National Health (Listing of Pharmaceutical Benefits) Amendment Instrument 2013 (No. 4) (No. PB 14 of 2013) (Cth)

Case

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

  1. 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

  1. 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

  1. Schedule 1, entry for Amlodipine

omit:

Tablet 5 mg (as maleate) Oral Amlo 5 ZP MP NP 30 5 30

  1. 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

  1. Schedule 1, entry for Amlodipine

omit:

Tablet 10 mg (as maleate) Oral Amlo 10 ZP MP NP 30 5 30

  1. 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

  1. 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

  1. 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

  1. 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

  1. 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

  1. 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

  1. 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

  1. 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

  1. 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

  1. Schedule 1, entry for Anastrozole

omit:

Anastrozole-PS FZ MP NP C2213 30 5 30

  1. Schedule 1, entry for Atenolol in the form Tablet 50 mg

omit:

Atenolol-PS FZ MP NP 30 5 30

  1. Schedule 1, entry for Atovaquone

omit from the column headed “Responsible Person”:                 GK          substitute:             AS

  1. Schedule 1, entry for Azathioprine in the form Tablet 50 mg

omit:

Azathioprine-PS FZ MP NP 100 5 100

  1. 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

  1. 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)

  1. Schedule 1, entry for Bupropion

omit from the column headed “Responsible Person” for the brand “Zyban” (all instances):            GK          substitute:             AS

  1. Schedule 1, entry for Calcitriol

omit:

Calcitriol-PS FZ MP NP C1165 C1166 C1167 C1467 C2636 100 3 100

  1. 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

  1. Schedule 1, entry for Cefuroxime in the form Tablet 250 mg (as axetil)

omit from the column headed “Responsible Person”:                 GK          substitute:             AS

  1. 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

  1. 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

  1. 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

  1. 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

  1. 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

  1. 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

  1. 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

  1. Schedule 1, entry for Clarithromycin in the form Tablet 250 mg

omit:

Clarithromycin-PS FZ MP NP 14 1 14

  1. 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

  1. 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

  1. 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

  1. Schedule 1, entry for Diltiazem in the form Tablet containing diltiazem hydrochloride 60 mg

omit:

Diltiazem-PS FZ MP NP 90 5 90

  1. 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

  1. 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

  1. 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

  1. 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

  1. 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

  1. 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)

  1. 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)

  1. Schedule 1, entry for Famotidine in the form Tablet 20 mg

omit:

Famotidine-PS FZ MP NP 60 5 60

  1. Schedule 1, entry for Famotidine in the form Tablet 40 mg

omit:

Famotidine-PS FZ MP NP 30 5 30

  1. Schedule 1, entry for Fludarabine in the form Tablet containing fludarabine phosphate 10 mg

omit from the column headed “Pack Quantity”:          1              substitute:             20

  1. 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

  1. 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

  1. Schedule 1, entry for Fluoxetine in the form Capsule 20 mg (as hydrochloride)

omit:

Fluoxetine-PS FZ MP NP C1211 C1241 28 5 28

  1. Schedule 1, entry for Flutamide

substitute:

Flutamide Tablet 250 mg Oral Flutamin AF MP NP C3674 100 5 100

  1. 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

  1. Schedule 1, entry for Indapamide in the form Tablet containing indapamide hemihydrate 2.5 mg

omit:

Indapamide-PS FZ MP NP 90 1 90

  1. 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

  1. 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

  1. 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

  1. 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)

  1. Schedule 1, entry for Isosorbide Mononitrate in the form Tablet 60 mg (sustained release)

omit:

Isosorbide-PS FZ MP NP 30 5 30

  1. Schedule 1, entry for Isotretinoin in the form Capsule 20 mg

omit:

Isotretinoin-PS FZ MP C1354 60 3 60

  1. 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

  1. 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

  1. 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

  1. 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

  1. 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

  1. Schedule 1, entry for Letrozole

omit:

Letara FZ MP NP C1608 C2691 C2692 30 5 30

  1. 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

  1. 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

  1. 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

  1. 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

  1. 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

  1. Schedule 1, entry for Mesalazine in the form Tablet 250 mg (enteric coated)

omit from the column headed “Responsible Person”:                 GK          substitute:             AS

  1. 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

  1. Schedule 1, entry for Metformin in the form Tablet containing metformin hydrochloride 500 mg

omit:

Metformin Pfizer FZ MP NP 100 5 100

  1. Schedule 1, entry for Metformin in the form Tablet containing metformin hydrochloride 850 mg

omit:

Metformin Pfizer FZ MP NP 60 5 60

  1. Schedule 1, entry for Metformin in the form Tablet containing metformin hydrochloride 1 g

omit:

Metformin Pfizer FZ MP NP 90 5 90

  1. Schedule 1, entry for Mirtazapine in the form Tablet 15 mg

omit:

Mirtazapine Pfizer FZ MP NP C1211 30 5 30

  1. Schedule 1, entry for Mirtazapine in the form Tablet 15 mg (orally disintegrating)

omit:

Mirtazapine Dispersible Pfizer FZ MP NP C1211 30 5 30

  1. Schedule 1, entry for Mirtazapine in the form Tablet 30 mg

omit:

Mirtazapine Pfizer FZ MP NP C1211 30 5 30

  1. Schedule 1, entry for Mirtazapine in the form Tablet 30 mg (orally disintegrating)

omit:

Mirtazapine Dispersible Pfizer FZ MP NP C1211 30 5 30

  1. Schedule 1, entry for Mirtazapine in the form Tablet 45 mg

omit:

Mirtazapine Pfizer FZ MP NP C1211 30 5 30

  1. Schedule 1, entry for Mirtazapine in the form Tablet 45 mg (orally disintegrating)

omit:

Mirtazapine Dispersible Pfizer FZ MP NP C1211 30 5 30

  1. 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

  1. 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

  1. 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

  1. Schedule 1, entry for Naratriptan

omit from the column headed “Responsible Person”:                 GK          substitute:             AS

  1. Schedule 1, entry for Norfloxacin

omit:

Norfloxacin-PS FZ MP NP C1002 C1070 14 1 14

  1. 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

  1. 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

  1. 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

  1. 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

  1. 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

  1. 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

  1. 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

  1. 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

  1. 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

  1. 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

  1. 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

  1. 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)

  1. 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)

  1. 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)

  1. 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

  1. 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

  1. 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

  1. 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

  1. 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

  1. 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

  1. 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

  1. 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

  1. Schedule 1, entry for Prochlorperazine in the form Tablet containing prochlorperazine maleate 5 mg

omit:

Prochlorperazine-PS FZ PDP MP NP 25 0 25

  1. Schedule 1, entry for Pyrimethamine

omit from the column headed “Responsible Person”:                 GK          substitute:             AS

  1. 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

  1. 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

  1. 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

  1. 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

  1. 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

  1. 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

  1. Schedule 1, entry for Ramipril in the form Capsule 10 mg

omit:

Ramipril-PS FZ MP NP 30 5 30

  1. 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

  1. 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

  1. 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

  1. 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

  1. 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

  1. 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

  1. 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

  1. 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

  1. 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

  1. 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

  1. 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

  1. 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

  1. 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

  1. 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

  1. 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

  1. 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

  1. Schedule 1, entry for Risperidone in the form Tablet 3 mg

omit:

Risperidone Pfizer FZ MP NP C1589 C2272 60 5 60

  1. Schedule 1, entry for Risperidone in the form Tablet 3 mg (orally disintegrating)

omit from the column headed “Pack Quantity”:          60           substitute:             28

  1. Schedule 1, entry for Risperidone in the form Tablet 4 mg

omit:

Risperidone Pfizer FZ MP NP C1589 C2272 60 5 60

  1. 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

  1. 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

  1. 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

  1. 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

  1. 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

  1. 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

  1. 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

  1. 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

  1. 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

  1. Schedule 1, entry for Strontium

omit from the column headed “Circumstances”:

C4071 C4107

substitute:

C4117 C4123

  1. 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)

  1. 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

  1. Schedule 1, entry for Ticarcillin with Clavulanic Acid

omit from the column headed “Responsible Person”:                 GK          substitute:             AS

  1. 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

  1. 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

  1. 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

  1. 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

  1. 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

  1. 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)

  1. Schedule 3, after details relevant to Responsible person code EL

insert:

EO Ego Pharmaceuticals Proprietary Limited  86 005 142 361

  1. 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

  1. 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

  1. 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

  1. 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

  1. 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

  1. 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

  1. 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

  1. 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

  1. 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.

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