PB 14 of 2013
National Health (Listing of Pharmaceutical Benefits) Amendment Instrument 2013
(No. 4)1
National Health Act 1953
I, FELICITY McNEILL, First Assistant Secretary, Pharmaceutical Benefits Division, Department of Health and Ageing, 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 March 2013
FELICITY McNEILL
First Assistant Secretary
Pharmaceutical Benefits Division
Department of Health and Ageing
1 Name of Instrument
(1) This Instrument is the National Health (Listing of Pharmaceutical Benefits) Amendment Instrument 2013 (No. 4).
(2) This Instrument may also be cited as PB 14 of 2013.
2 Commencement
This Instrument commences on 1 April 2013.
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 Albendazole in each of the forms: Tablet 200 mg; and Tablet 400 mg
omit from the column headed “Responsible Person”: GK substitute: AS
[2] Schedule 1, entry for Alendronic Acid in the form Tablet 70 mg (as alendronate sodium)
omit:
Alendronate Pfizer
FZ
MP NP
C4122 C4123 C4133
4
5
4
[3] Schedule 1, entry for Amlodipine in the form Tablet 5 mg (as besylate)
insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
Amlo 5
QA
MP NP
30
5
30
[4] Schedule 1, entry for Amlodipine
omit:
Tablet 5 mg (as maleate)
Oral
Amlo 5
ZP
MP NP
30
5
30
[5] Schedule 1, entry for Amlodipine in the form Tablet 10 mg (as besylate)
insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
Amlo 10
QA
MP NP
30
5
30
[6] Schedule 1, entry for Amlodipine
omit:
Tablet 10 mg (as maleate)
Oral
Amlo 10
ZP
MP NP
30
5
30
[7] Schedule 1, entry for Amoxycillin in the form Capsule 250 mg (as trihydrate) [Maximum Quantity 20; Number of Repeats 0]
(a) omit from the column headed “Responsible Person” for the brand “Amoxil”: GK substitute: AS
(b) omit:
Amoxycillin-PS
FZ
PDP
20
0
20
[8] Schedule 1, entry for Amoxycillin in the form Capsule 250 mg (as trihydrate) [Maximum Quantity 20; Number of Repeats 1]
(a) omit from the column headed “Responsible Person” for the brand “Amoxil”: GK substitute: AS
(b) omit:
Amoxycillin-PS
FZ
MP NP MW
20
1
20
[9] Schedule 1, entry for Amoxycillin in the form Capsule 500 mg (as trihydrate) [Maximum Quantity 20; Number of Repeats 0]
(a) omit from the column headed “Responsible Person” for the brand “Amoxil”: GK substitute: AS
(b) omit:
Amoxycillin-PS
FZ
PDP
20
0
20
[10] Schedule 1, entry for Amoxycillin in the form Capsule 500 mg (as trihydrate) [Maximum Quantity 20; Number of Repeats 1]
(a) omit from the column headed “Responsible Person” for the brand “Amoxil”: GK substitute: AS
(b) omit:
Amoxycillin-PS
FZ
MP NP MW
20
1
20
[11] Schedule 1, entry for Amoxycillin in each of the forms: Powder for paediatric oral drops 100 mg (as trihydrate) per mL, 20 mL; Powder for oral suspension 125 mg (as trihydrate) per 5 mL, 100 mL; and Powder for oral suspension 250 mg (as trihydrate) per 5 mL, 100 mL
omit from the column headed “Responsible Person” for the brands “Amoxil” and “Amoxil Forte” (all instances): GK substitute: AS
[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)
omit from the column headed “Responsible Person” for the brand “Augmentin Duo” (all instances): GK substitute: AS
[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)
omit from the column headed “Responsible Person” for the brand “Augmentin Duo forte” (all instances): GK substitute: AS
[14] 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
omit from the column headed “Responsible Person” for the brand “Augmentin” (all instances): GK substitute: AS
[15] 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
omit from the column headed “Responsible Person” for the brand “Augmentin Duo 400” (all instances): GK substitute: AS
[16] Schedule 1, entry for Anastrozole
omit:
Anastrozole-PS
FZ
MP NP
C2213
30
5
30
[17] Schedule 1, entry for Atenolol in the form Tablet 50 mg
omit:
Atenolol-PS
FZ
MP NP
30
5
30
[18] Schedule 1, entry for Atovaquone
omit from the column headed “Responsible Person”: GK substitute: AS
[19] Schedule 1, entry for Azathioprine in the form Tablet 50 mg
omit:
Azathioprine-PS
FZ
MP NP
100
5
100
[20] Schedule 1, entry for Bisoprolol in each of the forms: Tablet containing bisoprolol fumarate 2.5 mg; Tablet containing bisoprolol fumarate 5 mg; and Tablet containing bisoprolol fumarate 10 mg
omit:
Bisoprolol Pfizer
FZ
MP NP
C3234
28
5
28
[21] Schedule 1, after entry for Bleomycin in the form Powder for injection containing bleomycin sulfate 15,000 I.U. [Hospira Pty Limited]
insert:
Boceprevir
Capsule 200 mg
Oral
Victrelis
MK
MP
See Note 1
C4182 C4196 C4202 C4205
See Note 3
See Note 3
336
D(100)
[22] Schedule 1, entry for Bupropion
omit from the column headed “Responsible Person” for the brand “Zyban” (all instances): GK substitute: AS
[23] Schedule 1, entry for Calcitriol
omit:
Calcitriol-PS
FZ
MP NP
C1165 C1166 C1167 C1467 C2636
100
3
100
[24] Schedule 1, entry for Ceftriaxone in the form Powder for injection 1 mg (as sodium)
omit from the column headed “Pack Quantity” for the brand “Max Pharma Ceftriaxone”: 1 substitute: 5
[25] Schedule 1, entry for Cefuroxime in the form Tablet 250 mg (as axetil)
omit from the column headed “Responsible Person”: GK substitute: AS
[26] Schedule 1, entry for Cephalexin in the form Capsule 250 mg (anhydrous)
(a) omit:
Cephalexin-PS
FZ
PDP
20
0
20
(b) omit:
Cephalexin-PS
FZ
MP NP MW
20
1
20
[27] Schedule 1, entry for Cephalexin in the form Capsule 500 mg (anhydrous)
(a) omit:
Cephalexin-PS
FZ
PDP
20
0
20
(b) omit:
Cephalexin-PS
FZ
MP NP MW
20
1
20
[28] Schedule 1, entry for Ciprofloxacin in the form Tablet 500 mg (as hydrochloride)
omit:
Ciprofloxacin-PS
FZ
MP NP
C1431 C1432 C1572 C1573
14
0
14
[29] Schedule 1, entry for Ciprofloxacin in the form Tablet 750 mg (as hydrochloride)
(a) omit:
Ciprofloxacin-PS
FZ
MP NP
C1431 C1432 C1572 C1573
14
0
14
(b) omit from the column headed “Pack Quantity” for the brand “Ciprol 750”: 1 substitute: 14
[30] Schedule 1, entry for Ciprofloxacin in the form Eye drops 3 mg (as hydrochloride) per mL, 5 mL [CiloQuin]
(a) omit from the column headed “Circumstances”: C1031 substitute: C4195
(b) omit from the column headed “Circumstances”: C3830 substitute: C4181
[31] Schedule 1, entry for Ciprofloxacin in the form Eye drops 3 mg (as hydrochloride) per mL, 5 mL [Ciloxan]
(a) omit from the column headed “Circumstances”: C1031 substitute: C4195
(b) omit from the column headed “Circumstances”: C3830 substitute: C4181
[32] Schedule 1, entry for Citalopram in each of the forms: Tablet 20 mg (as hydrobromide); and Tablet 40 mg (as hydrobromide)
omit:
Citalopram Pfizer
FZ
MP NP
C1211
28
5
28
[33] Schedule 1, entry for Clarithromycin in the form Tablet 250 mg
omit:
Clarithromycin-PS
FZ
MP NP
14
1
14
[34] Schedule 1, entry for Clopidogrel in the form Tablet 75 mg (as besilate)
omit:
Clopidogrel-PS
FZ
MP NP
C1719 C1720 C1721 C1722 C1723 C1724
28
5
28
[35] Schedule 1, entry for Cyproterone in the form Tablet containing cyproterone acetate 50 mg
(a) omit:
Cyproterone-PS
FZ
MP
C1014 C1230 C1404
P1230
20
5
20
(b) omit:
Cyproterone-PS
FZ
MP
C1014 C1230 C1404
P1014 P1404
100
5
50
[36] Schedule 1, entry for Cyproterone in the form Tablet containing cyproterone acetate 100 mg
omit:
Cyproterone-PS 100
FZ
MP
C1014 C1404
50
5
50
[37] Schedule 1, entry for Diltiazem in the form Tablet containing diltiazem hydrochloride 60 mg
omit:
Diltiazem-PS
FZ
MP NP
90
5
90
[38] Schedule 1, entry for Donepezil
substitute:
Donepezil
Tablet containing donepezil hydrochloride 5 mg
Oral
APO-Donepezil
TX
MP NP
C2934 C2938 C3875 C3876
28
5
28
Arazil
AF
MP NP
C2934 C2938 C3875 C3876
28
5
28
Aricept
PF
MP NP
C2934 C2938 C3875 C3876
28
5
28
Aridon 5
QA
MP NP
C2934 C2938 C3875 C3876
28
5
28
Chem mart Donepezil
CH
MP NP
C2934 C2938 C3875 C3876
28
5
28
Donepezil-DRLA
RZ
MP NP
C2934 C2938 C3875 C3876
28
5
28
Donepezil-GA
GM
MP NP
C2934 C2938 C3875 C3876
28
5
28
Donepezil generichealth
GQ
MP NP
C2934 C2938 C3875 C3876
28
5
28
Donepezil RBX
RA
MP NP
C2934 C2938 C3875 C3876
28
5
28
Donepezil Sandoz
SZ
MP NP
C2934 C2938 C3875 C3876
28
5
28
Donepezil-Synthon
ZT
MP NP
C2934 C2938 C3875 C3876
28
5
28
STADA Donepezil
TD
MP NP
C2934 C2938 C3875 C3876
28
5
28
Terry White Chemists Donepezil
TW
MP NP
C2934 C2938 C3875 C3876
28
5
28
Tablet containing donepezil hydrochloride 10 mg
Oral
APO-Donepezil
TX
MP NP
C2934 C2938 C3875 C3876
28
5
28
Arazil
AF
MP NP
C2934 C2938 C3875 C3876
28
5
28
Aricept
PF
MP NP
C2934 C2938 C3875 C3876
28
5
28
Aridon 10
QA
MP NP
C2934 C2938 C3875 C3876
28
5
28
Chem mart Donepezil
CH
MP NP
C2934 C2938 C3875 C3876
28
5
28
Donepezil-DRLA
RZ
MP NP
C2934 C2938 C3875 C3876
28
5
28
Donepezil-GA
GM
MP NP
C2934 C2938 C3875 C3876
28
5
28
Donepezil generichealth
GQ
MP NP
C2934 C2938 C3875 C3876
28
5
28
Donepezil RBX
RA
MP NP
C2934 C2938 C3875 C3876
28
5
28
Donepezil Sandoz
SZ
MP NP
C2934 C2938 C3875 C3876
28
5
28
Donepezil-Synthon
ZT
MP NP
C2934 C2938 C3875 C3876
28
5
28
STADA Donepezil
TD
MP NP
C2934 C2938 C3875 C3876
28
5
28
Terry White Chemists Donepezil
TW
MP NP
C2934 C2938 C3875 C3876
28
5
28
[39] Schedule 1, entry for Doxycycline in the form Tablet 100 mg (as monohydrate) [Maximum Quantity 21; Number of Repeats 0]
omit from the column headed “Pack Quantity” for the brand “GenRx Doxycycline”: 7 substitute: 21
[40] Schedule 1, entry for Doxycycline in the form Capsule 100 mg (as hydrochloride) (containing enteric coated pellets)
[Maximum Quantity 21; Number of Repeats 0]
omit from the column headed “Pack Quantity” for the brands “Doryx” and “Mayne Pharma Doxycycline”: 7 substitute: 21
[41] Schedule 1, entry for Duloxetine
substitute:
Duloxetine
Capsule 30 mg (as hydrochloride)
Oral
Andepra
EL
MP NP
C1211
28
0
28
APO-Duloxetine
TX
MP NP
C1211
28
0
28
Chem mart Duloxetine
CH
MP NP
C1211
28
0
28
Cymbalta
LY
MP NP
C1211
28
0
28
Terry White Chemists Duloxetine
TW
MP NP
C1211
28
0
28
Capsule 60 mg (as hydrochloride)
Oral
Andepra
EL
MP NP
C1211
28
5
28
APO-Duloxetine
TX
MP NP
C1211
28
5
28
Chem mart Duloxetine
CH
MP NP
C1211
28
5
28
Cymbalta
LY
MP NP
C1211
28
5
28
Terry White Chemists Duloxetine
TW
MP NP
C1211
28
5
28
[42] Schedule 1, entry for Enalapril in each of the forms: Tablet containing enalapril maleate 5 mg; Tablet containing enalapril maleate 10 mg; and Tablet containing enalapril maleate 20 mg
omit:
Enalapril-PS
FZ
MP NP
30
5
30
[43] Schedule 1, entry for Epirubicin in the form Solution for injection containing epirubicin hydrochloride 50 mg in 25 mL
insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
Epirubicin SZ
HX
MP
See Note 3
See Note 3
1
D(100)
[44] Schedule 1, entry for Epirubicin in the form Solution for injection containing epirubicin hydrochloride 200 mg in 100 mL
insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
Epirubicin SZ
HX
MP
See Note 3
See Note 3
1
D(100)
[45] Schedule 1, entry for Famotidine in the form Tablet 20 mg
omit:
Famotidine-PS
FZ
MP NP
60
5
60
[46] Schedule 1, entry for Famotidine in the form Tablet 40 mg
omit:
Famotidine-PS
FZ
MP NP
30
5
30
[47] Schedule 1, entry for Fludarabine in the form Tablet containing fludarabine phosphate 10 mg
omit from the column headed “Pack Quantity”: 1 substitute: 20
[48] Schedule 1, entry for Fludarabine in the form Powder for I.V. injection containing fludarabine phosphate 50 mg
omit from the column headed “Pack Quantity” for the brand “Fludara”: 1 substitute: 5
[49] Schedule 1, entry for Fludarabine in the form Solution for I.V. injection 50 mg fludarabine phosphate in 2 mL
omit from the column headed “Pack Quantity” for the brand “AS-Fludarabine”: 5 substitute: 1
[50] Schedule 1, entry for Fluoxetine in the form Capsule 20 mg (as hydrochloride)
omit:
Fluoxetine-PS
FZ
MP NP
C1211 C1241
28
5
28
[51] Schedule 1, entry for Flutamide
substitute:
Flutamide
Tablet 250 mg
Oral
Flutamin
AF
MP NP
C3674
100
5
100
[52] Schedule 1, entry for Frusemide in each of the forms: Tablet 20 mg; and Tablet 40 mg
omit:
Frusemide-PS
FZ
MP NP
100
1
100
[53] Schedule 1, entry for Indapamide in the form Tablet containing indapamide hemihydrate 2.5 mg
omit:
Indapamide-PS
FZ
MP NP
90
1
90
[54] Schedule 1, entry for Interferon Beta-1b
insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
Extavia
NV
MP
C1175 C1751
15
5
15
[55] Schedule 1, entry for Irbesartan
substitute:
Irbesartan
Tablet 75 mg
Oral
Abisart
AF
MP NP
30
5
30
APO-Irbesartan
TX
MP NP
30
5
30
Avapro
AV
MP NP
30
5
30
Chem mart Irbesartan
CH
MP NP
30
5
30
Irbesartan-DRLA
RZ
MP NP
30
5
30
Irbesartan-GA
GM
MP NP
30
5
30
Irbesartan RBX
RA
MP NP
30
5
30
Irbesartan Sandoz
SZ
MP NP
30
5
30
Irbesartan Winthrop
WA
MP NP
30
5
30
Irbesat
GQ
MP NP
30
5
30
Karbesat 75
QA
MP NP
30
5
30
Karvea
SW
MP NP
30
5
30
Terry White Chemists Irbesartan
TW
MP NP
30
5
30
Tablet 150 mg
Oral
Abisart
AF
