Federal Register of Legislation - Australian Government

Primary content

PB 14 of 2013 Lists as made
This instrument amends the National Health (Listing of Pharmaceutical Benefits) Instrument 2012 (No. PB 71 of 2012) to provide for additions, deletions and changes to drugs, forms, brands, responsible person codes, maximum quantities, the circumstances for prescribing various pharmaceutical benefits (including authority requirements), determined quantities, pack quantities and section 100 only status.
Administered by: Health
Made 21 Mar 2013
Registered 27 Mar 2013
Tabled HR 14 May 2013
Tabled Senate 14 May 2013
Date of repeal 02 Apr 2013
Repealed by Division 1 of Part 5A of the Legislative Instruments Act 2003

PB 14 of 2013

National Health (Listing of Pharmaceutical Benefits) Amendment Instrument 2013
(No. 4)1

National Health Act 1953

I, FELICITY McNEILL, First Assistant Secretary, Pharmaceutical Benefits Division, Department of Health and Ageing, delegate of the Minister for Health, make this Instrument under sections 84AF, 84AK, 85, 85A, 88 and 101 of the National Health Act 1953.

Dated                                          21 March 2013

 

 

 

 

 

 

 

 

 

 

 

FELICITY McNEILL

First Assistant Secretary

Pharmaceutical Benefits Division

Department of Health and Ageing


 


1          Name of Instrument

            (1)        This Instrument is the National Health (Listing of Pharmaceutical Benefits) Amendment Instrument 2013 (No. 4).

            (2)        This Instrument may also be cited as PB 14 of 2013.

2          Commencement

This Instrument commences on 1 April 2013.

3          Amendment of National Health (Listing of Pharmaceutical Benefits) Instrument 2012 (PB 71 of 2012)

            Schedule 1 amends the National Health (Listing of Pharmaceutical Benefits) Instrument 2012 (PB 71 of 2012).



Schedule 1     Amendments

 

[1]           Schedule 1, entry for Albendazole in each of the forms: Tablet 200 mg; and Tablet 400 mg

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

[2]           Schedule 1, entry for Alendronic Acid in the form Tablet 70 mg (as alendronate sodium)

omit:

 

 

 

Alendronate Pfizer

FZ

MP NP

C4122 C4123 C4133

 

4

5

4

 

 

[3]           Schedule 1, entry for Amlodipine in the form Tablet 5 mg (as besylate)

insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:

 

 

 

Amlo 5

QA

MP NP

 

30

5

30

 

 

[4]           Schedule 1, entry for Amlodipine

omit:

 

Tablet 5 mg (as maleate)

Oral

Amlo 5

ZP

MP NP

 

30

5

30

 

 

[5]           Schedule 1, entry for Amlodipine in the form Tablet 10 mg (as besylate)

insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:

 

 

 

Amlo 10

QA

MP NP

 

30

5

30

 

 

[6]           Schedule 1, entry for Amlodipine

omit:

 

Tablet 10 mg (as maleate)

Oral

Amlo 10

ZP

MP NP

 

30

5

30

 

 

[7]           Schedule 1, entry for Amoxycillin in the form Capsule 250 mg (as trihydrate) [Maximum Quantity 20; Number of Repeats 0]

(a)      omit from the column headed “Responsible Person” for the brand “Amoxil”:           GK          substitute:             AS

(b)      omit:

 

 

 

Amoxycillin-PS

FZ

PDP

 

20

0

20

 

 

[8]           Schedule 1, entry for Amoxycillin in the form Capsule 250 mg (as trihydrate) [Maximum Quantity 20; Number of Repeats 1]

(a)      omit from the column headed “Responsible Person” for the brand “Amoxil”:           GK          substitute:             AS

(b)      omit:

 

 

 

Amoxycillin-PS

FZ

MP NP MW

 

20

1

20

 

 

[9]           Schedule 1, entry for Amoxycillin in the form Capsule 500 mg (as trihydrate) [Maximum Quantity 20; Number of Repeats 0]

(a)      omit from the column headed “Responsible Person” for the brand “Amoxil”:           GK          substitute:             AS

(b)      omit:

 

 

 

Amoxycillin-PS

FZ

PDP

 

20

0

20

 

 

[10]         Schedule 1, entry for Amoxycillin in the form Capsule 500 mg (as trihydrate) [Maximum Quantity 20; Number of Repeats 1]

(a)      omit from the column headed “Responsible Person” for the brand “Amoxil”:           GK          substitute:             AS

(b)      omit:

 

 

 

Amoxycillin-PS

FZ

MP NP MW

 

20

1

20

 

 

[11]          Schedule 1, entry for Amoxycillin in each of the forms: Powder for paediatric oral drops 100 mg (as trihydrate) per mL, 20 mL; Powder for oral suspension 125 mg (as trihydrate) per 5 mL, 100 mL; and Powder for oral suspension 250 mg (as trihydrate) per 5 mL, 100 mL

omit from the column headed “Responsible Person” for the brands “Amoxil” and “Amoxil Forte” (all instances):    GK                substitute:             AS

[12]          Schedule 1, entry for Amoxycillin with Clavulanic Acid in the form Tablet containing 500 mg amoxycillin (as trihydrate) with 125 mg clavulanic acid (as potassium clavulanate)

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

[13]          Schedule 1, entry for Amoxycillin with Clavulanic Acid in the form Tablet containing 875 mg amoxycillin (as trihydrate) with 125 mg clavulanic acid (as potassium clavulanate)

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

[14]          Schedule 1, entry for Amoxycillin with Clavulanic Acid in the form Powder for oral suspension containing 125 mg amoxycillin (as trihydrate) with 31.25 mg clavulanic acid (as potassium clavulanate) per 5 mL, 75 mL

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

[15]         Schedule 1, entry for Amoxycillin with Clavulanic Acid in the form Powder for oral suspension containing 400 mg amoxycillin (as trihydrate) with 57 mg clavulanic acid (as potassium clavulanate) per 5 mL, 60 mL

omit from the column headed “Responsible Person” for the brand “Augmentin Duo 400” (all instances):                   GK                substitute:             AS

[16]         Schedule 1, entry for Anastrozole

omit:

 

 

 

Anastrozole-PS

FZ

MP NP

C2213

 

30

5

30

 

 

[17]         Schedule 1, entry for Atenolol in the form Tablet 50 mg

omit:

 

 

 

Atenolol-PS

FZ

MP NP

 

30

5

30

 

[18]         Schedule 1, entry for Atovaquone

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

[19]         Schedule 1, entry for Azathioprine in the form Tablet 50 mg

omit:

 

 

 

Azathioprine-PS

FZ

MP NP

 

100

5

100

 

 

[20]          Schedule 1, entry for Bisoprolol in each of the forms: Tablet containing bisoprolol fumarate 2.5 mg; Tablet containing bisoprolol fumarate 5 mg; and Tablet containing bisoprolol fumarate 10 mg

omit:

