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PB 52 of 2014 Lists as made
This instrument amends the National Health (Listing of Pharmaceutical Benefits) Instrument 2012 (No. PB 71 of 2012) to determine the pharmaceutical benefits that are on the PBS.
Administered by: Health
Made 14 Jul 2014
Registered 31 Jul 2014
Tabled HR 26 Aug 2014
Tabled Senate 26 Aug 2014
Date of repeal 02 Aug 2014
Repealed by Division 1 of Part 5A of the Legislative Instruments Act 2003

PB 52 of 2014

National Health (Listing of Pharmaceutical Benefits) Amendment Instrument 2014
(No. 8)

National Health Act 1953

I, PAUL CREECH, First Assistant Secretary (Acting), 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 14 JULY 2014

 

 

 

 

 

 

 

 

 

 

 

PAUL CREECH

First Assistant Secretary (Acting)

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. 8).

            (2)        This Instrument may also be cited as PB 52 of 2014.

2          Commencement

This Instrument commences on 1 August 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, after entry for Acitretin in the form Capsule 25 mg [Brand: Novatin]

insert:

Aclidinium

Powder for oral inhalation in breath actuated device containing aclidinium bromide 400 micrograms per dose, 60 doses

Inhalation by mouth

Bretaris Genuair

FK

MP NP

C4516

 

1

5

1

 

 

[2]           Schedule 1, entry for Alprazolam in each of the forms: Tablet 250 micrograms; and Tablet 500 micrograms

omit:

 

 

 

Alprazolam Sandoz

SZ

MP NP

C1975

 

50

0

50

 

[3]           Schedule 1, entry for Alprazolam in each of the forms: Tablet 1 mg; and Tablet 2 mg

omit:

 

 

 

Alprazolam Sandoz

SZ

MP NP

C1975

 

50

2

50

 

[4]           Schedule 1, entry for Amiodarone in the form Tablet containing amiodarone hydrochloride 100 mg

omit:

 

 

 

Amiodarone Sandoz

SZ

MP NP

C1350

 

30

5

30

 

[5]           Schedule 1, entry for Atomoxetine in each of the forms: Capsule 10 mg (as hydrochloride); Capsule 18 mg (as hydrochloride);
Capsule 25 mg (as hydrochloride); Capsule 40 mg (as hydrochloride); Capsule 60 mg (as hydrochloride); Capsule 80 mg (as hydrochloride); and Capsule 100 mg (as hydrochloride)

omit from the column headed “Circumstances”:          C3025  C3026  C3027  C3028       substitute:             C4578  C4591

[6]           Schedule 1, after entry for Benzylpenicillin in the form Powder for injection 3 g (as sodium)

insert:

Betaine

Oral powder 180 g

Oral

Cystadane

EU

MP

C4599

 

1

5

1

 

 

[7]           Schedule 1, entry for Bevacizumab in each of the forms: Solution for I.V. infusion 100 mg in 4 mL; and Solution for I.V. infusion 400 mg
in 16 mL

omit from the column headed “Circumstances”:          C3430  C3431  C3894  C3896      

substitute:             C4584  C4585  C4587  C4588  C4589  C4594  C4597  C4598


 

[8]           Schedule 1, entry for Calcium in the form Tablet, chewable, 500 mg (as carbonate)

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

 

 

 

Cal‑500

PP

MP NP

C4586

 

240

1

60

 

 

(b)      omit from the column headed “Circumstances” for the brand “Cal-Sup”:  C2212    substitute:             C4586

[9]           Schedule 1, entry for Calcium in the form Tablet 600 mg (as carbonate)

omit from the column headed “Circumstances”:          C2212    substitute:             C4586

[10]         Schedule 1, entry for Capecitabine

substitute:

Capecitabine

Tablet 150 mg

Oral

Capecitabine Actavis

GN

MP

C1522 C1614 C1738 C1739 C3509 C3942

 

60

2

60

 

 

 

 

 

Capecitabine Alphapharm

AF

MP

C1522 C1614 C1738 C1739 C3509 C3942

 

60

2

60

 

 

 

 

 

Capecitabine-DRLA

RZ

MP

C1522 C1614 C1738 C1739 C3509 C3942

 

60

2

60

 

 

 

 

 

Capecitabine Sandoz

SZ

MP

C1522 C1614 C1738 C1739 C3509 C3942

 

60

2

60

 

 

 

 

 

Xeloda

RO

MP

C1522 C1614 C1738 C1739 C3509 C3942

 

60

2

60

 

 

 

Tablet 500 mg

Oral

Capecitabine Actavis

GN

MP

C1522 C1614 C1738 C1739 C3509 C3942

 

120

2

120

 

 

 

 

 

Capecitabine Alphapharm

AF

MP

C1522 C1614 C1738 C1739 C3509 C3942

 

120

2

120

 

 

 

 

 

Capecitabine Apotex

TX

MP

C1522 C1614 C1738 C1739 C3509 C3942

 

120

2

120

 

 

 

 

 

Capecitabine-DRLA

RZ

MP

C1522 C1614 C1738 C1739 C3509 C3942

 

120

2

120

 

 

 

 

 

Capecitabine GH

GQ

MP

C1522 C1614 C1738 C1739 C3509 C3942

 