MP NP
30
5
30
APO-Irbesartan
TX
MP NP
30
5
30
Avapro
AV
MP NP
30
5
30
Chem mart Irbesartan
CH
MP NP
30
5
30
Irbesartan-DRLA
RZ
MP NP
30
5
30
Irbesartan-GA
GM
MP NP
30
5
30
Irbesartan RBX
RA
MP NP
30
5
30
Irbesartan Sandoz
SZ
MP NP
30
5
30
Irbesartan Winthrop
WA
MP NP
30
5
30
Irbesat
GQ
MP NP
30
5
30
Karbesat 150
QA
MP NP
30
5
30
Karvea
SW
MP NP
30
5
30
Terry White Chemists Irbesartan
TW
MP NP
30
5
30
Tablet 300 mg
Oral
Abisart
AF
MP NP
30
5
30
APO-Irbesartan
TX
MP NP
30
5
30
Avapro
AV
MP NP
30
5
30
Chem mart Irbesartan
CH
MP NP
30
5
30
Irbesartan-DRLA
RZ
MP NP
30
5
30
Irbesartan-GA
GM
MP NP
30
5
30
Irbesartan RBX
RA
MP NP
30
5
30
Irbesartan Sandoz
SZ
MP NP
30
5
30
Irbesartan Winthrop
WA
MP NP
30
5
30
Irbesat
GQ
MP NP
30
5
30
Karbesat 300
QA
MP NP
30
5
30
Karvea
SW
MP NP
30
5
30
Terry White Chemists Irbesartan
TW
MP NP
30
5
30
[56] Schedule 1, entry for Irbesartan with Hydrochlorothiazide
substitute:
Irbesartan with Hydrochlorothiazide
Tablet 150 mg-12.5 mg
Oral
Abisart HCT 150/12.5
AF
MP NP
C3307
30
5
30
APO-Irbesartan HCTZ
TX
MP NP
C3307
30
5
30
Avapro HCT 150/12.5
AV
MP NP
C3307
30
5
30
Chem mart Irbesartan HCTZ
CH
MP NP
C3307
30
5
30
Irbesartan/HCT Sandoz
SZ
MP NP
C3307
30
5
30
Irbesartan HCT Winthrop 150/12.5
WA
MP NP
C3307
30
5
30
Irbesartan HCTZ-GA 150/12.5
GM
MP NP
C3307
30
5
30
Irbesartan/HCTZ RBX 150/12.5
RA
MP NP
C3307
30
5
30
Irbesatzide 150/12.5
GQ
MP NP
C3307
30
5
30
Karvezide 150/12.5
SW
MP NP
C3307
30
5
30
KSART HCT 150/12.5
QA
MP NP
C3307
30
5
30
STADA Irbesartan HCT 150/12.5
TD
MP NP
C3307
30
5
30
Terry White Chemists Irbesartan HCTZ
TW
MP NP
C3307
30
5
30
Tablet 300 mg-12.5 mg
Oral
Abisart HCT 300/12.5
AF
MP NP
C3307
30
5
30
APO-Irbesartan HCTZ
TX
MP NP
C3307
30
5
30
Avapro HCT 300/12.5
AV
MP NP
C3307
30
5
30
Chem mart Irbesartan HCTZ
CH
MP NP
C3307
30
5
30
Irbesartan/HCT Sandoz
SZ
MP NP
C3307
30
5
30
Irbesartan HCT Winthrop 300/12.5
WA
MP NP
C3307
30
5
30
Irbesartan HCTZ-GA 300/12.5
GM
MP NP
C3307
30
5
30
Irbesartan/HCTZ RBX 300/12.5
RA
MP NP
C3307
30
5
30
Irbesatzide 300/12.5
GQ
MP NP
C3307
30
5
30
Karvezide 300/12.5
SW
MP NP
C3307
30
5
30
KSART HCT 300/12.5
QA
MP NP
C3307
30
5
30
STADA Irbesartan HCT 300/12.5
TD
MP NP
C3307
30
5
30
Terry White Chemists Irbesartan HCTZ
TW
MP NP
C3307
30
5
30
Tablet 300 mg-25 mg
Oral
Abisart HCT 300/25
AF
MP NP
C3307
30
5
30
APO-Irbesartan HCTZ
TX
MP NP
C3307
30
5
30
Avapro HCT 300/25
AV
MP NP
C3307
30
5
30
Chem mart Irbesartan HCTZ
CH
MP NP
C3307
30
5
30
Irbesartan/HCT Sandoz
SZ
MP NP
C3307
30
5
30
Irbesartan HCT Winthrop 300/25
WA
MP NP
C3307
30
5
30
Irbesartan HCTZ-GA 300/25
GM
MP NP
C3307
30
5
30
Irbesartan/HCTZ RBX 300/25
RA
MP NP
C3307
30
5
30
Irbesatzide 300/25
GQ
MP NP
C3307
30
5
30
Karvezide 300/25
SW
MP NP
C3307
30
5
30
KSART HCT 300/25
QA
MP NP
C3307
30
5
30
STADA Irbesartan HCT 300/25
TD
MP NP
C3307
30
5
30
Terry White Chemists Irbesartan HCTZ
TW
MP NP
C3307
30
5
30
[57] Schedule 1, entry for Irinotecan in each of the forms: I.V. injection containing irinotecan hydrochloride trihydrate 40 mg in 2 mL; and
I.V. injection containing irinotecan hydrochloride trihydrate 100 mg in 5 mL
insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
Irinotecan SZ
HX
MP
C3184
See Note 3
See Note 3
1
D(100)
[58] Schedule 1, entry for Isosorbide Mononitrate in the form Tablet 60 mg (sustained release)
omit:
Isosorbide-PS
FZ
MP NP
30
5
30
[59] Schedule 1, entry for Isotretinoin in the form Capsule 20 mg
omit:
Isotretinoin-PS
FZ
MP
C1354
60
3
60
[60] Schedule 1, entry for Lamivudine in the form Tablet 100 mg
omit from the column headed “Responsible Person” for the brand “Zeffix”: GK substitute: AS
[61] Schedule 1, entry for Lamivudine in the form Oral solution 5 mg per mL, 240 mL
omit from the column headed “Responsible Person”: GK substitute: AS
[62] Schedule 1, entry for Lamotrigine in the form Tablet 5 mg
omit from the column headed “Responsible Person” for the brand “Lamictal”: GK substitute: AS
[63] 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
(a) omit from the column headed “Responsible Person” for the brand “Lamictal”: GK substitute: AS
(b) omit:
Lamotrigine-PS
FZ
MP NP
C1426
56
5
56
[64] Schedule 1, entry for Lercanidipine in each of the forms: Tablet containing lercanidipine hydrochloride 10 mg; and Tablet containing lercanidipine hydrochloride 20 mg
insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
Lercanidipine GH
GQ
MP NP
28
5
28
[65] Schedule 1, entry for Letrozole
omit:
Letara
FZ
MP NP
C1608 C2691 C2692
30
5
30
[66] Schedule 1, entry for Levetiracetam in each of the forms: Tablet 250 mg; Tablet 500 mg; and Tablet 1 g
omit:
Levetiracetam Pfizer
FZ
MP NP
C2664
60
5
60
[67] Schedule 1, entry for Levonorgestrel with Ethinyloestradiol
insert as first entry in the columns in the order indicated:
Pack containing 21 tablets 100 micrograms-20 micrograms and 7 inert tablets
Oral
Femme-Tab ED 20/100
AE
MP NP
4
2
4
[68] Schedule 1, entry for Levonorgestrel with Ethinyloestradiol in the form Pack containing 21 tablets 150 micrograms-30 micrograms
and 7 inert tablets
insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
Femme-Tab ED 30/150
AE
MP NP
4
2
4
[69] Schedule 1, entry for Lisinopril in each of the forms: Tablet 5 mg; Tablet 10 mg; and Tablet 20 mg
omit:
Lisinopril-PS
FZ
MP NP
30
5
30
[70] Schedule 1, entry for Lithium in the form Tablet containing lithium carbonate 450 mg (slow release)
omit from the column headed “Responsible Person”: GK substitute: AS
[71] Schedule 1, entry for Mesalazine in the form Tablet 250 mg (enteric coated)
omit from the column headed “Responsible Person”: GK substitute: AS
[72] Schedule 1, entry for Meloxicam in each of the forms: Tablet 7.5 mg; and Tablet 15 mg
omit:
Meloxicam-PS
FZ
MP NP
C1547 C1848
30
3
30
[73] Schedule 1, entry for Metformin in the form Tablet containing metformin hydrochloride 500 mg
omit:
Metformin Pfizer
FZ
MP NP
100
5
100
[74] Schedule 1, entry for Metformin in the form Tablet containing metformin hydrochloride 850 mg
omit:
Metformin Pfizer
FZ
MP NP
60
5
60
[75] Schedule 1, entry for Metformin in the form Tablet containing metformin hydrochloride 1 g
omit:
Metformin Pfizer
FZ
MP NP
90
5
90
[76] Schedule 1, entry for Mirtazapine in the form Tablet 15 mg
omit:
Mirtazapine Pfizer
FZ
MP NP
C1211
30
5
30
[77] Schedule 1, entry for Mirtazapine in the form Tablet 15 mg (orally disintegrating)
omit:
Mirtazapine Dispersible Pfizer
FZ
MP NP
C1211
30
5
30
[78] Schedule 1, entry for Mirtazapine in the form Tablet 30 mg
omit:
Mirtazapine Pfizer
FZ
MP NP
C1211
30
5
30
[79] Schedule 1, entry for Mirtazapine in the form Tablet 30 mg (orally disintegrating)
omit:
Mirtazapine Dispersible Pfizer
FZ
MP NP
C1211
30
5
30
[80] Schedule 1, entry for Mirtazapine in the form Tablet 45 mg
omit:
Mirtazapine Pfizer
FZ
MP NP
C1211
30
5
30
[81] Schedule 1, entry for Mirtazapine in the form Tablet 45 mg (orally disintegrating)
omit:
Mirtazapine Dispersible Pfizer
FZ
MP NP
C1211
30
5
30
[82] Schedule 1, entry for Moclobemide in each of the forms: Tablet 150 mg; and Tablet 300 mg
omit:
Moclobemide-PS
FZ
MP NP
C1211
60
5
60
[83] Schedule 1, entry for Mometasone in each of the forms: Ointment containing mometasone furoate 1 mg per g, 15 g; and Lotion containing mometasone furoate 1 mg per g, 30 mL
insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
Zatamil
EO
MP NP
C1422
1
0
1
[84] Schedule 1, entry for Morphine in the form Injection containing morphine sulphate 10 mg in 1 mL (with preservative)
(a) omit from the column headed “Maximum Quantity”: 1 substitute: 10
(b) omit from the column headed “Pack Quantity”: 1 substitute: 10
[85] Schedule 1, entry for Naratriptan
omit from the column headed “Responsible Person”: GK substitute: AS
[86] Schedule 1, entry for Norfloxacin
omit:
Norfloxacin-PS
FZ
MP NP
C1002 C1070
14
1
14
[87] Schedule 1, entry for Ofloxacin
(a) omit from the column headed “Circumstances”: C1031 substitute: C4195
(b) omit from the column headed “Circumstances”: C3830 substitute: C4181
[88] Schedule 1, entry for Olanzapine in each of the forms: Tablet 2.5 mg; Tablet 5 mg; Tablet 7.5 mg; and Tablet 10 mg
omit:
Olanzapine-PS
FZ
MP NP
C1589 C2044
28
5
28
[89] Schedule 1, entry for Olanzapine in each of the forms: Tablet 5 mg (orally disintegrating); and Tablet 10 mg (orally disintegrating)
omit:
PS Olanzapine ODT
FZ
MP NP
C1589 C2044
28
5
28
[90] Schedule 1, entry for Omeprazole in the form Tablet 20 mg
(a) omit:
Omeprazole-PS
FZ
MP NP
C4074 C4075 C4089 C4152
P4074
30
1
30
(b) omit:
Omeprazole-PS
FZ
MP NP
C4074 C4075 C4089 C4152
P4075 P4089 P4152
30
5
30
[91] Schedule 1, entry for Ondansetron in the form Tablet 4 mg (as hydrochloride dihydrate) [Maximum Quantity 4; Number of Repeats 0]
omit from the column headed “Responsible Person” for the brand “Zofran”: GK substitute: AS
[92] Schedule 1, entry for Ondansetron in the form Tablet 4 mg (as hydrochloride dihydrate)
[Maximum Quantity 10; Number of Repeats 1]
(a) omit:
Ondansetron Tabs Pfizer
FZ
MP NP
C3050 C3611
P3611
10
1
10
(b) omit from the column headed “Responsible Person” for the brand “Zofran”: GK substitute: AS
[93] Schedule 1, entry for Ondansetron in the form Tablet 8 mg (as hydrochloride dihydrate) [Maximum Quantity 4; Number of Repeats 0]
omit from the column headed “Responsible Person” for the brand “Zofran”: GK substitute: AS
[94] Schedule 1, entry for Ondansetron in the form Tablet 8 mg (as hydrochloride dihydrate) [Maximum Quantity 10; Number of Repeats 1]
(a) omit:
Ondansetron Tabs Pfizer
FZ
MP NP
C3050 C3611
P3611
10
1
10
(b) omit from the column headed “Responsible Person” for the brand “Zofran”: GK substitute: AS
[95] Schedule 1, entry for Ondansetron in each of the forms: Wafer 4 mg; and Wafer 8 mg
omit from the column headed “Responsible Person” for the brand “Zofran Zydis” (all instances): GK substitute: AS
[96] Schedule 1, entry for Ondansetron in the form Syrup 4 mg (as hydrochloride dihydrate) per 5 mL, 50 mL
omit from the column headed “Responsible Person”: GK substitute: AS
[97] Schedule 1, entry for Ondansetron in each of the forms: I.V. injection 4 mg (as hydrochloride dihydrate) in 2 mL; and I.V. injection 8 mg (as hydrochloride dihydrate) in 4 mL
(a) insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
Ondansetron Kabi
PK
MP NP
See Note 1
C3050 C3611
See Note 2
See Note 2
1
See Note 2
0
See Note 2
1
(b) omit from the column headed “Responsible Person” for the brand “Zofran”: GK substitute: AS
[98] Schedule 1, entry for Oxaliplatin in the form Solution concentrate for I.V. infusion 100 mg in 20 mL
insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
Oxaliplatin SZ
HX
MP
C3900 C3901 C3930 C3939
See Note 3
See Note 3
1
D(100)
[99] Schedule 1, entry for Pamidronic Acid
omit:
Concentrated injection containing disodium pamidronate 30 mg in 10 mL
Injection
Pamisol
HH
MP NP
C3256
2
0
1
MP
See Note 1
C1500 C3341
2
2
1
C(100)
substitute:
Concentrated injection containing disodium pamidronate 30 mg in 10 mL
Injection
Pamidronate Strides
YA
MP NP
C3256
2
0
1
MP
See Note 1
C1500 C3341
2
2
1
C(100)
Pamisol
HH
MP NP
C3256
2
0
1
MP
See Note 1
C1500 C3341
2
2
1
C(100)
[100] Schedule 1, entry for Pamidronic Acid in the form Concentrated injection containing disodium pamidronate 90 mg in 10 mL
insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
Pamidronate Strides
YA
MP
See Note 1
C1035 C1233 C1500 C3341 C3342 C3343
1
11
1
PB(100)
[101] Schedule 1, entry for Pantoprazole in the form Tablet (enteric coated) 40 mg (as sodium sesquihydrate)
(a) omit:
Pantoprazole-PS
FZ
MP NP
C1177 C1337 C1476 C1533
P1177
30
2
30
(b) omit:
Pantoprazole-PS
FZ
MP NP
C1177 C1337 C1476 C1533
P1337 P1476 P1533
30
5
30
[102] Schedule 1, entry for Pantoprazole in the form Tablet (enteric coated) 20 mg (as sodium sesquihydrate)
omit:
Pantoprazole-PS
FZ
MP NP
C1337 C1476 C1533
30
5
30
[103] Schedule 1, entry for Paroxetine in the form Tablet 20 mg (as hydrochloride)
(a) omit from the column headed “Responsible Person” for the brand “Aropax”: GK substitute: AS
(b) omit:
Paroxetine-PS
FZ
MP NP
C1211 C1241 C1862
30
5
30
[104] Schedule 1, entry for Pioglitazone in each of the forms: Tablet 15 mg (as hydrochloride); Tablet 30 mg (as hydrochloride);
and Tablet 45 mg (as hydrochloride)
omit:
Pioglitazone Pfizer
FZ
MP NP
C3540 C3541 C3542
28
5
28
[105] Schedule 1, entry for Pravastatin in the form Tablet containing pravastatin sodium 10 mg
(a) omit:
Pravastatin-PS
FZ
MP
C1540 C3047
P1540
30
5
30
NP
C1540
30
5
30
(b) omit:
Pravastatin-PS
FZ
MP
C1540 C3047
P3047
30
11
30
[106] Schedule 1, entry for Pravastatin in the form Tablet containing pravastatin sodium 20 mg
(a) omit:
Pravastatin-PS
FZ
MP
C1540 C3047
P1540
30
5
30
NP
C1540
30