 

 

 

Bisoprolol Pfizer

FZ

MP NP

C3234

 

28

5

28

 

 

[21]         Schedule 1, after entry for Bleomycin in the form Powder for injection containing bleomycin sulfate 15,000 I.U. [Hospira Pty Limited]

insert:

Boceprevir

Capsule 200 mg

Oral

Victrelis

MK

MP
See Note 1

C4182 C4196 C4202 C4205

 

See Note 3

See Note 3

336

D(100)

[22]         Schedule 1, entry for Bupropion

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

[23]         Schedule 1, entry for Calcitriol

omit:

 

 

 

Calcitriol-PS

FZ

MP NP

C1165 C1166 C1167 C1467 C2636

 

100

3

100

 

 

[24]         Schedule 1, entry for Ceftriaxone in the form Powder for injection 1 mg (as sodium)

omit from the column headed “Pack Quantity” for the brand “Max Pharma Ceftriaxone”:              1              substitute:             5

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

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

[26]         Schedule 1, entry for Cephalexin in the form Capsule 250 mg (anhydrous)

(a)      omit:

 

 

 

Cephalexin-PS

FZ

PDP

 

20

0

20

 

 

(b)      omit:

 

 

 

Cephalexin-PS

FZ

MP NP MW

 

20

1

20

 

 

[27]         Schedule 1, entry for Cephalexin in the form Capsule 500 mg (anhydrous)

(a)      omit:

 

 

 

Cephalexin-PS

FZ

PDP

 

20

0

20

 

 

(b)      omit:

 

 

 

Cephalexin-PS

FZ

MP NP MW

 

20

1

20

 

 

[28]         Schedule 1, entry for Ciprofloxacin in the form Tablet 500 mg (as hydrochloride)

omit:

 

 

 

Ciprofloxacin-PS

FZ

MP NP

C1431 C1432 C1572 C1573

 

14

0

14

 

 

[29]         Schedule 1, entry for Ciprofloxacin in the form Tablet 750 mg (as hydrochloride)

(a)      omit:

 

 

 

Ciprofloxacin-PS

FZ

MP NP

C1431 C1432 C1572 C1573

 

14

0

14

 

 

(b)      omit from the column headed “Pack Quantity” for the brand “Ciprol 750”:             1              substitute:             14

[30]         Schedule 1, entry for Ciprofloxacin in the form Eye drops 3 mg (as hydrochloride) per mL, 5 mL [CiloQuin]

(a)      omit from the column headed “Circumstances”:               C1031   substitute:             C4195

(b)      omit from the column headed “Circumstances”:               C3830   substitute:             C4181

[31]         Schedule 1, entry for Ciprofloxacin in the form Eye drops 3 mg (as hydrochloride) per mL, 5 mL [Ciloxan]

(a)      omit from the column headed “Circumstances”:               C1031   substitute:             C4195

(b)      omit from the column headed “Circumstances”:               C3830   substitute:             C4181

[32]         Schedule 1, entry for Citalopram in each of the forms: Tablet 20 mg (as hydrobromide); and Tablet 40 mg (as hydrobromide)

omit:

 

 

 

Citalopram Pfizer

FZ

MP NP

C1211

 

28

5

28

 

 

[33]         Schedule 1, entry for Clarithromycin in the form Tablet 250 mg

omit:

 

 

 

Clarithromycin-PS

FZ

MP NP

 

14

1

14

 

 

[34]         Schedule 1, entry for Clopidogrel in the form Tablet 75 mg (as besilate)

omit:

 

 

 

Clopidogrel-PS

FZ

MP NP

C1719 C1720 C1721 C1722 C1723 C1724

 

28

5

28

 

 

[35]         Schedule 1, entry for Cyproterone in the form Tablet containing cyproterone acetate 50 mg

(a)      omit:

 

 

 

Cyproterone-PS

FZ

MP

C1014 C1230 C1404

P1230

20

5

20

 

(b)      omit:

 

 

 

Cyproterone-PS

FZ

MP

C1014 C1230 C1404

P1014 P1404

100

5

50

 

 

[36]         Schedule 1, entry for Cyproterone in the form Tablet containing cyproterone acetate 100 mg

omit:

 

 

 

Cyproterone-PS 100

FZ

MP

C1014 C1404

 

50

5

50

 

 

[37]         Schedule 1, entry for Diltiazem in the form Tablet containing diltiazem hydrochloride 60 mg

omit:

 

 

 

Diltiazem-PS

FZ

MP NP

 

90

5

90

 

 

[38]         Schedule 1, entry for Donepezil

substitute:

Donepezil

Tablet containing donepezil hydrochloride 5 mg

Oral

APO-Donepezil

TX

MP NP

C2934 C2938 C3875 C3876

 

28

5

28

 

 

 

 

 

Arazil

AF

MP NP

C2934 C2938 C3875 C3876

 

28

5

28

 

 

 

 

 

Aricept

PF

MP NP

C2934 C2938 C3875 C3876

 

28

5

28

 

 

 

 

 

Aridon 5

QA

MP NP

C2934 C2938 C3875 C3876

 

28

5

28

 

 

 

 

 

Chem mart Donepezil

CH

MP NP

C2934 C2938 C3875 C3876

 

28

5

28

 

 

 

 

 

Donepezil-DRLA

RZ

MP NP

C2934 C2938 C3875 C3876

 

28

5

28

 

 

 

 

 

Donepezil-GA

GM

MP NP

C2934 C2938 C3875 C3876

 

28

5

28

 

 

 

 

 

Donepezil generichealth

GQ

MP NP

C2934 C2938 C3875 C3876

 

28

5

28

 

 

 

 

 

Donepezil RBX

RA

MP NP

C2934 C2938 C3875 C3876

 

28

5

28

 

 

 

 

 

Donepezil Sandoz

SZ

MP NP

C2934 C2938 C3875 C3876

 

28

5

28

 

 

 

 

 

Donepezil-Synthon

ZT

MP NP

C2934 C2938 C3875 C3876

 

28

5

28

 

 

 

 

 

STADA Donepezil

TD

MP NP

C2934 C2938 C3875 C3876

 

28

5

28

 

 

 

 

 

Terry White Chemists Donepezil

TW

MP NP

C2934 C2938 C3875 C3876

 

28

5

28

 

 

 

Tablet containing donepezil hydrochloride 10 mg

Oral

APO-Donepezil

TX

MP NP

C2934 C2938 C3875 C3876

 

28

5

28

 

 

 

 

 

Arazil

AF

MP NP

C2934 C2938 C3875 C3876

 

28

5

28

 

 

 

 

 

Aricept

PF

MP NP

C2934 C2938 C3875 C3876

 

28

5

28

 

 

 

 

 

Aridon 10

QA

MP NP

C2934 C2938 C3875 C3876

 

28

5

28

 

 

 

 

 

