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PB 9 of 2014 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, section 100 only status and prescriber bag only status.
Administered by: Health
Registered 17 Feb 2014
Tabling HistoryDate
Tabled HR24-Feb-2014
Tabled Senate03-Mar-2014
Date of repeal 02 Mar 2014
Repealed by Division 1 of Part 5A of the Legislative Instruments Act 2003

PB 9 of 2014

National Health (Listing of Pharmaceutical Benefits) Amendment Instrument 2014
(No. 2)

National Health Act 1953

I, FELICITY McNEILL, First Assistant Secretary, Pharmaceutical Benefits Division, Department of Health, 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 12th February 2014

 

 

 

 

 

 

 

 

 

 

 

FELICITY McNEILL

First Assistant Secretary

Pharmaceutical Benefits Division

Department of Health


 


1          Name of Instrument

            (1)        This Instrument is the National Health (Listing of Pharmaceutical Benefits) Amendment Instrument 2014 (No. 2).

            (2)        This Instrument may also be cited as PB 9 of 2014.

2          Commencement

This Instrument commences on 1 March 2014.

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 Amino acid formula with vitamins and minerals without phenylalanine

omit:

 

Oral powder 400 g (Phenex‑2)

Oral

Phenex-2

AB

MP NP

C4295

 

8

5

1

 

[2]           Schedule 1, entry for Amlodipine in each of the forms: Tablet 5 mg (as besylate); and Tablet 10 mg (as besylate)

omit:

 

 

 

Amlodipine Pfizer

FZ

MP NP

 

30

5

30

 

[3]           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) [Maximum Quantity: 10; Number of Repeats: 0]

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

 

 

 

Clavam 875 mg/125 mg

NJ

PDP

C1836 C1837

 

10

0

10

 

 

[4]           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) [Maximum Quantity: 10; Number of Repeats: 1]

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

 

 

 

Clavam 875 mg/125 mg

NJ

MP NP

C1836 C1837

 

10

1

10

 

 

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

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

 

 

 

Azastrole

ER

MP NP

C2213

 

30

5

30

 

 

[6]           Schedule 1, after entry for Aprepitant

insert:

Arachidonic acid and docosahexaenoic acid with carbohydrate

Sachets of oral powder 4 g containing 200 mg arachidonic acid and 100 mg  docosahexaenoic acid , 30 (keyomega)

Oral

keyomega

VF

MP NP

C4434

 

4

5

1

 

[7]           Schedule 1, entry for Bicalutamide in the form Tablet 50 mg

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

 

 

 

Bicalox

ER

MP NP

C3674

 

28

5

28

 

 

[8]           Schedule 1, after entry for Bimatoprost in the form Eye drops 300 micrograms per mL, 3 mL

insert in the columns in the order indicated:

 

Eye drops 300 micrograms per mL, single dose units 0.4 mL, 30

Application to the eye

Lumigan PF

AG

MP AO

 

1

5

1

 

[9]           Schedule 1, entry for Carbohydrate, fat, vitamins, minerals and trace elements

omit from the column headed “Circumstances”:          C1276   substitute:          C4438

[10]         Schedule 1, after entry for Carbohydrate, fat, vitamins, minerals and trace elements

insert:

Carbohydrate, fat, vitamins, minerals and trace elements and supplemented with arachidonic acid and docosahexaenoic acid

Sachets containing oral powder 21.5 g, 30 (basecal 100)

Oral

basecal 100

VF

MP NP

C4438

 

4

5

1

 

 

Sachets containing oral powder 43 g, 30 (basecal 200)

Oral

basecal 200

VF

MP NP

C4438

 

4

5

1

 

 

[11]         Schedule 1, entry for Carboplatin in the form Solution for I.V. injection 150 mg in 15 mL

omit:

 

 

 

Pfizer Australia Pty Ltd

PF

MP

 

See Note 3

See
Note 3

1

D(100)

[12]         Schedule 1, entry for Cisplatin in each of the forms: I.V. injection 50 mg in 50 mL; and I.V. injection 100 mg in 100 mL

omit:

 

 

 

Pfizer Australia Pty Ltd

PF

MP

 

See Note 3

See
Note 3

1

D(100)

[13]         Schedule 1, entry for Dicloxacillin in the form Capsule 500 mg (as sodium)

omit:

 

 

 

