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PB 96 of 2011 Lists as made
This instrument amends the National Health (Listing of Pharmaceutical Benefits) Instrument 2010 (No. PB 108 of 2010)to make changes to the pharmaceutical benefits listed on the Pharmaceutical Benefits Scheme (PBS) and related matters.
Administered by: Health
Registered 15 Dec 2011
Tabling HistoryDate
Tabled HR07-Feb-2012
Tabled Senate07-Feb-2012
Date of repeal 19 Mar 2014
Repealed by Health (Spent and Redundant Instruments) Repeal Regulation 2014

PB 96 of 2011

National Health (Listing of Pharmaceutical Benefits) Amendment Instrument 2011
(No.14)1

National Health Act 1953

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

Dated                                          9 December 2011

 

 

 

 

 

 

 

 

 

 

 

FELICITY McNEILL

First Assistant Secretary (Acting)

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 2011 (No. 14).

            (2)        This Instrument may also be cited as PB 96 of 2011.

2          Commencement

            This Instrument commences on 1 January 2012.

3          Amendment of the National Health (Listing of Pharmaceutical Benefits) Instrument 2010 (PB 108 of 2010)

            Schedule 1 amends the National Health (Listing of Pharmaceutical Benefits) Instrument 2010 (PB 108 of 2010).



Schedule 1     Amendments

 

[1]           Schedule 1, entry for Aciclovir in the form Tablet 200 mg [Max Quantity 90; Number of Repeats 5]

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

 

 

 

Aciclovir GH

GQ

MP NP

C3633

P3633

90

5

 

[2]           Schedule 1, entry for Amisulpride in the form Tablet 100 mg

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

 

 

 

APO-Amisulpride

TX

MP NP

C1589

 

30

5

 

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

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

 

 

 

APO-Amisulpride

TX

MP NP

C1589

 

60

5

 

[4]           Schedule 1, after entry for Anastrozole

insert:

Apixaban

Tablet 2.5 mg

Oral

Eliquis

BQ

MP NP

C3153 C3154

C3957

P3957

20

0

 

 

 

 

 

 

MP NP

C3153 C3154

C3957

P3154

30

0

 

 

 

 

 

 

MP NP

C3153 C3154

C3957

P3153

60

0

 

[5]           Schedule 1, entry for Carboplatin in the form Solution for I.V. injection 450 mg in 45 mL

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

 

 

 

Carboplatin Kabi

PK

MP

See Note 1

 

 

See Note 3

See Note 3

D

[6]           Schedule 1, entry for Cefaclor in the form Tablet (sustained release) 375 mg (as monohydrate) [Max Quantity 10; Number of Repeats 0]

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

 

 

 

Cefaclor GH

GQ

PDP

 

 

10

0

 


[7]           Schedule 1, entry for Cefaclor in the form Tablet (sustained release) 375 mg (as monohydrate) [Max Quantity 10; Number of Repeats 1]

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

 

 

 

Cefaclor GH

GQ

MP

 

 

10

1

 

[8]           Schedule 1, entry for Docetaxel in the form Solution concentrate for I.V. infusion 140 mg in 7 mL

omit from the column headed “Circumstances”:

C3893

and

C3918

insert in numerical order:

C3955  C3956

[9]           Schedule 1, entry for Docetaxel in the form Solution concentrate for I.V. infusion 160 mg in 16 mL

omit from the column headed “Circumstances”:

C3893

and

C3918

insert in numerical order:

C3955  C3956

[10]         Schedule 1, entry for Docetaxel in each of the forms: Powder for I.V. infusion 20 mg with solvent; and Powder for I.V. infusion 80 mg with solvent

omit from the column headed “Circumstances”:

C3893

insert in numerical order:

C3955


[11]         Schedule 1, entry for Docetaxel in the form Solution concentrate for I.V. infusion 20 mg in 1 mL

omit from the column headed “Circumstances” (twice occurring):

