risperidone‑DRLA
RZ
MP NP
C5902 C5903 C5908 C5911
P5902 P5908 P5911
60
2
60
(b) omit:
Risperidone‑DRLA
RZ
MP NP
C5902 C5903 C5908 C5911
P5903
60
5
60
[94] Schedule 1, entry for Risperidone in the form Tablet 1 mg
(a) omit:
Risperidone‑DRLA
RZ
MP NP
C4246 C5897 C5898 C5907 C5916
P5897 P5898 P5916
60
2
60
(b) omit:
Risperidone‑DRLA
RZ
MP NP
C4246 C5897 C5898 C5907 C5916
P4246 P5907
60
5
60
[95] Schedule 1, entry for Risperidone in the form Tablet 2 mg
(a) omit:
Risperidone‑DRLA
RZ
MP NP
C4246 C5898 C5907 C5916
P5898 P5916
60
2
60
(b) omit:
Risperidone‑DRLA
RZ
MP NP
C4246 C5898 C5907 C5916
P4246 P5907
60
5
60
[96] Schedule 1, entry for Risperidone in the form Tablet 3 mg
omit:
Risperidone‑DRLA
RZ
MP NP
C4246 C5907
60
5
60
[97] Schedule 1, entry for Risperidone in the form Tablet 4 mg
omit:
Risperidone‑DRLA
RZ
MP NP
C4246 C5907
60
5
60
[98] Schedule 1, entry for Rosuvastatin in the form Tablet 5 mg (as calcium) [Maximum Quantity: 30; Number of Repeats: 5]
(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
Rosuvastatin AMNEAL
EF
MP
C4225 C4226 C4238 C4263
P4226 P4263
30
5
30
NP
C4226 C4263
30
5
30
[99] Schedule 1, entry for Rosuvastatin in the form Tablet 5 mg (as calcium) [Maximum Quantity: 30; Number of Repeats: 11]
(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
Rosuvastatin AMNEAL
EF
MP
C4225 C4226 C4238 C4263
P4225 P4238
30
11
30
[100] Schedule 1, entry for Rosuvastatin in the form Tablet 10 mg (as calcium) [Maximum Quantity: 30; Number of Repeats: 5]
(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
Rosuvastatin AMNEAL
EF
MP
C4225 C4226 C4238 C4263
P4226 P4263
30
5
30
NP
C4226 C4263
30
5
30
[101] Schedule 1, entry for Rosuvastatin in the form Tablet 10 mg (as calcium) [Maximum Quantity: 30; Number of Repeats: 11]
(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
Rosuvastatin AMNEAL
EF
MP
C4225 C4226 C4238 C4263
P4225 P4238
30
11
30
[102] Schedule 1, entry for Rosuvastatin in the form Tablet 20 mg (as calcium) [Maximum Quantity: 30; Number of Repeats: 5]
(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
Rosuvastatin AMNEAL
EF
MP
C4225 C4226 C4238 C4263
P4226 P4263
30
5
30
NP
C4226 C4263
30
5
30
[103] Schedule 1, entry for Rosuvastatin in the form Tablet 20 mg (as calcium) [Maximum Quantity: 30; Number of Repeats: 11]
(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
Rosuvastatin AMNEAL
EF
MP
C4225 C4226 C4238 C4263
P4225 P4238
30
11
30
[104] Schedule 1, entry for Rosuvastatin in the form Tablet 40 mg (as calcium) [Maximum Quantity: 30; Number of Repeats: 5]
(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
Rosuvastatin AMNEAL
EF
MP
C4225 C4226 C4238 C4263
P4226 P4263
30
5
30
NP
C4226 C4263
30
5
30
[105] Schedule 1, entry for Rosuvastatin in the form Tablet 40 mg (as calcium) [Maximum Quantity: 30; Number of Repeats: 11]
(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
Rosuvastatin AMNEAL
EF
MP
C4225 C4226 C4238 C4263
P4225 P4238
30
11
30
[106] Schedule 1, entry for Sertraline in each of the forms: Tablet 50 mg (as hydrochloride); and Tablet 100 mg (as hydrochloride)
omit:
Sertraline‑DRLA
RZ
MP NP
C1211
30
5
30
[107] Schedule 1, entry for Simeprevir
omit from the column headed “Circumstances”: C4758 C4759
[108] Schedule 1, entry for Simvastatin in the form Tablet 10 mg
(a) omit:
Simvastatin‑DRLA
RZ
MP
C1540 C3047
P1540
30
5
30
NP
C1540
30
5
30
(b) omit:
Simvastatin‑DRLA
RZ
MP
C1540 C3047
P3047
30
11
30
[109] Schedule 1, entry for Simvastatin in the form Tablet 20 mg
(a) omit:
Simvastatin‑DRLA
RZ
MP
C1540 C3047
P1540
30
5
30
NP
C1540
30
5
30
(b) omit:
Simvastatin‑DRLA
RZ
MP
C1540 C3047
P3047
30
11
30
[110] Schedule 1, entry for Simvastatin in the form Tablet 40 mg
(a) omit:
Simvastatin‑DRLA
RZ
MP
C1540 C3047
P1540
30
5
30
NP
C1540
30
5
30
(b) omit:
Simvastatin‑DRLA
RZ
MP
C1540 C3047
P3407
30
11
30
[111] Schedule 1, entry for Simvastatin in the form Tablet 80 mg
(a) omit:
Simvastatin‑DRLA
RZ
MP
C1540 C3047
P1540
30
5
30
NP
C1540
30
5
30
(b) omit:
Simvastatin‑DRLA
RZ
MP
C1540 C3047
P3047
30
11
30
[112] Schedule 1, after entry for Sodium Lactate Compound
insert:
Sofosbuvir
Tablet 400 mg
Oral
Sovaldi
GI
MP
C5969 C5972
P5969
28
2
28
MP
C5969 C5972
P5972
28
5
28
MP
See Note 2
See Note 2
See Note 2
See Note 2
28
C(100)
[113] Schedule 1, entry for Sumatriptan in the form Tablet 50 mg (as succinate)
(a) omit:
Sumatab
AF
MP NP
C5259
4
5
2
(b) omit from the column headed “Responsible Person” for the brand “Sumatran” (twice occurring): QA substitute: OW
[114] Schedule 1, entry for Temazepam
omit:
APO‑Temazepam
TX
MP NP
P5661 P5684 P5770
50CN5661 CN5684 CN5770