Diclocil

BQ

MP NP MW PDP

C1345

 

24

0

24

 

[14]         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 “Responsible Person”:                 YA        substitute:             AF


 

[15]         Schedule 1, after 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

insert:

Docosahexaenoic acid with carbohydrate

Sachets of oral powder 4 g containing 200 mg docosahexaenoic acid, 30 (docomega)

Oral

docomega

VF

MP NP

C4434

 

4

5

1

 

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

omit:

 

 

 

Epirubicin Kabi

PK

MP

 

See Note 3

See
Note 3

1

D(100)

[17]         Schedule 1, entry for Felodipine in each of the forms: Tablet 2.5 mg (extended release); Tablet 5 mg (extended release); and
Tablet 10 mg (extended release)

omit from the column headed “Responsible Person” for the brand “Plendil ER”:              AP        substitute:             GX

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

omit:

 

 

 

AS-Fludarabine

YA

MP

C3887

 

See Note 3

See
Note 3

1

PB(100)

[19]         Schedule 1, entry for Gabapentin in each of the forms: Capsule 100 mg; Capsule 300 mg; and Capsule 400 mg

omit:

 

 

 

Gabapentin Pfizer

FZ

MP NP

C2664

 

100

5

100

 

 

[20]         Schedule 1, entry for Gabapentin in the form Tablet 800 mg

omit:

 

 

 

Gabapentin Pfizer

FZ

MP NP

C2664

 

100

5

100

 

 

[21]         Schedule 1, entry for Gemcitabine in the form Powder for I.V. infusion 200 mg (as hydrochloride)

omit:

 

 

 

Gemcitabine Kabi

PK

MP

 

See Note 3

See
Note 3

1

D(100)

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

omit:

 

 

 

Gemcitabine-AS

YA

MP

 

See Note 3

See
Note 3

1

D(100)


 

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

omit:

 

 

 

Gemcitabine-AS

YA

MP

 

See Note 3

See
Note 3

1

D(100)

[24]         Schedule 1, entry for Gemcitabine in the form Powder for I.V. infusion 2 g (as hydrochloride)

omit:

 

 

 

Gemcitabine Kabi

PK

MP

 

See Note 3

See
Note 3

1

D(100)

[25]         Schedule 1, entry for Imiquimod in the form Cream 50 mg per g, 250 mg single use sachets, 12

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

 

 

 

Aldiq

QA

MP

C4229

 

1

1

1

 

 

[26]         Schedule 1, entry for Irinotecan in the form I.V. injection containing irinotecan hydrochloride trihydrate 40 mg in 2 mL

omit:

 

 

 

Irinotecan Kabi

PK

MP

C3184

 

See Note 3

See
Note 3

1

D(100)

[27]         Schedule 1, entry for Lactulose in the form Solution BP 3.34 g per 5 mL, 500 mL

(a)      omit:

 

 

 

Lactocur

SZ

MP NP

C1150 C1613 C3642 C3643

P3643

3

0

1

 

(b)      omit:

 

 

 

Lactocur

SZ

MP NP

C1150 C1613 C3642 C3643

P3642

3

3

1

 

(c)      omit:

 

 

 

Lactocur

SZ

MP NP

C1150 C1613 C3642 C3643

P1150 P1613

1

5

1

 

[28]         Schedule 1, after entry for Linagliptin

insert:

Linagliptin with metformin

Tablet containing 2.5 mg linagliptin with 500 mg metformin hydrochloride

Oral

Trajentamet

BY

MP NP

C4423 C4448

 

60

5

60

 

 

Tablet containing 2.5 mg linagliptin with 850 mg metformin hydrochloride

Oral

Trajentamet

BY

MP NP

C4423 C4448

 

60

5

60

 

 

 

Tablet containing 2.5 mg linagliptin with 1000 mg metformin hydrochloride

Oral

Trajentamet

BY

MP NP

C4423 C4448

 

60

5

60

 

 

[29]         Schedule 1, entry for Lisinopril in the form Tablet 5 mg

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

 

 

 

Auro‑Lisinopril 5

DO

MP NP

 

 

30

5

30

 

 

[30]         Schedule 1, entry for Lisinopril in the form Tablet 10 mg

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

 

 

 

Auro-Lisinopril 10

DO

MP NP

 

 

30

5

30

 

 

[31]         Schedule 1, entry for Lisinopril in the form Tablet 20 mg

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

 