120

2

120

 

 

 

 

 

Capecitabine Sandoz

SZ

MP

C1522 C1614 C1738 C1739 C3509 C3942

 

120

2

120

 

 

 

 

 

Xeloda

RO

MP

C1522 C1614 C1738 C1739 C3509 C3942

 

120

2

120

 

 

[11]         Schedule 1, entry for Captopril in each of the forms: Tablet 12.5 mg; Tablet 25 mg; and Tablet 50 mg

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

 

 

 

APO-Captopril

TX

MP NP

 

 

90

5

90

 

 

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

omit:

 

 

 

Carbaccord

GN

MP

 

 

See Note 3

See
Note 3

1

 

D(100)

[13]         Schedule 1, entry for Cyproterone in the form Tablet containing cyproterone acetate 50 mg [Maximum Quantity: 100;
Number of Repeats: 5]

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

 

 

 

Cyrotone

ER

MP

C1014 C1230 C1404

P1014 P1404

100

5

50

 

 

[14]         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

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

 

 

 

Malean

FM

MP NP

 

 

30

5

30

 

 

[15]         Schedule 1, entry for Epirubicin in each of the forms: Solution for injection containing epirubicin hydrochloride 10 mg in 5 mL; Solution for injection containing epirubicin hydrochloride 20 mg in 10 mL; Solution for injection containing epirubicin hydrochloride 50 mg in
25 mL; and Solution for injection containing epirubicin hydrochloride 200 mg in 100 mL

omit:

 

 

 

Epiccord

GN

MP

 

 

See Note 3

See
Note 3

1

 

D(100)

[16]         Schedule 1, after entry for Epoprostenol in the form Powder for I.V. infusion, 500 micrograms (as sodium) infusion administration set

insert in the columns in the order indicated:

 

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

Injection

Veletri

AT

MP
See Note 1

See Note 3

See Note 3

See Note 3

See
Note 3

1

 

D(100)

[17]         Schedule 1, after entry for Epoprostenol in the form Powder for I.V. infusion, 1.5 mg (as sodium) infusion administration set

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

 

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

Injection

Veletri

AT

MP
See Note 1

See Note 3

See Note 3

See Note 3

See
Note 3

1

 

D(100)

[18]         Schedule 1, entry for Erlotinib in each of the forms: Tablet 25 mg (as hydrochloride); Tablet 100 mg (as hydrochloride); and Tablet 150 mg (as hydrochloride)

(a)      omit from the column headed “Circumstances”:               C4481  C4525  C4536     

(b)      insert in numerical order:       C4600

[19]         Schedule 1, entry for Esomeprazole

substitute:

Esomeprazole

Tablet (enteric coated) 20 mg (as magnesium trihydrate)

Oral

Esomeprazole RBX

RA

MP NP

C1337 C1629 C2273 C3429

P2273

30

1

30

 

 

 

 

 

Nexium

AP

MP NP

C1337 C1629 C2273 C3429

P2273

30

1

30

 

 

 

 

 

Esomeprazole RBX

RA

MP NP

C1337 C1629 C2273 C3429

P1337 P1629 P3429

30

5

30

 

 

 

 

 

Nexium

AP

MP NP

C1337 C1629 C2273 C3429

P1337 P1629 P3429

30

5

30

 

 

 

Tablet (enteric coated) 40 mg (as magnesium trihydrate)

Oral

Esomeprazole RBX

RA

MP NP

C1337 C1628 C3429

P1628

30

1

30

 

 

 

 

 

Nexium

AP

MP NP

C1337 C1628 C3429

P1628

30

1

30

 

 

 

 

 

Esomeprazole RBX

RA

MP NP

C1337 C1628 C3429

P1337 P3429

30

5

30

 

 

 

 

 

Nexium

AP

MP NP

C1337 C1628 C3429

P1337 P3429

30

5

30

 

 

[20]         Schedule 1, entry for Fondaparinux

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

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

(a)      omit:

 

 

 

Gemcitabine Actavis

GN

MP

 

 

See Note 3

See
Note 3

1

 

D(100)

(b)      omit:

 

 

 

Gemplan

GN

MP

 

 

See Note 3

See
Note 3

1

 

D(100)

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

omit:

 

 

 

Gemplan

GN

MP

 

 

See Note 3

See
Note 3

1

 

D(100)


 

[23]         Schedule 1, entry for Irbesartan in the form Tablet 75 mg

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

 

 

 

Irprestan 75

ZP

MP NP

 

 

30

5

30

 

 

[24]         Schedule 1, entry for Irbesartan in the form Tablet 150 mg

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

 

 

 

Irprestan 150

ZP

MP NP

 

 

30

5

30

 

 

[25]         Schedule 1, entry for Irbesartan in the form Tablet 300 mg

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

 

 

 

Irprestan 300

ZP

MP NP

 

 

30

5

30

 

 

[26]         Schedule 1, entry for Irbesartan with Hydrochlorothiazide in the form Tablet 150 mg-12.5 mg

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

 

 

 

Irbesartan HCT Actavis 150/12.5

UA

MP NP

C4374

 

30

5

30

 

 

[27]         Schedule 1, entry for Irbesartan with Hydrochlorothiazide in the form Tablet 300 mg-25 mg