5
30
(b) omit:
Pravastatin-PS
FZ
MP
C1540 C3047
P3047
30
11
30
[107] Schedule 1, entry for Pravastatin in the form Tablet containing pravastatin sodium 40 mg
(a) omit:
Pravastatin-PS
FZ
MP
C1540 C3047
P1540
30
5
30
NP
C1540
30
5
30
(b) omit:
Pravastatin-PS
FZ
MP
C1540 C3047
P3047
30
11
30
[108] Schedule 1, entry for Pravastatin in the form Tablet containing pravastatin sodium 80 mg
(a) omit:
Pravastatin-PS
FZ
MP
C1540 C3047
P1540
30
5
30
NP
C1540
30
5
30
(b) omit:
Pravastatin-PS
FZ
MP
C1540 C3047
P3047
30
11
30
[109] Schedule 1, entry for Prochlorperazine in the form Tablet containing prochlorperazine maleate 5 mg
omit:
Prochlorperazine-PS
FZ
PDP MP NP
25
0
25
[110] Schedule 1, entry for Pyrimethamine
omit from the column headed “Responsible Person”: GK substitute: AS
[111] Schedule 1, entry for Quetiapine in the form Tablet 25 mg (as fumarate)
omit:
Quetiapine Pfizer
FZ
MP NP
C1589 C2044 C2765
60
5
60
[112] Schedule 1, entry for Quetiapine in the form Tablet 100 mg (as fumarate)
omit:
Quetiapine Pfizer
FZ
MP NP
C1589 C2044 C2765
90
5
90
[113] Schedule 1, entry for Quetiapine in each of the forms: Tablet 200 mg (as fumarate); and Tablet 300 mg (as fumarate)
omit:
Quetiapine Pfizer
FZ
MP NP
C1589 C2044 C2765
60
5
60
[114] Schedule 1, entry for Rabeprazole in the form Tablet containing rabeprazole sodium 10 mg (enteric coated)
omit:
Rabeprazole Pfizer
FZ
MP NP
C1337 C1533
28
5
28
[115] Schedule 1, entry for Rabeprazole in the form Tablet containing rabeprazole sodium 20 mg (enteric coated)
(a) omit:
Rabeprazole Pfizer
FZ
MP NP
C1177 C1337 C1533
P1177
30
2
30
(b) omit:
Rabeprazole Pfizer
FZ
MP NP
C1177 C1337 C1533
P1337 P1533
30
5
30
[116] Schedule 1, entry for Ramipril in each of the forms: Tablet 1.25 mg; Tablet 2.5 mg; Tablet 5 mg; and Tablet 10 mg
omit:
Ramipril Tabs Pfizer
FZ
MP NP
30
5
30
[117] Schedule 1, entry for Ramipril in the form Capsule 10 mg
omit:
Ramipril-PS
FZ
MP NP
30
5
30
[118] Schedule 1, entry for Ranitidine in the form Tablet 150 mg (as hydrochloride)
(a) omit:
Ranitidine-PS
FZ
MP NP MW
60
5
60
(b) omit from the column headed “Responsible Person” for the brand “Zantac”: GK substitute: AS
[119] Schedule 1, entry for Ranitidine in the form Tablet, effervescent, 150 mg (as hydrochloride)
(a) omit from the column headed “Responsible Person”: GK substitute: AS
(b) omit from the column headed “Pack Quantity”: 60 substitute: 30
[120] Schedule 1, entry for Ranitidine in the form Tablet 300 mg (as hydrochloride)
omit from the column headed “Responsible Person” for the brand “Zantac”: GK substitute: AS
[121] Schedule 1, entry for Ranitidine in the form Syrup 150 mg (as hydrochloride) per 10 mL, 300 mL
omit from the column headed “Responsible Person”: GK substitute: AS
[122] Schedule 1, entry for Ribavirin and Peginterferon Alfa-2a
omit from the column headed “Circumstances” (all instances):
C3053
C3055
C3413
C3414
substitute:
C4184
C4185
C4187
C4188
C4193
C4197
C4206
C4207
[123] Schedule 1, entry for Ribavirin and Peginterferon Alfa-2b in the form Pack containing 112 capsules ribavirin 200 mg
and 4 single use injection pens containing peginterferon alfa-2b powder for injection 50 micrograms with diluent
omit from the column headed “Circumstances”:
C3053
C3414
C3948
C3949
substitute:
C4184
C4185
C4187
C4188
C4189
C4192
C4193
C4197
C4198
C4199
C4200
C4203
C4206
C4207
C4208
C4209
[124] Schedule 1, entry for Ribavirin and Peginterferon Alfa-2b in the form Pack containing 84 capsules ribavirin 200 mg
and 4 single use injection pens containing peginterferon alfa-2b powder for injection 80 micrograms with diluent
omit from the column headed “Circumstances”:
C3053
C3414
C3948
C3949
substitute:
C4184
C4185
C4187
C4188
C4189
C4192
C4193
C4197
C4198
C4199
C4200
C4203
C4206
C4207
C4208
C4209
[125] Schedule 1, entry for Ribavirin and Peginterferon Alfa-2b in the form Pack containing 140 capsules ribavirin 200 mg
and 4 single use injection pens containing peginterferon alfa-2b powder for injection 80 micrograms with diluent
omit from the column headed “Circumstances”:
C3053
C3055
C3413
C3414
substitute:
C4184
C4185
C4187
C4188
C4193
C4197
C4206
C4207
[126] Schedule 1, entry for Ribavirin and Peginterferon Alfa-2b in the form Pack containing 112 capsules ribavirin 200 mg
and 4 single use injection pens containing peginterferon alfa-2b powder for injection 100 micrograms with diluent
omit from the column headed “Circumstances”:
C3053
C3414
C3948
C3949
substitute:
C4184
C4185
C4187
C4188
C4189
C4192
C4193
C4197
C4198
C4199
C4200
C4203
C4206
C4207
C4208
C4209
[127] Schedule 1, entry for Ribavirin and Peginterferon Alfa-2b in the form Pack containing 140 capsules ribavirin 200 mg
and 4 single use injection pens containing peginterferon alfa-2b powder for injection 120 micrograms with diluent
omit from the column headed “Circumstances”:
C3053
C3055
C3413
C3414
substitute:
C4184
C4185
C4187
C4188
C4193
C4197
C4206
C4207
[128] Schedule 1, entry for Ribavirin and Peginterferon Alfa-2b in the form Pack containing 140 capsules ribavirin 200 mg
and 4 single use injection pens containing peginterferon alfa-2b powder for injection 150 micrograms with diluent
omit from the column headed “Circumstances”:
C3053
C3055
C3413
C3414
substitute:
C4184
C4185
C4187
C4188
C4193
C4197
C4206
C4207
[129] Schedule 1, entry for Ribavirin and Peginterferon Alfa-2b in the form Pack containing 168 capsules ribavirin 200 mg
and 4 single use injection pens containing peginterferon alfa-2b powder for injection 150 micrograms with diluent
omit from the column headed “Circumstances”:
C3053
C3055
C3413
C3414
substitute:
C4184
C4185
C4187
C4188
C4193
C4197
C4206
C4207
[130] Schedule 1, entry for Ribavirin and Peginterferon Alfa-2b in the form Pack containing 196 capsules ribavirin 200 mg
and 4 single use injection pens containing peginterferon alfa-2b powder for injection 150 micrograms with diluent
omit from the column headed “Circumstances”:
C3053
C3055
C3413
C3414
substitute:
C4184
C4185
C4187
C4188
C4193
C4197
C4206
C4207
[131] Schedule 1, entry for Risperidone in the form Tablet 0.5 mg
(a) omit:
Risperidone Pfizer
FZ
MP NP
C1589 C2061 C3083
P2061 P3083
60
2
60
(b) omit:
Risperidone Pfizer
FZ
MP NP
C1589 C2061 C3083
P1589
60
5
60
[132] Schedule 1, entry for Risperidone in the form Tablet 1 mg
(a) omit:
Risperidone Pfizer
FZ
MP NP
C1589 C2061 C2272 C3083
P2061 P3083
60
2
60
(b) omit:
Risperidone Pfizer
FZ
MP NP
C1589 C2061 C2272 C3083
P1589 P2272
60
5
60
[133] Schedule 1, entry for Risperidone in the form Tablet 2 mg
(a) omit:
Risperidone Pfizer
FZ
MP NP
C1589 C2272 C3083
P3083
60
2
60
(b) omit:
Risperidone Pfizer
FZ
MP NP
C1589 C2272 C3083
P1589 P2272
60
5
60
[134] Schedule 1, entry for Risperidone in the form Tablet 3 mg
omit:
Risperidone Pfizer
FZ
MP NP
C1589 C2272
60
5
60
[135] Schedule 1, entry for Risperidone in the form Tablet 3 mg (orally disintegrating)
omit from the column headed “Pack Quantity”: 60 substitute: 28
[136] Schedule 1, entry for Risperidone in the form Tablet 4 mg
omit:
Risperidone Pfizer
FZ
MP NP
C1589 C2272
60
5
60
[137] Schedule 1, after entry for Rosuvastatin in the form Tablet 40 mg (as calcium)
insert:
Rotigotine
Transdermal patch 4.5 mg
Transdermal
Neupro
UC
MP
C4190
28
5
28
Transdermal patch 9 mg
Transdermal
Neupro
UC
MP
C4204
28
5
28
Transdermal patch 13.5 mg
Transdermal
Neupro
UC
MP
C4204
28
5
28
[138] Schedule 1, entry for Roxithromycin in the form Tablet 150 mg
(a) omit:
Roxithromycin-PS
FZ
PDP
10
0
10
(b) omit:
Roxithromycin-PS
FZ
MP NP
10
1
10
[139] Schedule 1, entry for Roxithromycin in the form Tablet 300 mg
(a) omit:
Roxithromycin-PS
FZ
PDP
5
0
5
(b) omit:
Roxithromycin-PS
FZ
MP NP
5
1
5
[140] Schedule 1, entry for Simvastatin in the form Tablet 10 mg
(a) omit:
Simvastatin Pfizer
FZ
MP
C1540 C3047
P1540
30
5
30
NP
C1540
30
5
30
(b) omit:
Simvastatin Pfizer
FZ
MP
C1540 C3047
P3047
30
11
30
[141] Schedule 1, entry for Simvastatin in the form Tablet 20 mg
(a) omit:
Simvastatin Pfizer
FZ
MP
C1540 C3047
P1540
30
5
30
NP
C1540
30
5
30
(b) omit:
Simvastatin Pfizer
FZ
MP
C1540 C3047
P3047
30
11
30
[142] Schedule 1, entry for Simvastatin in the form Tablet 40 mg
(a) omit:
Simvastatin Pfizer
FZ
MP
C1540 C3047
P1540
30
5
30
NP
C1540
30
5
30
(b) omit:
Simvastatin Pfizer
FZ
MP
C1540 C3047
P3047
30
11
30
[143] Schedule 1, entry for Simvastatin in the form Tablet 80 mg
(a) omit:
Simvastatin Pfizer
FZ
MP
C1540 C3047
P1540
30
5
30
NP
C1540
30
5
30
(b) omit:
Simvastatin Pfizer
FZ
MP
C1540 C3047
P3047
30
11
30
[144] Schedule 1, after entry for Sitagliptin with metformin in the form Tablet containing 50 mg sitagliptin (as phosphate monohydrate) with 1000 mg metformin hydrochloride
insert:
Sitagliptin with simvastatin
Tablet 100 mg (as phosphate monohydrate)-10 mg
Oral
Juvicor
MK
MP NP
C4183
28
5
28
Tablet 100 mg (as phosphate monohydrate)-20 mg
Oral
Juvicor
MK
MP NP
C4183
28
5
28
Tablet 100 mg (as phosphate monohydrate)-40 mg
Oral
Juvicor
MK
MP NP
C4183
28
5
28
[145] Schedule 1, entry for Sumatriptan
substitute:
Sumatriptan
Tablet 50 mg (as succinate)
Oral
APO-Sumatriptan
TX
MP NP
C3233
4
5
2
Chem mart Sumatriptan
CH
MP NP
C3233
4
5
2
Imigran
LN
MP NP
C3233
4
5
2
Sumagran 50
QA
MP NP
C3233
4
5
2
Sumagran Aspen 50
AS
MP NP
C3233
4
5
2
Sumatab
AF
MP NP
C3233
4
5
2
Terry White Chemists Sumatriptan
TW
MP NP
C3233
4
5
2
APO-Sumatriptan
TX
MP NP
C3233
4
5
4
Chem mart Sumatriptan
CH
MP NP
C3233
4
5
4
Pharmacor Sumatriptan 50
CR
MP NP
C3233
4
5
4
Sumatriptan-GA
GM
MP NP
C3233
4
5
4
Sumatriptan generichealth
GQ
MP NP
C3233
4
5
4
Sumatriptan RBX
RA
MP NP
C3233
4
5
4
Terry White Chemists Sumatriptan
TW
MP NP
C3233
4
5
4
Tablet (fast disintegrating) 50 mg (as succinate)
Oral
Imigran FDT
AS
MP NP
C3233
4
5
2
Nasal spray 20 mg in 0.1 mL single dose unit
Nasal
Imigran
AS
MP NP
C3233
2
5
2
[146] Schedule 1, entry for Strontium
omit from the column headed “Circumstances”:
C4071
C4107
substitute:
C4117
C4123
[147] Schedule 1, after entry for Tamoxifen in the form Tablet 20 mg (as citrate) [Tamoxifen Sandoz]
insert:
Telaprevir
Tablet 375 mg
Oral
Incivo
JC
MP
See Note 1
C4186 C4191 C4194 C4201
See Note 3
See Note 3
42
D(100)
[148] Schedule 1, entry for Thiamine
(a) omit from the column headed “Brand”: Betamin substitute: Betavit
(b) omit from the column headed “Responsible Person”: SW substitute: PP
[149] Schedule 1, entry for Ticarcillin with Clavulanic Acid
omit from the column headed “Responsible Person”: GK substitute: AS
[150] Schedule 1, entry for Topotecan in the form Powder for I.V. infusion 4 mg (as hydrochloride)
omit from the column headed “Pack Quantity” for the brand “Topotecan Agila”: 5 substitute: 1
[151] Schedule 1, entry for Tropisetron in the form I.V. injection 5 mg (as hydrochloride) in 5 mL
insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
Tropisetron-AFT
AE
MP NP
See Note 1
C3050
1
0
1
[152] Schedule 1, entry for Valaciclovir in the form Tablet 500 mg (as hydrochloride) [Maximum Quantity 20; Number of Repeats 0]
(a) omit:
Valaciclovir Pfizer
FZ
MP NP
C3622 C3623 C3624 C3631 C3632
P3632
20
0
10
(b) omit from the column headed “Responsible Person” for the brand “Valtrex”: GK substitute: AS
(c) omit:
Valvala
NV
MP NP
C3622 C3624 C3631 C3632
P3632
20
0
10
[153] Schedule 1, entry for Valaciclovir in the form Tablet 500 mg (as hydrochloride) [Maximum Quantity 30; Number of Repeats 5]
(a) omit:
Valaciclovir Pfizer
FZ
MP NP
C3622 C3623 C3624 C3631 C3632
P3623 P3624
30
5
30
(b) omit from the column headed “Responsible Person” for the brand “Valtrex”: GK substitute: AS
(c) omit:
Valvala
NV
MP NP
C3622 C3624 C3631 C3632
P3624
30
5
30
[154] Schedule 1, entry for Valaciclovir in the form Tablet 500 mg (as hydrochloride) [Maximum Quantity 42; Number of Repeats 0]
(a) omit:
Valaciclovir Pfizer
FZ
MP NP
C3622 C3623 C3624 C3631 C3632
P3622 P3631
42
0
42
(b) omit from the column headed “Responsible Person” for the brand “Valtrex”: GK substitute: AS
(c) omit:
Valvala
NV
MP NP
C3622 C3624 C3631 C3632
P3622 P3631
42
0
42
[155] Schedule 1, entry for Valaciclovir in the form Tablet 500 mg (as hydrochloride) [Maximum Quantity 500; Number of Repeats 2]
(a) omit from the column headed “Responsible Person” for the brand “Valtrex”: GK substitute: AS
(b) omit:
Valvala
NV
MP
See Note 1
C1494 C3419
500
2
100
C(100)
[156] Schedule 3, after details relevant to Responsible person code EL
insert:
EO
Ego Pharmaceuticals Proprietary Limited
86 005 142 361
[157] Schedule 4, Part 1, after entry for Bleomycin
insert:
Boceprevir
C4182
Where the patient is receiving treatment at/from a public hospital
Chronic genotype 1 hepatitis C infection
Must be treated in an accredited treatment centre;
Patient must have compensated liver disease;