C3893

and

C3918

insert in numerical order:

C3955  C3956

[12]         Schedule 1, entry for Docetaxel in the form Solution concentrate for I.V. infusion 20 mg in 2 mL [DBL Docetaxel Concentrated Injection]

omit from the column headed “Circumstances”:

C3893

and

C3918

insert in numerical order:

C3955  C3956

[13]         Schedule 1, entry for Docetaxel in the form Solution concentrate for I.V. infusion 20 mg in 2 mL [Docetaxel Ebewe]

omit from the column headed “Circumstances”:

C3893

insert in numerical order:

C3955

[14]         Schedule 1, entry for Docetaxel in the form Solution concentrate for I.V. infusion 20 mg in 2 mL [Docetaxel Sandoz]

omit from the column headed “Circumstances”:

C3893

and

C3918

insert in numerical order:

C3955  C3956

[15]         Schedule 1, entry for Docetaxel in the form Injection set containing 1 single use vial concentrate for I.V. infusion 20 mg (anhydrous)
in 0.5 mL with solvent

omit from the column headed “Circumstances”:

C3893

and

C3918

insert in numerical order:

C3955  C3956

[16]         Schedule 1, entry for Docetaxel in the form Solution concentrate for I.V. infusion 80 mg in 4 mL

omit from the column headed “Circumstances” (twice occurring):

C3893

and

C3918

insert in numerical order:

C3955  C3956

[17]         Schedule 1, entry for Docetaxel in the form Solution concentrate for I.V. infusion 80 mg in 8 mL [DBL Docetaxel Concentrated Injection]

omit from the column headed “Circumstances”:

C3893

and

C3918

insert in numerical order:

C3955  C3956


[18]         Schedule 1, entry for Docetaxel in the form Solution concentrate for I.V. infusion 80 mg in 8 mL [Docetaxel Ebewe]

omit from the column headed “Circumstances”:

C3893

insert in numerical order:

C3955

[19]         Schedule 1, entry for Docetaxel in the form Solution concentrate for I.V. infusion 80 mg in 8 mL [Docetaxel Sandoz]

omit from the column headed “Circumstances”:

C3893

and

C3918

insert in numerical order:

C3955  C3956

[20]         Schedule 1, entry for Docetaxel in the form Injection set containing 1 single use vial concentrate for I.V. infusion 80 mg (anhydrous)
in 2 mL with solvent

omit from the column headed “Circumstances”:

C3893

and

C3918

insert in numerical order:

C3955  C3956

[21]         Schedule 1, omit entry for Drotrecogin Alfa (activated)

[22]         Schedule 1, after entry for Epoprostenol in the form Powder for I.V. infusion 500 micrograms (as sodium) with diluent

insert in the columns in the order indicated:

 

Powder for I.V. infusion, 500 micrograms (as sodium) infusion administration set

Injection

Flolan Kit

GK

MP

See Note 1

See Note 3

See Note 3

See Note 3

See Note 3

D

[23]         Schedule 1, after entry for Epoprostenol in the form Powder for I.V. infusion 1.5 mg (as sodium) with diluent

insert in the columns in the order indicated:

 

Powder for I.V. infusion, 1.5 mg (as sodium) infusion administration set

Injection

Flolan Kit

GK

MP

See Note 1

See Note 3

See Note 3

See Note 3

See Note 3

D

[24]         Schedule 1, after entry for Etravirine in the form Tablet 100 mg

insert in the columns in the order indicated:

 

Tablet 200 mg

Oral

Intelence

JC

MP

See Note 1

C3596 C3597

 

120

5

D

[25]         Schedule 1, entry for Exemestane in the form Tablet 25 mg

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

 

 

 

APO-Exemestane

TX

MP NP

C1541 C2457

 

30

5

 

[26]         Schedule 1, entry for Fentanyl in each of the forms: Transdermal patch 2.1 mg; Transdermal patch 4.2 mg; Transdermal patch 8.4 mg; Transdermal patch 12.6 mg; and Transdermal patch 16.8 mg