Chem mart Donepezil

CH

MP NP

C2934 C2938 C3875 C3876

 

28

5

28

 

 

 

 

 

Donepezil-DRLA

RZ

MP NP

C2934 C2938 C3875 C3876

 

28

5

28

 

 

 

 

 

Donepezil-GA

GM

MP NP

C2934 C2938 C3875 C3876

 

28

5

28

 

 

 

 

 

Donepezil generichealth

GQ

MP NP

C2934 C2938 C3875 C3876

 

28

5

28

 

 

 

 

 

Donepezil RBX

RA

MP NP

C2934 C2938 C3875 C3876

 

28

5

28

 

 

 

 

 

Donepezil Sandoz

SZ

MP NP

C2934 C2938 C3875 C3876

 

28

5

28

 

 

 

 

 

Donepezil-Synthon

ZT

MP NP

C2934 C2938 C3875 C3876

 

28

5

28

 

 

 

 

 

STADA Donepezil

TD

MP NP

C2934 C2938 C3875 C3876

 

28

5

28

 

 

 

 

 

Terry White Chemists Donepezil

TW

MP NP

C2934 C2938 C3875 C3876

 

28

5

28

 

 

[39]         Schedule 1, entry for Doxycycline in the form Tablet 100 mg (as monohydrate) [Maximum Quantity 21; Number of Repeats 0]

omit from the column headed “Pack Quantity” for the brand “GenRx Doxycycline”:        7              substitute:             21

[40]          Schedule 1, entry for Doxycycline in the form Capsule 100 mg (as hydrochloride) (containing enteric coated pellets)
[Maximum Quantity 21; Number of Repeats 0]

omit from the column headed “Pack Quantity” for the brands “Doryx” and “Mayne Pharma Doxycycline”:              7                substitute:             21

[41]         Schedule 1, entry for Duloxetine

substitute:

Duloxetine

Capsule 30 mg (as hydrochloride)

Oral

Andepra

EL

MP NP

C1211

 

28

0

28

 

 

 

 

 

APO-Duloxetine

TX

MP NP

C1211

 

28

0

28

 

 

 

 

 

Chem mart Duloxetine

CH

MP NP

C1211

 

28

0

28

 

 

 

 

 

Cymbalta

LY

MP NP

C1211

 

28

0

28

 

 

 

 

 

Terry White Chemists Duloxetine

TW

MP NP

C1211

 

28

0

28

 

 

 

Capsule 60 mg (as hydrochloride)

Oral

Andepra

EL

MP NP

C1211

 

28

5

28

 

 

 

 

 

APO-Duloxetine

TX

MP NP

C1211

 

28

5

28

 

 

 

 

 

Chem mart Duloxetine

CH

MP NP

C1211

 

28

5

28

 

 

 

 

 

Cymbalta

LY

MP NP

C1211

 

28

5

28

 

 

 

 

 

Terry White Chemists Duloxetine

TW

MP NP

C1211

 

28

5

28

 

 

[42]          Schedule 1, entry for Enalapril in each of the forms: Tablet containing enalapril maleate 5 mg; Tablet containing enalapril maleate 10 mg; and Tablet containing enalapril maleate 20 mg

omit:

 

 

 

Enalapril-PS

FZ

MP NP

 

30

5

30

 

 

[43]         Schedule 1, entry for Epirubicin in the form Solution for injection containing epirubicin hydrochloride 50 mg in 25 mL

insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:

 

 

 

Epirubicin SZ

HX

MP

 

See Note 3

See Note 3

1

D(100)

[44]         Schedule 1, entry for Epirubicin in the form Solution for injection containing epirubicin hydrochloride 200 mg in 100 mL

insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:

 

 

 

Epirubicin SZ

HX

MP

 

See Note 3

See Note 3

1

D(100)

[45]         Schedule 1, entry for Famotidine in the form Tablet 20 mg

omit:

 

 

 

Famotidine-PS

FZ

MP NP

 

60

5

60

 

 

[46]         Schedule 1, entry for Famotidine in the form Tablet 40 mg

omit:

 

 

 

Famotidine-PS

FZ

MP NP

 

30

5

30

 

 

[47]         Schedule 1, entry for Fludarabine in the form Tablet containing fludarabine phosphate 10 mg

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

[48]         Schedule 1, entry for Fludarabine in the form Powder for I.V. injection containing fludarabine phosphate 50 mg

omit from the column headed “Pack Quantity” for the brand “Fludara”:             1              substitute:             5

[49]         Schedule 1, entry for Fludarabine in the form Solution for I.V. injection 50 mg fludarabine phosphate in 2 mL

omit from the column headed “Pack Quantity” for the brand “AS-Fludarabine”:              5              substitute:             1

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

omit:

 

 

 

Fluoxetine-PS

FZ

MP NP

C1211 C1241

 

28

5

28

 

 

[51]         Schedule 1, entry for Flutamide

substitute:

Flutamide

Tablet 250 mg

Oral

Flutamin

AF

MP NP

C3674

 

100

5

100

 

 

[52]         Schedule 1, entry for Frusemide in each of the forms: Tablet 20 mg; and Tablet 40 mg

omit:

 

 

 

Frusemide-PS

FZ

MP NP

 

100

1

100

 

 

[53]         Schedule 1, entry for Indapamide in the form Tablet containing indapamide hemihydrate 2.5 mg

omit:

 

 

 

Indapamide-PS

FZ

MP NP

 

90

1

90

 

 

[54]         Schedule 1, entry for Interferon Beta-1b

insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:

 

 

 

Extavia

NV

MP

C1175 C1751

 

15

5

15

 

[55]         Schedule 1, entry for Irbesartan

substitute:

Irbesartan

Tablet 75 mg

Oral

Abisart

AF

MP NP

 

 

30

5

30

 

 

 

 

 

APO-Irbesartan

TX

MP NP

 

 

30

5

30

 

 

 

 

 

Avapro

AV

MP NP

 

 

30

5

30

 

 

 

 

 

Chem mart Irbesartan

CH

MP NP

 

 

30

5

30

 

 

 

 

 

Irbesartan-DRLA

RZ

MP NP

 

 

30

5

30

 

 

 

 

 

Irbesartan-GA

GM

MP NP

 

 

30

5

30

 

 

 

 

 

Irbesartan RBX

RA

MP NP

 

 

30

5

30

 

 

 

 

 

Irbesartan Sandoz

SZ

MP NP

 

 

30

5

30

 

 

 

 

 

Irbesartan Winthrop

WA

MP NP

 

 

30

5

30

 

 

 

 

 

Irbesat

GQ

MP NP

 

 

30

5

30

 

 

 

 

 

Karbesat 75

QA

MP NP

 

 

30

5

30

 

 

 

 

 

Karvea

SW

MP NP

 

 

30

5

30

 

 

 

 

 

Terry White Chemists Irbesartan

TW

MP NP

 

 

30

5

30

 