Patient must have received no more than one prior treatment with interferon alfa or peginterferon alfa for hepatitis C;
The treatment must be in combination with peginterferon alfa and ribavirin;
The treatment must be limited to a maximum duration of 32 weeks in patients without hepatic cirrhosis who were partial responders or relapsers to the prior course of interferon based therapy for hepatitis C; OR
The treatment must be limited to a maximum duration of 44 weeks in patients without hepatic cirrhosis who were null responders to the prior course of interferon based therapy for hepatitis C; OR
The treatment must be limited to a maximum duration of 44 weeks for all patients with hepatic cirrhosis;
The treatment must cease after the first 8 weeks of boceprevir treatment if plasma HCV RNA is detectable by an HCV RNA qualitative assay at treatment week 12;
The treatment must cease after the first 20 weeks of boceprevir treatment if plasma HCV RNA is detectable by an HCV RNA qualitative assay at treatment week 24
Patient must be 18 years or older
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
Chronic genotype 1 hepatitis C infection (repeated anti-HCV positive and HCV RNA positive) must be documented in the patient's medical records
Patients who have received prior treatment with an NS3/4A protease inhibitor are not eligible to receive PBS-subsidised boceprevir, 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
For patients without hepatic cirrhosis who were partial responders or relapsers to the prior course of interferon based therapy, a maximum of 7 repeats may be prescribed
For patients without hepatic cirrhosis who were null responders to the prior course of interferon based therapy, a maximum of 10 repeats may be prescribed
For patients with hepatic cirrhosis, a maximum of 10 repeats may be prescribed
Compliance with Written or Telephone Authority Required procedures - Streamlined Authority Code 4182
C4196
Where the patient is receiving treatment at/from a private hospital
Chronic genotype 1 hepatitis C infection
Must be treated in an accredited treatment centre;
Patient must have compensated liver disease;
Patient must not have received prior interferon alfa or peginterferon alfa treatment for hepatitis C;
The treatment must be in combination with peginterferon alfa and ribavirin;
The treatment must be limited to a maximum duration of 24 weeks in patients without hepatic cirrhosis; OR
The treatment must be limited to a maximum duration of 44 weeks in patients with hepatic cirrhosis;
The treatment must cease after the first 20 weeks of boceprevir treatment if plasma HCV RNA is detectable by an HCV RNA qualitative assay at treatment week 24
Patient must be 18 years or older;
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
Evidence of chronic genotype 1 hepatitis C infection (repeated anti-HCV positive and HCV RNA positive) must be documented in the patient's medical records
Patients who have received prior treatment with an NS3/4A protease inhibitor are not eligible to receive PBS-subsidised boceprevir, 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
For patients without hepatic cirrhosis, a maximum of 5 repeats may be prescribed
For patients with hepatic cirrhosis, a maximum of 10 repeats may be prescribed
Compliance with Written or Telephone Authority Required procedures
C4202
Where the patient is receiving treatment at/from a public hospital
Chronic genotype 1 hepatitis C infection
Must be treated in an accredited treatment centre;
Patient must have compensated liver disease;
Patient must not have received prior interferon alfa or peginterferon alfa treatment for hepatitis C;
The treatment must be in combination with peginterferon alfa and ribavirin;
The treatment must be limited to a maximum duration of 24 weeks in patients without hepatic cirrhosis; OR
The treatment must be limited to a maximum duration of 44 weeks in patients with hepatic cirrhosis;
The treatment must cease after the first 20 weeks of boceprevir treatment if plasma HCV RNA is detectable by an HCV RNA qualitative assay at treatment week 24;
Patient must be 18 years or older,
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
Evidence of chronic genotype 1 hepatitis C infection (repeated anti-HCV positive and HCV RNA positive) must be documented in the patient's medical records
Patients who have received prior treatment with an NS3/4A protease inhibitor are not eligible to receive PBS-subsidised boceprevir, 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
For patients without hepatic cirrhosis, a maximum of 5 repeats may be prescribed
For patients with hepatic cirrhosis, a maximum of 10 repeats may be prescribed
Compliance with Written or Telephone Authority Required procedures - Streamlined Authority Code 4202
C4205
Where the patient is receiving treatment at/from a private hospital
Chronic genotype 1 hepatitis C infection
Must be treated in an accredited treatment centre;
Patient must have compensated liver disease;
Patient must have received no more than one prior treatment with interferon alfa or peginterferon alfa for hepatitis C;
The treatment must be in combination with peginterferon alfa and ribavirin;
The treatment must be limited to a maximum duration of 32 weeks in patients without hepatic cirrhosis who were partial responders or relapsers to the prior course of interferon based therapy for hepatitis C; OR
The treatment must be limited to a maximum duration of 44 weeks in patients without hepatic cirrhosis who were null responders to the prior course of interferon based therapy for hepatitis C; OR
The treatment must be limited to a maximum duration of 44 weeks for all patients with hepatic cirrhosis;
The treatment must cease after the first 8 weeks of boceprevir treatment if plasma HCV RNA is detectable by an HCV RNA qualitative assay at treatment week 12;
The treatment must cease after the first 20 weeks of boceprevir treatment if plasma HCV RNA is detectable by an HCV RNA qualitative assay at treatment week 24
Patient must be 18 years or older;
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
Chronic genotype 1 hepatitis C infection (repeated anti-HCV positive and HCV RNA positive) must be documented in the patient's medical records
Patients who have received prior treatment with an NS3/4A protease inhibitor are not eligible to receive PBS-subsidised boceprevir, 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
For patients without hepatic cirrhosis who were partial responders or relapsers to the prior course of interferon based therapy, a maximum of 7 repeats may be prescribed
For patients without hepatic cirrhosis who were null responders to the prior course of interferon based therapy, a maximum of 10 repeats may be prescribed
For patients with hepatic cirrhosis, a maximum of 10 repeats may be prescribed
Compliance with Written or Telephone Authority Required procedures
[158] Schedule 4, Part 1, entry for Ciprofloxacin
(a) omit:
C1031
Bacterial keratitis
Compliance with Authority Required procedures
(b) omit:
C3830
Bacterial keratitis under the supervision and direction of an ophthalmologist
Compliance with Authority Required procedures
(c) insert in numerical order after existing text:
C4181
Bacterial keratitis
Must be treated by an ophthalmologist or in consultation with an ophthalmologist
Compliance with Authority Required procedures
C4195
Bacterial keratitis
Must be treated by an ophthalmologist or in consultation with an ophthalmologist
Compliance with Authority Required procedures
[159] Schedule 4, Part 1, entry for Ofloxacin
substitute:
Ofloxacin
C4181
Bacterial keratitis
Must be treated by an ophthalmologist or in consultation with an ophthalmologist
Compliance with Authority Required procedures
C4195
Bacterial keratitis
Must be treated by an ophthalmologist or in consultation with an ophthalmologist
Compliance with Authority Required procedures
[160] Schedule 4, Part 1, entry for Ribavirin and Peginterferon Alfa-2a
substitute:
Ribavirin and Peginterferon Alfa-2a
C4184
Where the patient is receiving treatment at/from a public hospital
Chronic genotype 1 hepatitis C infection
Must be treated in an accredited treatment centre;
Patient must have compensated liver disease
Patient must have failed prior treatment with interferon based therapies (non-pegylated or pegylated);
Patient must have received no more than one prior treatment with interferon alfa or peginterferon alfa for hepatitis C if using peginterferon and ribavirin without an NS3 protease inhibitor, or, in triple combination therapy with boceprevir; OR
Patient must have received prior treatment with interferon alfa or peginterferon alfa for hepatitis C if using peginterferon and ribavirin in triple combination therapy with telaprevir
The treatment must be limited to a maximum duration of 24 weeks in patients using peginterferon and ribavirin in triple combination therapy with telaprevir who were prior treatment relapsers and in whom plasma HCV RNA is undetectable by an HCV RNA qualitative assay at weeks 4 and 12; OR
The treatment must be limited to a maximum duration of 36 weeks in patients using peginterferon and ribavirin in triple combination therapy with boceprevir who were prior treatment partial responders or relapsers and in whom plasma HCV RNA is undetectable by an HCV RNA qualitative assay at weeks 8 and 12; OR
The treatment must be limited to a maximum duration of 48 weeks in patients using peginterferon and ribavirin without an NS3 protease inhibitor; OR
The treatment must be limited to a maximum duration of 48 weeks in patients using peginterferon and ribavirin in triple combination therapy with boceprevir who: (i) were prior treatment null responders; or (ii) were prior treatment partial responders or relapsers and in whom plasma HCV RNA is detectable by an HCV RNA qualitative assay at week 8, and undetectable by an HCV RNA qualitative assay at week 12; or (iii) have hepatic cirrhosis; OR
The treatment must be limited to a maximum duration of 48 weeks in patients using peginterferon and ribavirin in triple combination therapy with telaprevir who: (i) were prior treatment partial or null responders; or (ii) were prior treatment relapsers and for whom the results of an HCV RNA quantitative assay at week 4 show that the plasma HCV RNA is detectable but less than or equal to 1000 IU/mL; or (iii) have hepatic cirrhosis;
The treatment must cease in patients using peginterferon and ribavirin without an NS3 protease inhibitor if HCV RNA is detectable by an HCV RNA qualitative assay at week 12;
The treatment must cease in patients using peginterferon and ribavirin in combination with boceprevir if HCV RNA is detectable by an HCV RNA qualitative assay at week 12;
The treatment must cease in patients using peginterferon and ribavirin in combination with boceprevir if HCV RNA is detectable by an HCV RNA qualitative assay at week 24;
The treatment must cease in patients using peginterferon and ribavirin in combination with telaprevir if the results of an HCV RNA quantitative assay at week 4 show that the plasma HCV RNA is greater than 1000 IU/mL;
The treatment must cease in patients using peginterferon and ribavirin in combination with telaprevir if HCV RNA is detectable by an HCV RNA qualitative assay at week 12;
The treatment must cease in patients using peginterferon and ribavirin in combination with telaprevir if HCV RNA is detectable by an HCV RNA qualitative assay at week 24
Patient must be aged 18 years or older;
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
Evidence of chronic genotype 1 hepatitis C infection (repeatedly anti-HCV positive and HCV RNA positive) must be documented in the patient's medical records.
Compliance with Written or Telephone Authority Required procedures - Streamlined Authority Code 4184
C4185
Where the patient is receiving treatment at/from a private hospital
Chronic genotype 1 hepatitis C infection
Must be treated in an accredited treatment centre;
Patient must have compensated liver disease;
Patient must not have received prior interferon alfa or peginterferon alfa treatment for hepatitis C
The treatment must be limited to a maximum duration of 24 weeks in patients using peginterferon and ribavirin in triple combination therapy with telaprevir and in whom plasma HCV RNA is undetectable by an HCV RNA qualitative assay at weeks 4 and 12; OR
The treatment must be limited to a maximum duration of 28 weeks in patients using peginterferon and ribavirin in triple combination therapy with boceprevir and in whom plasma HCV RNA is undetectable by an HCV RNA qualitative assay at weeks 8 and 24; OR