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

 

 

 

Irbesartan HCT Actavis 300/25

UA

MP NP

C4374

 

30

5

30

 

 

[28]         Schedule 1, entry for Levetiracetam in the form Tablet 250 mg

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

 

 

 

Levi 250

FM

MP NP

C2664

 

60

5

60

 

 

[29]         Schedule 1, entry for Levetiracetam in the form Tablet 500 mg

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

 

 

 

Levi 500

FM

MP NP

C2664

 

60

5

60

 

 

[30]         Schedule 1, entry for Levetiracetam in the form Tablet 1 g

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

 

 

 

Levi 1000

FM

MP NP

C2664

 

60

5

60

 

 


 

[31]         Schedule 1, entry for Macrogol 3350

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

 

Oral liquid 13.125 g with electrolytes, 500 mL

Oral

Movicol Liquid

NE

MP NP

C4576 C4577 C4580 C4590 C4595 C4596 C4601

P4590

2

0

1

 

 

 

 

 

 

 

MP NP

C4576 C4577 C4580 C4590 C4595 C4596 C4601

P4595

2

3

1

 

 

 

 

 

 

 

MP NP

C4576 C4577 C4580 C4590 C4595 C4596 C4601

P4576 P4577 P4580 P4596 P4601

2

5

1

 

 

[32]         Schedule 1, entry for Macrogol 3350

omit:

 

Sachets containing powder for oral solution 13.125 g with electrolytes, 30

Oral

APO‑MACROGOL plus ELECTROLYTES

TX

MP NP
See Note 1

C1263 C1613 C2693 C2823 C3642 C3643
See Note 2

P3643
See Note 2

2
See Note 2

0
See
Note 2

1

 

 

 

 

 

 

 

MP NP
See Note 1

C1263 C1613 C2693 C2823 C3642 C3643
See Note 2

P3642
See Note 2

2
See Note 2

3
See
Note 2

1

 

 

 

 

 

 

 

MP NP
See Note 1

C1263 C1613 C2693 C2823 C3642 C3643
See Note 2

P1263 P1613 P2693 P2823
See Note 2

1
See Note 2

5
See
Note 2

1

 

 

 

 

 

LaxaCon

GN

MP NP
See Note 1

C1263 C1613 C2693 C2823 C3642 C3643
See Note 2

P3643
See Note 2

2
See Note 2

0
See
Note 2

1

 

 

 

 

 

 

 

MP NP
See Note 1

C1263 C1613 C2693 C2823 C3642 C3643
See Note 2

P3642
See Note 2

2
See Note 2

3
See
Note 2

1

 

 

 

 

 

 

 

MP NP
See Note 1

C1263 C1613 C2693 C2823 C3642 C3643
See Note 2

P1263 P1613 P2693 P2823
See Note 2

1
See Note 2

5
See
Note 2

1

 

 

 

 

 

lax‑sachets

AE

MP NP
See Note 1

C1263 C1613 C2693 C2823 C3642 C3643
See Note 2

P3643
See Note 2

2
See Note 2

0
See
Note 2

1

 

 


 

 

 

 

 

 

MP NP
See Note 1

C1263 C1613 C2693 C2823 C3642 C3643
See Note 2

P3642
See Note 2

2
See Note 2

3
See
Note 2

1

 

 

 

 

 

 

 

MP NP
See Note 1

C1263 C1613 C2693 C2823 C3642 C3643
See Note 2

P1263 P1613 P2693 P2823
See Note 2

1
See Note 2

5
See
Note 2

1

 

 

 

 

 

Molaxole

HM

MP NP
See Note 1

C1263 C1613 C2693 C2823 C3642 C3643
See Note 2

P3643
See Note 2

2
See Note 2

0
See
Note 2

1

 

 

 

 

 

 

 

MP NP
See Note 1

C1263 C1613 C2693 C2823 C3642 C3643
See Note 2

P3642
See Note 2

2
See Note 2

3
See
Note 2

1

 

 

 

 

 

 

 

MP NP
See Note 1

C1263 C1613 C2693 C2823 C3642 C3643
See Note 2

P1263 P1613 P2693 P2823
See Note 2

1
See Note 2

5
See
Note 2

1

 

 

 

 

 

Movicol

NE

MP NP
See Note 1

C1263 C1613 C2693 C2823 C3642 C3643
See Note 2

P3643
See Note 2

2
See Note 2

0
See
Note 2

1

 

 

 

 

 

 

 

MP NP
See Note 1

C1263 C1613 C2693 C2823 C3642 C3643
See Note 2

P3642
See Note 2

2
See Note 2

3
See
Note 2

1

 

 

 

 

 

 

 

MP NP
See Note 1

C1263 C1613 C2693 C2823 C3642 C3643
See Note 2

P1263 P1613 P2693 P2823
See Note 2

1
See Note 2

5
See
Note 2

1

 

 

substitute:

 

Sachets containing powder for oral solution 13.125 g with electrolytes, 30

Oral

APO-MACROGOL plus ELECTROLYTES

TX

MP NP
See Note 1

C4576 C4577 C4580 C4590 C4595 C4596 C4601
See Note 2

P4576 P4577 P4580 P4596 P4601
See Note 2

1
See Note 2

5
See
Note 2

1

 