 

 

Auro-Lisinopril 20

DO

MP NP

 

 

30

5

30

 

 

[32]         Schedule 1, entry for Mitozantrone in the form Injection 20 mg (as hydrochloride) in 10 mL

omit:

 

 

 

Pfizer Australia Pty Ltd

PF

MP

 

See Note 3

See
Note 3

1

D(100)

[33]         Schedule 1, entry for Nevirapine in the form Tablet 200 mg

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

 

 

 

Nevipin

GN

MP
See Note 1

C3586 C3587 C3588 C3589

 

120

5

60

 

D(100)

[34]         Schedule 1, entry for Olanzapine in the form Tablet 2.5 mg

omit:

 

 

 

Zylap 2.5

QA

MP NP

C1589 C2044

 

28

5

28

 

[35]         Schedule 1, entry for Olanzapine in the form Tablet 5 mg

omit:

 

 

 

Zylap 5

QA

MP NP

C1589 C2044

 

28

5

28

 

[36]         Schedule 1, entry for Olanzapine in the form Tablet 7.5 mg

omit:

 

 

 

Zylap 7.5

QA

MP NP

C1589 C2044

 

28

5

28

 

[37]         Schedule 1, entry for Olanzapine in the form Tablet 10 mg

omit:

 

 

 

Zylap 10

QA

MP NP

C1589 C2044

 

28

5

28

 

[38]         Schedule 1, entry for Olanzapine in the form Tablet 5 mg (orally disintegrating)

omit:

 

 

 

Zylap ODT 5

QA

MP NP

C1589 C2044

 

28

5

28

 

[39]         Schedule 1, entry for Olanzapine in the form Tablet 10 mg (orally disintegrating)

omit:

 

 

 

Zylap ODT 10

QA

MP NP

C1589 C2044

 

28

5

28

 

[40]         Schedule 1, entry for Oxaliplatin in the form Solution concentrate for I.V. infusion 50 mg in 10 mL

omit:

 

 

 

Oxaliplatin Kabi

PK

MP

C3900 C3901 C3930 C3939

 

See Note 3

See
Note 3

1

D(100)

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

omit:

 

 

 

Taxol

BQ

MP

C3186 C3890 C3902 C3917 C3955 C3956

 

See Note 3

See
Note 3

1

D(100)

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

(a)      omit:

 

 

 

Paclitaxel Kabi

PK

MP

C3186 C3890 C3902 C3917 C3955 C3956

 

See Note 3

See
Note 3

1

D(100)

(b)      omit:

 

 

 

Taxol

BQ

MP

C3186 C3890 C3902 C3917 C3955 C3956

 

See Note 3

See
Note 3

1

D(100)

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

omit:

 

 

 

Taxol

BQ

MP

C3186 C3890 C3902 C3917 C3955 C3956

 

See Note 3

See
Note 3

1

D(100)

[44]         Schedule 1, entry for Pantoprazole in the form Tablet (enteric coated) 40 mg (as sodium sesquihydrate) [Maximum Quantity: 30;
Number of Repeats: 2]

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

 

 

 

Topra 40

DO

MP NP

C1177 C1337 C1476 C1533

P1177

30

2

30

 

 

[45]         Schedule 1, entry for Pantoprazole in the form Tablet (enteric coated) 40 mg (as sodium sesquihydrate) [Maximum Quantity: 30;
Number of Repeats: 5]

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

 

 

 

Topra 40

DO

MP NP

C1177 C1337 C1476 C1533

P1337 P1476 P1533

30

5

30

 

 

[46]         Schedule 1, entry for Pazopanib in the form Tablet 200 mg (as hydrochloride) [Maximum Quantity: 30; Number of Repeats: 5]

(a)      insert in numerical order in the column headed “Circumstances”:               C4435  C4439  C4444

(b)      insert in numerical order in the column headed “Purposes”:         P4439

[47]         Schedule 1, entry for Pazopanib in the form Tablet 200 mg (as hydrochloride) [Maximum Quantity: 90; Number of Repeats: 2]

(a)      insert in numerical order in the column headed “Circumstances”:               C4435  C4439  C4444

(b)      insert in numerical order in the column headed “Purposes”:         P4444

[48]         Schedule 1, entry for Pazopanib in the form Tablet 200 mg (as hydrochloride) [Maximum Quantity: 90; Number of Repeats: 5]

