National Health Act 1953 Amendment determination under sections 85, 85A and 88 pharmaceutical benefits (No. PB 76 of 2009) (Cth)

Case

COMMONWEALTH OF AUSTRALIA

Instrument number PB 76 of 2009

Amendment determinations under sections 85, 85A and 88 of the National Health Act 1953

I, LINDA JACKSON, Assistant Secretary, Pharmaceutical Evaluation Branch, Department of Health and Ageing, delegate of the Minister for Health and Ageing, make this instrument under sections 85, 85A and 88 of the National Health Act 1953.

Dated 31 July 2009

LINDA JACKSON

Assistant Secretary

Pharmaceutical Evaluation Branch

Department of Health and Ageing

Amendment determination — pharmaceutical benefits

1              Commencement

This instrument commences on 1 September 2009.

2              Amendment of PB 114 of 2008

Schedule 1 amends PB 114 of 2008.

Schedule 1        Amendments

  1. Part 1 of Schedule 1, item dealing with Amoxycillin in the form Capsule 250 mg (as trihydrate)

omit from the column headed “Brand”:

Amohexal

  1. Part 1 of Schedule 1, item dealing with Amoxycillin with Clavulanic Acid in the form Tablet containing 500 mg amoxycillin (as trihydrate) with 125 mg clavulanic acid (as potassium clavulanate)

omit from the column headed “Brand”:

Curam 500/125

and substitute:

Curam Duo 500/125

  1. Part 1 of Schedule 1, item dealing with Amoxycillin with Clavulanic Acid in the form Tablet containing 875 mg amoxycillin (as trihydrate) with 125 mg clavulanic acid (as potassium clavulanate)

omit from the column headed “Brand”:

Curam 875/125

and substitute:

Curam Duo Forte 875/125

  1. Part 1 of Schedule 1, item dealing with Carboplatin

omit from the column headed “Brand”:

Baxter Carboplatin

  1. Part 1 of Schedule 1, item dealing with Cephalexin in the form Capsule 500 mg (anhydrous)

in the column headed “Brand” insert in alphabetical order:

Cephalexin generichealth

  1. Part 1 of Schedule 1, item dealing with Ciprofloxacin in the forms Tablet 500 mg (as hydrochloride) and


    Tablet 750 mg (as hydrochloride)

omit from the column headed “Brand”:

Genepharm Pty Ltd

and substitute:

Genepharm (Australia) Limited

  1. Part 1 of Schedule 1, item dealing with Cladribine in the form Injection 10 mg in 5 mL vial

omit from the column headed “Form”:

vial

  1. Part 1 of Schedule 1, item dealing with Clotrimazole

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

Cream 10 mg per g, 20 g Application 2 3 Clonea

  1. Part 1 of Schedule 1, item dealing with Escitalopram in the forms Tablet 10 mg (as oxalate) and Tablet 20 mg


    (as oxalate)

in the column headed “Brand” insert in alphabetical order:

LoxaLate

  1. Part 1 of Schedule 1, item dealing with Etanercept

omit from the columns in the order indicated:

Injection set containing 4 vials powder for injection
50 mg and 4 pre-filled syringes solvent 1 mL 		Injection 1 3 Enbrel

  1. Part 1 of Schedule 1, item dealing with Fludarabine in the form Powder for I.V. injection containing fludarabine phosphate 50 mg

in the column headed “Brand” insert in alphabetical order:

Fludarabine Actavis

  1. Part 1 of Schedule 1, item dealing with Gliclazide in the form Tablet 30 mg (modified release)

(a)  in the column headed “Brand” insert in alphabetical order:

APO-Gliclazide MR

(b)  in the column headed “Brand” insert in alphabetical order:

Chem mart Gliclazide MR

(c)  in the column headed “Brand” insert in alphabetical order:

Terry White Chemists Gliclazide MR

  1. Part 1 of Schedule 1, item dealing with Glimepiride in the forms Tablet 1 mg, Tablet 2 mg, Tablet 3 mg and


    Tablet 4 mg

in the column headed “Brand” insert in alphabetical order:

APO-Glimepiride

  1. Part 1 of Schedule 1, item dealing with Glucose in the form I.V. infusion 278 mmol (anhydrous) per L, 1 L

in the column headed “Brand” insert in alphabetical order:

Pharmatel Fresenius Kabi Pty Limited

  1. Part 1 of Schedule 1, item dealing with Lansoprazole

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

Tablet 30 mg (orally disintegrating) Oral 28 1 Zoton FasTabs

  1. Part 1 of Schedule 1, item dealing with Metformin in the form Tablet containing metformin hydrochloride 500 mg

omit from the column headed “Brand”:

Genepharm Pty Ltd

and substitute:

Genepharm (Australia) Limited

  1. Part 1 of Schedule 1, item dealing with Metformin in the form Tablets (extended release) containing metformin hydrochloride 500 mg, 120

(a)  in the column headed “Brand” insert in alphabetical order:

Diaformin XR

(b)  in the column headed “Brand” insert in alphabetical order:

Metex XR

  1. Part 1 of Schedule 1, item dealing with Metformin in the form Tablet containing metformin hydrochloride 850 mg

omit from the column headed “Brand”:

Genepharm Pty Ltd

and substitute:

Genepharm (Australia) Limited

  1. Part 1 of Schedule 1, item dealing with Paclitaxel in the forms Solution concentrate for I.V. infusion 30 mg in 5 mL, Solution concentrate for I.V. infusion 100 mg in 16.7 mL and Solution concentrate for I.V. infusion 300 mg in 50 mL

omit from the column headed “Brand”:

Baxter Paclitaxel

  1. Part 1 of Schedule 1, after item dealing with Polygeline

insert in the columns in the order indicated:

Poly-l-lactic acid Powder for injection 150 mg Injection 2 . . Sculptra

  1. Part 1 of Schedule 1, item dealing with Pravastatin in the form Tablet containing pravastatin sodium 10 mg

in the column headed “Brand” insert in alphabetical order:

APO-Pravastatin

  1. Part 1 of Schedule 1, item dealing with Roxithromycin in the forms Tablet 150 mg and Tablet 300 mg

in the column headed “Brand” insert in alphabetical order:

Roxithromycin-GA

  1. Part 1 of Schedule 1, after item dealing with Sevelamer

insert in the columns in the order indicated:

Silver sulfadiazine Cream 10 mg per g, 50 g Application 1 . . Flamazine

  1. Part 1 of Schedule 1, item dealing with Simvastatin in the forms Tablet 10 mg, Tablet 20 mg, Tablet 40 mg and Tablet 80 mg

omit from the column headed “Brand”:

Genepharm Pty Ltd

  1. Part 1 of Schedule 1, after item dealing with Sodium Acid Phosphate

insert in the columns in the order indicated:

Sodium bicarbonate Capsule 840 mg Oral 100 2 Sodibic

  1. Part 1 of Schedule 1, item dealing with Sodium Chloride in the form I.V. infusion 154 mmol per L, 1 L

in the column headed “Brand” insert in alphabetical order:

Pharmatel Fresenius Kabi Pty Limited

  1. Part 1 of Schedule 1, item dealing with Sodium Lactate Compound in the form I.V. infusion containing approximately 131 mmol sodium (as lactate and chloride), 5 mmol potassium (as chloride), 2 mmol calcium (as chloride), 29 mmol bicarbonate (as lactate) and 111 mmol chloride per L, 1 L

in the column headed “Brand” insert in alphabetical order:

Pharmatel Fresenius Kabi Pty Limited

  1. Part 1 of Schedule 1, item dealing with Tramadol in the form Capsule containing tramadol hydrochloride 50 mg

in the column headed “Brand” insert in alphabetical order:

Lodam 50

  1. Part 1 of Schedule 1, item dealing with Tramadol in the form Tablet (sustained release) containing tramadol hydrochloride 100 mg

in the column headed “Brand” insert in alphabetical order:

Lodam SR 100

  1. Part 1 of Schedule 1, item dealing with Tramadol in the form Tablet (sustained release) containing tramadol hydrochloride 150 mg

in the column headed “Brand” insert in alphabetical order:

Lodam SR 150

  1. Part 1 of Schedule 1, item dealing with Tramadol in the form Tablet (sustained release) containing tramadol hydrochloride 200 mg

in the column headed “Brand” insert in alphabetical order:

Lodam SR 200

  1. Part 2 of Schedule 1, item dealing with Escitalopram in the form Tablet 10 mg (as oxalate)

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

Esitalo

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

Lexam 10

  1. Part 2 of Schedule 1, item dealing with Escitalopram in the form Tablet 20 mg (as oxalate)

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

Esitalo

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

Lexam 20

  1. Part 2 of Schedule 1, omit all instances of the item dealing with Etanercept in the form Injection set containing


    4 vials powder for injection 50 mg and 4 pre-filled syringes solvent 1 mL (7 instances)