 

 

 

 

LaxaCon

GN

MP NP
See Note 1

C4576 C4577 C4580 C4590 C4595 C4596 C4601
See Note 2

P4576 P4577 P4580 P4596 P4601
See Note 2

1
See Note 2

5
See
Note 2

1

 

 


 

 

 

 

lax-sachets

AE

MP NP
See Note 1

C4576 C4577 C4580 C4590 C4595 C4596 C4601
See Note 2

P4576 P4577 P4580 P4596 P4601
See Note 2

1
See Note 2

5
See
Note 2

1

 

 

 

 

 

Molaxole

HM

MP NP
See Note 1

C4576 C4577 C4580 C4590 C4595 C4596 C4601
See Note 2

P4576 P4577 P4580 P4596 P4601
See Note 2

1
See Note 2

5
See
Note 2

1

 

 

 

 

 

Movicol

NE

MP NP
See Note 1

C4576 C4577 C4580 C4590 C4595 C4596 C4601
See Note 2

P4576 P4577 P4580 P4596 P4601
See Note 2

1
See Note 2

5
See
Note 2

1

 

 

 

 

 

APO-MACROGOL plus ELECTROLYTES

TX

MP NP
See Note 1

C4576 C4577 C4580 C4590 C4595 C4596 C4601
See Note 2

P4590
See Note 2

2
See Note 2

0
See
Note 2

1

 

 

 

 

 

LaxaCon

GN

MP NP
See Note 1

C4576 C4577 C4580 C4590 C4595 C4596 C4601
See Note 2

P4590
See Note 2

2
See Note 2

0
See
Note 2

1

 

 

 

 

 

lax-sachets

AE

MP NP
See Note 1

C4576 C4577 C4580 C4590 C4595 C4596 C4601
See Note 2

P4590
See Note 2

2
See Note 2

0
See
Note 2

1

 

 

 

 

 

Molaxole

HM

MP NP
See Note 1

C4576 C4577 C4580 C4590 C4595 C4596 C4601
See Note 2

P4590
See Note 2

2
See Note 2

0
See
Note 2

1

 

 

 

 

 

Movicol

NE

MP NP
See Note 1

C4576 C4577 C4580 C4590 C4595 C4596 C4601
See Note 2

P4590
See Note 2

2
See Note 2

0
See
Note 2

1

 

 

 

 

 

APO-MACROGOL plus ELECTROLYTES

TX

MP NP
See Note 1

C4576 C4577 C4580 C4590 C4595 C4596 C4601
See Note 2

P4595
See Note 2

2
See Note 2

3
See
Note 2

1

 

 


 

 

 

 

LaxaCon

GN

MP NP
See Note 1

C4576 C4577 C4580 C4590 C4595 C4596 C4601
See Note 2

P4595
See Note 2

2
See Note 2

3
See
Note 2

1

 

 

 

 

 

lax-sachets

AE

MP NP
See Note 1

C4576 C4577 C4580 C4590 C4595 C4596 C4601
See Note 2

P4595
See Note 2

2
See Note 2

3
See
Note 2

1

 

 

 

 

 

Molaxole

HM

MP NP
See Note 1

C4576 C4577 C4580 C4590 C4595 C4596 C4601
See Note 2

P4595
See Note 2

2
See Note 2

3
See
Note 2

1

 

 

 

 

 

Movicol

NE

MP NP
See Note 1

C4576 C4577 C4580 C4590 C4595 C4596 C4601
See Note 2

P4595
See Note 2

2
See Note 2

3
See
Note 2

1

 

 

[33]         Schedule 1, entry for Metoprolol succinate in the form Tablet 23.75 mg (controlled release)

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

 

 

 

Metrol-XL 23.75

QA

MP NP

C3234

 

15

0

15

 

 

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

 

 

 

Minax XL

AF

MP NP

C3234

 

15

0

15

 

 

[34]         Schedule 1, entry for Metoprolol succinate in the form Tablet 47.5 mg (controlled release)

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

 

 

 

Metrol-XL 47.5

QA

MP NP

C3234

 

30

5

30

 

 

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

 

 

 

Minax XL

AF

MP NP

C3234

 

30

5

30

 

 

[35]         Schedule 1, entry for Metoprolol succinate in the form Tablet 95 mg (controlled release)

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

 

 

 

Metrol-XL 95

QA

MP NP

C3234

 

30

5

30

 

 

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

 

 

 

Minax XL

AF

MP NP

C3234

 

30

5

30

 

 


 

[36]         Schedule 1, entry for Metoprolol succinate in the form Tablet 190 mg (controlled release)

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

 

 

 

Metrol-XL 190

QA

MP NP

C3234

 

30

5

30

 

 

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

 

 

 

Minax XL

AF

MP NP

C3234

 

30

5

30

 

 

[37]         Schedule 1, entry for Metronidazole

omit:

 

I.V. infusion 500 mg in 100 mL

Injection

Baxter Healthcare Pty Ltd

BX

MP NP

C4167 C4168 C4169

 

10

0

1

 

 

 

 

 

 

 

PDP

C4169

 

10

0

1

 

 

 

 

 

DBL Metronidazole Intravenous Infusion

HH

MP NP

C4167 C4168 C4169

 

