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PB 49 of 2011 Lists as made
This instrument amends the National Health (Listing of Pharmaceutical Benefits) Instrument 2010 (No. PB 108 of 2010) to provide for additions, deletions and changes to forms, brands, responsible persons, circumstances for prescribing, and to the maximum quantities and number of repeats that may be prescribed.
Administered by: Health
Registered 28 Jul 2011
Tabling HistoryDate
Tabled HR18-Aug-2011
Tabled Senate18-Aug-2011
Date of repeal 19 Mar 2014
Repealed by Health (Spent and Redundant Instruments) Repeal Regulation 2014

 

PB 49 of 2011

National Health (Listing of Pharmaceutical Benefits) Amendment Instrument 2011
(No.8)1

National Health Act 1953

I, FELICITY McNEILL, Acting First Assistant Secretary, 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    twenty-first  July           2011

 

 

 

 

 

 

 

 

 

 

 

FELICITY McNEILL

Acting First Assistant Secretary

Pharmaceutical Benefits Division

Department of Health and Ageing


 


1          Name of Instrument

            (1)        This Instrument is the National Health (Listing of Pharmaceutical Benefits) Amendment Instrument 2011 (No. 8).

            (2)        This Instrument may also be cited as PB 49 of 2011.

2          Commencement

            This Instrument commences on 1 August 2011.

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 Adalimumab in the form Injection 40 mg in 0.8 mL pre-filled pen [Max Quantity 2; Number of Repeats 4]

omit from the column headed “Circumstances”:

C3568  C3569

insert in numerical order:

C3706  C3707

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

omit:

 

 

 

Rithmik 100

QA

MP NP

C1350

 

30

5

 

[3] Schedule 1, entry for Cephalexin in the form Capsule 250 mg (anhydrous) [Max Quantity 20; Number of Repeats 0]

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

 

 

 

Pharmacor Cephalexin 250

CR

PDP

 

 

20

0

 

[4] Schedule 1, entry for Cephalexin in the form Capsule 250 mg (anhydrous) [Max Quantity 20; Number of Repeats 1]

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

 

 

 

Pharmacor Cephalexin 250

CR

MP NP MW

 

 

20

1

 

[5] Schedule 1, entry for Cephalexin in the form Capsule 500 mg (anhydrous) [Max Quantity 20; Number of Repeats 0]

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

 

 

 

Pharmacor Cephalexin 500

CR

PDP

 

 

20

0

 

[6] Schedule 1, entry for Cephalexin in the form Capsule 500 mg (anhydrous) [Max Quantity 20; Number of Repeats 1]

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

 

 

 

Pharmacor Cephalexin 500

CR

MP NP MW

 

 

20

1

 

[7] Schedule 1, after entry for Desmopressin in the form Wafer 120 micrograms (as acetate)

insert in the columns in the order indicated:

 

Wafer 240 micrograms (as acetate)

Sublingual

Minirin Melt

FP

MP NP

C2641 C2642

 

30

5

 

[8] Schedule 1, entry for Desvenlafaxine

omit from the column headed “Responsible Person” (twice occurring):                                WX       substitute:          PF

[9] Schedule 1, entry for Docetaxel in the form Solution concentrate for I.V. infusion 20 mg in 2 mL (DBL Docetaxel Concentrated Injection) [Max Quantity 1; Number of Repeats 0]

omit from the column headed “Circumstances”:

C3292

[10]         Schedule 1, entry for Docetaxel in the form Solution concentrate for I.V. infusion 20 mg in 2 mL (DBL Docetaxel Concentrated Injection) [Max Quantity 2; Number of Repeats 0]

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

C3292

(b)        omit from the column headed “Purposes”:

P3292

[11]         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”:

C3292

[12]         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”:

C3292

[13]         Schedule 1, omit entry for Dolasetron


[14]         Schedule 1, after entry for Dutasteride

insert:

Dutasteride with tamsulosin

Capsule containing dutasteride 500 micrograms with tamsulosin hydrochloride 400 micrograms

Oral

Duodart 500ug/400ug

GK

MP NP

C3687

 

30

5

 

[15]         Schedule 1, entry for Epoetin Alfa

omit:

 

Injection 30,000 units in 0.75 mL pre-filled syringe

Injection

Eprex 30,000

JC

MP
See Note 1

C1957 C3334

 

12

5

D

[16]         Schedule 1, entry for Etanercept

omit from the column headed “Responsible Person” (all instances):                      WX       substitute:          PF

[17]         Schedule 1, entry for Exemestane

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

 

 

 

Exaccord

RA

MP NP

C1541 C2457

 

30

5

 

 


[18]         Schedule 1, entry for Fentanyl

omit:

 

Lozenges 200 micrograms (as citrate), 3

Buccal

Actiq

OA

MP NP

C3663 C3664

P3663

3

0

 

 

 

 

 

 

MP NP

C3663 C3664

P3664

20

0

 

 

Lozenges 400 micrograms (as citrate), 3

Buccal

Actiq

OA

MP NP

C3663 C3664

P3663

3

0

 

 

 

 

 

 

MP NP

C3663 C3664

P3664

20

0

 

 

Lozenges 600 micrograms (as citrate), 3

Buccal

Actiq

OA

MP NP

C3663 C3664

P3663

3

0

 

 

 

 

 

 

MP NP

C3663 C3664

P3664

20

0

 

 

Lozenges 800 micrograms (as citrate), 3

Buccal

Actiq

OA

MP NP

C3663 C3664

P3663

3

0

 

 

 

 

 

 

MP NP

C3663 C3664

P3664

20

0

 

 

Lozenges 1200 micrograms (as citrate), 3

Buccal

Actiq

OA

MP NP

C3663 C3664

P3663

3

0

 

 

 

 

 

 

MP NP

C3663 C3664

P3664

20

0

 

 

Lozenges 1600 micrograms (as citrate), 3

Buccal

Actiq

OA

MP NP

C3663 C3664

P3663

3

0

 

 

 

 

 

 

MP NP

C3663 C3664

P3664

20

0

 

substitute:

 

Lozenges 200 micrograms (as citrate), 3

Buccal

Actiq

OA

MP NP

C3663

 

3

0

 

 

Lozenges 400 micrograms (as citrate), 3

Buccal

Actiq

OA

MP NP

C3663

 

3

0

 

 

Lozenges 600 micrograms (as citrate), 3

Buccal

Actiq

OA

MP NP

C3663

 

3

0

 

 

Lozenges 800 micrograms (as citrate), 3

Buccal

Actiq

OA

MP NP

C3663

 

3

0

 

 

Lozenges 1200 micrograms (as citrate), 3

Buccal

Actiq

OA

MP NP

C3663

 

3

0

 

 

Lozenges 1600 micrograms (as citrate), 3

Buccal

Actiq

OA

MP NP

C3663

 

3

0

 

 

Lozenges 200 micrograms (as citrate), 30

Buccal

Actiq

OA

MP NP

C3664

 

2

0

 

 

Lozenges 400 micrograms (as citrate), 30

Buccal

Actiq

OA

MP NP

C3664

 

2

0

 

 

Lozenges 600 micrograms (as citrate), 30

Buccal

Actiq

OA

MP NP

C3664

 

2

0

 

 

Lozenges 800 micrograms (as citrate), 30

Buccal

Actiq

OA

MP NP

C3664

 

2

0

 

 

Lozenges 1200 micrograms (as citrate), 30

Buccal

Actiq

OA

MP NP

C3664

 

2

0

 

 

Lozenges 1600 micrograms (as citrate), 30

Buccal

Actiq

OA

MP NP

C3664

 

2

0

 

[19]         Schedule 1, after entry for Fentanyl in the form Transdermal patch 2.1 mg

insert in the columns in the order indicated:

 

Transdermal patch 2.55 mg

Transdermal

Denpax

AF

MP NP

C1062

 

5

0

 

[20]         Schedule 1, after entry for Fentanyl in the form Transdermal patch 4.2 mg

insert in the columns in the order indicated:

 

Transdermal patch 5.10 mg

Transdermal

Denpax

AF

MP NP

C1062

 

5

0

 

 

Transdermal patch 7.65 mg

Transdermal

Denpax

AF

MP NP

C1062

 