The treatment must be limited to a maximum duration of 48 weeks in patients using peginterferon and ribavirin without an NS3 protease inhibitor; OR
The treatment must be limited to a maximum duration of 48 weeks in patients: (i) using peginterferon and ribavirin in triple combination therapy with boceprevir and in whom plasma HCV RNA is detectable by an HCV RNA qualitative assay at week 8, and undetectable by an HCV RNA qualitative assay at week 24; or (ii) using peginterferon and ribavirin in triple combination therapy with boceprevir who have hepatic cirrhosis; OR
The treatment must be limited to a maximum duration of 48 weeks in patients: (i) using peginterferon and ribavirin in triple combination therapy with telaprevir and for whom the results of an HCV RNA quantitative assay at week 4 show that the plasma HCV RNA is detectable but less than or equal to 1000 IU/mL; or (ii) using peginterferon and ribavirin in triple combination therapy with telaprevir who have hepatic cirrhosis;
The treatment must cease in patients using peginterferon and ribavirin without an NS3 protease inhibitor unless the results of an HCV RNA quantitative assay at week 12 (performed at the same laboratory using the same test) show that plasma HCV RNA has become undetectable or the viral load has decreased by at least a 2 log drop;
The treatment must cease in patients using peginterferon and ribavirin in combination with boceprevir if HCV RNA is detectable by an HCV RNA qualitative assay at week 24
The treatment must cease in patients using peginterferon and ribavirin in combination with telaprevir if the results of an HCV RNA quantitative assay at week 4 show that the plasma HCV RNA is greater than 1000 IU/mL;
The treatment must cease in patients using peginterferon and ribavirin in combination with telaprevir if HCV RNA is detectable by an HCV RNA qualitative assay at week 12;
The treatment must cease in patients using peginterferon and ribavirin in combination with telaprevir if HCV RNA is detectable by an HCV RNA qualitative assay at week 24
Patient must be aged 18 years or older;
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
Evidence of chronic hepatitis C infection (repeated anti-HCV positive and HCV RNA positive) must be documented in the patient's medical records
For patients using peginterferon and ribavirin without an NS3 protease inhibitor who are viral negative at week 12, an HCV RNA qualitative assay at week 24 is unnecessary
Compliance with Written or Telephone Authority Required procedures
C4187
Where the patient is receiving treatment at/from a public hospital
Chronic non-genotype 1 hepatitis C infection
Must be treated in an accredited treatment centre;
The treatment must be the sole PBS-subsidised treatment for hepatitis C;
Patient must have compensated liver disease;
Patient must not have received prior interferon alfa or peginterferon alfa treatment for hepatitis C;
The condition must be genotype 2, 3, 4, 5 or 6 hepatitis C
The treatment must be limited to a maximum duration of 24 weeks for patients with genotype 2 or 3 hepatitis C without hepatic cirrhosis or bridging fibrosis; OR
The treatment must be limited to a maximum duration of 48 weeks for patients with genotype 4, 5 or 6 hepatitis C; OR
The treatment must be limited to a maximum duration of 48 weeks for patients with genotype 2 or 3 hepatitis C with hepatic cirrhosis or bridging fibrosis;
The treatment must cease in patients with genotype 4, 5, or 6 hepatitis C unless the results of an HCV RNA quantitative assay at week 12 (performed at the same laboratory using the same test) shows that plasma HCV RNA has become undetectable or the viral load has decreased by at least a 2 log drop;
The treatment must cease in patients eligible for 48 weeks of treatment if HCV RNA is detectable by an HCV RNA qualitative assay at week 24
Patient must be aged 18 years or older;
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
Evidence of chronic hepatitis C infection (repeated anti-HCV positive and HCV RNA positive) must be documented in the patient's medical records
For patients with genotype 4, 5, or 6 who are viral negative at week 12, an HCV RNA qualitative assay at week 24 is unnecessary
For patients with genotype 2 or 3 without cirrhosis, an HCV RNA assay at week 12 is unnecessary because of the high likelihood of early viral response by week 12
For patients who are eligible for 24 weeks of treatment, a maximum of 2 repeats may be prescribed
For patients who are eligible for 48 weeks of treatment, a maximum of 5 repeats may be prescribed
Compliance with Written or Telephone Authority Required procedures - Streamlined Authority Code 4187
C4188
Where the patient is receiving treatment at/from a private hospital
Chronic genotype 1 hepatitis C infection
Must be treated in an accredited treatment centre;
Patient must have compensated liver disease;
Patient must have failed prior treatment with interferon based therapies (non-pegylated or pegylated);
Patient must have received no more than one prior treatment with interferon alfa or peginterferon alfa for hepatitis C if using peginterferon and ribavirin without an NS3 protease inhibitor, or, in triple combination therapy with boceprevir; OR
Patient must have received prior treatment with interferon alfa or peginterferon alfa for hepatitis C if using peginterferon and ribavirin in triple combination therapy with telaprevir
The treatment must be limited to a maximum duration of 24 weeks in patients using peginterferon and ribavirin in triple combination therapy with telaprevir who were prior treatment relapsers and in whom plasma HCV RNA is undetectable by an HCV RNA qualitative assay at weeks 4 and 12; OR
The treatment must be limited to a maximum duration of 36 weeks in patients using peginterferon and ribavirin in triple combination therapy with boceprevir who were prior treatment partial responders or relapsers and in whom plasma HCV RNA is undetectable by an HCV RNA qualitative assay at weeks 8 and 12; OR
The treatment must be limited to a maximum duration of 48 weeks in patients using peginterferon and ribavirin without an NS3 protease inhibitor; OR
The treatment must be limited to a maximum duration of 48 weeks in patients using peginterferon and ribavirin in triple combination therapy with boceprevir who: (i) were prior treatment null responders; or (ii) were prior treatment partial responders or relapsers and in whom plasma HCV RNA is detectable by an HCV RNA qualitative assay at week 8, and undetectable by an HCV RNA qualitative assay at week 12; or (iii) have hepatic cirrhosis; OR
The treatment must be limited to a maximum duration of 48 weeks in patients using peginterferon and ribavirin in triple combination therapy with telaprevir who: (i) were prior treatment partial or null responders; or (ii) were prior treatment relapsers and for whom the results of an HCV RNA quantitative assay at week 4 show that the plasma HCV RNA is detectable but less than or equal to 1000 IU/mL; or (iii) have hepatic cirrhosis;
The treatment must cease in patients using peginterferon and ribavirin without an NS3 protease inhibitor if HCV RNA is detectable by an HCV RNA qualitative assay at week 12;
The treatment must cease in patients using peginterferon and ribavirin in combination with boceprevir if HCV RNA is detectable by an HCV RNA qualitative assay at week 12;
The treatment must cease in patients using peginterferon and ribavirin in combination with boceprevir if HCV RNA is detectable by an HCV RNA qualitative assay at week 24;
The treatment must cease in patients using peginterferon and ribavirin in combination with telaprevir if the results of an HCV RNA quantitative assay at week 4 show that the plasma HCV RNA is greater than 1000 IU/mL;
The treatment must cease in patients using peginterferon and ribavirin in combination with telaprevir if HCV RNA is detectable by an HCV RNA qualitative assay at week 12;
The treatment must cease in patients using peginterferon and ribavirin in combination with telaprevir if HCV RNA is detectable by an HCV RNA qualitative assay at week 24
Patient must be aged 18 years or older;
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
Evidence of chronic genotype 1 hepatitis C infection (repeatedly anti-HCV positive and HCV RNA positive) must be documented in the patient's medical records
Compliance with Written or Telephone Authority Required procedures
C4193
Where the patient is receiving treatment at/from a private hospital
Chronic non-genotype 1 hepatitis C infection
Must be treated in an accredited treatment centre;
The treatment must be the sole PBS-subsidised treatment for hepatitis C;
Patient must have compensated liver disease;
The condition must be genotype 2, 3, 4, 5 or 6 hepatitis C;
Patient must have failed prior treatment with interferon based therapies (non-pegylated or pegylated);
Patient must have received no more than one prior treatment with interferon alfa or peginterferon alfa for hepatitis C
The treatment must be limited to a maximum duration of 48 weeks;
The treatment must cease if HCV RNA is detectable by an HCV RNA qualitative assay at week 12
Patient must be aged 18 years or older;
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
Evidence of chronic hepatitis C infection (repeated anti-HCV positive and HCV RNA positive) must be documented in the patient's medical records
Compliance with Written or Telephone Authority Required procedures
C4197
Where the patient is receiving treatment at/from a public hospital
Chronic genotype 1 hepatitis C infection
Must be treated in an accredited treatment centre;
Patient must have compensated liver disease;
Patient must not have received prior interferon alfa or peginterferon alfa treatment for hepatitis C
The treatment must be limited to a maximum duration of 24 weeks in patients using peginterferon and ribavirin in triple combination therapy with telaprevir and in whom plasma HCV RNA is undetectable by an HCV RNA qualitative assay at weeks 4 and 12; OR
The treatment must be limited to a maximum duration of 28 weeks in patients using peginterferon and ribavirin in triple combination therapy with boceprevir and in whom plasma HCV RNA is undetectable by an HCV RNA qualitative assay at weeks 8 and 24; OR
The treatment must be limited to a maximum duration of 48 weeks in patients using peginterferon and ribavirin without an NS3 protease inhibitor; OR
The treatment must be limited to a maximum duration of 48 weeks in patients: (i) using peginterferon and ribavirin in triple combination therapy with boceprevir and in whom plasma HCV RNA is detectable by an HCV RNA qualitative assay at week 8, and undetectable by an HCV RNA qualitative assay at week 24; or (ii) using peginterferon and ribavirin in triple combination therapy with boceprevir who have hepatic cirrhosis; OR
The treatment must be limited to a maximum duration of 48 weeks in patients: (i) using peginterferon and ribavirin in triple combination therapy with telaprevir and for whom the results of an HCV RNA quantitative assay at week 4 show that the plasma HCV RNA is detectable but less than or equal to 1000 IU/mL; or (ii) using peginterferon and ribavirin in triple combination therapy with telaprevir who have hepatic cirrhosis;
The treatment must cease in patients using peginterferon and ribavirin without an NS3 protease inhibitor unless the results of an HCV RNA quantitative assay at week 12 (performed at the same laboratory using the same test) show that plasma HCV RNA has become undetectable or the viral load has decreased by at least a 2 log drop;
The treatment must cease in patients using peginterferon and ribavirin in combination with boceprevir if HCV RNA is detectable by an HCV RNA qualitative assay at week 24;
The treatment must cease in patients using peginterferon and ribavirin in combination with telaprevir if the results of an HCV RNA quantitative assay at week 4 show that the plasma HCV RNA is greater than 1000 IU/mL;
The treatment must cease in patients using peginterferon and ribavirin in combination with telaprevir if HCV RNA is detectable by an HCV RNA qualitative assay at week 12;
The treatment must cease in patients using peginterferon and ribavirin in combination with telaprevir if HCV RNA is detectable by an HCV RNA qualitative assay at week 24
Patient must be aged 18 years or older;
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
Evidence of chronic hepatitis C infection (repeated anti-HCV positive and HCV RNA positive) must be documented in the patient's medical records