5CN5661 CN5684 CN5770
25
Normison
QA
MP NP
P5661 P5684 P5770
50CN5661 CN5684 CN5770
5CN5661 CN5684 CN5770
25
Temaze
AF
MP NP
P5661 P5684 P5770
50CN5661 CN5684 CN5770
5CN5661 CN5684 CN5770
25
Temtabs
FM
MP NP
P5661 P5684 P5770
50CN5661 CN5684 CN5770
5CN5661 CN5684 CN5770
25
substitute:
APO‑Temazepam
TX
MP NP
P5661 P5941 P5950
50CN5661 CN5941 CN5950
5CN5661 CN5941 CN5950
25
Normison
QA
MP NP
P5661 P5941 P5950
50CN5661 CN5941 CN5950
5CN5661 CN5941 CN5950
25
Temaze
AF
MP NP
P5661 P5941 P5950
50CN5661 CN5941 CN5950
5CN5661 CN5941 CN5950
25
Temtabs
FM
MP NP
P5661 P5941 P5950
50CN5661 CN5941 CN5950
5CN5661 CN5941 CN5950
25
[115] Schedule 1, entry for Terbinafine in the form Tablet 250 mg (as hydrochloride)
(a) omit:
Pharmacy Choice Terbinafine
RI
MP NP
C2191 C2865 C3244
P2865 P3244
42
0
42
(b) omit:
Pharmacy Choice Terbinafine
RI
MP NP
C2191 C2865 C3244
P2191
42
1
42
[116] Schedule 1, entry for Ursodeoxycholic Acid
(a) insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
a
Ursodox GH
GQ
MP NP
C5757
200
2
100
(b) insert in the column headed “Schedule Equivalent” for the brands “Ursofalk” and “Ursosan”: a
[117] Schedule 1, entry for Valaciclovir
substitute:
Valaciclovir
Tablet 500 mg (as hydrochloride)
Oral
a
APO‑Valaciclovir
TX
MP NP
C5940 C5960 C5961 C5962 C5968
P5960
20
0
10
a
Vaclovir
AF
MP NP
C5940 C5960 C5961 C5962 C5968
P5960
20
0
10
a
Valaciclovir Actavis
ED
MP NP
C5940 C5960 C5961 C5962 C5968
P5960
20
0
10
a
Valaciclovir AN
EA
MP NP
C5940 C5960 C5961 C5962 C5968
P5960
20
0
10
a
Valaciclovir GA
GN
MP NP
C5940 C5960 C5961 C5962 C5968
P5960
20
0
10
a
Valaciclovir Sandoz
SZ
MP NP
C5960 C5961 C5962 C5968
P5960
20
0
10
a
Valnir
QA
MP NP
C5940 C5960 C5961 C5962 C5968
P5960
20
0
10
a
Valtrex
AS
MP NP
C5940 C5960 C5961 C5962 C5968
P5960
20
0
10
a
Zelitrex
FM
MP NP
C5940 C5960 C5961 C5962 C5968
P5960
20
0
10
a
APO‑Valaciclovir
TX
MP NP
C5940 C5960 C5961 C5962 C5968
P5940 P5961
30
5
30
a
Chem mart Valaciclovir
CH
MP NP
C5940 C5961 C5962 C5968
P5940 P5961
30
5
30
a
Shilova 500
DO
MP NP
C5940 C5961
30
5
30
a
Terry White Chemists Valaciclovir
TW
MP NP
C5940 C5961 C5962 C5968
P5940 P5961
30
5
30
a
Vaclovir
AF
MP NP
C5940 C5960 C5961 C5962 C5968
P5940 P5961
30
5
30
a
Valaciclovir Actavis
ED
MP NP
C5940 C5960 C5961 C5962 C5968
P5940 P5961
30
5
30
a
Valaciclovir AN
EA
MP NP
C5940 C5960 C5961 C5962 C5968
P5940 P5961
30
5
30
a
Valaciclovir GA
GN
MP NP
C5940 C5960 C5961 C5962 C5968
P5940 P5961
30
5
30
a
Valaciclovir generichealth
GQ
MP NP
C5940 C5961 C5962 C5968
P5940 P5961
30
5
30
a
Valaciclovir RBX
RA
MP NP
C5940 C5961 C5962 C5968
P5940 P5961
30
5
30
a
Valaciclovir Sandoz
SZ
MP NP
C5960 C5961 C5962 C5968
P5961
30
5
30
a
Valaciclovir SZ
HX
MP NP
C5940 C5961
30
5
30
a
Valacor 500
CR
MP NP
C5940 C5961 C5962 C5968
P5940 P5961
30
5
30
a
Valnir
QA
MP NP
C5940 C5960 C5961 C5962 C5968
P5940 P5961
30
5
30
a
Valtrex
AS
MP NP
C5940 C5960 C5961 C5962 C5968
P5940 P5961
30
5
30
a
Zelitrex
FM
MP NP
C5940 C5960 C5961 C5962 C5968
P5940 P5961
30
5
30
a
APO‑Valaciclovir
TX
MP NP
C5940 C5960 C5961 C5962 C5968
P5962 P5968
42
0
42
a
Chem mart Valaciclovir
CH
MP NP
C5940 C5961 C5962 C5968
P5962 P5968
42
0
42
a
Terry White Chemists Valaciclovir
TW
MP NP
C5940 C5961 C5962 C5968
P5962 P5968
42
0
42
a
Vaclovir
AF
MP NP
C5940 C5960 C5961 C5962 C5968
P5962 P5968
42
0
42
a
Valaciclovir Actavis
ED
MP NP
C5940 C5960 C5961 C5962 C5968
P5962 P5968
42
0
42
a
Valaciclovir AN
EA
MP NP
C5940 C5960 C5961 C5962 C5968
P5962 P5968
42
0
42
a
Valaciclovir GA
GN
MP NP
C5940 C5960 C5961 C5962 C5968
P5962 P5968
42
0
42
a
Valaciclovir generichealth
GQ
MP NP
C5940 C5961 C5962 C5968
P5962 P5968
42
0
42
a
Valaciclovir RBX
RA
MP NP
C5940 C5961 C5962 C5968
P5962 P5968
42
0
42
a
Valaciclovir Sandoz
SZ
MP NP
C5960 C5961 C5962 C5968
P5962 P5968
42
0
42
a
Valacor 500
CR
MP NP
C5940 C5961 C5962 C5968
P5962 P5968
42
0
42
a
Valnir
QA
MP NP
C5940 C5960 C5961 C5962 C5968
P5962 P5968
42
0
42
a
Valtrex
AS
MP NP
C5940 C5960 C5961 C5962 C5968
P5962 P5968
42
0
42
a
Zelitrex
FM
MP NP
C5940 C5960 C5961 C5962 C5968
P5962 P5968
42
0
42
a
APO‑Valaciclovir
TX
MP
C5939 C5975
500
2
100
C(100)
a
Valaciclovir RBX
RA
MP
C5939 C5975
500
2
100
C(100)
a
Valtrex
AS
MP
C5939 C5975
500
2
100
C(100)
a
Zelitrex
FM
MP
C5939 C5975
500
2
100
C(100)
[118] Schedule 1, entry for Voriconazole in the form Tablet 50 mg [Maximum Quantity: 56; Number of Repeats: 0]
insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
a
Vttack
AF
MP NP
C4683 C4685 C5692 C5725 C5748
P4685
56
0
56
[119] Schedule 1, entry for Voriconazole in the form Tablet 50 mg [Maximum Quantity: 56; Number of Repeats: 2]
insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
a
Vttack
AF
MP NP
C4683 C4685 C5692 C5725 C5748
P4683 P5692 P5725 P5748
56
2
56
[120] Schedule 1, entry for Voriconazole in the form Tablet 200 mg [Maximum Quantity: 56; Number of Repeats: 0]
insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
a
Vttack
AF
MP NP
C4683 C4685 C5692 C5725 C5748
P4685
56
0
56
[121] Schedule 1, entry for Voriconazole in the form Tablet 200 mg [Maximum Quantity: 56; Number of Repeats: 2]
insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
a
Vttack
AF
MP NP
C4683 C4685 C5692 C5725 C5748
P4683 P5692 P5725 P5748
56
2
56
[122] Schedule 1, entry for Zolmitriptan
omit from the column headed “Responsible Person” for the brand “Zoltrip”: QA substitute: RW
[123] Schedule 3, after details relevant to Responsible Person code OE
insert:
OH
Orpharma Pty Ltd
19 157 901 267
[124] Schedule 3
omit:
ZF
Sun Pharmaceutical Industries (Australia) Pty Ltd
64 130119603
[125] Schedule 4, Part 1, entry for Aciclovir
substitute:
Aciclovir
C5936
P5936
Initial moderate to severe genital herpesMicrobiological confirmation of diagnosis [viral culture, antigen detection or nucleic acid amplification by polymerase chain reaction (PCR)] is desirable but need not delay treatment.
Compliance with Authority Required procedures - Streamlined Authority Code 5936
C5942
P5942
Recurrent moderate to severe genital herpesEpisodic treatment or suppressive therapyMicrobiological confirmation of diagnosis [viral culture, antigen detection or nucleic acid amplification by polymerase chain reaction (PCR)] is desirable but need not delay treatment.
Compliance with Authority Required procedures - Streamlined Authority Code 5942
C5946
P5946
Advanced human immunodeficiency virus (HIV) diseasePatient must have CD4 cell counts of less than 150 million per litre.
Compliance with Authority Required procedures - Streamlined Authority Code 5946
C5959
P5959
Herpes zoster ophthalmicus
Compliance with Authority Required procedures - Streamlined Authority Code 5959
C5964
Herpes simplex keratitis
C5965
Herpes simplex keratitis
C5967
P5967
Herpes zosterThe treatment must be administered within 72 hours of the onset of the rash.
Compliance with Authority Required procedures - Streamlined Authority Code 5967
[126] Schedule 4, Part 1, after entry for Amino acid formula with fat, carbohydrate, vitamins, minerals, and trace elements, without methionine and supplemented with docosahexanoic acid
insert:
Amino acid formula with fat, carbohydrate, vitamins, minerals and trace elements without phenylalanine
C5970
Phenylketonuria
[127] Schedule 4, Part 1, entry for Amino acid formula with fat, carbohydrate, vitamins, minerals, trace elements and medium chain triglycerides
insert in numerical order:
C5945
Eosinophilic oesophagitisInitial treatment for up to 3 monthsPatient must require an amino acid based formula as a component of a dietary elimination program.Patient must be 18 years of age or less.Must be treated by a clinical immunologist, suitably qualified allergist or gastroenterologist.Treatment with oral steroids should not be commenced during the period of initial treatment.Eosinophilic oesophagitis is demonstrated by the following criteria:(i) Chronic symptoms of reflux that persisted despite a 2-month trial of a proton pump inhibitor or chronic dysphagia; and(ii) A lack of demonstrable anatomic abnormality with the exception of stricture, which can be attributable to eosinophilic oesophagitis; and(iii) Eosinophilic infiltration of the oesophagus, demonstrated by oesophageal biopsy specimens obtained by endoscopy and where the most densely involved oesophageal biopsy had 20 or more eosinophils in any single 400 x high powered field, along with normal antral and duodenal biopsies.The date of birth of the patient must be included in the authority application.
Compliance with Authority Required procedures
C5974
Eosinophilic oesophagitisContinuing treatmentPatient must have responded to an initial course of PBS-subsidised treatment.Patient must be 18 years of age or less.Must be treated by a clinical immunologist, suitably qualified allergist or gastroenterologist.Response to initial treatment is demonstrated by oesophageal biopsy specimens obtained by endoscopy, where the most densely involved oesophageal biopsy had 5 or less eosinophils in any single 400 x high powered field, along with normal antral and duodenal biopsies. The response criteria will not be deemed to have been met if oral steroids were commenced during initial treatment.