 

 

Tablet 150 mg

Oral

Abisart

AF

MP NP

 

 

30

5

30

 

 

 

 

 

APO-Irbesartan

TX

MP NP

 

 

30

5

30

 

 

 

 

 

Avapro

AV

MP NP

 

 

30

5

30

 

 

 

 

 

Chem mart Irbesartan

CH

MP NP

 

 

30

5

30

 

 

 

 

 

Irbesartan-DRLA

RZ

MP NP

 

 

30

5

30

 

 

 

 

 

Irbesartan-GA

GM

MP NP

 

 

30

5

30

 

 

 

 

 

Irbesartan RBX

RA

MP NP

 

 

30

5

30

 

 

 

 

 

Irbesartan Sandoz

SZ

MP NP

 

 

30

5

30

 

 

 

 

 

Irbesartan Winthrop

WA

MP NP

 

 

30

5

30

 

 

 

 

 

Irbesat

GQ

MP NP

 

 

30

5

30

 

 

 

 

 

Karbesat 150

QA

MP NP

 

 

30

5

30

 

 

 

 

 

Karvea

SW

MP NP

 

 

30

5

30

 

 

 

 

 

Terry White Chemists Irbesartan

TW

MP NP

 

 

30

5

30

 

 

 

Tablet 300 mg

Oral

Abisart

AF

MP NP

 

 

30

5

30

 

 

 

 

 

APO-Irbesartan

TX

MP NP

 

 

30

5

30

 

 

 

 

 

Avapro

AV

MP NP

 

 

30

5

30

 

 

 

 

 

Chem mart Irbesartan

CH

MP NP

 

 

30

5

30

 

 

 

 

 

Irbesartan-DRLA

RZ

MP NP

 

 

30

5

30

 

 

 

 

 

Irbesartan-GA

GM

MP NP

 

 

30

5

30

 

 

 

 

 

Irbesartan RBX

RA

MP NP

 

 

30

5

30

 

 

 

 

 

Irbesartan Sandoz

SZ

MP NP

 

 

30

5

30

 

 

 

 

 

Irbesartan Winthrop

WA

MP NP

 

 

30

5

30

 

 

 

 

 

Irbesat

GQ

MP NP

 

 

30

5

30

 

 

 

 

 

Karbesat 300

QA

MP NP

 

 

30

5

30

 

 

 

 

 

Karvea

SW

MP NP

 

 

30

5

30

 

 

 

 

 

Terry White Chemists Irbesartan

TW

MP NP

 

 

30

5

30

 

 

[56]         Schedule 1, entry for Irbesartan with Hydrochlorothiazide

substitute:

Irbesartan with Hydrochlorothiazide

Tablet 150 mg-12.5 mg

Oral

Abisart HCT 150/12.5

AF

MP NP

C3307

 

30

5

30

 

 

 

 

 

APO-Irbesartan HCTZ

TX

MP NP

C3307

 

30

5

30

 

 

 

 

 

Avapro HCT 150/12.5

AV

MP NP

C3307

 

30

5

30

 

 

 

 

 

Chem mart Irbesartan HCTZ

CH

MP NP

C3307

 

30

5

30

 

 

 

 

 

Irbesartan/HCT Sandoz

SZ

MP NP

C3307

 

30

5

30

 

 

 

 

 

Irbesartan HCT Winthrop 150/12.5

WA

MP NP

C3307

 

30

5

30

 

 

 

 

 

Irbesartan HCTZ-GA 150/12.5

GM

MP NP

C3307

 

30

5

30

 

 

 

 

 

Irbesartan/HCTZ RBX 150/12.5

RA

MP NP

C3307

 

30

5

30

 

 

 

 

 

Irbesatzide 150/12.5

GQ

MP NP

C3307

 

30

5

30

 

 

 

 

 

Karvezide 150/12.5

SW

MP NP

C3307

 

30

5

30

 

 

 

 

 

KSART HCT 150/12.5

QA

MP NP

C3307

 

30

5

30

 

 

 

 

 

STADA Irbesartan HCT 150/12.5

TD

MP NP

C3307

 

30

5

30

 

 

 

 

 

Terry White Chemists Irbesartan HCTZ

TW

MP NP

C3307

 

30

5

30

 

 

 

Tablet 300 mg-12.5 mg

Oral

Abisart HCT 300/12.5

AF

MP NP

C3307

 

30

5

30

 

 

 

 

 

APO-Irbesartan HCTZ

TX

MP NP

C3307

 

30

5

30

 

 

 

 

 

Avapro HCT 300/12.5

AV

MP NP

C3307

 

30

5

30

 

 

 

 

 

Chem mart Irbesartan HCTZ

CH

MP NP

C3307

 

30

5

30

 

 

 

 

 

Irbesartan/HCT Sandoz

SZ

MP NP

C3307

 

30

5

30

 

 

 

 

 

Irbesartan HCT Winthrop 300/12.5

WA

MP NP

C3307

 

30

5

30

 

 

 

 

 

Irbesartan HCTZ-GA 300/12.5

GM

MP NP

C3307

 

30

5

30

 

 

 

 

 

Irbesartan/HCTZ RBX 300/12.5

RA

MP NP

C3307

 

30

5

30

 

 

 

 

 

Irbesatzide 300/12.5

GQ

MP NP

C3307

 

30

5

30

 

 

 

 

 

Karvezide 300/12.5

SW

MP NP

C3307

 

30

5

30

 

 

 

 

 

KSART HCT 300/12.5

QA

MP NP

C3307

 

30

5

30

 

 

 

 

 

STADA Irbesartan HCT 300/12.5

TD

MP NP

C3307

 

30

5

30

 

 

 

 

 

Terry White Chemists Irbesartan HCTZ

TW

MP NP

C3307

 

30

5

30

 

 

 

Tablet 300 mg-25 mg

Oral

Abisart HCT 300/25

AF

MP NP

C3307

 

30

5

30

 

 

 

 

 

APO-Irbesartan HCTZ

TX

MP NP

C3307

 

30

5

30

 

 

 

 

 

Avapro HCT 300/25

AV

MP NP

C3307

 

30

5

30

 

 

 

 

 

Chem mart Irbesartan HCTZ

CH

MP NP

C3307

 

30

5

30

 

 

 

 

 

Irbesartan/HCT Sandoz

SZ

MP NP

C3307

 

30

5

30

 

 

 

 

 

Irbesartan HCT Winthrop 300/25

WA

MP NP

C3307

 

30

5

30

 

 

 

 

 

Irbesartan HCTZ-GA 300/25

GM

MP NP

C3307

 

30

5

30

 

 

 

 

 

Irbesartan/HCTZ RBX 300/25

RA

MP NP

C3307

 

30

5

30

 

 

 

 

 

Irbesatzide 300/25

GQ

MP NP

C3307

 

30

5

30

 

 

 

 

 

Karvezide 300/25

SW

MP NP

C3307

 