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

 

 

 

Fentanyl Sandoz

SZ

MP NP

C1062

 

5

0

 

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

(a)        omit from the column headed “Responsible Person” for the brand “Fluohexal”:                               SZ          substitute:                HX

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

 

 

 

Fluoxetine Sandoz

SZ

MP NP

C1211 C1241

 

28

5

 

[28]         Schedule 1, entry for Gemcitabine

omit:

Gemcitabine

Powder for I.V. infusion 200 mg (as hydrochloride)

Injection

DBL Gemcitabine for Injection

HH

MP

See Note 1

C1193 C1194 C1740 C2069 C2141 C3889 C3890 C3906 C3913 C3914

 

See Note 3

See Note 3

D

insert in the columns in the order indicated:

Gemcitabine

Solution for injection 200 mg (as hydrochloride) in 5.3 mL

Injection

DBL Gemcitabine Injection

HH

MP

See Note 1

C1193 C1194 C1740 C2069 C2141 C3889 C3890 C3906 C3913 C3914

 

See Note 3

See Note 3

D

 

Powder for I.V. infusion 200 mg (as hydrochloride)

Injection

DBL Gemcitabine for Injection

HH

MP

See Note 1

C1193 C1194 C1740 C2069 C2141 C3889 C3890 C3906 C3913 C3914

 

See Note 3

See Note 3

D

[29]         Schedule 1, after entry for Gemcitabine in the form Solution concentrate for I.V. infusion 200 mg (as hydrochloride) in 20 mL

insert in the columns in the order indicated:

 

Solution for injection 1 g (as hydrochloride) in 26.3 mL

Injection

DBL Gemcitabine Injection

HH

MP

See Note 1

C1193 C1194 C1740 C2069 C2141 C3889 C3890 C3906 C3913 C3914

 

See Note 3

See Note 3

D

[30]         Schedule 1, after entry for Gemcitabine in the form Solution concentrate for I.V. infusion 1000 mg (as hydrochloride) in 100 mL

insert in the columns in the order indicated:

 

Solution for injection 2 g (as hydrochloride) in 52.6 mL

Injection

DBL Gemcitabine Injection

HH

MP

See Note 1

C1193 C1194 C1740 C2069 C2141 C3889 C3890 C3906 C3913 C3914

 

See Note 3

See Note 3

D

[31]         Schedule 1, entry for Glimepiride in the form Tablet 1 mg

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

 

 

 

Pharmacor Glimepiride 1

CR

MP NP

 

 

30

5

 

[32]         Schedule 1, entry for Glimepiride in the form Tablet 2 mg

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

 

 

 

Pharmacor Glimepiride 2

CR

MP NP

 

 

30

5

 

[33]         Schedule 1, entry for Glimepiride in the form Tablet 3 mg

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

 

 

 

Pharmacor Glimepiride 3

CR

MP NP

 

 

30

5

 

[34]         Schedule 1, entry for Glimepiride in the form Tablet 4 mg

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

 

 

 

Pharmacor Glimepiride 4

CR

MP NP

 

 

30

5

 

[35]         Schedule 1, after entry for Glucose Indicator—Blood in the form Test strips, 25 (On-Call Plus)

insert in the columns in the order indicated:

 

Test strips, 50 (Accu-Chek Aviva)

For external use

Accu-Chek Aviva

RD

MP NP

 

 

2

5

 

 

 

 

 

 

MP

 

P3035

2

11

 

[36]         Schedule 1, after entry for Glucose Indicator—Blood in the form Test strips, 50 (Advantage II)

insert in the columns in the order indicated:

 

Test strips, 50 (AgaMatrix Jazz)

For external use

AgaMatrix Jazz

HE

MP NP

 

 

2

5

 

 

 

 

 

 

MP

 

P3035

2

11

 

