National Health Act 1953 Amendment determination under section 84AF responsible persons (No. PB 97 of 2010) (Cth)

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COMMONWEALTH OF AUSTRALIA

Instrument number PB 97 of 2010

Amendment determination under section 84AF of the National Health Act 1953

I, DAVID LEARMONTH, Deputy Secretary, Department of Health and Ageing, delegate of the Minister for Health and Ageing, make this instrument under section 84AF of the National Health Act 1953.

Dated Twenty Ninth October 2010

DAVID LEARMONTH

Deputy Secretary

Department of Health and Ageing

Amendment determination – responsible persons

1              Commencement

This instrument commences on 1 November 2010.

2              Amendment of PB 69 of 2010

Schedule 1 amends PB 69 of 2010.

Schedule 1            Amendments

  1. Schedule 1, items dealing with Aciclovir in the form Tablet 800 mg

omit:

Aciclovir Tablet 800 mg Oral Lovir Ascent Pharma Pty Ltd  68 118 734 795

  1. Schedule 1, after item dealing with Amlodipine with valsartan in the form Tablet 5 mg (as besylate)-80 mg

insert in the columns in the order indicated:

Amlodipine with valsartan and hydrochlorothiazide Tablet 10 mg (as besylate)-160 mg-12.5 mg Oral Exforge HCT 10/160/12.5 Novartis Pharmaceuticals Australia Pty Limited  18 004 244 160
Amlodipine with valsartan and hydrochlorothiazide Tablet 10 mg (as besylate)-160 mg-25 mg Oral Exforge HCT 10/160/25 Novartis Pharmaceuticals Australia Pty Limited  18 004 244 160
Amlodipine with valsartan and hydrochlorothiazide Tablet 10 mg (as besylate)-320 mg-25 mg Oral Exforge HCT 10/320/25 Novartis Pharmaceuticals Australia Pty Limited  18 004 244 160
Amlodipine with valsartan and hydrochlorothiazide Tablet 5 mg (as besylate)-160 mg-12.5 mg Oral Exforge HCT 5/160/12.5 Novartis Pharmaceuticals Australia Pty Limited  18 004 244 160
Amlodipine with valsartan and hydrochlorothiazide Tablet 5 mg (as besylate)-160 mg-25 mg Oral Exforge HCT 5/160/25 Novartis Pharmaceuticals Australia Pty Limited  18 004 244 160

  1. Schedule 1, after item dealing with Arsenic

insert in the columns in the order indicated:

Artemether with lumefantrine Tablet (dispersible) 20 mg-120 mg Oral Riamet 20mg/120mg Dispersible Novartis Pharmaceuticals Australia Pty Limited  18 004 244 160

  1. Schedule 1, after item dealing with Bortezomib

insert in the columns in the order indicated:

Brimonidine Eye drops containing brimonidine tartrate 1.5 mg per mL, 5 mL Application to the eye Alphagan P 1.5 Allergan Australia Pty Limited  85 000 612 831

  1. Schedule 1, item dealing with Ceftriaxone in the form Powder for injection 1 g (as sodium) (Ceftriaxone ICP)

omit:

Intensive Care Products Pty Limited  35 003 772 012

and substitute:

Petrus Pharmaceuticals Pty Ltd 21 108 884 126

  1. Schedule 1, item dealing with Ceftriaxone in the form Powder for injection 2 g (as sodium) (Ceftriaxone ICP)

omit:

Intensive Care Products Pty Limited  35 003 772 012

and substitute:

Petrus Pharmaceuticals Pty Ltd 21 108 884 126

  1. Schedule 1, item dealing with Ceftriaxone in the form Powder for injection 500 mg (as sodium) (Ceftriaxone ICP)

omit:

Intensive Care Products Pty Limited  35 003 772 012

and substitute:

Petrus Pharmaceuticals Pty Ltd 21 108 884 126

  1. Schedule 1, after item dealing with Enalapril in the form Tablet containing enalapril maleate 10 mg (Enalapril generichealth)

insert in the columns in the order indicated:

Enalapril Tablet containing enalapril maleate 10 mg Oral Enalapril Sandoz Sandoz Pty Ltd  60 075 449 553

  1. Schedule 1, after item dealing with Enalapril in the form Tablet containing enalapril maleate 20 mg (Enalapril generichealth)

insert in the columns in the order indicated:

Enalapril Tablet containing enalapril maleate 20 mg Oral Enalapril Sandoz Sandoz Pty Ltd  60 075 449 553