(a)      insert in numerical order in the column headed “Circumstances”:               C4435  C4439  C4444

(b)      insert in numerical order in the column headed “Purposes”:         P4435

[49]         Schedule 1, entry for Pazopanib in the form Tablet 400 mg (as hydrochloride) [Maximum Quantity: 30; Number of Repeats: 5]

(a)      insert in numerical order in the column headed “Circumstances”:               C4435  C4439  C4444

(b)      insert in numerical order in the column headed “Purposes”:         P4439

[50]         Schedule 1, entry for Pazopanib in the form Tablet 400 mg (as hydrochloride) [Maximum Quantity: 60; Number of Repeats: 2]

(a)      insert in numerical order in the column headed “Circumstances”:               C4435  C4439  C4444

(b)      insert in numerical order in the column headed “Purposes”:         P4444

[51]         Schedule 1, entry for Pazopanib in the form Tablet 400 mg (as hydrochloride) [Maximum Quantity: 60; Number of Repeats: 5]

(a)      insert in numerical order in the column headed “Circumstances”:               C4435  C4439  C4444

(b)      insert in numerical order in the column headed “Purposes”:         P4435

[52]         Schedule 1, entry for Quinapril in each of the forms: Tablet 5 mg (as hydrochloride); Tablet 10 mg (as hydrochloride); and Tablet 20 mg
(as hydrochloride)

omit:

 

 

 

Quinapril Pfizer

FZ

MP NP

 

30

5

30

 

[53]         Schedule 1, entry for Risperidone in the form Tablet 0.5 mg [Maximum Quantity: 60; Number of Repeats: 2]

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

 

 

 

Rispernia

ER

MP NP

C1589 C2061 C3083

P2061 P3083

60

2

60

 

 

[54]         Schedule 1, entry for Risperidone in the form Tablet 0.5 mg [Maximum Quantity: 60; Number of Repeats: 5]

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

 

 

 

Rispernia

ER

MP NP

C1589 C2061 C3083

P1589

60

5

60

 

 

[55]         Schedule 1, entry for Risperidone in the form Tablet 1 mg [Maximum Quantity: 60; Number of Repeats: 2]

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

 

 

 

Rispernia

ER

MP NP

C1589 C2061 C2272 C3083

P2061 P3083

60

2

60

 

 

[56]         Schedule 1, entry for Risperidone in the form Tablet 1 mg [Maximum Quantity: 60; Number of Repeats: 5]

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

 

 

 

Rispernia

ER

MP NP

C1589 C2061 C2272 C3083

P1589 P2272

60

5

60

 

 

[57]         Schedule 1, entry for Risperidone in the form Tablet 2 mg [Maximum Quantity: 60; Number of Repeats: 2]

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

 

 

 

Rispernia

ER

MP NP

C1589 C2272 C3083

P3083

60

2

60

 

 

[58]         Schedule 1, entry for Risperidone in the form Tablet 2 mg [Maximum Quantity: 60; Number of Repeats: 5]

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

 

 

 

Rispernia

ER

MP NP

C1589 C2272 C3083

P1589 P2272

60

5

60

 

 

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

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

 

 

 

Rispernia

ER

MP NP

C1589 C2272

 

60

5

60

 

 

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

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

 

 

 

Rispernia

ER

MP NP

C1589 C2272

 

60

5

60

 

 


 

[61]         Schedule 1, after entry for Saxagliptin

insert:

Saxagliptin with metformin

Tablet (modified release) containing 2.5 mg saxagliptin (as hydrochloride) with 1000 mg metformin hydrochloride

Oral

Kombiglyze XR 2.5/1000

BQ

MP NP

C4423 C4451

 

56

5

56

 

 

Tablet (modified release) containing 5 mg saxagliptin (as hydrochloride) with 500 mg metformin hydrochloride

Oral

Kombiglyze XR 5/500

BQ

MP NP

C4423 C4451

 

28

5

28

 

 

 

Tablet (modified release) containing 5 mg saxagliptin (as hydrochloride) with 1000 mg metformin hydrochloride

Oral

Kombiglyze XR 5/1000

BQ

MP NP

C4423 C4451

 

28

5

28

 

 

[62]         Schedule 1, entry for Sertraline in the form Tablet 50 mg (as hydrochloride)

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

 

 

 