For patients using peginterferon and ribavirin without an NS3 protease inhibitor who are viral negative at week 12, an HCV RNA qualitative assay at week 24 is unnecessary
Compliance with Written or Telephone Authority Required procedures - Streamlined Authority Code 4197
C4206
Where the patient is receiving treatment at/from a public hospital
Chronic non-genotype 1 hepatitis C infection
Must be treated in an accredited treatment centre;
The treatment must be the sole PBS-subsidised treatment for hepatitis C;
Patient must have compensated liver disease;
The condition must be genotype 2, 3, 4, 5 or 6 hepatitis C;
Patient must have failed prior treatment with interferon based therapies (non-pegylated or pegylated);
Patient must have received no more than one prior treatment with interferon alfa or peginterferon alfa for hepatitis C;
The treatment must be limited to a maximum duration of 48 weeks;
The treatment must cease if HCV RNA is detectable by an HCV RNA qualitative assay at week 12
Patient must be aged 18 years or older;
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
Evidence of chronic hepatitis C infection (repeated anti-HCV positive and HCV RNA positive) must be documented in the patient's medical records
Compliance with Written or Telephone Authority Required procedures - Streamlined Authority Code 4206
C4207
Where the patient is receiving treatment at/from a private hospital
Chronic non-genotype 1 hepatitis C infection
Must be treated in an accredited treatment centre;
The treatment must be the sole PBS-subsidised treatment for hepatitis C;
Patient must have compensated liver disease;
Patient must not have received prior interferon alfa or peginterferon alfa treatment for hepatitis C;
The condition must be genotype 2, 3, 4, 5 or 6 hepatitis C;
The treatment must be limited to a maximum duration of 24 weeks for patients with genotype 2 or 3 hepatitis C without hepatic cirrhosis or bridging fibrosis; OR
The treatment must be limited to a maximum duration of 48 weeks for patients with genotype 4, 5 or 6 hepatitis C; OR
The treatment must be limited to a maximum duration of 48 weeks for patients with genotype 2 or 3 hepatitis C with hepatic cirrhosis or bridging fibrosis;
The treatment must cease in patients with genotype 4, 5, or 6 hepatitis C unless the results of an HCV RNA quantitative assay at week 12 (performed at the same laboratory using the same test) shows that plasma HCV RNA has become undetectable or the viral load has decreased by at least a 2 log drop;
The treatment must cease in patients eligible for 48 weeks of treatment if HCV RNA is detectable by an HCV RNA qualitative assay at week 24
Patient must be aged 18 years or older;
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
Evidence of chronic hepatitis C infection (repeated anti-HCV positive and HCV RNA positive) must be documented in the patient's medical records
For patients with genotype 4, 5, or 6 who are viral negative at week 12, an HCV RNA qualitative assay at week 24 is unnecessary
For patients with genotype 2 or 3 without cirrhosis, an HCV RNA assay at week 12 is unnecessary because of the high likelihood of early viral response by week 12.
For patients who are eligible for 24 weeks of treatment, a maximum of 2 repeats may be prescribed
For patients who are eligible for 48 weeks of treatment, a maximum of 5 repeats may be prescribed
Compliance with Written or Telephone Authority Required procedures
[161]
[162] Schedule 4, Part 1, entry for Ribavirin and Peginterferon Alfa-2b
substitute:
Ribavirin and Peginterferon Alfa-2b
C4184
Where the patient is receiving treatment at/from a public hospital
Chronic genotype 1 hepatitis C infection
Must be treated in an accredited treatment centre;
Patient must have compensated liver disease
Patient must have failed prior treatment with interferon based therapies (non-pegylated or pegylated);
Patient must have received no more than one prior treatment with interferon alfa or peginterferon alfa for hepatitis C if using peginterferon and ribavirin without an NS3 protease inhibitor, or, in triple combination therapy with boceprevir; OR
Patient must have received prior treatment with interferon alfa or peginterferon alfa for hepatitis C if using peginterferon and ribavirin in triple combination therapy with telaprevir
The treatment must be limited to a maximum duration of 24 weeks in patients using peginterferon and ribavirin in triple combination therapy with telaprevir who were prior treatment relapsers and in whom plasma HCV RNA is undetectable by an HCV RNA qualitative assay at weeks 4 and 12; OR
The treatment must be limited to a maximum duration of 36 weeks in patients using peginterferon and ribavirin in triple combination therapy with boceprevir who were prior treatment partial responders or relapsers and in whom plasma HCV RNA is undetectable by an HCV RNA qualitative assay at weeks 8 and 12; OR
The treatment must be limited to a maximum duration of 48 weeks in patients using peginterferon and ribavirin without an NS3 protease inhibitor; OR
The treatment must be limited to a maximum duration of 48 weeks in patients using peginterferon and ribavirin in triple combination therapy with boceprevir who: (i) were prior treatment null responders; or (ii) were prior treatment partial responders or relapsers and in whom plasma HCV RNA is detectable by an HCV RNA qualitative assay at week 8, and undetectable by an HCV RNA qualitative assay at week 12; or (iii) have hepatic cirrhosis; OR
The treatment must be limited to a maximum duration of 48 weeks in patients using peginterferon and ribavirin in triple combination therapy with telaprevir who: (i) were prior treatment partial or null responders; or (ii) were prior treatment relapsers and for whom the results of an HCV RNA quantitative assay at week 4 show that the plasma HCV RNA is detectable but less than or equal to 1000 IU/mL; or (iii) have hepatic cirrhosis;
The treatment must cease in patients using peginterferon and ribavirin without an NS3 protease inhibitor if HCV RNA is detectable by an HCV RNA qualitative assay at week 12;
The treatment must cease in patients using peginterferon and ribavirin in combination with boceprevir if HCV RNA is detectable by an HCV RNA qualitative assay at week 12;
The treatment must cease in patients using peginterferon and ribavirin in combination with boceprevir if HCV RNA is detectable by an HCV RNA qualitative assay at week 24;
The treatment must cease in patients using peginterferon and ribavirin in combination with telaprevir if the results of an HCV RNA quantitative assay at week 4 show that the plasma HCV RNA is greater than 1000 IU/mL;
The treatment must cease in patients using peginterferon and ribavirin in combination with telaprevir if HCV RNA is detectable by an HCV RNA qualitative assay at week 12;
The treatment must cease in patients using peginterferon and ribavirin in combination with telaprevir if HCV RNA is detectable by an HCV RNA qualitative assay at week 24
Patient must be aged 18 years or older;
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
Evidence of chronic genotype 1 hepatitis C infection (repeatedly anti-HCV positive and HCV RNA positive) must be documented in the patient's medical records
Compliance with Written or Telephone Authority Required procedures - Streamlined Authority Code 4184
C4185
Where the patient is receiving treatment at/from a private hospital
Chronic genotype 1 hepatitis C infection
Must be treated in an accredited treatment centre;
Patient must have compensated liver disease;
Patient must not have received prior interferon alfa or peginterferon alfa treatment for hepatitis C
The treatment must be limited to a maximum duration of 24 weeks in patients using peginterferon and ribavirin in triple combination therapy with telaprevir and in whom plasma HCV RNA is undetectable by an HCV RNA qualitative assay at weeks 4 and 12; OR
The treatment must be limited to a maximum duration of 28 weeks in patients using peginterferon and ribavirin in triple combination therapy with boceprevir and in whom plasma HCV RNA is undetectable by an HCV RNA qualitative assay at weeks 8 and 24; OR
The treatment must be limited to a maximum duration of 48 weeks in patients using peginterferon and ribavirin without an NS3 protease inhibitor; OR
The treatment must be limited to a maximum duration of 48 weeks in patients: (i) using peginterferon and ribavirin in triple combination therapy with boceprevir and in whom plasma HCV RNA is detectable by an HCV RNA qualitative assay at week 8, and undetectable by an HCV RNA qualitative assay at week 24; or (ii) using peginterferon and ribavirin in triple combination therapy with boceprevir who have hepatic cirrhosis; OR
The treatment must be limited to a maximum duration of 48 weeks in patients: (i) using peginterferon and ribavirin in triple combination therapy with telaprevir and for whom the results of an HCV RNA quantitative assay at week 4 show that the plasma HCV RNA is detectable but less than or equal to 1000 IU/mL; or (ii) using peginterferon and ribavirin in triple combination therapy with telaprevir who have hepatic cirrhosis;
The treatment must cease in patients using peginterferon and ribavirin without an NS3 protease inhibitor unless the results of an HCV RNA quantitative assay at week 12 (performed at the same laboratory using the same test) show that plasma HCV RNA has become undetectable or the viral load has decreased by at least a 2 log drop;
The treatment must cease in patients using peginterferon and ribavirin in combination with boceprevir if HCV RNA is detectable by an HCV RNA qualitative assay at week 24
The treatment must cease in patients using peginterferon and ribavirin in combination with telaprevir if the results of an HCV RNA quantitative assay at week 4 show that the plasma HCV RNA is greater than 1000 IU/mL;
The treatment must cease in patients using peginterferon and ribavirin in combination with telaprevir if HCV RNA is detectable by an HCV RNA qualitative assay at week 12;
The treatment must cease in patients using peginterferon and ribavirin in combination with telaprevir if HCV RNA is detectable by an HCV RNA qualitative assay at week 24
Patient must be aged 18 years or older;
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
Evidence of chronic hepatitis C infection (repeated anti-HCV positive and HCV RNA positive) must be documented in the patient's medical records
For patients using peginterferon and ribavirin without an NS3 protease inhibitor who are viral negative at week 12, an HCV RNA qualitative assay at week 24 is unnecessary
Compliance with Written or Telephone Authority Required procedures
C4187
Where the patient is receiving treatment at/from a public hospital
Chronic non-genotype 1 hepatitis C infection
Must be treated in an accredited treatment centre;
The treatment must be the sole PBS-subsidised treatment for hepatitis C;
Patient must have compensated liver disease;
Patient must not have received prior interferon alfa or peginterferon alfa treatment for hepatitis C;
The condition must be genotype 2, 3, 4, 5 or 6 hepatitis C
The treatment must be limited to a maximum duration of 24 weeks for patients with genotype 2 or 3 hepatitis C without hepatic cirrhosis or bridging fibrosis; OR
The treatment must be limited to a maximum duration of 48 weeks for patients with genotype 4, 5 or 6 hepatitis C; OR
The treatment must be limited to a maximum duration of 48 weeks for patients with genotype 2 or 3 hepatitis C with hepatic cirrhosis or bridging fibrosis;
The treatment must cease in patients with genotype 4, 5, or 6 hepatitis C unless the results of an HCV RNA quantitative assay at week 12 (performed at the same laboratory using the same test) shows that plasma HCV RNA has become undetectable or the viral load has decreased by at least a 2 log drop;
The treatment must cease in patients eligible for 48 weeks of treatment if HCV RNA is detectable by an HCV RNA qualitative assay at week 24
Patient must be aged 18 years or older;
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
Evidence of chronic hepatitis C infection (repeated anti-HCV positive and HCV RNA positive) must be documented in the patient's medical records
For patients with genotype 4, 5, or 6 who are viral negative at week 12, an HCV RNA qualitative assay at week 24 is unnecessary
For patients with genotype 2 or 3 without cirrhosis, an HCV RNA assay at week 12 is unnecessary because of the high likelihood of early viral response by week 12.