30

5

30

 

 

 

 

 

KSART HCT 300/25

QA

MP NP

C3307

 

30

5

30

 

 

 

 

 

STADA Irbesartan HCT 300/25

TD

MP NP

C3307

 

30

5

30

 

 

 

 

 

Terry White Chemists Irbesartan HCTZ

TW

MP NP

C3307

 

30

5

30

 

 

[57]          Schedule 1, entry for Irinotecan in each of the forms: I.V. injection containing irinotecan hydrochloride trihydrate 40 mg in 2 mL; and
I.V. injection containing irinotecan hydrochloride trihydrate 100 mg in 5 mL

insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:

 

 

 

Irinotecan SZ

HX

MP

C3184

 

See Note 3

See Note 3

1

D(100)

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

omit:

 

 

 

Isosorbide-PS

FZ

MP NP

 

30

5

30

 

 

[59]         Schedule 1, entry for Isotretinoin in the form Capsule 20 mg

omit:

 

 

 

Isotretinoin-PS

FZ

MP

C1354

 

60

3

60

 

 

[60]         Schedule 1, entry for Lamivudine in the form Tablet 100 mg

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

[61]         Schedule 1, entry for Lamivudine in the form Oral solution 5 mg per mL, 240 mL

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

[62]         Schedule 1, entry for Lamotrigine in the form Tablet 5 mg

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

[63]         Schedule 1, entry for Lamotrigine in each of the forms: Tablet 5 mg; Tablet 25 mg; Tablet 50 mg; Tablet 100 mg; and Tablet 200 mg

(a)      omit from the column headed “Responsible Person” for the brand “Lamictal”:        GK          substitute:             AS

(b)      omit:

 

 

 

Lamotrigine-PS

FZ

MP NP

C1426

 

56

5

56

 

 

[64]          Schedule 1, entry for Lercanidipine in each of the forms: Tablet containing lercanidipine hydrochloride 10 mg; and Tablet containing lercanidipine hydrochloride 20 mg

insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:

 

 

 

Lercanidipine GH

GQ

MP NP

 

28

5

28

 

[65]         Schedule 1, entry for Letrozole

omit:

 

 

 

Letara

FZ

MP NP

C1608 C2691 C2692

 

30

5

30

 

 

[66]         Schedule 1, entry for Levetiracetam in each of the forms: Tablet 250 mg; Tablet 500 mg; and Tablet 1 g

omit:

 

 

 

Levetiracetam Pfizer

FZ

MP NP

C2664

 

60

5

60

 

 

[67]         Schedule 1, entry for Levonorgestrel with Ethinyloestradiol

insert as first entry in the columns in the order indicated:

 

Pack containing 21 tablets 100 micrograms-20 micrograms and 7 inert tablets

Oral

Femme-Tab ED 20/100

AE

MP NP

 

4

2

4

 

 

[68]          Schedule 1, entry for Levonorgestrel with Ethinyloestradiol in the form Pack containing 21 tablets 150 micrograms-30 micrograms
and 7 inert tablets

insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:

 

 

 

Femme-Tab ED 30/150

AE

MP NP

 

4

2

4

 

 

[69]         Schedule 1, entry for Lisinopril in each of the forms: Tablet 5 mg; Tablet 10 mg; and Tablet 20 mg

omit:

 

 

 

Lisinopril-PS

FZ

MP NP

 

30

5

30

 

 

[70]         Schedule 1, entry for Lithium in the form Tablet containing lithium carbonate 450 mg (slow release)

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

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

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

[72]         Schedule 1, entry for Meloxicam in each of the forms: Tablet 7.5 mg; and Tablet 15 mg

omit:

 

 

 

Meloxicam-PS

FZ

MP NP

C1547 C1848

 

30

3

30

 

 

[73]         Schedule 1, entry for Metformin in the form Tablet containing metformin hydrochloride 500 mg

omit:

 

 

 

Metformin Pfizer

FZ

MP NP

 

100

5

100

 

 

[74]         Schedule 1, entry for Metformin in the form Tablet containing metformin hydrochloride 850 mg

omit:

 

 

 

Metformin Pfizer

FZ

MP NP

 

60

5

60

 

 

[75]         Schedule 1, entry for Metformin in the form Tablet containing metformin hydrochloride 1 g

omit:

 

 

 

Metformin Pfizer

FZ

MP NP

 

90

5

90

 

 

[76]         Schedule 1, entry for Mirtazapine in the form Tablet 15 mg

omit:

 

 

 

Mirtazapine Pfizer

FZ

MP NP

C1211

 

30

5

30

 

 

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

omit:

 

 

 

Mirtazapine Dispersible Pfizer

FZ

MP NP

C1211

 

30

5

30

 

[78]         Schedule 1, entry for Mirtazapine in the form Tablet 30 mg

omit:

 

 

 

Mirtazapine Pfizer

FZ

MP NP

C1211

 

30

5

30

 

 

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

omit:

 

 

 

Mirtazapine Dispersible Pfizer

FZ

MP NP

C1211

 

30

5

30

 

[80]         Schedule 1, entry for Mirtazapine in the form Tablet 45 mg

omit:

 

 

 

Mirtazapine Pfizer

FZ

MP NP

C1211

 

30

5

30

 

 

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

omit:

 

 

 

Mirtazapine Dispersible Pfizer

FZ

MP NP

C1211

 

30

5

30

 

[82]         Schedule 1, entry for Moclobemide in each of the forms: Tablet 150 mg; and Tablet 300 mg

omit:

 

 

 

Moclobemide-PS

FZ

MP NP

C1211

 

60

5

60

 

 

[83]          Schedule 1, entry for Mometasone in each of the forms: Ointment containing mometasone furoate 1 mg per g, 15 g; and Lotion containing mometasone furoate 1 mg per g, 30 mL

insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:

 

 

 

Zatamil

EO

MP NP

C1422

 

1

0

1

 

 

[84]         Schedule 1, entry for Morphine in the form Injection containing morphine sulphate 10 mg in 1 mL (with preservative)

(a)      omit from the column headed “Maximum Quantity”:       1              substitute:             10

(b)      omit from the column headed “Pack Quantity”:                                1              substitute:             10

[85]         Schedule 1, entry for Naratriptan

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

[86]         Schedule 1, entry for Norfloxacin

omit:

 

 

 

Norfloxacin-PS

FZ

MP NP

C1002 C1070

 

14

1

14

 

 

[87]         Schedule 1, entry for Ofloxacin

(a)      omit from the column headed “Circumstances”:               C1031   substitute:             C4195

(b)      omit from the column headed “Circumstances”:               C3830   substitute:             C4181

[88]         Schedule 1, entry for Olanzapine in each of the forms: Tablet 2.5 mg; Tablet 5 mg; Tablet 7.5 mg; and Tablet 10 mg

omit:

 

 

 