Sertraline Actavis

UA

MP NP

C1211 C1241 C1975

 

30

5

30

 

(b)      omit:

 

 

 

Sertraline‑GA

UA

MP NP

C1211

 

30

5

30

 

(c)      omit:

 

 

 

Sertraline Pfizer

FZ

MP NP

C1211 C1241 C1975

 

30

5

30

 

[63]         Schedule 1, entry for Sertraline in the form Tablet 100 mg (as hydrochloride)

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

 

 

 

Sertraline Actavis

UA

MP NP

C1211 C1241 C1975

 

30

5

30

 

(b)      omit:

 

 

 

Sertraline‑GA

UA

MP NP

C1211

 

30

5

30

 

(c)      omit:

 

 

 

Sertraline Pfizer

FZ

MP NP

C1211 C1241 C1975

 

30

5

30

 

[64]         Schedule 1, entry for Somatropin

omit:

 

Injection 5 mg (15 i.u.) in 1 mL cartridge (with preservative)

Injection

Genotropin

PF

MP
See Note 1

See Note 3

See Note 3

See Note 3

See
Note 3

1

 

D(100)

[65]         Schedule 1, entry for Temozolomide in the form Capsule 5 mg [Maximum Quantity: 5; Number of Repeats: 5]

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

 

 

 

Temozolomide Alphapharm

AF

MP

C1736 C1737 C2100 C2101

P1736 P1737 P2101

5

5

5

 

 

[66]         Schedule 1, entry for Temozolomide in the form Capsule 5 mg [Maximum Quantity: 15; Number of Repeats: 2]

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

 

 

 

Temozolomide Alphapharm

AF

MP

C1736 C1737 C2100 C2101

P2100

15

2

5

 

 

[67]         Schedule 1, entry for Temozolomide in the form Capsule 20 mg [Maximum Quantity: 5; Number of Repeats: 5]

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

 

 

 

Temozolomide Alphapharm

AF

MP

C1736 C1737 C2100 C2101

P1736 P1737 P2101

5

5

5

 

 

[68]         Schedule 1, entry for Temozolomide in the form Capsule 20 mg [Maximum Quantity: 15; Number of Repeats: 2]

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

 

 

 

Temozolomide Alphapharm

AF

MP

C1736 C1737 C2100 C2101

P2100

15

2

5

 

 

[69]         Schedule 1, entry for Temozolomide in the form Capsule 100 mg [Maximum Quantity: 5; Number of Repeats: 5]

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

 

 

 

Temozolomide Alphapharm

AF

MP

C1736 C1737 C2100 C2101

P1736 P1737 P2101

5

5

5

 

 

[70]         Schedule 1, entry for Temozolomide in the form Capsule 100 mg [Maximum Quantity: 15; Number of Repeats: 2]

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

 

 

 

Temozolomide Alphapharm

AF

MP

C1736 C1737 C2100 C2101

P2100

15

2

5

 

 

[71]         Schedule 1, entry for Temozolomide in the form Capsule 140 mg [Maximum Quantity: 5; Number of Repeats: 5]

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

 

 

 

Temozolomide Alphapharm

AF

MP

C1736 C1737 C2100 C2101

P1736 P1737 P2101

5

5

5

 

 

[72]         Schedule 1, entry for Temozolomide in the form Capsule 140 mg [Maximum Quantity: 15; Number of Repeats: 2]

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

 

 

 

Temozolomide Alphapharm

AF

MP

C1736 C1737 C2100 C2101

P2100

15

2

5

 

 

[73]         Schedule 1, entry for Temozolomide in the form Capsule 250 mg

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

 

 

 

Temozolomide Alphapharm

AF

MP

C1736 C1737 C2101

 

5

5

5

 

 

[74]         Schedule 1, entry for Terbutaline

omit:

 

Powder for oral inhalation in breath actuated device containing terbutaline sulfate 500 micrograms per dose, 200 doses

Inhalation by mouth

Bricanyl Turbuhaler

AP

MP NP

 

 

1

5

1

 

 

[75]         Schedule 1, entry for Topotecan in the form Powder for I.V. infusion 4 mg (as hydrochloride)

omit from the column headed “Responsible Person” for the brand “Topotecan Agila”:    YA        substitute:             AF

[76]         Schedule 1, after entry for Trifluoperazine in the form Tablet 5 mg (as hydrochloride)

insert:

Triglycerides, long chain

Oral liquid 250 mL, 18 (carbzero)

Oral

carbzero

VF

MP NP

C4437

 

2

5

1

 

 

[77]         Schedule 1, after entry for Triglycerides, medium chain in the form Oral emulsion 250 mL (Liquigen)

insert in the columns in the order indicated:

 

Oral liquid 250 mL, 18 (betaquik)

Oral

betaquik

VF

MP NP

C4443 C4447

 

2

5

1

 

 

 

[78]         Schedule 3, after details relevant to Responsible Person code NI

insert:

NJ

Norac Pharma Australia Pty Ltd

 22 164 670 008

[79]         Schedule 3

omit:

YA

Agila Australasia Pty Ltd

 12 154 055 339

 

[80]         Schedule 4, Part 1, after entry for Aprepitant

insert:

Arachidonic acid and docosahexaenoic acid with carbohydrate

C4434

 

 

Peroxisomal biogenesis disorders

Compliance with Authority Required procedures

[81]         Schedule 4, Part 1, entry for Carbohydrate, fat, vitamins, minerals and trace elements

substitute:

Carbohydrate, fat, vitamins, minerals and trace elements

C4438

 

 

Proven inborn errors of protein metabolism

Patient must be unable to meet their energy requirements with permitted food and formulae

 

[82]         Schedule 4, Part 1, after entry for Carbohydrate, fat, vitamins, minerals and trace elements

insert:

Carbohydrate, fat, vitamins, minerals and trace elements and supplemented with arachidonic acid and docosahexaenoic acid

C4438

 

 

Proven inborn errors of protein metabolism

Patient must be unable to meet their energy requirements with permitted food and formulae

 

[83]         Schedule 4, Part 1, after entry for Docetaxel

insert:

Docosahexaenoic acid with carbohydrate

C4434

 

 

Peroxisomal biogenesis disorders

Compliance with Authority Required procedures

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

insert:

Linagliptin with metformin

C4423

 

 

Diabetes mellitus type 2

Patient must have, or have had, a HbA1c measurement greater than 7% despite treatment with metformin; 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 despite treatment with metformin

The date and level of the qualifying HbA1c measurement must be, or must have been, documented in the patient's medical records at the time treatment with a dipeptidyl peptidase 4 inhibitor (gliptin), a thiazolidinedione (glitazone), a glucagon-like peptide-1 or a sodium-glucose co-transporter 2 (SGLT2) inhibitor is initiated

The HbA1c must be no more than 4 months old at the time treatment with a gliptin, a glitazone, a glucagon-like peptide-1 or an SGLT2 inhibitor was initiated

Blood glucose monitoring may be used as an alternative assessment to HbA1c levels in the following circumstances:

(a) A clinical condition with reduced red blood cell survival, including haemolytic anaemias and haemoglobinopathies; and/or
(b) Had red cell transfusion within the previous 3 months

The results of the blood glucose monitoring, which must be no more than 4 months old at the time of initiation of treatment with a gliptin, a glitazone, a glucagon-like peptide-1 or an SGLT2 inhibitor, must be documented in the patient's medical records

A patient whose diabetes was previously demonstrated unable to be controlled with metformin does not need to requalify on this criterion before being eligible for PBS-subsidised treatment with this fixed dose combination

Compliance with Authority Required procedures - Streamlined Authority Code 4423


 

C4448

 

 

Diabetes mellitus type 2

Continuing treatment

Patient must have previously received and been stabilised on a PBS-subsidised regimen of oral diabetic medicines which includes metformin and linagliptin

Compliance with Authority Required procedures - Streamlined Authority Code 4448

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

insert in numerical order following existing text:

 

C4435

P4435

 

Advanced (unresectable and/or metastatic) soft tissue sarcoma

Continuing treatment beyond 3 months

Patient must have previously been issued with an authority prescription for pazopanib; AND
Patient must have stable or responding disease according to the Response Evaluation Criteria In Solid Tumours (RECIST); AND
The treatment must be the sole PBS-subsidised therapy for this condition

Applications for continuing therapy may be made by telephone

Compliance with Authority Required procedures

 

C4439

P4439

 

