National Health Act 1953 Amendment determination under sections 85, 85A and 88 pharmaceutical benefits (No. PB 45 of 2010) (Cth)

Case

COMMONWEALTH OF AUSTRALIA

Instrument number PB 45 of 2010

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

I, FELICITY McNEILL, 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    12 May 2010

FELICITY McNEILL

Assistant Secretary

Pharmaceutical Evaluation Branch

Department of Health and Ageing

Amendment determination — pharmaceutical benefits

1              Commencement

This instrument commences on 1 June 2010.

2              Amendment of PB 15 of 2010

Schedule 1 amends PB 15 of 2010.

Schedule 1            Amendments

  1. Part 1 of Schedule 1, after item dealing with Alendronic acid with colecalciferol

insert in the columns in the order indicated:

Alendronic acid with colecalciferol and calcium Pack containing 4 tablets containing alendronic acid 70 mg (as alendronate sodium) with 140 micrograms colecalciferol and 48 tablets calcium 500 mg (as carbonate) Oral 1 5 Fosamax Plus D-Cal

  1. Part 1 of Schedule 1, omit item dealing with Amino acid formula without methionine, threonine and valine and low in isoleucine

  1. Part 1 of Schedule 1, omit item dealing with Amino acid formula without phenylalanine, tyrosine and methionine

  1. Part 1 of Schedule 1, item dealing with Amino acid formula with vitamins and minerals without phenylalanine

omit from the columns in the order indicated:

Oral powder 400 g (Phenex-2) Oral 8 5 Phenex-2

  1. Part 1 of Schedule 1, item dealing with Amlodipine in the forms Tablet 5 mg (as besylate) and Tablet 10 mg (as besylate)

insert in alphabetical order in the column headed “Brand”: Amlodipine-DRLA

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

omit from the column headed “Brand”: Amoxycillin-DP

  1. Part 1 of Schedule 1, item dealing with Amoxycillin in the form Capsule 500 mg (as trihydrate)

insert in alphabetical order in the column headed “Brand”: Amoxycillin-GA

  1. Part 1 of Schedule 1, item dealing with Atenolol in the form Tablet 50 mg

omit from the column headed “Brand”: Atehexal     and insert in alphabetical order: Atenolol Sandoz

  1. Part 1 of Schedule 1, item dealing with Captopril in the form Tablet 25 mg

(a)insert in alphabetical order in the column headed “Brand”: Ascent Pharma Pty Ltd

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

  1. Part 1 of Schedule 1, item dealing with Captopril in the form Tablet 50 mg

(a)insert in alphabetical order in the column headed “Brand”: Ascent Pharma Pty Ltd

(b)omit from the column headed “Brand”: Captohexal     and substitute: Captopril Sandoz

(c)omit from the column headed “Brand”: Genepharm Pty Ltd

  1. Part 1 of Schedule 1, item dealing with Cephalexin in the forms Granules for oral suspension 125 mg per 5 mL, 100 mL and Granules for oral suspension 250 mg per 5 mL, 100 mL

insert in alphabetical order in the column headed “Brand”: APO-Cephalexin

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

omit from the columns in the order indicated:

Solution for I.V. infusion 100 mg in 50 mL Injection 1 .. Erbitux

  1. Part 1 of Schedule 1, item dealing with Ciprofloxacin in the form Tablet 250 mg (as hydrochloride)

insert in alphabetical order in the column headed “Brand”: Ciprofloxacin-DRLA

  1. Part 1 of Schedule 1, item dealing with Ciprofloxacin in the forms Tablet 500 mg (as hydrochloride) and Tablet 750 mg (as hydrochloride)

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

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

(c)omit from the column headed “Brand”: Genepharm (Australia) Limited

  1. Part 1 of Schedule 1, after item dealing with Clopidogrel in the form Tablet 75 mg (as hydrogen sulfate)

insert in the columns in the order indicated:

Tablet 75 mg (as besilate) Oral 28 5 Clovix 75

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

omit from the columns in the order indicated:

Lotion 10 mg per mL, 20 mL Application 2 3 Canesten

  1. Part 1 of Schedule 1, item dealing with Cromoglycic Acid

omit from the columns in the order indicated:

Pressurised inhalation containing sodium cromoglycate 1 mg per dose, 200 doses

Inhalation by mouth

1

5

Intal

  1. Part 1 of Schedule 1, item dealing with Diltiazem in the form Tablet containing diltiazem hydrochloride 60 mg

omit from the column headed “Brand”: Diltahexal     and substitute: Diltiazem Sandoz

  1. Part 1 of Schedule 1, after item dealing with Everolimus in the form Tablet 0.75 mg

insert in the columns in the order indicated:

Tablet 1 mg Oral 120 3 Certican

  1. Part 1 of Schedule 1, item dealing with Famciclovir in the form Tablet 125 mg

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

  1. Part 1 of Schedule 1, item dealing with Famciclovir in the form Tablet 250 mg

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

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

  1. Part 1 of Schedule 1, item dealing with Follitropin Alfa

(a)omit from the columns in the order indicated:

Injection set containing 1 vial powder for injection 75 I.U. and 1 pre-filled syringe solvent 1 mL Injection 5 5 Gonal-f 75
Injection set containing 10 vials powder for injection 75 I.U. and 10 pre-filled syringes solvent 1 mL Injection 1 5 Gonal-f 75

(b)omit from the columns in the order indicated:

Injection set containing 1 vial powder for injection 450 I.U. and 1 pre-filled syringe solvent 1 mL Injection 3 5 Gonal-f

(c)omit from the columns in the order indicated:

Injection set containing 1 vial powder for injection 1,050 I.U. and 1 pre-filled syringe solvent 2 mL Injection 1 5 Gonal-f

  1. Part 1 of Schedule 1, item dealing with Gabapentin in the form Capsule 300 mg

(a)omit from  the column headed “Brand”: Douglas Gabapentin 300mg

(b)omit from  the column headed “Brand”: Gabahexal 300mg

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

  1. Part 1 of Schedule 1, item dealing with Gabapentin in the form Capsule 400 mg

(a)omit from  the column headed “Brand”: Gabahexal 400mg

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

(c)omit from  the column headed “Brand”: Pendine 400

  1. Part 1 of Schedule 1, item dealing with Gabapentin in the form Tablet 600 mg

insert in alphabetical order in the column headed “Brand”: Gabatine 600

  1. Part 1 of Schedule 1, item dealing with Gabapentin in the form Tablet 800 mg

insert in alphabetical order in the column headed “Brand”: Gabatine 800

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

omit from the column headed “Brand”: Diamicron MR

  1. Part 1 of Schedule 1, item dealing with Glucose in the forms I.V. infusion 139 mmol (anhydrous) per 500 mL, 500 mL, I.V. infusion
    278 mmol (anhydrous) per 500 mL, 500 mL and I.V. infusion 278 mmol (anhydrous) per L, 1 L

omit from the column headed “Brand”: Pharmatel Fresenius Kabi Pty Limited

and substitute: Fresenius Kabi Australia Pty Limited

  1. Part 1 of Schedule 1, item dealing with Glucose Indicator—Blood

omit from the columns in the order indicated:

Test strips, 50 (Accu-Chek Mobile)

For external use

2

5

Accu-Chek Mobile

  1. Part 1 of Schedule 1, after item dealing with Glucose Indicator—Blood in the form Test strips, 50 (WaveSense Jazz)

insert in the columns in the order indicated:

Test strips, 100 (Accu-Chek Mobile)

For external use

1

5

Accu-Chek Mobile

  1. Part 1 of Schedule 1, item dealing with Glucose Indicator—Blood

omit from the columns in the order indicated:

Test strips, 100 (Precision Plus)