Olanzapine-PS

FZ

MP NP

C1589 C2044

 

28

5

28

 

[89]         Schedule 1, entry for Olanzapine in each of the forms: Tablet 5 mg (orally disintegrating); and Tablet 10 mg (orally disintegrating)

omit:

 

 

 

PS Olanzapine ODT

FZ

MP NP

C1589 C2044

 

28

5

28

 

 

[90]         Schedule 1, entry for Omeprazole in the form Tablet 20 mg

(a)      omit:

 

 

 

Omeprazole-PS

FZ

MP NP

C4074 C4075 C4089 C4152

P4074

30

1

30

 

 

(b)      omit:

 

 

 

Omeprazole-PS

FZ

MP NP

C4074 C4075 C4089 C4152

P4075 P4089 P4152

30

5

30

 

 

[91]         Schedule 1, entry for Ondansetron in the form Tablet 4 mg (as hydrochloride dihydrate) [Maximum Quantity 4; Number of Repeats 0]

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

[92]          Schedule 1, entry for Ondansetron in the form Tablet 4 mg (as hydrochloride dihydrate)
[Maximum Quantity 10; Number of Repeats 1]

(a)      omit:

 

 

 

Ondansetron Tabs Pfizer

FZ

MP NP

C3050 C3611

P3611

10

1

10

 

 

(b)      omit from the column headed “Responsible Person” for the brand “Zofran”:           GK          substitute:             AS

[93]         Schedule 1, entry for Ondansetron in the form Tablet 8 mg (as hydrochloride dihydrate) [Maximum Quantity 4; Number of Repeats 0]

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

[94]         Schedule 1, entry for Ondansetron in the form Tablet 8 mg (as hydrochloride dihydrate) [Maximum Quantity 10; Number of Repeats 1]

(a)      omit:

 

 

 

Ondansetron Tabs Pfizer

FZ

MP NP

C3050 C3611

P3611

10

1

10

 

 

(b)      omit from the column headed “Responsible Person” for the brand “Zofran”:           GK          substitute:             AS

[95]         Schedule 1, entry for Ondansetron in each of the forms: Wafer 4 mg; and Wafer 8 mg

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

[96]         Schedule 1, entry for Ondansetron in the form Syrup 4 mg (as hydrochloride dihydrate) per 5 mL, 50 mL

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

[97]          Schedule 1, entry for Ondansetron in each of the forms: I.V. injection 4 mg (as hydrochloride dihydrate) in 2 mL; and I.V. injection 8 mg (as hydrochloride dihydrate) in 4 mL

(a)      insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:

 

 

 

Ondansetron Kabi

PK

MP NP
See Note 1

C3050 C3611
See Note 2

See Note 2

1
See Note 2

0
See Note 2

1

 

 

(b)      omit from the column headed “Responsible Person” for the brand “Zofran”:           GK          substitute:             AS

[98]         Schedule 1, entry for Oxaliplatin in the form Solution concentrate for I.V. infusion 100 mg in 20 mL

insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:

 

 

 

Oxaliplatin SZ

HX

MP

C3900 C3901 C3930 C3939

 

See Note 3

See Note 3

1

D(100)

[99]         Schedule 1, entry for Pamidronic Acid

omit:

 

Concentrated injection containing disodium pamidronate 30 mg in 10 mL

Injection

Pamisol

HH

MP NP

C3256

 

2

0

1

 

 

 

 

 

 

MP
See Note 1

C1500 C3341

 

2

2

1

 

C(100)

substitute:

 

Concentrated injection containing disodium pamidronate 30 mg in 10 mL

Injection

Pamidronate Strides

YA

MP NP

C3256

 

2

0

1

 

 

 

 

 

 

MP
See Note 1

C1500 C3341

 

2

2

1

 

C(100)

 

 

 

Pamisol

HH

MP NP

C3256

 

2

0

1

 

 

 

 

 

 

 

MP
See Note 1

C1500 C3341

 

2

2

1

 

C(100)

[100]       Schedule 1, entry for Pamidronic Acid in the form Concentrated injection containing disodium pamidronate 90 mg in 10 mL

insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:

 

 

 

Pamidronate Strides

YA

MP
See Note 1

C1035 C1233 C1500 C3341 C3342 C3343

 

1

11

1

PB(100)

[101]       Schedule 1, entry for Pantoprazole in the form Tablet (enteric coated) 40 mg (as sodium sesquihydrate)

(a)      omit:

 

 

 

Pantoprazole-PS

FZ

MP NP

C1177 C1337 C1476 C1533

P1177

30

2

30

 

 

(b)      omit:

 

 

 

Pantoprazole-PS

FZ

MP NP

C1177 C1337 C1476 C1533

P1337 P1476 P1533

30

5

30

 

 

[102]       Schedule 1, entry for Pantoprazole in the form Tablet (enteric coated) 20 mg (as sodium sesquihydrate)

omit:

 

 

 

Pantoprazole-PS

FZ

MP NP

C1337 C1476 C1533

 

30

5

30

 

 

[103]       Schedule 1, entry for Paroxetine in the form Tablet 20 mg (as hydrochloride)

(a)      omit from the column headed “Responsible Person” for the brand “Aropax”:          GK          substitute:             AS

(b)      omit:

 

 

 

Paroxetine-PS

FZ

MP NP

C1211 C1241 C1862

 

30

5

30

 

 

[104]        Schedule 1, entry for Pioglitazone in each of the forms: Tablet 15 mg (as hydrochloride); Tablet 30 mg (as hydrochloride);
and Tablet 45 mg (as hydrochloride)

omit:

 

 

 

Pioglitazone Pfizer

FZ

MP NP

C3540 C3541 C3542

 

28

5

28

 

[105]       Schedule 1, entry for Pravastatin in the form Tablet containing pravastatin sodium 10 mg

(a)      omit:

 

 

 

Pravastatin-PS

FZ

MP

C1540 C3047

P1540

30

5

30

 

 

 

 

 

 

 

NP

C1540

 

30

5

30

 

 

(b)      omit:

 

 

 

Pravastatin-PS

FZ

MP

C1540 C3047

P3047

30

11

30

 

 

[106]       Schedule 1, entry for Pravastatin in the form Tablet containing pravastatin sodium 20 mg

(a)      omit:

 

 

 

Pravastatin-PS

FZ

MP

C1540 C3047

P1540

30

5

30

 

 

 

 

 

 

 

NP

C1540

 

30

5

30

 

 

(b)      omit:

 

 

 

Pravastatin-PS

FZ

MP

C1540 C3047

P3047

30

11

30

 

 

[107]       Schedule 1, entry for Pravastatin in the form Tablet containing pravastatin sodium 40 mg

(a)      omit:

 

 

 

Pravastatin-PS

FZ

MP

C1540 C3047

P1540

30

5

30

 

 

 

 

 

 

 

NP

C1540

 

30

5

30

 

 

(b)      omit:

 