Compliance with Authority Required procedures
[128] Schedule 4, Part 1, entry for Amino acid synthetic formula supplemented with long chain polyunsaturated fatty acids and medium chain triglycerides
insert in numerical order:
C4415
Severe intestinal malabsorption including short bowel syndromePatient must have failed to respond to protein hydrolysate formulae; ORPatient must have been receiving parenteral nutrition.
Compliance with Authority Required procedures
C5945
Eosinophilic oesophagitisInitial treatment for up to 3 monthsPatient must require an amino acid based formula as a component of a dietary elimination program.Patient must be 18 years of age or less.Must be treated by a clinical immunologist, suitably qualified allergist or gastroenterologist.Treatment with oral steroids should not be commenced during the period of initial treatment.Eosinophilic oesophagitis is demonstrated by the following criteria:(i) Chronic symptoms of reflux that persisted despite a 2-month trial of a proton pump inhibitor or chronic dysphagia; and(ii) A lack of demonstrable anatomic abnormality with the exception of stricture, which can be attributable to eosinophilic oesophagitis; and(iii) Eosinophilic infiltration of the oesophagus, demonstrated by oesophageal biopsy specimens obtained by endoscopy and where the most densely involved oesophageal biopsy had 20 or more eosinophils in any single 400 x high powered field, along with normal antral and duodenal biopsies.The date of birth of the patient must be included in the authority application.
Compliance with Authority Required procedures
C5974
Eosinophilic oesophagitisContinuing treatmentPatient must have responded to an initial course of PBS-subsidised treatment.Patient must be 18 years of age or less.Must be treated by a clinical immunologist, suitably qualified allergist or gastroenterologist.Response to initial treatment is demonstrated by oesophageal biopsy specimens obtained by endoscopy, where the most densely involved oesophageal biopsy had 5 or less eosinophils in any single 400 x high powered field, along with normal antral and duodenal biopsies. The response criteria will not be deemed to have been met if oral steroids were commenced during initial treatment.
Compliance with Authority Required procedures
[129] Schedule 4, Part 1, entry for Calcipotriol with betamethasone
(a) omit:
C3827
Chronic stable plaque type psoriasis vulgaris of the scalp in a patient who is not adequately controlled with either calcipotriol or potent topical corticosteroid monotherapy
C5465
P5465
CN5465
Chronic stable plaque type psoriasis vulgarisThe condition must be on the patient's scalp; ANDThe condition must be inadequately controlled with either a vitamin D analogue or potent topical corticosteroid as monotherapy; ANDPatient must require more than 30 grams of the product per month.
Compliance with Authority Required procedures - Streamlined Authority Code 5465
(b) insert in numerical order after existing text:
C5955
Chronic stable plaque type psoriasis vulgarisThe condition must be inadequately controlled with either a vitamin D analogue or potent topical corticosteroid as monotherapy.
C5963
Chronic stable plaque type psoriasis vulgarisThe condition must be inadequately controlled with either a vitamin D analogue or potent topical corticosteroid as monotherapy; ANDPatient must require more than 30 grams of product per month.
Compliance with Authority Required procedures - Streamlined Authority Code 5963
[130] Schedule 4, Part 1, after entry for Dabrafenib
insert:
Daclatasvir
C5969
P5969
Chronic hepatitis C infectionPatient must meet the criteria set out in the General Statement for Drugs for the Treatment of Hepatitis C; ANDPatient must be taking this drug as part of a regimen set out in the matrix in the General Statement for Drugs for the Treatment of Hepatitis C, based on the hepatitis C virus genotype, patient treatment history and cirrhotic status; ANDThe treatment must be limited to a maximum duration of 12 weeks.
Compliance with Written or Telephone Authority Required procedures
C5972
P5972
Chronic hepatitis C infectionPatient must meet the criteria set out in the General Statement for Drugs for the Treatment of Hepatitis C; ANDPatient must be taking this drug as part of a regimen set out in the matrix in the General Statement for Drugs for the Treatment of Hepatitis C, based on the hepatitis C virus genotype, patient treatment history and cirrhotic status; ANDThe treatment must be limited to a maximum duration of 24 weeks.
Compliance with Written or Telephone Authority Required procedures
[131] Schedule 4, Part 1, entry for Empagliflozin
substitute:
Empagliflozin
C4983
Diabetes mellitus type 2The treatment must be in combination with metformin; ORThe treatment must be in combination with a sulfonylurea; ANDPatient must have, or have had, a HbA1c measurement greater than 7% despite treatment with either metformin or a sulfonylurea; ORPatient must have, or have had, where HbA1c measurement is clinically inappropriate, blood glucose levels greater than 10 mmol per L in more than 20% of tests over a 2 week period despite treatment with either metformin or a sulfonylurea.The date and level of the qualifying HbA1c measurement must be, or must have been, documented in the patient's medical records at the time treatment with a dipeptidyl peptidase 4 inhibitor (gliptin), a thiazolidinedione (glitazone), a glucagon-like peptide-1 or a sodium-glucose co-transporter 2 (SGLT2) inhibitor is initiated.The HbA1c must be no more than 4 months old at the time treatment with a gliptin, a glitazone, a glucagon-like peptide-1 or an SGLT2 inhibitor was initiated.Blood glucose monitoring may be used as an alternative assessment to HbA1c levels in the following circumstances:(a) A clinical condition with reduced red blood cell survival, including haemolytic anaemias and haemoglobinopathies; and/or(b) Had red cell transfusion within the previous 3 months.The results of the blood glucose monitoring, which must be no more than 4 months old at the time of initiation of treatment with a gliptin, a glitazone, a glucagon-like peptide-1 or an SGLT2 inhibitor, must be documented in the patient's medical records.A patient whose diabetes was previously demonstrated unable to be controlled with metformin or a sulfonylurea does not need to requalify on this criterion before being eligible for PBS-subsidised treatment with this drug.