5

0

 

[21]         Schedule 1, after entry for Fentanyl in the form Transdermal patch 8.4 mg

insert in the columns in the order indicated:

 

Transdermal patch 10.20 mg

Transdermal

Denpax

AF

MP NP

C1062

 

5

0

 


[22]         Schedule 1, entry for Filgrastim

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

 

Injection 120 micrograms in 0.2 mL single use pre-filled syringe (Nivestim)

Injection

Nivestim

HH

MP
See Note 1

C2912 C2913 C2914 C2915 C2916 C2917 C2918 C2919 C2920 C2921 C2922 C2923 C2924 C2925 C2926 C2927 C2928 C2929 C2930 C3087 C3187 C3357 C3358 C3359 C3360 C3361 C3362 C3363 C3364 C3365 C3366 C3367 C3368 C3369 C3370 C3371 C3372 C3373 C3374 C3375 C3376 C3377

 

20

11

D

[23]         Schedule 1, entry for Fluconazole in the form Capsule 100 mg

omit:

 

 

 

Fluconazole Winthrop

WA

MP NP

C3613 C3614 C3615 C3616 C3617 C3618

 

28

5

 

[24]         Schedule 1, entry for Glucose Indicator—Urine

omit:

 

Test strips, 50 (Clinistix)

For external use

Clinistix

BN

MP NP

 

 

2

2

 

 

 

 

 

 

MP

 

P3035

2

4

 

[25]         Schedule 1, entry for Golimumab

omit from the column headed “Responsible Person” (twice occurring):                                SH        substitute:          JC

[26]         Schedule 1, entry for Hypromellose in the form Oral gel 20 mg per g, 100 g

omit from the column headed “Responsible Person”:                 HA        substitute:          VT

[27]         Schedule 1, entry for Infliximab

omit from the column headed “Responsible Person”:                 SH        substitute:          JC

[28]         Schedule 1, entry for Lansoprazole in each of the forms: Tablet 30 mg (orally disintegrating); and Tablet 15 mg (orally disintegrating)

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

[29]         Schedule 1, entry for Leflunomide in the form Tablet 10 mg

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

 

 

 

APO-Leflunomide

TX

MP

C2644

30

5

 

 

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

 

 

 

Lunava 10

ZP

MP

C2644

30

5

 

 

[30]         Schedule 1, entry for Leflunomide in the form Tablet 20 mg

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

 

 

 

APO-Leflunomide

TX

MP

C2644

30

5

 

 

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

 

 

 

Lunava 20

ZP

MP

C2644

30

5

 

 

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

(a)           omit from the column headed “Responsible Person:             WX       substitute:          FZ

(b)        omit from the column headed “Responsible Person:             WY       substitute:          PF


[32]         Schedule 1, entry for Levonorgestrel with Ethinyloestradiol in the form Pack containing 6 tablets 50 micrograms-30 micrograms,
5 tablets 75 micrograms-40 micrograms, 10 tablets 125 micrograms-30 micrograms and 7 inert tablets

(a)           omit from the column headed “Responsible Person:             WX       substitute:          FZ

(b)        omit from the column headed “Responsible Person:             WY       substitute:          PF

[33]         Schedule 1, entry for Maraviroc

omit from the column headed “Responsible Person” (twice occurring):                                PF        substitute:          VI

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

omit:

 

 

 

Meloxicam Winthrop

WA

MP NP

C1547 C1848

 

30

3

 

[35]         Schedule 1, entry for Methylnaltrexone

omit from the column headed “Responsible Person:                   WX       substitute:          PF

[36]         Schedule 1, after entry for Methylprednisolone in the form Injection containing methylprednisolone acetate 40 mg in 1 mL
(Depo-Nisolone)

insert in the columns in the order indicated:

 

Powder for injection 40 mg (as sodium succinate)

Injection

Methylpred

AS

MP NP

 

 

5

0

 

[37]         Schedule 1, after entry for Methylprednisolone in the form Powder for injection 1 g (as sodium succinate) with diluent

insert in the columns in the order indicated:

 

Powder for injection 1 g (as sodium succinate)

Injection

Methylpred

AS

MP NP

 