10

0

10

 

 

 

 

 

 

 

PDP

C4169

 

10

0

10

 

 

 

 

 

Metronidazole‑
Claris

AE

MP NP

C4167 C4168 C4169

 

10

0

5

 

 

 

 

 

 

 

PDP

C4169

 

10

0

5

 

 

 

 

 

Metronidazole Sandoz IV

SZ

MP NP

C4167 C4168 C4169

 

10

0

10

 

 

 

 

 

 

 

PDP

C4169

 

10

0

10

 

 

substitute:

 

I.V. infusion 500 mg in 100 mL

Injection

DBL Metronidazole Intravenous Infusion

HH

MP NP

C4592 C4593

 

10

0

5

 

 

 

 

 

 

 

PDP

C4581

 

10

0

5

 

 

 

 

 

Metronidazole‑
Claris

AE

MP NP

C4592 C4593

 

10

0

10

 

 

 

 

 

 

 

PDP

C4581

 

10

0

10

 

 

 

 

 

Metronidazole Sandoz IV

SZ

MP NP

C4592 C4593

 

10

0

10

 

 

 

 

 

 

 

PDP

C4581

 

10

0

10

 

 

[38]         Schedule 1, entry for Norethisterone in the form Tablets 350 micrograms, 28

omit:

 

 

 

Locilan 28 Day

FZ

MP NP

 

4

2

4

 

[39]         Schedule 1, entry for Omalizumab

substitute:

Omalizumab

Injection 75 mg in 0.5 mL single dose pre-filled syringe

Injection

Xolair

NV

MP
See Note 1

See Note 3

See Note 3

See Note 3

See
Note 3

1

 

D(100)

 

Injection 150 mg in 1 mL single dose pre-filled syringe

Injection

Xolair

NV

MP
See Note 1

See Note 3

See Note 3

See Note 3

See
Note 3

1

 

D(100)

 

Powder for injection 150 mg with diluent

Injection

Xolair

NV

MP
See Note 1

See Note 3

See Note 3

See Note 3

See
Note 3

1

 

D(100)

[40]         Schedule 1, entry for Oxaliplatin in the form Powder for I.V. infusion 50 mg

omit:

 

 

 

Xalox

GN

MP

 

 

See Note 3

See
Note 3

1

 

D(100)

[41]         Schedule 1, entry for Oxaliplatin in the form Powder for I.V. infusion 100 mg

omit:

 

 

 

Xalox

GN

MP

 

 

See Note 3

S See
Note 3

1

 

D(100)

[42]         Schedule 1, after entry for Panitumumab in the form Solution concentrate for I.V. infusion 100 mg in 5 mL

insert in the columns in the order indicated:

 

Solution concentrate for I.V. infusion 400 mg in 20 mL

Injection

Vectibix

AN

MP

C4462 C4498 C4530 C4543

See Note 3

See Note 3

See
Note 3

1

D(100)

[43]         Schedule 1, after entry for Progesterone in the form Vaginal gel (prolonged release) 90 mg in single dose pre‑filled applicator

insert in the columns in the order indicated:

 

Vaginal tablet 100 mg

Vaginal

Endometrin

FP

MP
See Note 1

See Note 3

See Note 3

See Note 3

See
Note 3

1

D(100)

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

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

 

 

 

Quetia 25

FM

MP NP

C4385 C4391 C4396

 

60

0

60

 

 

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

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

 

 

 

Quetia 100

FM

MP NP

C1589 C2044 C2765

 

90

5

90

 

 

[46]         Schedule 1, entry for Quetiapine in the form Tablet 200 mg (as fumarate)

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

 

 

 

Quetia 200

FM

MP NP

C1589 C2044 C2765

 

60

5

60

 

 

[47]         Schedule 1, entry for Quetiapine in the form Tablet 300 mg (as fumarate)

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

 

 

 

Quetia 300

FM

MP NP

C1589 C2044 C2765

 

60

5

60

 

 

[48]         Schedule 1, entry for Saxagliptin

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

 

Tablet 2.5 mg (as hydrochloride)

Oral

Onglyza

AP

MP NP

C4520

 

28

5

28

 

 

[49]         Schedule 1, entry for Sildenafil

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

 

 

 

APO-Sildenafil PHT

TX

MP
See Note 1

See Note 3

See Note 3

See Note 3

See
Note 3

90

 

D(100)

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

 

 

 

Sildenafil Sandoz PHT 20

SZ

MP
See Note 1

See Note 3

See Note 3

See Note 3

See
Note 3

90

 

D(100)

[50]         Schedule 1, entry for Tacrolimus in the form Capsule 0.5 mg [Maximum Quantity: 100; Number of Repeats: 3]

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

 

 

 

Pharmacor Tacrolimus 0.5

CR

MP

C3080

 

100

3

100

 

 

[51]         Schedule 1, entry for Tacrolimus in the form Capsule 0.5 mg [Maximum Quantity: 200; Number of Repeats: 5]

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

 

 

 

Pharmacor Tacrolimus 0.5

CR

MP
See Note 1

C1654 C3328

 

200

5

100

 

C(100)

[52]         Schedule 1, entry for Tacrolimus in the form Capsule 1 mg [Maximum Quantity: 100; Number of Repeats: 3]