For patients who are eligible for 24 weeks of treatment, a maximum of 2 repeats may be prescribed
For patients who are eligible for 48 weeks of treatment, a maximum of 5 repeats may be prescribed
Compliance with Written or Telephone Authority Required procedures - Streamlined Authority Code 4187
C4188
Where the patient is receiving treatment at/from a private hospital
Chronic genotype 1 hepatitis C infection
Must be treated in an accredited treatment centre;
Patient must have compensated liver disease;
Patient must have failed prior treatment with interferon based therapies (non-pegylated or pegylated);
Patient must have received no more than one prior treatment with interferon alfa or peginterferon alfa for hepatitis C if using peginterferon and ribavirin without an NS3 protease inhibitor, or, in triple combination therapy with boceprevir; OR
Patient must have received prior treatment with interferon alfa or peginterferon alfa for hepatitis C if using peginterferon and ribavirin in triple combination therapy with telaprevir
The treatment must be limited to a maximum duration of 24 weeks in patients using peginterferon and ribavirin in triple combination therapy with telaprevir who were prior treatment relapsers and in whom plasma HCV RNA is undetectable by an HCV RNA qualitative assay at weeks 4 and 12; OR
The treatment must be limited to a maximum duration of 36 weeks in patients using peginterferon and ribavirin in triple combination therapy with boceprevir who were prior treatment partial responders or relapsers and in whom plasma HCV RNA is undetectable by an HCV RNA qualitative assay at weeks 8 and 12; OR
The treatment must be limited to a maximum duration of 48 weeks in patients using peginterferon and ribavirin without an NS3 protease inhibitor; OR
The treatment must be limited to a maximum duration of 48 weeks in patients using peginterferon and ribavirin in triple combination therapy with boceprevir who: (i) were prior treatment null responders; or (ii) were prior treatment partial responders or relapsers and in whom plasma HCV RNA is detectable by an HCV RNA qualitative assay at week 8, and undetectable by an HCV RNA qualitative assay at week 12; or (iii) have hepatic cirrhosis; OR
The treatment must be limited to a maximum duration of 48 weeks in patients using peginterferon and ribavirin in triple combination therapy with telaprevir who: (i) were prior treatment partial or null responders; or (ii) were prior treatment relapsers and for whom the results of an HCV RNA quantitative assay at week 4 show that the plasma HCV RNA is detectable but less than or equal to 1000 IU/mL; or (iii) have hepatic cirrhosis;
The treatment must cease in patients using peginterferon and ribavirin without an NS3 protease inhibitor if HCV RNA is detectable by an HCV RNA qualitative assay at week 12;
The treatment must cease in patients using peginterferon and ribavirin in combination with boceprevir if HCV RNA is detectable by an HCV RNA qualitative assay at week 12;
The treatment must cease in patients using peginterferon and ribavirin in combination with boceprevir if HCV RNA is detectable by an HCV RNA qualitative assay at week 24;
The treatment must cease in patients using peginterferon and ribavirin in combination with telaprevir if the results of an HCV RNA quantitative assay at week 4 show that the plasma HCV RNA is greater than 1000 IU/mL;
The treatment must cease in patients using peginterferon and ribavirin in combination with telaprevir if HCV RNA is detectable by an HCV RNA qualitative assay at week 12;
The treatment must cease in patients using peginterferon and ribavirin in combination with telaprevir if HCV RNA is detectable by an HCV RNA qualitative assay at week 24
Patient must be aged 18 years or older;
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
Evidence of chronic genotype 1 hepatitis C infection (repeatedly anti-HCV positive and HCV RNA positive) must be documented in the patient's medical records
Compliance with Written or Telephone Authority Required procedures
C4189
Where the patient is receiving treatment at/from a public hospital
Chronic genotype 1 hepatitis C infection
Must be treated in an accredited treatment centre;
The treatment must be the sole PBS-subsidised treatment for hepatitis C;
Patient must have compensated liver disease;
Patient must have failed prior treatment with interferon based therapies (non-pegylated or pegylated);
Patient must have received no more than one prior treatment with interferon alfa or peginterferon alfa for hepatitis C
The treatment must be limited to a maximum duration of 48 weeks;
The treatment must cease if HCV RNA is detectable by an HCV RNA qualitative assay at week 12,
Patient must weigh at least 27 kg;
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
Evidence of chronic genotype 1 hepatitis C infection (repeatedly anti-HCV positive and HCV RNA positive) must be documented in the patient's medical records
Compliance with Written or Telephone Authority Required procedures - Streamlined Authority Code 4189
C4192
Where the patient is receiving treatment at/from a public hospital
Chronic non-genotype 1 hepatitis C infection
Must be treated in an accredited treatment centre;
The treatment must be the sole PBS-subsidised treatment for hepatitis C;
Patient must have compensated liver disease;
Patient must not have received prior interferon alfa or peginterferon alfa treatment for hepatitis C;
The condition must be genotype 2, 3, 4, 5 or 6 hepatitis C
The treatment must be limited to a maximum duration of 24 weeks for patients with genotype 2 or 3 hepatitis C without hepatic cirrhosis or bridging fibrosis; OR
The treatment must be limited to a maximum duration of 48 weeks for patients with genotype 4, 5 or 6 hepatitis C; OR
The treatment must be limited to a maximum duration of 48 weeks for patients with genotype 2 or 3 hepatitis C with hepatic cirrhosis or bridging fibrosis;
The treatment must cease in patients with genotype 4, 5, or 6 hepatitis C unless the results of an HCV RNA quantitative assay at week 12 (performed at the same laboratory using the same test) shows that plasma HCV RNA has become undetectable or the viral load has decreased by at least a 2 log drop;
The treatment must cease in patients eligible for 48 weeks of treatment if HCV RNA is detectable by an HCV RNA qualitative assay at week 24
Patient must weigh at least 27 kg;
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
Evidence of chronic hepatitis C infection (repeated anti-HCV positive and HCV RNA positive) must be documented in the patient's medical records
For patients with genotype 4, 5, or 6 who are viral negative at week 12, an HCV RNA qualitative assay at week 24 is unnecessary
For patients with genotype 2 or 3 without cirrhosis, an HCV RNA assay at week 12 is unnecessary because of the high likelihood of early viral response by week 12
For patients who are eligible for 24 weeks of treatment, a maximum of 2 repeats may be prescribed
For patients who are eligible for 48 weeks of treatment, a maximum of 5 repeats may be prescribed
Compliance with Written or Telephone Authority Required procedures - Streamlined Authority Code 4192
C4193
Where the patient is receiving treatment at/from a private hospital
Chronic non-genotype 1 hepatitis C infection
Must be treated in an accredited treatment centre;
The treatment must be the sole PBS-subsidised treatment for hepatitis C;
Patient must have compensated liver disease;
The condition must be genotype 2, 3, 4, 5 or 6 hepatitis C;
Patient must have failed prior treatment with interferon based therapies (non-pegylated or pegylated);
Patient must have received no more than one prior treatment with interferon alfa or peginterferon alfa for hepatitis C
The treatment must be limited to a maximum duration of 48 weeks;
The treatment must cease if HCV RNA is detectable by an HCV RNA qualitative assay at week 12
Patient must be aged 18 years or older;
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
Evidence of chronic hepatitis C infection (repeated anti-HCV positive and HCV RNA positive) must be documented in the patient's medical records
Compliance with Written or Telephone Authority Required procedures
C4197
Where the patient is receiving treatment at/from a public hospital
Chronic genotype 1 hepatitis C infection
Must be treated in an accredited treatment centre;
Patient must have compensated liver disease;
Patient must not have received prior interferon alfa or peginterferon alfa treatment for hepatitis C
The treatment must be limited to a maximum duration of 24 weeks in patients using peginterferon and ribavirin in triple combination therapy with telaprevir and in whom plasma HCV RNA is undetectable by an HCV RNA qualitative assay at weeks 4 and 12; OR
The treatment must be limited to a maximum duration of 28 weeks in patients using peginterferon and ribavirin in triple combination therapy with boceprevir and in whom plasma HCV RNA is undetectable by an HCV RNA qualitative assay at weeks 8 and 24; OR
The treatment must be limited to a maximum duration of 48 weeks in patients using peginterferon and ribavirin without an NS3 protease inhibitor; OR
The treatment must be limited to a maximum duration of 48 weeks in patients: (i) using peginterferon and ribavirin in triple combination therapy with boceprevir and in whom plasma HCV RNA is detectable by an HCV RNA qualitative assay at week 8, and undetectable by an HCV RNA qualitative assay at week 24; or (ii) using peginterferon and ribavirin in triple combination therapy with boceprevir who have hepatic cirrhosis; OR
The treatment must be limited to a maximum duration of 48 weeks in patients: (i) using peginterferon and ribavirin in triple combination therapy with telaprevir and for whom the results of an HCV RNA quantitative assay at week 4 show that the plasma HCV RNA is detectable but less than or equal to 1000 IU/mL; or (ii) using peginterferon and ribavirin in triple combination therapy with telaprevir who have hepatic cirrhosis;
The treatment must cease in patients using peginterferon and ribavirin without an NS3 protease inhibitor unless the results of an HCV RNA quantitative assay at week 12 (performed at the same laboratory using the same test) show that plasma HCV RNA has become undetectable or the viral load has decreased by at least a 2 log drop;
The treatment must cease in patients using peginterferon and ribavirin in combination with boceprevir if HCV RNA is detectable by an HCV RNA qualitative assay at week 24;
The treatment must cease in patients using peginterferon and ribavirin in combination with telaprevir if the results of an HCV RNA quantitative assay at week 4 show that the plasma HCV RNA is greater than 1000 IU/mL;
The treatment must cease in patients using peginterferon and ribavirin in combination with telaprevir if HCV RNA is detectable by an HCV RNA qualitative assay at week 12;
The treatment must cease in patients using peginterferon and ribavirin in combination with telaprevir if HCV RNA is detectable by an HCV RNA qualitative assay at week 24
Patient must be aged 18 years or older;
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
Evidence of chronic hepatitis C infection (repeated anti-HCV positive and HCV RNA positive) must be documented in the patient's medical records
For patients using peginterferon and ribavirin without an NS3 protease inhibitor who are viral negative at week 12, an HCV RNA qualitative assay at week 24 is unnecessary
Compliance with Written or Telephone Authority Required procedures - Streamlined Authority Code 4197
C4198
Where the patient is receiving treatment at/from a public hospital
Chronic genotype 1 hepatitis C infection
Must be treated in an accredited treatment centre;
The treatment must be the sole PBS-subsidised treatment for hepatitis C;
Patient must have compensated liver disease;
Patient must not have received prior interferon alfa or peginterferon alfa treatment for hepatitis C
The treatment must be limited to a maximum duration of 48 weeks;
The treatment must cease unless the results of an HCV RNA quantitative assay at week 12 (performed at the same laboratory using the same test) show that plasma HCV RNA has become undetectable or the viral load has decreased by at least a 2 log drop
Patient must weigh at least 27 kg;
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
Evidence of chronic hepatitis C infection (repeated anti-HCV positive and HCV RNA positive) must be documented in the patient's medical records
For patients who are viral negative at week 12, an HCV RNA qualitative assay at week 24 is unnecessary
Compliance with Written or Telephone Authority Required procedures - Streamlined Authority Code 4198
C4199
Where the patient is receiving treatment at/from a public hospital
Chronic non-genotype 1 hepatitis C infection
Must be treated in an accredited treatment centre;
The treatment must be the sole PBS-subsidised treatment for hepatitis C;
Patient must have compensated liver disease;
The condition must be genotype 2, 3, 4, 5 or 6 hepatitis C;
Patient must have failed prior treatment with interferon based therapies (non-pegylated or pegylated);
Patient must have received no more than one prior treatment with interferon alfa or peginterferon alfa for hepatitis C
The treatment must be limited to a maximum duration of 48 weeks;
The treatment must cease if HCV RNA is detectable by an HCV RNA qualitative assay at week 12
Patient must weigh at least 27 kg;
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
Evidence of chronic hepatitis C infection (repeated anti-HCV positive and HCV RNA positive) must be documented in the patient's medical records
Compliance with Written or Telephone Authority Required procedures - Streamlined Authority Code 4199
C4200
Where the patient is receiving treatment at/from a private hospital
Chronic genotype 1 hepatitis C infection
Must be treated in an accredited treatment centre;
The treatment must be the sole PBS-subsidised treatment for hepatitis C;
Patient must have compensated liver disease;
Patient must have failed prior treatment with interferon based therapies (non-pegylated or pegylated);
Patient must have received no more than one prior treatment with interferon alfa or peginterferon alfa for hepatitis C
The treatment must be limited to a maximum duration of 48 weeks;
The treatment must cease if HCV RNA is detectable by an HCV RNA qualitative assay at week 12
Patient must weigh at least 27 kg,
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
Evidence of chronic genotype 1 hepatitis C infection (repeatedly anti-HCV positive and HCV RNA positive) must be documented in the patient's medical records
Compliance with Written or Telephone Authority Required procedures
C4203
Where the patient is receiving treatment at/from a private hospital