[37]         Schedule 1, entry for Glucose Indicator—Blood in the form Test strips, 50

omit:

 

Test strips, 50 (WaveSense Jazz)

For external use

WaveSense Jazz

HE

MP NP

 

 

2

5

 

 

 

 

 

 

MP

 

P3035

2

11

 

[38]         Schedule 1, entry for Glucose Indicator—Blood in the form Test strips, 100 (Optium glucose)

(a)        omit from the column headed “Form”:           (Optium glucose)                            substitute:             (FreeStyle Optium)

(b)        omit from the column headed “Brand”:         Optium glucose                               substitute:             FreeStyle Optium


[39]         Schedule 1, entry for Irinotecan in the form I.V. injection containing irinotecan hydrochloride trihydrate 500 mg in 25 mL

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

 

 

 

Tecan

WQ

MP

See Note 1

C3184

 

See Note 3

See Note 3

D

[40]         Schedule 1, entry for Macrogol 3350 in the form Powder for oral solution 510 g

omit from the column headed “Responsible Person” for the brand “your pharmacy Clear Laxative” (all instances):                                TW         substitute:             OY

[41]         Schedule 1, entry for Meloxicam

omit:

 

Capsule 7.5 mg

Oral

Mobic

BY

MP NP

C1547 C1848

 

30

3

 

 

 

 

Movalis 7.5

QA

MP NP

C1547 C1848

 

30

3

 

 

Capsule 15 mg

Oral

Mobic

BY

MP NP

C1547 C1848

 

30

3

 

 

 

 

Movalis 15

QA

MP NP

C1547 C1848

 

30

3

 

substitute:

 

Capsule 7.5 mg

Oral

APO-Meloxicam

TX

MP NP

C1547 C1848

 

30

3

 

 

 

 

Chem mart Meloxicam

CH

MP NP

C1547 C1848

 

30

3

 

 

 

 

Mobic

BY

MP NP

C1547 C1848

 

30

3

 

 

 

 

Movalis 7.5

QA

MP NP

C1547 C1848

 

30

3

 

 

 

 

Terry White Chemists Meloxicam

TW

MP NP

C1547 C1848

 

30

3

 

 

Capsule 15 mg

Oral

APO-Meloxicam

TX

MP NP

C1547 C1848

 

30

3

 

 

 

 

Chem mart Meloxicam

CH

MP NP

C1547 C1848

 

30

3

 

 

 

 

Mobic

BY

MP NP

C1547 C1848

 

30

3

 

 

 

 

Movalis 15

QA

MP NP

C1547 C1848

 

30

3

 

 

 

 

Terry White Chemists Meloxicam

TW

MP NP

C1547 C1848

 

30

3

 

[42]         Schedule 1, entry for Methylnaltrexone in the form Solution for injection containing methylnaltrexone bromide 12 mg in 0.6 mL

omit from the column headed “Responsible Person”:                 PF          substitute:             LM


[43]         Schedule 1, entry for Nicotine

substitute:

Nicotine

Transdermal patch 17.5 mg

Transdermal

Nicotinell Step 3

NC

MP NP

C3447 C3448

 

28

0

 

 

Transdermal patch 24.9 mg

Transdermal

Nicorette Patch

JT

MP NP

C3042 C3447 C3448

 

28

2

 

 

Transdermal patch 35 mg

Transdermal

Nicotinell Step 2

NC

MP NP

C3447 C3448

 

28

0

 

 

Transdermal patch 52.5 mg

Transdermal

Nicotinell Step 1

NC

MP NP

C3042 C3447 C3448

P3447 P3448

28

0

 

 

 

 

 

 

MP NP

C3042 C3447 C3448

P3042

28

2

 

 

Transdermal patch 114 mg

Transdermal

Nicabate P

GC

MP NP

C3042 C3447 C3448

 

28

2

 