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

 

 

 

Pharmacor Tacrolimus 1

CR

MP

C3080

 

100

3

100

 

 

[53]         Schedule 1, entry for Tacrolimus in the form Capsule 1 mg [Maximum Quantity: 200; Number of Repeats: 5]

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

 

 

 

Pharmacor Tacrolimus 1

CR

MP
See Note 1

C1654 C3328

 

200

5

100

 

C(100)

[54]         Schedule 1, entry for Tacrolimus in the form Capsule 5 mg [Maximum Quantity: 50; Number of Repeats: 3]

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

 

 

 

Pharmacor Tacrolimus 5

CR

MP

C3080

 

50

3

50

 

 

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

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

 

 

 

Pharmacor Tacrolimus 5

CR

MP
See Note 1

C1654 C3328

 

100

5

50

 

C(100)

[56]         Schedule 1, entry for Ticarcillin with Clavulanic Acid

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

[57]         Schedule 1, entry for Tirofiban

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

 

 

 

Tirofiban AC

GN

MP NP

C1275 C1729 C1730

 

1

2

1

 

 

[58]         Schedule 1, entry for Vancomycin in the form Powder for injection 500 mg (500,000 I.U.) (as hydrochloride)

(a)      omit:

 

 

 

Vycin IV

GN

MP

C1091 C1302 C1464

P1302

2

0

1

 

 

 

 

 

 

 

PDP

C1302

 

2

0

1

 

 

(b)      omit:

 

 

 

Vycin IV

GN

MP

C1091 C1302 C1464

P1091 P1464

5

0

1

 

 


 

[59]         Schedule 3, after details relevant to Responsible Person code ER

insert:

EU

Emerge Health Pty Ltd

 72 145 180 865

[60]         Schedule 4, Part 1, after entry for Acitretin

insert:

Aclidinium

C4516

 

 

Chronic obstructive pulmonary disease (COPD)

 

[61]         Schedule 4, Part 1, entry for Atomoxetine

substitute:

Atomoxetine

C4578

 

 

Attention deficit hyperactivity disorder
Continuing treatment

Patient must have previously been issued with an authority prescription for this drug

Compliance with Authority Required procedures - Streamlined Authority Code 4578

 

C4591

 

 

Attention deficit hyperactivity disorder
Initial treatment

The condition must be or have been diagnosed by a paediatrician or psychiatrist according to the DSM-5 criteria; AND
Patient must have a contraindication to dexamphetamine or methylphenidate as specified in TGA-approved product information; OR
Patient must have a comorbid mood disorder that has developed or worsened as a result of dexamphetamine or methylphenidate treatment and is of a severity necessitating treatment withdrawal; OR
Patient must be at an unacceptable medical risk of a severity necessitating permanent stimulant treatment withdrawal if given a stimulant treatment with another agent; OR
Patient must have experienced adverse reactions of a severity necessitating permanent treatment withdrawal following treatment with dexamphetamine and treatment with methylphenidate (not simultaneously)

Patient must be or have been diagnosed between the ages of 6 and 18 years inclusive

Compliance with Authority Required procedures - Streamlined Authority Code 4591


[62]         Schedule 4, Part 1, after entry for Benzydamine

insert:

Betaine

C4599

 

 

Homocystinuria

The treatment must be as adjunctive therapy to current standard care; AND
The condition must be treated by or in consultation with a metabolic physician

The name of the specialist must be included in the authority application

Compliance with Authority Required procedures


[63]         Schedule 4, Part 1, entry for Bevacizumab

substitute:

Bevacizumab

C4584

 

 

Where the patient is receiving treatment at/from a Public Hospital

Advanced International Federation of Gynecology and Obstetrics (FIGO) Stage IIIB, IIIC or Stage IV epithelial ovarian, fallopian tube or primary peritoneal cancer
Continuing treatment

Patient must have previously received PBS-subsidised treatment with bevacizumab for this condition; AND
Patient must not have progressive disease; AND
The treatment must not exceed a dose of 7.5 mg per kg every 3 weeks; AND
The treatment must not exceed a lifetime total of 18 cycles of bevacizumab for epithelial ovarian, fallopian tube or primary peritoneal cancer

Compliance with Authority Required procedures - Streamlined Authority Code 4584


 

C4585

 

 

Where the patient is receiving treatment in the community setting or at/from a Private Hospital

Advanced International Federation of Gynecology and Obstetrics (FIGO) Stage IIIB, IIIC or Stage IV epithelial ovarian, fallopian tube or primary peritoneal cancer
Continuing treatment

Patient must have previously received PBS-subsidised treatment with bevacizumab for this condition; AND
Patient must not have progressive disease; AND
The treatment must not exceed a dose of 7.5 mg per kg every 3 weeks; AND
The treatment must not exceed a lifetime total of 18 cycles of bevacizumab for epithelial ovarian, fallopian tube or primary peritoneal cancer

Compliance with Authority Required procedures


 

C4587

 

 

Where the patient is receiving treatment at/from a Public Hospital

Metastatic colorectal cancer
Continuing treatment

Patient must have previously received PBS-subsidised treatment with bevacizumab for this condition; AND
Patient must not have progressive disease; AND
The treatment must be in combination with first-line chemotherapy; AND
The treatment must not exceed a dose of 5 mg per kg every 2 weeks; OR
The treatment must not exceed a dose of 7.5 mg per kg every 3 weeks