Chronic genotype 1 hepatitis C infection
Must be treated in an accredited treatment centre;
The treatment must be the sole PBS-subsidised treatment for hepatitis C;
Patient must have compensated liver disease;
Patient must not have received prior interferon alfa or peginterferon alfa treatment for hepatitis C
The treatment must be limited to a maximum duration of 48 weeks;
The treatment must cease unless the results of an HCV RNA quantitative assay at week 12 (performed at the same laboratory using the same test) show that plasma HCV RNA has become undetectable or the viral load has decreased by at least a 2 log drop
Patient must weigh at least 27 kg;
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
Evidence of chronic hepatitis C infection (repeated anti-HCV positive and HCV RNA positive) must be documented in the patient's medical records
For patients who are viral negative at week 12, an HCV RNA qualitative assay at week 24 is unnecessary
Compliance with Written or Telephone Authority Required procedures
C4206
Where the patient is receiving treatment at/from a public hospital
Chronic non-genotype 1 hepatitis C infection
Must be treated in an accredited treatment centre;
The treatment must be the sole PBS-subsidised treatment for hepatitis C;
Patient must have compensated liver disease;
The condition must be genotype 2, 3, 4, 5 or 6 hepatitis C;
Patient must have failed prior treatment with interferon based therapies (non-pegylated or pegylated);
Patient must have received no more than one prior treatment with interferon alfa or peginterferon alfa for hepatitis C;
The treatment must be limited to a maximum duration of 48 weeks;
The treatment must cease if HCV RNA is detectable by an HCV RNA qualitative assay at week 12
Patient must be aged 18 years or older;
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
Evidence of chronic hepatitis C infection (repeated anti-HCV positive and HCV RNA positive) must be documented in the patient's medical records
Compliance with Written or Telephone Authority Required procedures - Streamlined Authority Code 4206
C4207
Where the patient is receiving treatment at/from a private hospital
Chronic non-genotype 1 hepatitis C infection
Must be treated in an accredited treatment centre;
The treatment must be the sole PBS-subsidised treatment for hepatitis C;
Patient must have compensated liver disease;
Patient must not have received prior interferon alfa or peginterferon alfa treatment for hepatitis C;
The condition must be genotype 2, 3, 4, 5 or 6 hepatitis C;
The treatment must be limited to a maximum duration of 24 weeks for patients with genotype 2 or 3 hepatitis C without hepatic cirrhosis or bridging fibrosis; OR
The treatment must be limited to a maximum duration of 48 weeks for patients with genotype 4, 5 or 6 hepatitis C; OR
The treatment must be limited to a maximum duration of 48 weeks for patients with genotype 2 or 3 hepatitis C with hepatic cirrhosis or bridging fibrosis;
The treatment must cease in patients with genotype 4, 5, or 6 hepatitis C unless the results of an HCV RNA quantitative assay at week 12 (performed at the same laboratory using the same test) shows that plasma HCV RNA has become undetectable or the viral load has decreased by at least a 2 log drop;
The treatment must cease in patients eligible for 48 weeks of treatment if HCV RNA is detectable by an HCV RNA qualitative assay at week 24
Patient must be aged 18 years or older;
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
Evidence of chronic hepatitis C infection (repeated anti-HCV positive and HCV RNA positive) must be documented in the patient's medical records
For patients with genotype 4, 5, or 6 who are viral negative at week 12, an HCV RNA qualitative assay at week 24 is unnecessary
For patients with genotype 2 or 3 without cirrhosis, an HCV RNA assay at week 12 is unnecessary because of the high likelihood of early viral response by week 12.
For patients who are eligible for 24 weeks of treatment, a maximum of 2 repeats may be prescribed
For patients who are eligible for 48 weeks of treatment, a maximum of 5 repeats may be prescribed
Compliance with Written or Telephone Authority Required procedures
C4208
Where the patient is receiving treatment at/from a private hospital
Chronic non-genotype 1 hepatitis C infection
Must be treated in an accredited treatment centre;
The treatment must be the sole PBS-subsidised treatment for hepatitis C;
Patient must have compensated liver disease;
The condition must be genotype 2, 3, 4, 5 or 6 hepatitis C;
Patient must have failed prior treatment with interferon based therapies (non-pegylated or pegylated);
Patient must have received no more than one prior treatment with interferon alfa or peginterferon alfa for hepatitis C
The treatment must be limited to a maximum duration of 48 weeks;
The treatment must cease if HCV RNA is detectable by an HCV RNA qualitative assay at week 12
Patient must weigh at least 27 kg;
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
Evidence of chronic hepatitis C infection (repeated anti-HCV positive and HCV RNA positive) must be documented in the patient's medical records
Compliance with Written or Telephone Authority Required procedures
C4209
Where the patient is receiving treatment at/from a private hospital
Chronic non-genotype 1 hepatitis C infection
Must be treated in an accredited treatment centre;
The treatment must be the sole PBS-subsidised treatment for hepatitis C;
Patient must have compensated liver disease;
Patient must not have received prior interferon alfa or peginterferon alfa treatment for hepatitis C;
The condition must be genotype 2, 3, 4, 5 or 6 hepatitis C
The treatment must be limited to a maximum duration of 24 weeks for patients with genotype 2 or 3 hepatitis C without hepatic cirrhosis or bridging fibrosis; OR
The treatment must be limited to a maximum duration of 48 weeks for patients with genotype 4, 5 or 6 hepatitis C; OR
The treatment must be limited to a maximum duration of 48 weeks for patients with genotype 2 or 3 hepatitis C with hepatic cirrhosis or bridging fibrosis;
The treatment must cease in patients with genotype 4, 5, or 6 hepatitis C unless the results of an HCV RNA quantitative assay at week 12 (performed at the same laboratory using the same test) shows that plasma HCV RNA has become undetectable or the viral load has decreased by at least a 2 log drop;
The treatment must cease in patients eligible for 48 weeks of treatment if HCV RNA is detectable by an HCV RNA qualitative assay at week 24
Patient must weigh at least 27 kg;
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
Evidence of chronic hepatitis C infection (repeated anti-HCV positive and HCV RNA positive) must be documented in the patient's medical records
For patients with genotype 4, 5, or 6 who are viral negative at week 12, an HCV RNA qualitative assay at week 24 is unnecessary
For patients with genotype 2 or 3 without cirrhosis, an HCV RNA assay at week 12 is unnecessary because of the high likelihood of early viral response by week 12
For patients who are eligible for 24 weeks of treatment, a maximum of 2 repeats may be prescribed
For patients who are eligible for 48 weeks of treatment, a maximum of 5 repeats may be prescribed
Compliance with Written or Telephone Authority Required procedures
[163] Schedule 4, Part 1, after entry for Rosuvastatin
insert:
Rotigotine
C4190
Parkinson disease
The treatment must be as adjunctive therapy to a levodopa-decarboxylase inhibitor combination
C4204
Parkinson disease
The treatment must be as adjunctive therapy to a levodopa-decarboxylase inhibitor combination
[164] Schedule 4, Part 1, after entry for Sitagliptin with metformin
insert:
Sitagliptin with simvastatin
C4183
Diabetes mellitus type 2 and hypercholesterolaemia
Patient must meet the criteria set out in the General Statement for Lipid-Lowering Drugs;
The treatment must be in combination with metformin; OR
The treatment must be in combination with a sulfonylurea;
Patient must have a contraindication to a combination of metformin and a sulfonylurea; OR
Patient must not have tolerated a combination of metformin and a sulfonylurea;
Patient 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) or a glucagon-like peptide-1 despite treatment with either metformin or a sulfonylurea; OR
Patient 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 or a glucagon-like peptide-1 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 gliptin, a glitazone or a glucagon-like peptide-1 is initiated
The HbA1c must be no more than 4 months old at the time treatment with a gliptin, a glitazone or a glucagon-like peptide-1 is or 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 or a glucagon-like peptide-1, must be documented in the patient's medical records
Compliance with Authority Required procedures - Streamlined Authority Code 4183
[165]
[166] Schedule 4, Part 1, entry for Strontium
substitute:
Strontium
C4117
Osteoporosis
Patient must be aged 70 years or older;
Patient must have a Bone Mineral Density (BMD) T-score of -3.0 or less;
Patient must not receive concomitant treatment with any other PBS-subsidised anti-resorptive agent for this condition
The date, site (femoral neck or lumbar spine) and score of the qualifying BMD measurement must be documented in the patient's medical records when treatment is initiated
Compliance with Authority Required procedures - Streamlined Authority Code 4117
C4123
Established osteoporosis
Patient must have fracture due to minimal trauma;
Patient must not receive concomitant treatment with any other PBS-subsidised anti-resorptive agent for this condition
The fracture must have been demonstrated radiologically and the year of plain x-ray or computed tomography (CT) scan or magnetic resonance imaging (MRI) scan must be documented in the patient's medical records when treatment is initiated
A vertebral fracture is defined as a 20% or greater reduction in height of the anterior or mid portion of a vertebral body relative to the posterior height of that body, or, a 20% or greater reduction in any of these heights compared to the vertebral body above or below the affected vertebral body
Compliance with Authority Required procedures - Streamlined Authority Code 4123
[167] Schedule 4, Part 1, after entry for Tamoxifen
insert:
Telaprevir
C4186
Where the patient is receiving treatment at/from a public hospital
Chronic genotype 1 hepatitis C infection
Must be treated in an accredited treatment centre;
Patient must have compensated liver disease;
Patient must not have received prior treatment with interferon alfa or peginterferon alfa for hepatitis C;
The treatment must be in combination with peginterferon alfa and ribavirin;
The treatment must be limited to a maximum duration of 12 weeks;
The treatment must cease if the results of an HCV RNA quantitative assay at week 4 show that the plasma HCV RNA is greater than 1000 IU/mL
Patient must be 18 years or older;
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
Evidence of chronic genotype 1 hepatitis C infection (repeatedly anti-HCV positive and HCV RNA positive) must be documented in the patient's medical records
Patients who have received prior treatment with an NS3/4A protease inhibitor are not eligible to receive PBS-subsidised telaprevir, 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 or Telephone Authority Required procedures - Streamlined Authority Code 4186
C4191
Where the patient is receiving treatment at/from a public hospital
Chronic genotype 1 hepatitis C infection
Must be treated in an accredited treatment centre;
Patient must have compensated liver disease;
Patient must have received prior treatment with interferon alfa or peginterferon alfa for hepatitis C;
The treatment must be in combination with peginterferon alfa and ribavirin;
The treatment must be limited to a maximum duration of 12 weeks;
The treatment must cease if the results of an HCV RNA quantitative assay at week 4 show that the plasma HCV RNA is greater than 1000 IU/mL
Patient must be 18 years or older;
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
Evidence of chronic genotype 1 hepatitis C infection (repeatedly anti-HCV positive and HCV RNA positive) must be documented in the patient's medical records
Patients who have received prior treatment with an NS3/4A protease inhibitor are not eligible to receive PBS-subsidised telaprevir, 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 or Telephone Authority Required procedures - Streamlined Authority Code 4191
C4194
Where the patient is receiving treatment at/from a private hospital
Chronic genotype 1 hepatitis C infection
Must be treated in an accredited treatment centre;
Patient must have compensated liver disease;
Patient must have received prior treatment with interferon alfa or peginterferon alfa for hepatitis C;
The treatment must be in combination with peginterferon alfa and ribavirin;
The treatment must be limited to a maximum duration of 12 weeks;
The treatment must cease if the results of an HCV RNA quantitative assay at week 4 show that the plasma HCV RNA is greater than 1000 IU/mL
Patient must be 18 years or older;
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
Evidence of chronic genotype 1 hepatitis C infection (repeatedly anti-HCV positive and HCV RNA positive) must be documented in the patient's medical records
Patients who have received prior treatment with an NS3/4A protease inhibitor are not eligible to receive PBS-subsidised telaprevir, 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 or Telephone Authority Required procedures
C4201
Where the patient is receiving treatment at/from a private hospital
Chronic genotype 1 hepatitis C infection
Must be treated in an accredited treatment centre;
Patient must have compensated liver disease;
Patient must not have received prior treatment with interferon alfa or peginterferon alfa for hepatitis C;
The treatment must be in combination with peginterferon alfa and ribavirin;
The treatment must be limited to a maximum duration of 12 weeks;
The treatment must cease if the results of an HCV RNA quantitative assay at week 4 show that the plasma HCV RNA is greater than 1000 IU/mL
Patient must be 18 years or older;
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
Evidence of chronic genotype 1 hepatitis C infection (repeatedly anti-HCV positive and HCV RNA positive) must be documented in the patient's medical records
Patients who have received prior treatment with an NS3/4A protease inhibitor are not eligible to receive PBS-subsidised telaprevir, 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 or Telephone Authority Required procedures
1Note
All legislative instruments and compilations are registered on the Federal Register of Legislative Instruments kept under the Legislative Instruments Act 2003.
See http://www.comlaw.gov.au