Compliance with Authority Required procedures - Streamlined Authority Code 4983
C4991
Diabetes mellitus type 2The treatment must be in combination with insulin; ANDPatient must have, or have had, a HbA1c measurement greater than 7% prior to the initiation of a dipeptidyl peptidase 4 inhibitor (gliptin), a thiazolidinedione (glitazone), a glucagon-like peptide-1 or a sodium-glucose co-transporter 2 (SGLT2) inhibitor despite treatment with insulin and oral antidiabetic agents, or insulin alone where metformin is contraindicated; ORPatient must have, or have had, where HbA1c measurement is clinically inappropriate, blood glucose levels greater than 10 mmol per L in more than 20% of tests over a 2 week period prior to initiation with a gliptin, a glitazone, a glucagon-like peptide-1 or an SGLT2 inhibitor despite treatment with insulin and oral antidiabetic agents, or insulin alone where metformin is contraindicated.The date and level of the qualifying HbA1c measurement must be, or must have been, documented in the patient's medical records at the time treatment with a gliptin, a glitazone, a glucagon-like peptide-1 or an SGLT2 inhibitor is initiated.The HbA1c must be no more than 4 months old at the time treatment with a gliptin, a glitazone, a glucagon-like peptide-1 or an SGLT2 inhibitor was initiated.Blood glucose monitoring may be used as an alternative assessment to HbA1c levels in the following circumstances:(a) A clinical condition with reduced red blood cell survival, including haemolytic anaemias and haemoglobinopathies; and/or(b) Had red cell transfusion within the previous 3 months.The results of the blood glucose monitoring, which must be no more than 4 months old at the time of initiation of treatment with a gliptin, a glitazone, a glucagon-like peptide-1 or an SGLT2 inhibitor, must be documented in the patient's medical records.
Compliance with Authority Required procedures - Streamlined Authority Code 4991
C5629
Diabetes mellitus type 2The treatment must be in combination with metformin; ANDThe treatment must be in combination with a sulfonylurea; ANDPatient must have, or have had, a HbA1c measurement greater than 7% prior to the initiation of a dipeptidyl peptidase 4 inhibitor (gliptin), a thiazolidinedione (glitazone), a glucagon-like peptide-1 or a sodium-glucose co-transporter 2 (SGLT2) inhibitor despite treatment with optimal doses of dual oral therapy; ORPatient must have, or have had, where HbA1c measurement is clinically inappropriate, blood glucose levels greater than 10 mmol per L in more than 20% of tests over a 2 week period prior to initiation with a gliptin, a glitazone, a glucagon-like peptide-1 or an SGLT2 despite treatment with optimal doses of dual oral therapy.The date and level of the qualifying HbA1c measurement must be, or must have been, documented in the patient's medical records at the time treatment with a gliptin, a glitazone, a glucagon-like peptide-1 or an SGLT2 inhibitor is initiated.The HbA1c must be no more than 4 months old at the time treatment with a gliptin, a glitazone, a glucagon-like peptide-1 or an SGLT2 inhibitor was initiated.Blood glucose monitoring may be used as an alternative assessment to HbA1c levels in the following circumstances:(a) A clinical condition with reduced red blood cell survival, including haemolytic anaemias and haemoglobinopathies; and/or(b) Had red cell transfusion within the previous 3 months.The results of the blood glucose monitoring, which must be no more than 4 months old at the time of initiation of treatment with a gliptin, a glitazone, a glucagon-like peptide-1 or an SGLT2 inhibitor, must be documented in the patient's medical records.A patient whose diabetes was previously demonstrated unable to be controlled with metformin or a sulfonylurea does not need to requalify on this criterion before being eligible for PBS-subsidised treatment with this drug.
Compliance with Authority Required procedures - Streamlined Authority Code 5629
[132] Schedule 4, Part 1, after entry for Empagliflozin
insert:
Empagliflozin with metformin
C5657
Diabetes mellitus type 2The treatment must be in combination with insulin; ANDPatient must have, or have had, a HbA1c measurement greater than 7% prior to the initiation of a dipeptidyl peptidase 4 inhibitor (gliptin), a thiazolidinedione (glitazone), a glucagon-like peptide-1 or a sodium-glucose co-transporter 2 (SGLT2) inhibitor despite treatment with insulin and oral antidiabetic agents, or insulin alone where metformin is contraindicated; ORPatient must have, or have had, where HbA1c measurement is clinically inappropriate, blood glucose levels greater than 10 mmol per L in more than 20% of tests over a 2 week period prior to initiation with a gliptin, a glitazone, a glucagon-like peptide-1 or an SGLT2 inhibitor despite treatment with insulin and oral antidiabetic agents, or insulin alone where metformin is contraindicated.The date and level of the qualifying HbA1c measurement must be, or must have been, documented in the patient's medical records at the time treatment with a gliptin, a glitazone, a glucagon-like peptide-1 or an SGLT2 inhibitor is initiated.The HbA1c must be no more than 4 months old at the time treatment with a gliptin, a glitazone, a glucagon-like peptide-1 or an SGLT2 inhibitor was initiated.Blood glucose monitoring may be used as an alternative assessment to HbA1c levels in the following circumstances:(a) A clinical condition with reduced red blood cell survival, including haemolytic anaemias and haemoglobinopathies; and/or(b) Had red cell transfusion within the previous 3 months.The results of the blood glucose monitoring, which must be no more than 4 months old at the time of initiation of treatment with a gliptin, a glitazone, a glucagon-like peptide-1 or an SGLT2 inhibitor, must be documented in the patient's medical records.
Compliance with Authority Required procedures - Streamlined Authority Code 5657
C5798
Diabetes mellitus type 2The treatment must be in combination with a sulfonylurea; ANDPatient must have, or have had, a HbA1c measurement greater than 7% prior to the initiation of a dipeptidyl peptidase 4 inhibitor (gliptin), a thiazolidinedione (glitazone), a glucagon-like peptide-1 or a sodium-glucose co-transporter 2 (SGLT2) inhibitor despite treatment with optimal doses of dual oral therapy; ORPatient must have, or have had, where HbA1c measurement is clinically inappropriate, blood glucose levels greater than 10 mmol per L in more than 20% of tests over a 2 week period prior to initiation with a gliptin, a glitazone, a glucagon-like peptide-1 or an SGLT2 despite treatment with optimal doses of dual oral therapy.The date and level of the qualifying HbA1c measurement must be, or must have been, documented in the patient's medical records at the time treatment with a gliptin, a glitazone, a glucagon-like peptide-1 or an SGLT2 inhibitor is initiated.The HbA1c must be no more than 4 months old at the time treatment with a gliptin, a glitazone, a glucagon-like peptide-1 or an SGLT2 inhibitor was initiated.Blood glucose monitoring may be used as an alternative assessment to HbA1c levels in the following circumstances:(a) A clinical condition with reduced red blood cell survival, including haemolytic anaemias and haemoglobinopathies; and/or(b) Had red cell transfusion within the previous 3 months.The results of the blood glucose monitoring, which must be no more than 4 months old at the time of initiation of treatment with a gliptin, a glitazone, a glucagon-like peptide-1 or an SGLT2 inhibitor, must be documented in the patient's medical records.A patient whose diabetes was previously demonstrated unable to be controlled with metformin or a sulfonylurea does not need to requalify on this criterion before being eligible for PBS-subsidised treatment with this fixed dose combination.