[44]         Schedule 1, entry for Omeprazole in the form Capsule 20 mg [Max Quantity 30; Number of Repeats 1]

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

 

 

 

APO-Omeprazole

TX

MP NP

C1177 C1337 C1476 C1533

P1177

30

1

 

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

 

 

 

Omeprazole Sandoz

HX

MP NP

C1177 C1337 C1476 C1533

P1177

30

1

 

[45]         Schedule 1, entry for Omeprazole in the form Capsule 20 mg [Max Quantity 30; Number of Repeats 5]

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

 

 

 

APO-Omeprazole

TX

MP NP

C1177 C1337 C1476 C1533

P1337 P1476 P1533

30

5

 

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

 

 

 

Omeprazole Sandoz

HX

MP NP

C1177 C1337 C1476 C1533

P1337 P1476 P1533

30

5

 


[46]         Schedule 1, entry for Paclitaxel in the form Solution concentrate for I.V. infusion 30 mg in 5 mL

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

C3893

and

C3918

insert in numerical order:

C3955  C3956

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

 

 

 

Paclitaxel Pfizer

PF

MP

See Note 1

C3186 C3890 C3902 C3917 C3955 C3956

 

See Note 3

See Note 3

D

[47]         Schedule 1, entry for Paclitaxel in the form Solution concentrate for I.V. infusion 100 mg in 16.7 mL

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

C3893

and

C3918

insert in numerical order:

C3955  C3956

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

 

 

 

Paclitaxel Pfizer

PF

MP

See Note 1

C3186 C3890 C3902 C3917 C3955 C3956

 

See Note 3

See Note 3

D

[48]         Schedule 1, entry for Paclitaxel in the form Solution concentrate for I.V. infusion 150 mg in 25 mL

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

C3893

and

C3918

insert in numerical order:

C3955  C3956

[49]         Schedule 1, entry for Paclitaxel in the form Solution concentrate for I.V. infusion 300 mg in 50 mL

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

C3893

and

C3918

insert in numerical order:

C3955  C3956

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

 

 

 

Paclitaxel Pfizer

PF

MP

See Note 1

C3186 C3890 C3902 C3917 C3955 C3956

 

See Note 3

See Note 3

D

[50]         Schedule 1, entry for Paclitaxel, nanoparticle albumin-bound

omit from the column headed “Circumstances”:

C3897

substitute:

C3955  C3956

[51]         Schedule 1, entry for Paracetamol in the form Tablet 500 mg

(a)        omit from the column headed “Responsible Person” for the brand “Chem mart Paracetamol” (all instances):           YM                substitute:             XS

(b)        omit from the column headed “Responsible Person” for the brand “Terry White Chemists Paracetamol” (all instances):                YM         substitute:     YS

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

omit from the column headed “Responsible Person” for the brand “Pharmacor Paroxo 20”:                          CR          substitute:                MI

[53]         Schedule 1, omit entry for Peginterferon Alfa-2b

[54]         Schedule 1, entry for Perindopril with Indapamide in the form Tablet containing perindopril erbumine 4 mg with indapamide hemihydrate 1.25 mg

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

 

 

 

Perindopril/Indapamide GH 4/1.25

GQ

MP NP

C3307

 

30

5

 

[55]         Schedule 1, entry for Phenoxybenzamine in the form Capsules containing phenoxybenzamine hydrochloride 10 mg, 100

omit from the column headed “Responsible Person”:                 GH          substitute:             BZ

[56]         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)

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

 

 

 

Pioglitazone-GA

GM

MP NP

C3540 C3541 C3542

 

28

5

 

[57]         Schedule 1, entry for Pravastatin in the form Tablet containing pravastatin sodium 10 mg [Max Quantity 30; Number of Repeats 5]

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

 

 

 

Pharmacor Pravastat 10

CR

MP

C1540 C3047

P1540

30

5

 

 

 

 

 

 

NP

C1540

 

30

5

 