The patient's body weight must be documented in the patient's medical records at the time the treatment cycle is initiated

Compliance with Authority Required procedures - Streamlined Authority Code 4587


 

C4588

 

 

Where the patient is receiving treatment in the community setting or at/from a Private Hospital

Metastatic colorectal cancer
Continuing treatment

Patient must have previously received PBS-subsidised treatment with bevacizumab for this condition; AND
Patient must not have progressive disease; AND
The treatment must be in combination with first-line chemotherapy; AND
The treatment must not exceed a dose of 5 mg per kg every 2 weeks; OR
The treatment must not exceed a dose of 7.5 mg per kg every 3 weeks

Compliance with Authority Required procedures


 

C4589

 

 

Where the patient is receiving treatment in the community setting or at/from a Private Hospital

Advanced International Federation of Gynecology and Obstetrics (FIGO) Stage IIIB, IIIC or Stage IV epithelial ovarian, fallopian tube or primary peritoneal cancer
Initial treatment

The condition must be suboptimally debulked (maximum diameter of any gross residual disease greater than 1 cm); AND
Patient must have a WHO performance status of 2 or less; AND
The condition must be previously untreated; AND
The treatment must be commenced in combination with platinum-based chemotherapy; AND
The treatment must not exceed a dose of 7.5 mg per kg every 3 weeks; AND
The treatment must not exceed a lifetime total of 18 cycles of bevacizumab for epithelial ovarian, fallopian tube or primary peritoneal cancer

The patient's WHO performance status and body weight must be documented in the patient's medical records at the time the treatment cycle is initiated

Compliance with Authority Required procedures


 

C4594

 

 

Where the patient is receiving treatment at/from a Public Hospital

Metastatic colorectal cancer
Initial treatment

The condition must be previously untreated; AND
Patient must have a WHO performance status of 0 or 1; AND
The treatment must be in combination with first-line chemotherapy; AND
The treatment must not exceed a dose of 5 mg per kg every 2 weeks; OR
*The treatment must not exceed a dose of 7.5 mg per kg every 3 weeks

The patient's WHO performance status and body weight must be documented in the patient's medical records at the time the treatment cycle is initiated

Compliance with Authority Required procedures - Streamlined Authority Code 4594


 

C4597

 

 

Where the patient is receiving treatment in the community setting or at/from a Private Hospital

Metastatic colorectal cancer
Initial treatment

The condition must be previously untreated; AND
Patient must have a WHO performance status of 0 or 1; AND
The treatment must be in combination with first-line chemotherapy; AND
The treatment must not exceed a dose of 5 mg per kg every 2 weeks; OR
The treatment must not exceed a dose of 7.5 mg per kg every 3 weeks

Compliance with Authority Required procedures


 

C4598

 

 

Where the patient is receiving treatment at/from a Public Hospital

Advanced International Federation of Gynecology and Obstetrics (FIGO) Stage IIIB, IIIC or Stage IV epithelial ovarian, fallopian tube or primary peritoneal cancer
Initial treatment

The condition must be suboptimally debulked (maximum diameter of any gross residual disease greater than 1 cm); AND
Patient must have a WHO performance status of 2 or less; AND
The condition must be previously untreated; AND
The treatment must be commenced in combination with platinum-based chemotherapy; AND
The treatment must not exceed a dose of 7.5 mg per kg every 3 weeks; AND
The treatment must not exceed a lifetime total of 18 cycles of bevacizumab for epithelial ovarian, fallopian tube or primary peritoneal cancer

The patient's WHO performance status and body weight must be documented in the patient's medical records at the time the treatment cycle is initiated

Compliance with Authority Required procedures - Streamlined Authority Code 4598


[64]         Schedule 4, Part 1, entry for Calcium

substitute:

Calcium

C4586

 

 

Hyperphosphataemia

The condition must be associated with chronic renal failure

Compliance with Authority Required procedures - Streamlined Authority Code 4586

[65]         Schedule 4, Part 1, entry for Erlotinib

(a)      omit:

 

C4481

 

 

Stage IIIB (locally advanced) or Stage IV (metastatic) non-small cell lung cancer (NSCLC)
Initial treatment

The treatment must be as monotherapy; AND
Patient must not have received previous PBS-subsidised treatment with another epidermal growth factor receptor (EGFR) tyrosine kinase inhibitor (TKI); OR
Patient must have developed intolerance to another epidermal growth factor receptor (EGFR) tyrosine kinase inhibitor (TKI) of a severity necessitating permanent treatment withdrawal; AND
Patient must have failed prior therapy which included a platinum compound; AND
Patient must have a WHO performance status of 3 or less; AND
The condition must have progressed following treatment with docetaxel or pemetrexed; OR
Patient must have a contraindication or intolerance to treatment with docetaxel and pemetrexed; AND
Patient must not be able to receive further chemotherapy subsidised by the PBS or from other sources following treatment with erlotinib

Patient must have a wild type epidermal growth factor receptor (EGFR) gene; OR
Patient must have an epidermal growth factor receptor (EGFR) gene of unknown type