  1. Part 2 of Schedule 1, item dealing with Lansoprazole

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

Tablet 30 mg (orally disintegrating)

Gastro-oesophageal reflux disease

Scleroderma oesophagus

 Oral 28 5 Zoton FasTabs

  1. Part 2 of Schedule 1, after item dealing with Polyethylene Glycol 400 with Propylene Glycol

insert in the columns in the order indicated:

Poly-l-lactic acid Powder for injection 150 mg

In compliance with authority procedures set out in subsubparagraph 11 (d) (i) or 11 (d) (ii):

Initial PBS-subsidised treatment, for facial administration only, of severe facial lipoatrophy caused by therapy for HIV infection;

 Injection 2 4 Sculptra
 accreditation following completion of injection administration training with Sanofi-Aventis is required to prescribe poly-l-lactic acid under the PBS;
 patients must be referred from the HIV physician to the accredited injector

  1. Part 2 of Schedule 1, item dealing with Pravastatin in the form Tablet containing pravastatin sodium 10 mg

in the column headed “Brand” insert in alphabetical order:

APO-Pravastatin

  1. Part 2 of Schedule 1, items dealing with Simvastatin in the forms Tablet 10 mg, Tablet 20 mg, Tablet 40 mg and Tablet 80 mg

omit from the column headed “Brand”:

Genepharm Pty Ltd

  1. Part 2 of Schedule 1, item dealing with Tramadol in the form Capsule containing tramadol hydrochloride 50 mg

in the column headed “Brand” insert in alphabetical order:

Lodam 50

  1. Part 2 of Schedule 1, item dealing with Tramadol in the form Tablet (sustained release) containing tramadol hydrochloride 100 mg

in the column headed “Brand” insert in alphabetical order:

Lodam SR 100

  1. Part 2 of Schedule 1, item dealing with Tramadol in the form Tablet (sustained release) containing tramadol hydrochloride 150 mg

in the column headed “Brand” insert in alphabetical order:

Lodam SR 150

  1. Part 2 of Schedule 1, item dealing with Tramadol in the form Tablet (sustained release) containing tramadol hydrochloride 200 mg

in the column headed “Brand” insert in alphabetical order:

Lodam SR 200

  1. Part 1 of Schedule 3, item dealing with Amoxycillin in the form Capsule 250 mg (as trihydrate)

omit from the column headed “Brand”:

Amohexal

  1. Part 1 of Schedule 3, item dealing with Amoxycillin with Clavulanic Acid in the form Tablet containing 500 mg amoxycillin (as trihydrate) with 125 mg clavulanic acid (as potassium clavulanate)

omit from the column headed “Brand”:

Curam 500/125

and substitute:

Curam Duo 500/125

  1. Part 1 of Schedule 3, item dealing with Amoxycillin with Clavulanic Acid in the form Tablet containing 875 mg amoxycillin (as trihydrate) with 125 mg clavulanic acid (as potassium clavulanate)

omit from the column headed “Brand”:

Curam 875/125

and substitute:

Curam Duo Forte 875/125

  1. Part 1 of Schedule 3, item dealing with Cephalexin in the form Capsule 500 mg (anhydrous)

in the column headed “Brand” insert in alphabetical order:

Cephalexin generichealth

  1. Part 1 of Schedule 3, item dealing with Glucose in the form I.V. infusion 278 mmol (anhydrous) per L, 1 L

in the column headed “Brand” insert in alphabetical order:

Pharmatel Fresenius Kabi Pty Limited

  1. Part 1 of Schedule 3, item dealing with Sodium Chloride in the form I.V. infusion 154 mmol per L, 1 L

in the column headed “Brand” insert in alphabetical order:

Pharmatel Fresenius Kabi Pty Limited

  1. Part 1 of Schedule 3, item dealing with Tramadol in the form Capsule containing tramadol hydrochloride 50 mg

in the column headed “Brand” insert in alphabetical order:

Lodam 50

  1. Part 1 of Schedule 3, item dealing with Tramadol in the form Tablet (sustained release) containing tramadol hydrochloride 100 mg

in the column headed “Brand” insert in alphabetical order:

Lodam SR 100

  1. Part 1 of Schedule 3, item dealing with Tramadol in the form Tablet (sustained release) containing tramadol hydrochloride 150 mg

in the column headed “Brand” insert in alphabetical order:

Lodam SR 150

  1. Part 1 of Schedule 3, item dealing with Tramadol in the form Tablet (sustained release) containing tramadol hydrochloride 200 mg

in the column headed “Brand” insert in alphabetical order:

Lodam SR 200

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