Compliance with Authority Required procedures - Streamlined Authority Code 5798
C5953
Diabetes mellitus type 2Patient must have, or have had, a HbA1c measurement greater than 7% despite treatment with metformin; ORPatient must have, or have had, where HbA1c measurement is clinically inappropriate, blood glucose levels greater than 10 mmol per L in more than 20% of tests over a 2 week period despite treatment with metformin.The date and level of the qualifying HbA1c measurement must be, or must have been, documented in the patient's medical records at the time treatment with a dipeptidyl peptidase 4 inhibitor (gliptin), a thiazolidinedione (glitazone), a glucagon-like peptide-1 or a sodium-glucose co-transporter 2 (SGLT2) inhibitor is initiated.The HbA1c must be no more than 4 months old at the time treatment with a gliptin, a glitazone, a glucagon-like peptide-1 or an SGLT2 inhibitor was initiated.Blood glucose monitoring may be used as an alternative assessment to HbA1c levels in the following circumstances:(a) A clinical condition with reduced red blood cell survival, including haemolytic anaemias and haemoglobinopathies; and/or(b) Had red cell transfusion within the previous 3 months.The results of the blood glucose monitoring, which must be no more than 4 months old at the time of initiation of treatment with a gliptin, a glitazone, a glucagon-like peptide-1 or an SGLT2 inhibitor, must be documented in the patient's medical records.
Compliance with Authority Required procedures - Streamlined Authority Code 5953
C5966
Diabetes mellitus type 2Continuing treatmentPatient must have previously received and been stabilised on a PBS-subsidised regimen of oral diabetic medicines which includes metformin and empagliflozin.
Compliance with Authority Required procedures - Streamlined Authority Code 5966
[133] Schedule 4, Part 1, entry for Famciclovir
substitute:
Famciclovir
C5937
P5937
Recurrent moderate to severe genital herpesEpisodic treatmentMicrobiological confirmation of diagnosis [viral culture, antigen detection or nucleic acid amplification by polymerase chain reaction (PCR)] is desirable but need not delay treatment.
Compliance with Authority Required procedures - Streamlined Authority Code 5937
C5943
P5943
Herpes zosterPatient must be immunocompromised; ANDThe treatment must be administered within 72 hours of the onset of the rash.
Compliance with Authority Required procedures - Streamlined Authority Code 5943
C5947
P5947
Recurrent moderate to severe oral or labial herpesEpisodic treatmentPatient must have HIV infection; ANDPatient must have a CD4 cell count of less than 500 million per litre.Microbiological confirmation of diagnosis [viral culture, antigen detection or nucleic acid amplification by polymerase chain reaction (PCR)] is desirable but need not delay treatment.
Compliance with Authority Required procedures - Streamlined Authority Code 5947
C5948
P5948
Recurrent moderate to severe oral or labial herpesSuppressive therapyPatient must have HIV infection; ANDPatient must have CD4 cell counts of less than 150 million per litre.Microbiological confirmation of diagnosis [viral culture, antigen detection or nucleic acid amplification by polymerase chain reaction (PCR)] is desirable but need not delay treatment.
Compliance with Authority Required procedures - Streamlined Authority Code 5948
C5949
P5949
Recurrent moderate to severe oral or labial herpesSuppressive therapyPatient must have HIV infection; ANDPatient must present with other opportunistic infections or AIDS defining tumours.Microbiological confirmation of diagnosis [viral culture, antigen detection or nucleic acid amplification by polymerase chain reaction (PCR)] is desirable but need not delay treatment.
Compliance with Authority Required procedures - Streamlined Authority Code 5949
C5951
P5951
Herpes zosterThe treatment must be administered within 72 hours of the onset of the rash.
Compliance with Authority Required procedures - Streamlined Authority Code 5951
C5954
P5954
Recurrent moderate to severe genital herpesEpisodic treatment or suppressive therapyPatient must be immunocompromised.Microbiological confirmation of diagnosis [viral culture, antigen detection or nucleic acid amplification by polymerase chain reaction (PCR)] is desirable but need not delay treatment.
Compliance with Authority Required procedures - Streamlined Authority Code 5954
C5971
P5971
Recurrent moderate to severe genital herpesSuppressive therapyMicrobiological confirmation of diagnosis [viral culture, antigen detection or nucleic acid amplification by polymerase chain reaction (PCR)] is desirable but need not delay treatment.
Compliance with Authority Required procedures - Streamlined Authority Code 5971
[134] Schedule 4, Part 1, entry for Folinic acid
substitute:
Folinic acid
C5938
Megaloblastic anaemiasThe condition must be a result of folic acid deficiency from the use of folic acid antagonists.
C5973
Megaloblastic anaemiasThe condition must be a result of folic acid deficiency from the use of folic acid antagonists.
[135] Schedule 4, Part 1, after entry for Latanoprost with timolol
insert:
Ledipasvir with sofosbuvir
C5944
P5944
Chronic hepatitis C infectionPatient must meet the criteria set out in the General Statement for Drugs for the Treatment of Hepatitis C; ANDPatient must be taking this drug as part of a regimen set out in the matrix in the General Statement for Drugs for the Treatment of Hepatitis C, based on the hepatitis C virus genotype, patient treatment history and cirrhotic status; ANDThe treatment must be limited to a maximum duration of 8 weeks.