 

 

Pravastatin-PS

FZ

MP

C1540 C3047

P3047

30

11

30

 

 

[108]       Schedule 1, entry for Pravastatin in the form Tablet containing pravastatin sodium 80 mg

(a)      omit:

 

 

 

Pravastatin-PS

FZ

MP

C1540 C3047

P1540

30

5

30

 

 

 

 

 

 

 

NP

C1540

 

30

5

30

 

 

(b)      omit:

 

 

 

Pravastatin-PS

FZ

MP

C1540 C3047

P3047

30

11

30

 

 

[109]       Schedule 1, entry for Prochlorperazine in the form Tablet containing prochlorperazine maleate 5 mg

omit:

 

 

 

Prochlorperazine-PS

FZ

PDP MP NP

 

25

0

25

 

 

[110]       Schedule 1, entry for Pyrimethamine

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

[111]       Schedule 1, entry for Quetiapine in the form Tablet 25 mg (as fumarate)

omit:

 

 

 

Quetiapine Pfizer

FZ

MP NP

C1589 C2044 C2765

 

60

5

60

 

 

[112]       Schedule 1, entry for Quetiapine in the form Tablet 100 mg (as fumarate)

omit:

 

 

 

Quetiapine Pfizer

FZ

MP NP

C1589 C2044 C2765

 

90

5

90

 

 

[113]       Schedule 1, entry for Quetiapine in each of the forms: Tablet 200 mg (as fumarate); and Tablet 300 mg (as fumarate)

omit:

 

 

 

Quetiapine Pfizer

FZ

MP NP

C1589 C2044 C2765

 

60

5

60

 

 

[114]       Schedule 1, entry for Rabeprazole in the form Tablet containing rabeprazole sodium 10 mg (enteric coated)

omit:

 

 

 

Rabeprazole Pfizer

FZ

MP NP

C1337 C1533

 

28

5

28

 

 

[115]       Schedule 1, entry for Rabeprazole in the form Tablet containing rabeprazole sodium 20 mg (enteric coated)

(a)      omit:

 

 

 

Rabeprazole Pfizer

FZ

MP NP

C1177 C1337 C1533

P1177

30

2

30

 

 

(b)      omit:

 

 

 

Rabeprazole Pfizer

FZ

MP NP

C1177 C1337 C1533

P1337 P1533

30

5

30

 

 

[116]       Schedule 1, entry for Ramipril in each of the forms: Tablet 1.25 mg; Tablet 2.5 mg; Tablet 5 mg; and Tablet 10 mg

omit:

 

 

 

Ramipril Tabs Pfizer

FZ

MP NP

 

30

5

30

 

 

[117]       Schedule 1, entry for Ramipril in the form Capsule 10 mg

omit:

 

 

 

Ramipril-PS

FZ

MP NP

 

30

5

30

 

 

[118]       Schedule 1, entry for Ranitidine in the form Tablet 150 mg (as hydrochloride)

(a)      omit:

 

 

 

Ranitidine-PS

FZ

MP NP MW

 

60

5

60

 

 

(b)      omit from the column headed “Responsible Person” for the brand “Zantac”:           GK          substitute:             AS

[119]       Schedule 1, entry for Ranitidine in the form Tablet, effervescent, 150 mg (as hydrochloride)

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

(b)      omit from the column headed “Pack Quantity”:                                60           substitute:             30

[120]       Schedule 1, entry for Ranitidine in the form Tablet 300 mg (as hydrochloride)

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

[121]       Schedule 1, entry for Ranitidine in the form Syrup 150 mg (as hydrochloride) per 10 mL, 300 mL

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

[122]       Schedule 1, entry for Ribavirin and Peginterferon Alfa-2a

omit from the column headed “Circumstances” (all instances):

 

C3053

C3055

C3413

C3414

substitute:

 

C4184

C4185

C4187

C4188

C4193

C4197

C4206

C4207

[123]        Schedule 1, entry for Ribavirin and Peginterferon Alfa-2b in the form Pack containing 112 capsules ribavirin 200 mg
and 4 single use injection pens containing peginterferon alfa-2b powder for injection 50 micrograms with diluent

omit from the column headed “Circumstances”:

 

C3053

C3414

C3948

C3949

substitute:

 

C4184

C4185

C4187

C4188

C4189

C4192

C4193

C4197

C4198

C4199

C4200

C4203

C4206

C4207

C4208

C4209

[124]        Schedule 1, entry for Ribavirin and Peginterferon Alfa-2b in the form Pack containing 84 capsules ribavirin 200 mg
and 4 single use injection pens containing peginterferon alfa-2b powder for injection 80 micrograms with diluent

omit from the column headed “Circumstances”:

 

C3053

C3414

C3948

C3949

substitute:

 

C4184

C4185

C4187

C4188

C4189

C4192

C4193

C4197

C4198

C4199

C4200

C4203

C4206

C4207

C4208

C4209

[125]        Schedule 1, entry for Ribavirin and Peginterferon Alfa-2b in the form Pack containing 140 capsules ribavirin 200 mg
and 4 single use injection pens containing peginterferon alfa-2b powder for injection 80 micrograms with diluent

omit from the column headed “Circumstances”:

 

C3053

C3055

C3413

C3414

substitute:

 

C4184

C4185

C4187

C4188

C4193

C4197

C4206

C4207

[126]        Schedule 1, entry for Ribavirin and Peginterferon Alfa-2b in the form Pack containing 112 capsules ribavirin 200 mg
and 4 single use injection pens containing peginterferon alfa-2b powder for injection 100 micrograms with diluent

omit from the column headed “Circumstances”:

 

C3053

C3414

C3948

C3949

substitute:

 

C4184

C4185

C4187

C4188

C4189

C4192

C4193

C4197

C4198

C4199

C4200

C4203

C4206

C4207

C4208

C4209

[127]        Schedule 1, entry for Ribavirin and Peginterferon Alfa-2b in the form Pack containing 140 capsules ribavirin 200 mg
and 4 single use injection pens containing peginterferon alfa-2b powder for injection 120 micrograms with diluent

omit from the column headed “Circumstances”:

 

C3053

C3055

C3413

C3414

substitute:

 

C4184

C4185

C4187

C4188

C4193

C4197

C4206

C4207

[128]        Schedule 1, entry for Ribavirin and Peginterferon Alfa-2b in the form Pack containing 140 capsules ribavirin 200 mg
and 4 single use injection pens containing peginterferon alfa-2b powder for injection 150 micrograms with diluent

omit from the column headed “Circumstances”:

 

C3053

C3055

C3413

C3414

substitute:

 

C4184

C4185

C4187

C4188

C4193

C4197

C4206

C4207

[129]        Schedule 1, entry for Ribavirin and Peginterferon Alfa-2b in the form Pack containing 168 capsules ribavirin 200 mg
and 4 single use injection pens containing peginterferon alfa-2b powder for injection 150 micrograms with diluent

omit from the column headed “Circumstances”:

 

C3053

C3055

C3413

C3414

substitute:

 

C4184

C4185

C4187

C4188

C4193

C4197

C4206

C4207

[130]        Schedule 1, entry for Ribavirin and Peginterferon Alfa-2b in the form Pack containing 196 capsules ribavirin 200 mg
and 4 single use injection pens containing peginterferon alfa-2b powder for injection 150 micrograms with diluent

omit from the column headed “Circumstances”:

 

C3053

C3055

C3413

C3414

substitute:

 

C4184

C4185

C4187

C4188

C4193

C4197

C4206

C4207

[131]       Schedule 1, entry for Risperidone in the form Tablet 0.5 mg

(a)      omit:

 

 

 

Risperidone Pfizer

FZ

MP NP

C1589 C2061 C3083

P2061 P3083

60

2

60

 

 

(b)      omit:

 

 

 

Risperidone Pfizer

FZ

MP NP

C1589 C2061 C3083

P1589

60

5

60

 

 

[132]       Schedule 1, entry for Risperidone in the form Tablet 1 mg

(a)      omit:

 

 

 

Risperidone Pfizer

FZ

MP NP

C1589 C2061 C2272 C3083

P2061 P3083

60

2

60

 

 

(b)      omit:

 

 

 

Risperidone Pfizer

FZ

MP NP

C1589 C2061 C2272 C3083

P1589 P2272

60

5

60

 

 

[133]       Schedule 1, entry for Risperidone in the form Tablet 2 mg

(a)      omit:

 

 

 

Risperidone Pfizer

FZ

MP NP

C1589 C2272 C3083

P3083

60

2

60

 

 

(b)      omit:

 

 

 

Risperidone Pfizer

FZ

MP NP

C1589 C2272 C3083

P1589 P2272

60

5

60

 

 

[134]       Schedule 1, entry for Risperidone in the form Tablet 3 mg

omit:

 

 

 

Risperidone Pfizer

FZ

MP NP

C1589 C2272

 

60

5

60

 

 

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

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

[136]       Schedule 1, entry for Risperidone in the form Tablet 4 mg

omit:

 

 

 

Risperidone Pfizer

FZ

MP NP

C1589 C2272

 

60

5

60

 

 

[137]       Schedule 1, after entry for Rosuvastatin in the form Tablet 40 mg (as calcium)

insert:

Rotigotine

Transdermal patch 4.5 mg

Transdermal

Neupro

UC

MP

C4190

 

28

5

28

 

 

Transdermal patch 9 mg

Transdermal

Neupro

UC

MP

C4204

 

28

5

28

 

 

 

Transdermal patch 13.5 mg

Transdermal

Neupro

UC

MP

C4204

 

28

5

28

 

 

[138]       Schedule 1, entry for Roxithromycin in the form Tablet 150 mg

(a)      omit:

 

 

 

Roxithromycin-PS

FZ

PDP

 

10

0

10

 

 

(b)      omit:

 

 

 

Roxithromycin-PS

FZ

MP NP

 

10

1

10

 

 

[139]       Schedule 1, entry for Roxithromycin in the form Tablet 300 mg

(a)      omit:

 

 

 

Roxithromycin-PS

FZ

PDP

 

5

0

5

 

 

(b)      omit:

 

 

 

Roxithromycin-PS

FZ

MP NP

 

5

1

5

 

 

[140]       Schedule 1, entry for Simvastatin in the form Tablet 10 mg

(a)      omit:

 

 

 

Simvastatin Pfizer

FZ

MP

C1540 C3047

P1540

30

5

30

 

 

 

 

 

 

 

NP

C1540

 

30

5

30

 

 

(b)      omit:

 

 

 

Simvastatin Pfizer

FZ

MP

C1540 C3047

P3047

30

11

30

 

 

[141]       Schedule 1, entry for Simvastatin in the form Tablet 20 mg

(a)      omit:

 

 

 

Simvastatin Pfizer

FZ

MP

C1540 C3047

P1540

30

5

30

 

 

 

 

 

 

 

NP

C1540

 

30

5

30

 

 

(b)      omit:

 

 

 

Simvastatin Pfizer

FZ

MP

C1540 C3047

P3047

30

11

30

 

 

[142]       Schedule 1, entry for Simvastatin in the form Tablet 40 mg

(a)      omit:

 

 

 

Simvastatin Pfizer

FZ

MP

C1540 C3047

P1540

30

5

30

 

 

 

 

 

 

 

NP

C1540

 

30

5

30

 

 

(b)      omit:

 

 

 

Simvastatin Pfizer

FZ

MP

C1540 C3047

P3047

30

11

30

 

 

[143]       Schedule 1, entry for Simvastatin in the form Tablet 80 mg

(a)      omit:

 

 

 

Simvastatin Pfizer

FZ

MP

C1540 C3047

P1540

30

5

30

 

 

 

 

 

 

 

NP

C1540

 

30

5

30

 

 

(b)      omit:

 

 

 

Simvastatin Pfizer

FZ

MP

C1540 C3047

P3047

30

11

30

 

 

[144]        Schedule 1, after entry for Sitagliptin with metformin in the form Tablet containing 50 mg sitagliptin (as phosphate monohydrate) with 1000 mg metformin hydrochloride

insert:

Sitagliptin with simvastatin

Tablet 100 mg (as phosphate monohydrate)-10 mg

Oral

Juvicor

MK

MP NP

C4183

 

28

5

28

 

 

Tablet 100 mg (as phosphate monohydrate)-20 mg

Oral

Juvicor

MK

MP NP

C4183

 

28

5

28

 

 

 

Tablet 100 mg (as phosphate monohydrate)-40 mg

Oral

Juvicor

MK

MP NP

C4183

 

28

5

28

 

 

[145]       Schedule 1, entry for Sumatriptan

substitute:

Sumatriptan

Tablet 50 mg (as succinate)

Oral

APO-Sumatriptan

TX

MP NP

C3233

 

4

5

2

 

 

 

 

 

Chem mart Sumatriptan

CH

MP NP

C3233

 

4

5

2

 

 

 

 

 

Imigran

LN

MP NP

C3233

 

4

5

2

 

 

 

 

 

Sumagran 50

QA

MP NP

C3233

 

4

5

2

 

 

 

 

 

Sumagran Aspen 50

AS

MP NP

C3233

 

4

5

2

 

 

 

 

 

Sumatab

AF

MP NP

C3233

 

4

5

2

 

 

 

 

 

Terry White Chemists Sumatriptan

TW

MP NP

C3233

 

4

5

2

 

 

 

 

 

APO-Sumatriptan

TX

MP NP

C3233

 

4

5

4

 

 

 

 

 

Chem mart Sumatriptan

CH

MP NP

C3233

 

4

5

4

 

 

 

 

 

Pharmacor Sumatriptan 50

CR

MP NP