For external use

1

5

Precision Plus

  1. Part 1 of Schedule 1, item dealing with Lansoprazole in the form Capsule 15 mg

omit from the column headed “Brand”: Zoton

  1. Part 1 of Schedule 1, item dealing with Levetiracetam in the form Tablet 250 mg

omit from the column headed “Brand”: Keppra

and substitute:

APO-Levetiracetam

Chem mart Levetiracetam

Kepcet

Keppra

Kevtam

Levitam 250

Terry White Chemists Levetiracetam

  1. Part 1 of Schedule 1, item dealing with Levetiracetam in the form Tablet 500 mg

omit from the column headed “Brand”: Keppra

and substitute:

APO-Levetiracetam

Chem mart Levetiracetam

Kepcet

Keppra

Kevtam

Levitam 500

Terry White Chemists Levetiracetam

  1. Part 1 of Schedule 1, item dealing with Levetiracetam in the form Tablet 1 g

omit from the column headed “Brand”: Keppra

and substitute:

APO-Levetiracetam

Chem mart Levetiracetam

Kepcet

Keppra

Kevtam

Levitam 1000

Terry White Chemists Levetiracetam

  1. Part 1 of Schedule 1, item dealing with Lisinopril in the form Tablet 5 mg

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

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

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

  1. Part 1 of Schedule 1, item dealing with Lisinopril in the form Tablet 10 mg

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

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

  1. Part 1 of Schedule 1, item dealing with Lisinopril in the form Tablet 20 mg

insert in alphabetical order in the column headed “Brand”: Lisinopril-DRLA

  1. Part 1 of Schedule 1, after item dealing with Mesalazine in the form Tablet 500 mg (prolonged release)

insert in the columns in the order indicated:

Tablet 1.2 g (prolonged release) Oral 60 5 Mezavant

  1. Part 1 of Schedule 1, item dealing with Metformin in the forms Tablet containing metformin hydrochloride 500 mg and Tablet containing metformin hydrochloride 850 mg

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

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

  1. Part 1 of Schedule 1, omit item dealing with Mineral mixture

  1. Part 1 of Schedule 1, item dealing with Norfloxacin in the form Tablet 400 mg

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

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

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

insert in the columns in the order indicated:

Perindopril with amlodipine Tablet containing 5 mg perindopril arginine with 5 mg amlodipine (as besylate) Oral 30 5 Coveram
Tablet containing 5 mg perindopril arginine with 10 mg amlodipine (as besylate) Oral 30 5 Coveram
Tablet containing 10 mg perindopril arginine with 5 mg amlodipine (as besylate) Oral 30 5 Coveram
Tablet containing 10 mg perindopril arginine with 10 mg amlodipine (as besylate) Oral 30 5 Coveram

  1. Part 1 of Schedule 1, item dealing with Ramipril in the form Capsule 1.25 mg

insert in alphabetical order in the column headed “Brand”: Ramipril-GA

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

omit from the columns in the order indicated:

Tablets 10 mg, 15

Oral

1

1

Xarelto

  1. Part 1 of Schedule 1, item dealing with Sodium Chloride in the forms I.V. infusion 77 mmol per 500 mL, 500 mL and I.V. infusion 154 mmol
    per L, 1 L

omit from the column headed “Brand”: Pharmatel Fresenius Kabi Pty Limited

and substitute: Fresenius Kabi Australia Pty Limited

  1. Part 1 of Schedule 1, item dealing with Sodium Lactate Compound in the forms I.V. infusion containing approximately 65 mmol sodium (as lactate and chloride), 2.7 mmol potassium (as chloride), 0.9 mmol calcium (as chloride), 14 mmol bicarbonate (as lactate) and 56 mmol chloride per 500 mL, 500 mL and 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

omit from the column headed “Brand”: Pharmatel Fresenius Kabi Pty Limited

and substitute: Fresenius Kabi Australia Pty Limited

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

insert in alphabetical order in the column headed “Brand”: GA Tramadol 50mg

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

insert in alphabetical order in the column headed “Brand”: GA Tramadol SR 100mg

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

insert in alphabetical order in the column headed “Brand”: GA Tramadol SR 150mg

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

insert in alphabetical order in the column headed “Brand”: GA Tramadol SR 200mg

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

omit from the columns in the order indicated:

Solution for I.V. infusion 100 mg in 50 mL

In compliance with authority procedures set out in subparagraph 11 (d):

Continuing treatment of stage III, IVa or IVb squamous cell cancer of the larynx, oropharynx or hypopharynx, in combination with radiotherapy, where cisplatin is either contraindicated or not tolerated

Injection

1

6

Erbitux

  1. Part 2 of Schedule 1, item dealing with Famciclovir in the form Tablet 250 mg (both instances)

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

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

  1. Part 2 of Schedule 1, item dealing with Famciclovir in the form Tablet 500 mg

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

  1. Part 2 of Schedule 1, item dealing with Glucose Indicator—Blood

omit from the columns in the order indicated:

Test strips, 50 (Accu-Chek Mobile)

For use in patients who are receiving treatment under a GP Management Plan or Team Care Arrangements where Medicare benefits were or are payable for the preparation of the Plan or coordination of the Arrangements

For external use

2

11

Accu-Chek Mobile

  1. Part 2 of Schedule 1, after item dealing with Glucose Indicator—Blood in the form Test strips, 50 (WaveSense Jazz)

insert in the columns in the order indicated:

Test strips, 100 (Accu-Chek Mobile)

For use in patients who are receiving treatment under a GP Management Plan or Team Care Arrangements where Medicare benefits were or are payable for the preparation of the Plan or coordination of the Arrangements

For external use

1

11

Accu-Chek Mobile

  1. Part 2 of Schedule 1, item dealing with Rivaroxaban in the form Tablet 10 mg

omit from the column headed “Maximum quantity”:             10         and substitute:     15

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

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

Tablets 10 mg, 10

In compliance with authority procedures set out in subparagraph 11 (d):

Prevention of venous thromboembolism in a patient undergoing total hip replacement

 Oral 1 1 Xarelto

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

insert in alphabetical order in the column headed “Brand”: GA Tramadol 50mg

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

insert in alphabetical order in the column headed “Brand”: GA Tramadol SR 100mg

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

insert in alphabetical order in the column headed “Brand”: GA Tramadol SR 150mg

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

insert in alphabetical order in the column headed “Brand”: GA Tramadol SR 200mg

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

omit from the column headed “Brand”: Amoxycillin-DP

  1. Part 1 of Schedule 3, item dealing with Amoxycillin in the form Capsule 500 mg (as trihydrate)

insert in alphabetical order in the column headed “Brand”: Amoxycillin-GA

  1. Part 1 of Schedule 3, item dealing with Cephalexin in the forms Granules for oral suspension 125 mg per 5 mL, 100 mL and Granules for oral suspension 250 mg per 5 mL, 100 mL

insert in alphabetical order in the column headed “Brand”: APO-Cephalexin

  1. Part 1 of Schedule 3, item dealing with Glucose in the forms I.V. infusion 139 mmol (anhydrous) per 500 mL, 500 mL and I.V. infusion 278 mmol (anhydrous) per L, 1 L

omit from the column headed “Brand”: Pharmatel Fresenius Kabi Pty Limited

and substitute: Fresenius Kabi Australia Pty Limited

  1. Part 1 of Schedule 3, item dealing with Sodium Chloride in the forms I.V. infusion 77 mmol per 500 mL, 500 mL and I.V. infusion 154 mmol
    per L, 1 L

omit from the column headed “Brand”: Pharmatel Fresenius Kabi Pty Limited

and substitute: Fresenius Kabi Australia Pty Limited

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

insert in alphabetical order in the column headed “Brand”: GA Tramadol 50mg

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

insert in alphabetical order in the column headed “Brand”: GA Tramadol SR 100mg

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

insert in alphabetical order in the column headed “Brand”: GA Tramadol SR 150mg

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

insert in alphabetical order in the column headed “Brand”: GA Tramadol SR 200mg

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