(b)        omit from the column headed “Responsible Person” for the brand “Pravastatin 10”:                       CR          substitute:                MI

[58]         Schedule 1, entry for Pravastatin in the form Tablet containing pravastatin sodium 10 mg [Max Quantity 30; Number of Repeats 11]

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

 

 

 

Pharmacor Pravastat 10

CR

MP

C1540 C3047

P3047

30

11

 

(b)        omit from the column headed “Responsible Person” for the brand “Pravastatin 10”:                       CR          substitute:                MI

[59]         Schedule 1, entry for Pravastatin in the form Tablet containing pravastatin sodium 20 mg [Max Quantity 30; Number of Repeats 5]

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

 

 

 

Pharmacor Pravastat 20

CR

MP

C1540 C3047

P1540

30

5

 

 

 

 

 

 

NP

C1540

 

30

5

 

(b)        omit from the column headed “Responsible Person” for the brand “Pravastatin 20”:                       CR          substitute:                MI

[60]         Schedule 1, entry for Pravastatin in the form Tablet containing pravastatin sodium 20 mg [Max Quantity 30; Number of Repeats 11]

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

 

 

 

Pharmacor Pravastat 20

CR

MP

C1540 C3047

P3047

30

11

 

(b)        omit from the column headed “Responsible Person” for the brand “Pravastatin 20”:                       CR          substitute:                MI

[61]         Schedule 1, entry for Pravastatin in the form Tablet containing pravastatin sodium 40 mg [Max Quantity 30; Number of Repeats 5]

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

 

 

 

Pharmacor Pravastat 40

CR

MP

C1540 C3047

P1540

30

5

 

 

 

 

 

 

NP

C1540

 

30

5

 

(b)        omit from the column headed “Responsible Person” for the brand “Pravastatin 40”:                       CR          substitute:                MI

[62]         Schedule 1, entry for Pravastatin in the form Tablet containing pravastatin sodium 40 mg [Max Quantity 30; Number of Repeats 11]

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

 

 

 

Pharmacor Pravastat 40

CR

MP

C1540 C3047

P3047

30

11

 

(b)        omit from the column headed “Responsible Person” for the brand “Pravastatin 40”:                       CR          substitute:                MI

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

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

 

 

 

Pharmacor Prozine 5

CR

PDP MP NP

 

 

25

0

 

[64]         Schedule 1, entry for Romiplostin

omit from the column headed “Listed Drug”:               Romiplostin     substitute:             Romiplostim

[65]         Schedule 1, entry for Simvastatin in the form Tablet 5 mg

(a)        omit:

 

 

 

Simvasyn

CR

MP

C1540 C3047

P1540

30

5

 

 

 

 

 

 

NP

C1540

 

30

5

 

(b)        omit:

 

 

 

Simvasyn

CR

MP

C1540 C3047

P3047

30

11

 

[66]         Schedule 1, entry for Simvastatin in the form Tablet 10 mg [Max Quantity 30; Number of Repeats 5]

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

 

 

 

Simvacor 10

CR

MP

C1540 C3047

P1540

30

5

 

 

 

 

 

 

NP

C1540

 

30

5

 

(b)        omit:

 

 

 

Simvasyn

CR

MP

C1540 C3047

P1540

30

5

 

 

 

 

 

 

NP

C1540

 

30

5

 

[67]         Schedule 1, entry for Simvastatin in the form Tablet 10 mg [Max Quantity 30; Number of Repeats 11]

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

 

 

 

Simvacor 10

CR

MP

C1540 C3047

P3047

30

11

 

(b)        omit:

 

 

 

Simvasyn

CR

MP

C1540 C3047

P3047

30

11

 

[68]         Schedule 1, entry for Simvastatin in the form Tablet 20 mg [Max Quantity 30; Number of Repeats 5]

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

 

 

 

Simvacor 20

CR

MP

C1540 C3047

P1540

30

5

 

 

 

 

 

 

NP

C1540

 