Advanced (unresectable and/or metastatic) soft tissue sarcoma

Continuing treatment beyond 3 months

Patient must have previously been issued with an authority prescription for pazopanib; AND
Patient must have stable or responding disease according to the Response Evaluation Criteria In Solid Tumours (RECIST); AND
Patient must require dose adjustment; AND
The treatment must be the sole PBS-subsidised therapy for this condition

Applications for continuing therapy may be made by telephone

Compliance with Authority Required procedures

 

C4444

P4444

 

Advanced (unresectable and/or metastatic) soft tissue sarcoma

Initial treatment

Patient must have a WHO performance status of 2 or less; AND
Patient must have received prior chemotherapy treatment including an anthracycline; AND
Patient must not have received prior treatment with an angiogenesis inhibitor; AND
The treatment must be the sole PBS-subsidised therapy for this condition

Patient must not have any of the following conditions:

adipocytic soft tissue sarcoma;
gastrointestinal stromal tumour (GIST);
rhabdomyosarcoma other than alveolar or pleomorphic;
chondrosarcoma;
osteosarcoma;
Ewings tumour/primitive neuroectodermal tumour;
dermofibromatosis sarcoma protuberans;
inflammatory myofibroblastic sarcoma;
malignant mesothelioma;
mixed mesodermal tumour of the uterus

The authority application must be made in writing

Compliance with written Authority Required procedures

[86]         Schedule 4, Part 1, after entry for Saxagliptin

insert:

Saxagliptin with metformin

C4423

 

 

Diabetes mellitus type 2

Patient must have, or have had, a HbA1c measurement greater than 7% despite treatment with metformin; 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 despite treatment with metformin

The date and level of the qualifying HbA1c measurement must be, or must have been, documented in the patient's medical records at the time treatment with a dipeptidyl peptidase 4 inhibitor (gliptin), a thiazolidinedione (glitazone), a glucagon-like peptide-1 or a sodium-glucose co-transporter 2 (SGLT2) inhibitor is initiated

The HbA1c must be no more than 4 months old at the time treatment with a gliptin, a glitazone, a glucagon-like peptide-1 or an SGLT2 inhibitor was initiated

Blood glucose monitoring may be used as an alternative assessment to HbA1c levels in the following circumstances:

(a) A clinical condition with reduced red blood cell survival, including haemolytic anaemias and haemoglobinopathies; and/or
(b) Had red cell transfusion within the previous 3 months

The results of the blood glucose monitoring, which must be no more than 4 months old at the time of initiation of treatment with a gliptin, a glitazone, a glucagon-like peptide-1 or an SGLT2 inhibitor, must be documented in the patient's medical records

A patient whose diabetes was previously demonstrated unable to be controlled with metformin does not need to requalify on this criterion before being eligible for PBS-subsidised treatment with this fixed dose combination

Compliance with Authority Required procedures - Streamlined Authority Code 4423


 

C4451

 

 

Diabetes mellitus type 2

Continuing treatment

Patient must have previously received and been stabilised on a PBS-subsidised regimen of oral diabetic medicines which includes metformin and saxagliptin

Compliance with Authority Required procedures - Streamlined Authority Code 4451

[87]         Schedule 4, Part 1, after entry for Triamcinolone

insert:

Triglycerides, long chain

C4437

 

 

Ketogenic diet

Patient must have intractable seizures requiring treatment with a ketogenic diet; OR
Patient must have a glucose transport protein defect; OR
Patient must have pyruvate dehydrogenase deficiency

Carbzero should only be used under strict supervision of a dietitian, together with a metabolic physician and/or neurologist

 

[88]         Schedule 4, Part 1, entry for Triglycerides, medium chain

insert in numerical order following existing text:

 

C4443

 

 

Ketogenic diet

Patient must have intractable seizures requiring treatment with a ketogenic diet; OR
Patient must have a glucose transport protein defect; OR
Patient must have pyruvate dehydrogenase deficiency

Compliance with Authority Required procedures

 

C4447

 

 

Dietary management of conditions requiring a source of medium chain triglycerides

Patient must have chylous ascites; OR
Patient must have chylothorax; OR
Patient must have hyperlipoproteinaemia type 1; OR
Patient must have long chain fatty acid oxidation disorders; OR
Patient must have fat malabsorption due to liver disease; OR
Patient must have fat malabsorption due to short gut syndrome; OR
Patient must have fat malabsorption due to cystic fibrosis; OR
Patient must have fat malabsorption due to gastrointestinal disorders

Compliance with Authority Required procedures