  1. Schedule 1, after item dealing with Enalapril in the form Tablet containing enalapril maleate 5 mg (Enalapril generichealth)

insert in the columns in the order indicated:

Enalapril Tablet containing enalapril maleate 5 mg Oral Enalapril Sandoz Sandoz Pty Ltd  60 075 449 553

  1. Schedule 1, after item dealing with Famotidine in the form Tablet 20 mg (Famohexal)

insert in the columns in the order indicated:

Famotidine Tablet 20 mg Oral Famotidine Sandoz Sandoz Pty Ltd  60 075 449 553

  1. Schedule 1, after item dealing with Fluconazole in the form Solution for I.V. infusion 100 mg in 50 mL (Fluconazole Hexal)

insert in the columns in the order indicated:

Fluconazole Solution for I.V. infusion 100 mg in 50 mL Injection Fluconazole-Claris AFT Pharmaceuticals Pty Ltd  29 105 636 413

  1. Schedule 1, after item dealing with Fluconazole in the form Solution for I.V. infusion 200 mg in 100 mL (Fluconazole Sandoz)

insert in the columns in the order indicated:

Fluconazole Solution for I.V. infusion 200 mg in 100 mL Injection Fluconazole-Claris AFT Pharmaceuticals Pty Ltd  29 105 636 413

  1. Schedule 1, after item dealing with Lamotrigine in the form Tablet 200 mg (Seaze 200)

insert in the columns in the order indicated:

Lamotrigine Tablet 25 mg Oral APO-Lamotrigine Apotex Pty Ltd  52 096 916 148

  1. Schedule 1, omit item dealing with Mexiletine

  1. Schedule 1, items dealing with Moclobemide in the form Tablet 300 mg

omit:

Moclobemide Tablet 300 mg Oral Maosig Sigma Pharmaceuticals (Australia) Pty Ltd  88 004 118 594

  1. Schedule 1, after item dealing with Olmesartan in the form Tablet containing olmesartan medoxomil 40 mg

insert in the columns in the order indicated:

Olmesartan with amlodipine Tablet containing olmesartan medoxomil 20 mg with amlodipine 5 mg (as besylate) Oral Sevikar 20/5 Schering-Plough Pty Limited  57 000 235 245
Olmesartan with amlodipine Tablet containing olmesartan medoxomil 40 mg with amlodipine 10 mg (as besylate) Oral Sevikar 40/10 Schering-Plough Pty Limited  57 000 235 245
Olmesartan with amlodipine Tablet containing olmesartan medoxomil 40 mg with amlodipine 5 mg (as besylate) Oral Sevikar 40/5 Schering-Plough Pty Limited  57 000 235 245

  1. Schedule 1, after items dealing with Paliperidone

insert in the columns in the order indicated:

Palonosetron Injection 250 micrograms (as hydrochloride) in 5 mL Injection Aloxi Specialised Therapeutics Australia Pty Ltd  73 124 031 241

  1. Schedule 1, after item dealing with Perindopril in the form Tablet containing perindopril arginine 5 mg

insert in the columns in the order indicated:

Perindopril Tablet containing perindopril erbumine 2 mg Oral APO-Perindopril Apotex Pty Ltd  52 096 916 148

  1. Schedule 1, omit items dealing with Tacrolimus

and substitute:

Tacrolimus Capsule 0.5 mg (once daily prolonged release) Oral Prograf XL Janssen-Cilag Pty Ltd  47 000 129 975
Tacrolimus Capsule 1 mg Oral Prograf Janssen-Cilag Pty Ltd  47 000 129 975
Tacrolimus Capsule 1 mg (once daily prolonged release) Oral Prograf XL Janssen-Cilag Pty Ltd  47 000 129 975
Tacrolimus Capsule 5 mg Oral Prograf Janssen-Cilag Pty Ltd  47 000 129 975
Tacrolimus Capsule 5 mg (once daily prolonged release) Oral Prograf XL Janssen-Cilag Pty Ltd  47 000 129 975
Tacrolimus Capsule 500 micrograms Oral Prograf Janssen-Cilag Pty Ltd  47 000 129 975

  1. Schedule 1, after item dealing with Triptorelin in the form Powder for I.M injection (prolonged release) 11.25 mg (as embonate) with solvent, syringe and needles

insert in the columns in the order indicated:

Triptorelin Powder for I.M. injection (prolonged release) 22.5 mg (as embonate) with solvent, syringe and needles Injection Diphereline Ipsen Pty Ltd  47 095 036 909

Note

All legislative instruments and compilations are registered on the Federal Register ofLegislative Instruments kept under the Legislative Instruments Act 2003.

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