 

1

0

 

[38]         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) (Pizaccord)

omit from the column headed “Responsible Person”:                 MI        substitute:          RA


[39]         Schedule 1, entry for Salbutamol in the form Pressurised inhalation 100 micrograms (as sulfate) per dose, 200 doses
(CFC-free formulation)

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

 

 

 

APO-Salbutamol Inhaler

TX

MP NP

 

 

2

5

 

[40]         Schedule 1, entry for Sirolimus in the form Tablet 0.5 mg

omit from the column headed “Brand”:       Rapamune (Pfizer Australia Pty Ltd)                 substitute:          Rapamune

[41]         Schedule 1, entry for Sirolimus

omit from the column headed “Responsible Person” (all instances):                      WX       substitute:          PF

[42]         Schedule 1, entry for Somatropin in the form Injection 4 mg (12 i.u.) vial with 3.5 mL diluent (with preservative)

omit from the column headed “Form”:           3.5 mL

[43]         Schedule 1, after entry for Somatropin in the form Solution for injection 10 mg (30 i.u.) in 2 mL cartridge (with preservative)

insert in the columns in the order indicated:

 

Injection 10 mg (30 i.u.) vial with diluent (with preservative)

Injection

Zomacton

FP

MP

See Note 1

See Note 3

See Note 3

See Note 3

See Note 3

D

[44]         Schedule 1, entry for Terbinafine in the form Tablet 250 mg (as hydrochloride) [Max Quantity 42; Number of Repeats 0]

(a)           omit from the column headed “Responsible Person:             AL        substitute:          AF

(b)        omit:

 

 

 

Zabel

AF

MP NP

C2191 C2865 C3244

P2865 P3244

42

0

 

[45]         Schedule 1, entry for Terbinafine in the form Tablet 250 mg (as hydrochloride) [Max Quantity 42; Number of Repeats 1]

(a)           omit from the column headed “Responsible Person:             AL        substitute:          AF

(b)        omit:

 

 

 

Zabel

AF

MP NP

C2191 C2865 C3244

P2191

42

1

 

[46]         Schedule 1, entry for Venlafaxine

omit from the column headed “Responsible Person” (all instances):                      WX       substitute:          PF

[47]         Schedule 3

omit:

SH

Schering-Plough Pty Limited

 57 000 235 245

[48]         Schedule 3

omit:

WX

Wyeth Australia Pty Limited

 16 000 296 211

WY

Wyeth Australia Pty Limited

 16 000 296 211

[49]         Schedule 4, Part 1, entry for Capecitabine for the circumstances code C3509

omit from the column headed “Circumstances and Purposes”:                                oesopho-gastric           substitute:            oesophago-gastric

[50]         Schedule 4, Part 1, omit entry for Dolasetron

[51]         Schedule 4, Part 1, after entry for Dutasteride

insert:

Dutasteride with tamsulosin

C3687

 

Treatment of lower urinary tract symptoms due to benign prostatic hyperplasia where treatment has been initiated by a urologist

Compliance with Authority Required procedures - Streamlined Authority Code 3687


[52]         Schedule 4, Part 1, entry for Ezetimibe with Simvastatin

omit:

 

C3194

 

Patients eligible for PBS-subsidised lipid-lowering medication (according to the criteria set out in the General Statement for Lipid-Lowering Drugs) where treatment with an HMG CoA reductase inhibitor (statin) must be reduced to a dose of 20 mg or less per day, because the patient developed a clinically important product-related adverse event during treatment with a statin.
A clinically important product-related adverse event is defined as follows:
(i) Severe myalgia (muscle symptoms without creatine kinase elevation) which is proven to be temporally associated with statin treatment; or
(ii) Myositis (clinically important creatine kinase elevation, with or without muscle symptoms) demonstrated by results twice the upper limit of normal on a single reading or a rising pattern on consecutive measurements and which is unexplained by other causes; or
(iii) Unexplained, persistent elevations of serum transaminases (greater than 3 times the upper limit of normal) during treatment with a statin

Compliance with Authority Required procedures - Streamlined Authority Code 3194


 

 

 

 

 

 

 

 

 

 

 

 

 

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.