Compliance with Written or Telephone Authority Required procedures
C5969
P5969
Chronic hepatitis C infectionPatient must meet the criteria set out in the General Statement for Drugs for the Treatment of Hepatitis C; ANDPatient must be taking this drug as part of a regimen set out in the matrix in the General Statement for Drugs for the Treatment of Hepatitis C, based on the hepatitis C virus genotype, patient treatment history and cirrhotic status; ANDThe treatment must be limited to a maximum duration of 12 weeks.
Compliance with Written or Telephone Authority Required procedures
C5972
P5972
Chronic hepatitis C infectionPatient must meet the criteria set out in the General Statement for Drugs for the Treatment of Hepatitis C; ANDPatient must be taking this drug as part of a regimen set out in the matrix in the General Statement for Drugs for the Treatment of Hepatitis C, based on the hepatitis C virus genotype, patient treatment history and cirrhotic status; ANDThe treatment must be limited to a maximum duration of 24 weeks.
Compliance with Written or Telephone Authority Required procedures
[136] Schedule 4, Part 1, entry for Nitrazepam
(a) omit:
P5684
CN5684
Benzodiazepine dependencePatient must be receiving long-term nursing care and in respect of whom a Carer Allowance is payable as a disabled adult; ANDPatient must have demonstrated, within the past 6 months, benzodiazepine dependence by an unsuccessful attempt at gradual withdrawal.
Compliance with Authority Required procedures
P5770
CN5770
Benzodiazepine dependencePatient must be receiving long-term nursing care on account of age, infirmity or other condition in hospitals, nursing homes or residential facilities; ANDPatient must have demonstrated, within the past 6 months, benzodiazepine dependence by an unsuccessful attempt at gradual withdrawal.
Compliance with Authority Required procedures
(b) insert in numerical order after existing text:
P5941
CN5941
InsomniaPatient must be receiving this drug for the management of insomnia; ANDPatient must be receiving long-term nursing care; ANDPatient must be one in respect of whom a Carer Allowance is payable as a disabled adult; ANDPatient must have demonstrated, within the past 6 months, benzodiazepine dependence by an unsuccessful attempt at gradual withdrawal.
Compliance with Authority Required procedures
P5950
CN5950
InsomniaPatient must be receiving this drug for the management of insomnia; ANDPatient must be receiving long-term nursing care on account of age, infirmity or other condition in a hospital, nursing home or residential facility; ANDPatient must have demonstrated, within the past 6 months, benzodiazepine dependence by an unsuccessful attempt at gradual withdrawal.
Compliance with Authority Required procedures
[137] Schedule 4, Part 1, after entry for Propantheline
insert:
Protein formula with amino acids, carbohydrates, vitamins and minerals without phenylalanine, and supplemented with docosahexaenoic acid
C5970
Phenylketonuria
[138] Schedule 4, Part 1, after entry for Reteplase
insert:
Ribavirin
C5957
P5957
Chronic hepatitis C infectionPatient must meet the criteria set out in the General Statement for Drugs for the Treatment of Hepatitis C; ANDPatient must be taking this drug as part of a regimen set out in the matrix in the General Statement for Drugs for the Treatment of Hepatitis C, based on the hepatitis C virus genotype, patient treatment history and cirrhotic status; ANDThe treatment must be limited to a maximum duration of 12 weeks.Patient must not be pregnant or breastfeeding. Female partners of male patients must not be pregnant. Patients and their partners must each be using an effective form of contraception if of child-bearing age.
Compliance with Written or Telephone Authority Required procedures
C5958
P5958
Chronic hepatitis C infectionPatient must meet the criteria set out in the General Statement for Drugs for the Treatment of Hepatitis C; ANDPatient must be taking this drug as part of a regimen set out in the matrix in the General Statement for Drugs for the Treatment of Hepatitis C, based on the hepatitis C virus genotype, patient treatment history and cirrhotic status; ANDThe treatment must be limited to a maximum duration of 24 weeks.Patient must not be pregnant or breastfeeding. Female partners of male patients must not be pregnant. Patients and their partners must each be using an effective form of contraception if of child-bearing age.
Compliance with Written or Telephone Authority Required procedures
[139] Schedule 4, Part 1, entry for Ribavirin and Peginterferon Alfa-2a
(a) insert in the column headed “Purposes Code” for Circumstances Codes C4184, C4185, C4187, C4188, C4193, C4197, C4206 and C4207 respectively:
P4184
P4185
P4187
P4188
P4193
P4197
P4206
P4207
(b) insert in numerical order:
C5956
P5956
Chronic hepatitis C infectionPatient must meet the criteria set out in the General Statement for Drugs for the Treatment of Hepatitis C; ANDPatient must be taking this drug as part of a regimen set out in the matrix in the General Statement for Drugs for the Treatment of Hepatitis C, based on the hepatitis C virus genotype, patient treatment history and cirrhotic status; ANDThe treatment must be limited to a maximum duration of 12 weeks.Patient must not be pregnant or breastfeeding. Female partners of male patients must not be pregnant. Patients and their partners must each be using an effective form of contraception if of child-bearing age.