30

5

 

(b)        omit:

 

 

 

Simvasyn

CR

MP

C1540 C3047

P1540

30

5

 

 

 

 

 

 

NP

C1540

 

30

5

 

[69]         Schedule 1, entry for Simvastatin in the form Tablet 20 mg [Max Quantity 30; Number of Repeats 11]

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

 

 

 

Simvacor 20

CR

MP

C1540 C3047

P3047

30

11

 

 


(b)        omit:

 

 

 

Simvasyn

CR

MP

C1540 C3047

P3047

30

11

 

[70]         Schedule 1, entry for Simvastatin in the form Tablet 40 mg [Max Quantity 30; Number of Repeats 5]

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

 

 

 

Simvacor 40

CR

MP

C1540 C3047

P1540

30

5

 

 

 

 

 

 

NP

C1540

 

30

5

 

(b)        omit:

 

 

 

Simvasyn

CR

MP

C1540 C3047

P1540

30

5

 

 

 

 

 

 

NP

C1540

 

30

5

 

[71]         Schedule 1, entry for Simvastatin in the form Tablet 40 mg [Max Quantity 30; Number of Repeats 11]

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

 

 

 

Simvacor 40

CR

MP

C1540 C3047

P3047

30

11

 

(b)        omit:

 

 

 

Simvasyn

CR

MP

C1540 C3047

P3047

30

11

 

[72]         Schedule 1, entry for Simvastatin in the form Tablet 80 mg [Max Quantity 30; Number of Repeats 5]

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

 

 

 

Simvacor 80

CR

MP

C1540 C3047

P1540

30

5

 

 

 

 

 

 

NP

C1540

 

30

5

 

(b)        omit from the column headed “Responsible Person” for the brand “Simvahexal”:                             SZ          substitute:                HX

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

 

 

 

Simvastatin Sandoz

SZ

MP

C1540 C3047

P1540

30

5

 

 

 

 

 

 

NP

C1540

 

30

5

 

 


(d)        omit:

 

 

 

Simvasyn

CR

MP

C1540 C3047

P1540

30

5

 

 

 

 

 

 

NP

C1540

 

30

5

 

[73]         Schedule 1, entry for Simvastatin in the form Tablet 80 mg [Max Quantity 30; Number of Repeats 11]

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

 

 

 

Simvacor 80

CR

MP

C1540 C3047

P3047

30

11

 

(b)        omit from the column headed “Responsible Person” for the brand “Simvahexal”:                             SZ          substitute:                HX

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

 

 

 

Simvastatin Sandoz

CR

MP

C1540 C3047

P3047

30

11

 

(d)        omit:

 

 

 

Simvasyn

CR

MP

C1540 C3047

P3047

30

11

 

[74]         Schedule 1, entry for Tacrolimus in the form Capsule 500 micrograms

omit from the column headed “Form”:           Capsule 500 micrograms             substitute:             Capsule 0.5 mg

[75]         Schedule 1, entry for Terbinafine in the form Tablet 250 mg (as hydrochloride)

omit from the column headed “Brand” (twice occurring):         Lamisil        substitute:          Lamisil (Novartis Pharmaceuticals Australia Pty Limited)

[76]         Schedule 1, entry for Testosterone

omit:

 

Injection containing testosterone esters (30 mg testosterone propionate, 60 mg testosterone phenylpropionate, 60 mg testosterone isocaproate, 100 mg testosterone decanoate) in 1 mL

Injection

Sustanon 250

MK

MP

C1021 C1022 C1226

 

3

3

 

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

omit from the column headed “Responsible Person” for the brand “Valacor 500” (twice occurring):                           RA                substitute:             QR


[78]         Schedule 3, after details relevant to Responsible person code BY

insert:

BZ

Boucher & Muir Pty Ltd

 58 000 140 474

[79]         Schedule 3, after details relevant to Responsible person code ON

insert:

OY

Orion Laboratories Pty Ltd

 56 009 293 136

[80]         Schedule 3, after details relevant to Responsible person code QB

insert:

QR

Ranbaxy Australia Pty Limited

 17 110 871 826

[81]         Schedule 3, after details relevant to Responsible person code XF

insert:

XS

Symbion Pty Ltd

 25 000 875 034

[82]         Schedule 3, details relevant to Responsible person code YM

omit:       Symbion Pharmacy Services Pty Ltd    substitute:             Symbion Pty Ltd

[83]         Schedule 3, after details relevant to Responsible person code YN

insert:

YS

Symbion Pty Ltd

 25 000 875 034


[84]         Schedule 4, Part 1, after entry for Anastrozole

insert:

Apixaban

C3153

P3153

Prevention of venous thromboembolism in a patient undergoing total hip replacement

Compliance with Authority Required procedures

 

C3154

P3154

Prevention of venous thromboembolism in a patient undergoing total knee replacement

Compliance with Authority Required procedures

 

C3957

P3957

Prevention of venous thromboembolism in a patient undergoing total knee replacement who requires up to 10 days of therapy

 

Compliance with Authority Required procedures

[85]         Schedule 4, Part 1, entry for Docetaxel

(a)           omit:

 

C3893

 

Advanced breast cancer after failure of prior therapy

Compliance with Authority Required procedures - Streamlined Authority Code 3893

(b)           omit:

 

C3918

 

Treatment of HER2 positive early breast cancer in combination with trastuzumab

Compliance with Authority Required procedures - Streamlined Authority Code 3918

 


(c)           insert after existing text in the columns in the order indicated:

 

C3955

 

Metastatic breast cancer

Compliance with Authority Required procedures - Streamlined Authority Code 3955

 

C3956

 

Treatment of HER2 positive breast cancer in combination with trastuzumab

Compliance with Authority Required procedures - Streamlined Authority Code 3956

[86]         Schedule 4, Part 1, omit entry for Drotrecogin Alfa (activated)

[87]         Schedule 4, Part 1, entry for Nicotine

(a)           insert in the column headed “Purposes” for the circumstances code “C3042”:   P3042

(b)           insert in the column headed “Purposes” for the circumstances code “C3447”:   P3447

(c)           insert in the column headed “Purposes” for the circumstances code “C3448”:   P3448

[88]         Schedule 4, Part 1, entry for Paclitaxel

(a)           omit:

 

C3893

 

Advanced breast cancer after failure of prior therapy

Compliance with Authority Required procedures - Streamlined Authority Code 3893

 


(b)           omit:

 

C3918

 

Treatment of HER2 positive early breast cancer in combination with trastuzumab

Compliance with Authority Required procedures - Streamlined Authority Code 3918

(c)           insert after existing text in the columns in the order indicated:

 

C3955

 

Metastatic breast cancer

Compliance with Authority Required procedures - Streamlined Authority Code 3955

 

C3956

 

Treatment of HER2 positive breast cancer in combination with trastuzumab

Compliance with Authority Required procedures - Streamlined Authority Code 3956

[89]         Schedule 4, Part 1, entry for Paclitaxel, nanoparticle albumin-bound

(a)           omit from the column headed “Circumstances Code”:               C3897                    substitute              C3955

(b)           omit from the column headed “Circumstances and Purposes”:                                after failure of prior therapy

(c)           omit from the column headed “Authority Requirements”:         3897       substitute              3955

(d)        insert after existing text in the columns in the order indicated:

 

C3956

 

Treatment of HER2 positive breast cancer in combination with trastuzumab

Compliance with Authority Required procedures - Streamlined Authority Code 3956

[90]         Schedule 4, Part 1, omit entry for Peginterferon Alfa-2b

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

1Note

All legislative instruments and compilations are registered on the Federal Register of Legislative Instruments kept under the Legislative Instruments Act 2003. 

See http://www.frli.gov.au.