The authority application must be made in writing and must include:

(1) a completed authority prescription form; and
(2) a completed Non-Small Cell Lung Cancer Erlotinib Authority Application - Supporting Information Form, which includes:

(i) evidence that the patient has been treated with platinum-based chemotherapy; AND
(ii) evidence that disease progression has occurred following treatment with docetaxel or pemetrexed. In patients in whom docetaxel or pemetrexed is contraindicated or cannot be tolerated the prescriber must state the reasons for intolerance or the contraindication; AND
(iii) a declaration from the prescriber that the patient has exhausted all opportunities for treatment with chemotherapy either on the PBS, through special access schemes or in a clinical trial; and
(3) a signed patient acknowledgement

Compliance with Written Authority Required procedures


 

C4525

 

 

Stage IIIB (locally advanced) or Stage IV (metastatic) non-small cell lung cancer (NSCLC)
Continuing treatment

The treatment must be as monotherapy; AND
Patient must have previously been issued with an authority prescription for this drug; AND
Patient must not have progressive disease

Patient must have a wild type epidermal growth factor receptor (EGFR) gene; OR
Patient must have an epidermal growth factor receptor (EGFR) gene of unknown type

The authority application must be made in writing and must include:

(1) a completed authority prescription form; and
(2) a completed Non-Small Cell Lung Cancer Erlotinib Authority Application - Supporting Information Form, which includes:

(i) evidence that the patient has been treated with platinum-based chemotherapy; AND
(ii) evidence that disease progression has occurred following treatment with docetaxel or pemetrexed. In patients in whom docetaxel or pemetrexed is contraindicated or cannot be tolerated the prescriber must state the reasons for intolerance or the contraindication; AND
(iii) a declaration from the prescriber that the patient has exhausted all opportunities for treatment with chemotherapy either on the PBS, through special access schemes or in a clinical trial; and
(3) a signed patient acknowledgement

Compliance with Written Authority Required procedures


 

C4536

 

 

Stage IIIB (locally advanced) or Stage IV (metastatic) non-small cell lung cancer (NSCLC)
Continuing treatment

The treatment must be as monotherapy; AND
Patient must have previously been issued with an authority prescription for this drug prior to 1 January 2014; AND
Patient must not have progressive disease

Patient must have a wild type epidermal growth factor receptor (EGFR) gene; OR
Patient must have an epidermal growth factor receptor (EGFR) gene of unknown type

Compliance with Authority Required procedures


(b)      insert in numerical order following existing text:

 

C4600

 

 

Stage IIIB (locally advanced) or Stage IV (metastatic) non-small cell lung cancer (NSCLC)
Continuing treatment

The treatment must be as monotherapy; AND
Patient must have previously been issued with an authority prescription for this drug prior to 1 August 2014; AND
Patient must not have progressive disease

Patient must have a wild type epidermal growth factor receptor (EGFR) gene; OR
Patient must have an epidermal growth factor receptor (EGFR) gene of unknown type

Compliance with Authority Required procedures


[66]         Schedule 4, Part 1, entry for Macrogol 3350

(a)      omit:

 

C1263

P1263

 

Patients receiving palliative care

 

 

C1613

P1613

 

Constipation in patients with malignant neoplasia

 

 

C2693

P2693

 

Paraplegic and quadriplegic patients and others with severe neurogenic impairment of bowel function not responding to other oral therapies

 

 

C2823

P2823

 

Chronic constipation or faecal impaction not adequately controlled with first line interventions such as bulk‑forming agents

 

 

C3642

P3642

 

Initial supply, for up to 4 months, for a palliative care patient where constipation is a problem

Compliance with Authority Required procedures – Streamlined Authority Code 3642

 

C3643

P3643

 

Continuing supply for a palliative care patient where constipation is a problem

Compliance with Authority Required procedures – Streamlined Authority Code 3643

(b)      insert in numerical order following existing text:

 

C4576

P4576

 

Constipation

Patient must have malignant neoplasia

 

 

C4577

P4577

 

Constipation

Patient must be receiving palliative care

 

 

C4580

P4580

 

Constipation

Patient must be paraplegic, quadriplegic or have severe neurogenic impairment of bowel function; AND
The condition must be unresponsive to other oral therapies

 

 

C4590

P4590

 

Constipation
Continuing treatment

Patient must be receiving palliative care

Compliance with Authority Required procedures - Streamlined Authority Code 4590

 

C4595

P4595

 

Constipation
Initial treatment

Patient must be receiving palliative care; AND
Patient must not receive more than 4 months treatment under this restriction

Compliance with Authority Required procedures - Streamlined Authority Code 4595

 

C4596

P4596

 

Chronic constipation

The condition must be inadequately controlled with first line interventions such as bulk-forming agents

 

 

C4601

P4601

 

Faecal impaction

The condition must be inadequately controlled with first line interventions such as bulk-forming agents

 

[67]         Schedule 4, Part 1, entry for Metronidazole

(a)      omit from the column headed “Circumstances Code”:     C4167   substitute:             C4581

(b)      omit from the column headed “Circumstances Code”:     C4168   substitute:             C4592

(c)      omit from the column headed “Circumstances Code”:     C4169   substitute:             C4593