Compliance with Written or Telephone Authority Required procedures
[140] Schedule 4, Part 1, entry for Simeprevir
(a) omit from the column headed “Circumstances and Purposes” for Circumstances Codes C4669 and C4684:
Where the patient is receiving treatment at/from a private hospital
(b) omit:
C4758
Where the patient is receiving treatment at/from a public hospitalChronic genotype 1 hepatitis C infectionPatient must have compensated liver disease; ANDPatient must not have received prior interferon alfa or peginterferon alfa treatment for hepatitis C; ANDThe treatment must be in combination with peginterferon alfa and ribavirin; ANDThe treatment must be limited to a maximum duration of 12 weeks; ANDThe treatment must cease if the results of an HCV RNA quantitative assay at week 4 show that the plasma HCV RNA is 25 IU/mL or greaterPatient must be aged 18 years or older; ANDPatient must not be pregnant or breastfeeding. Female partners of male patients must not be pregnant. Patients and their partners must each be using an effective form of contraception if of child-bearing ageMust be treated in an accredited treatment centreEvidence of chronic genotype 1 hepatitis C infection (repeatedly anti-HCV positive and HCV RNA positive) must be documented in the patient's medical recordsPatients who have received prior treatment with an NS3/4A protease inhibitor are not eligible to receive PBS-subsidised simeprevir, except where the patient has developed an intolerance to the other NS3/4A protease inhibitor of a severity necessitating permanent treatment withdrawal. Details of the intolerance must be documented in the patient's medical records
Compliance with Written and Telephone Authority Required procedures - Streamlined Authority Code 4758
C4759
Where the patient is receiving treatment at/from a public hospitalChronic genotype 1 hepatitis C infectionPatient must have compensated liver disease; ANDPatient must have received prior treatment with interferon alfa or peginterferon alfa for hepatitis C; ANDThe treatment must be in combination with peginterferon alfa and ribavirin; ANDThe treatment must be limited to a maximum duration of 12 weeks; ANDThe treatment must cease if the results of an HCV RNA quantitative assay at week 4 show that the plasma HCV RNA is 25 IU/mL or greaterPatient must be 18 years or older; ANDPatient must not be pregnant or breastfeeding. Female partners of male patients must not be pregnant. Patients and their partners must each be using an effective form of contraception if of child-bearing ageMust be treated in an accredited treatment centreEvidence of chronic genotype 1 hepatitis C infection (repeatedly anti-HCV positive and HCV RNA positive) must be documented in the patient's medical recordsPatients who have received prior treatment with an NS3/4A protease inhibitor are not eligible to receive PBS-subsidised simeprevir, except where the patient has developed an intolerance to the other NS3/4A protease inhibitor of a severity necessitating permanent treatment withdrawal. Details of the intolerance must be documented in the patient's medical records
Compliance with Written and Telephone Authority Required procedures - Streamlined Authority Code 4759
[141] Schedule 4, Part 1, after entry for Sodium Acid Phosphate
insert:
Sofosbuvir
C5969
P5969
Chronic hepatitis C infectionPatient must meet the criteria set out in the General Statement for Drugs for the Treatment of Hepatitis C; ANDPatient must be taking this drug as part of a regimen set out in the matrix in the General Statement for Drugs for the Treatment of Hepatitis C, based on the hepatitis C virus genotype, patient treatment history and cirrhotic status; ANDThe treatment must be limited to a maximum duration of 12 weeks.
Compliance with Written or Telephone Authority Required procedures
C5972
P5972
Chronic hepatitis C infectionPatient must meet the criteria set out in the General Statement for Drugs for the Treatment of Hepatitis C; ANDPatient must be taking this drug as part of a regimen set out in the matrix in the General Statement for Drugs for the Treatment of Hepatitis C, based on the hepatitis C virus genotype, patient treatment history and cirrhotic status; ANDThe treatment must be limited to a maximum duration of 24 weeks.
Compliance with Written or Telephone Authority Required procedures
[142] Schedule 4, Part 1, entry for Temazepam
(a) omit:
P5684
CN5684
Benzodiazepine dependencePatient must be receiving long-term nursing care and in respect of whom a Carer Allowance is payable as a disabled adult; ANDPatient must have demonstrated, within the past 6 months, benzodiazepine dependence by an unsuccessful attempt at gradual withdrawal.
Compliance with Authority Required procedures
P5770
CN5770
Benzodiazepine dependencePatient must be receiving long-term nursing care on account of age, infirmity or other condition in hospitals, nursing homes or residential facilities; ANDPatient must have demonstrated, within the past 6 months, benzodiazepine dependence by an unsuccessful attempt at gradual withdrawal.
Compliance with Authority Required procedures
(b) insert in numerical order after existing text:
P5941
CN5941
InsomniaPatient must be receiving this drug for the management of insomnia; ANDPatient must be receiving long-term nursing care; ANDPatient must be one in respect of whom a Carer Allowance is payable as a disabled adult; ANDPatient must have demonstrated, within the past 6 months, benzodiazepine dependence by an unsuccessful attempt at gradual withdrawal.
Compliance with Authority Required procedures
P5950
CN5950
InsomniaPatient must be receiving this drug for the management of insomnia; ANDPatient must be receiving long-term nursing care on account of age, infirmity or other condition in a hospital, nursing home or residential facility; ANDPatient must have demonstrated, within the past 6 months, benzodiazepine dependence by an unsuccessful attempt at gradual withdrawal.
Compliance with Authority Required procedures
[143] Schedule 4, Part 1, entry for Valaciclovir
substitute:
Valaciclovir
C5939
Where the patient is receiving treatment at/from a private hospitalCytomegalovirus infection and diseaseProphylaxisPatient must have undergone a renal transplant; ANDPatient must be at risk of cytomegalovirus disease.
Compliance with Written or Telephone Authority Required procedures
C5940
P5940
Recurrent moderate to severe genital herpesSuppressive therapyMicrobiological confirmation of diagnosis [viral culture, antigen detection or nucleic acid amplification by polymerase chain reaction (PCR)] is desirable but need not delay treatment.
Compliance with Authority Required procedures - Streamlined Authority Code 5940
C5960
P5960
Initial moderate to severe genital herpesMicrobiological confirmation of diagnosis [viral culture, antigen detection or nucleic acid amplification by polymerase chain reaction (PCR)] is desirable but need not delay treatment.
Compliance with Authority Required procedures - Streamlined Authority Code 5960
C5961
P5961
Recurrent moderate to severe genital herpesEpisodic treatmentMicrobiological confirmation of diagnosis [viral culture, antigen detection or nucleic acid amplification by polymerase chain reaction (PCR)] is desirable but need not delay treatment.
Compliance with Authority Required procedures - Streamlined Authority Code 5961
C5962
P5962
Herpes zosterThe treatment must be administered within 72 hours of the onset of the rash.
Compliance with Authority Required procedures - Streamlined Authority Code 5962
C5968
P5968
Herpes zoster ophthalmicus
Compliance with Authority Required procedures - Streamlined Authority Code 5968
C5975
Where the patient is receiving treatment at/from a public hospitalCytomegalovirus infection and diseaseProphylaxisPatient must have undergone a renal transplant; ANDPatient must be at risk of cytomegalovirus disease.
Compliance with Written or Telephone Authority Required procedures - Streamlined Authority Code 5975