National Health Act 1953 Amendment determination under section 84AF responsible persons (No. PB 46 of 2010) (Cth)

Case

COMMONWEALTH OF AUSTRALIA

Instrument number PB 46 of 2010

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

Dated    12 May 2010

FELICITY McNEILL

Assistant Secretary

Pharmaceutical Evaluation Branch

Department of Health and Ageing

Amendment determination – responsible persons

1              Commencement

This instrument commences on 1 June 2010.

2              Amendment of PB 16 of 2010

Schedule 1 amends PB 16 of 2010.

Schedule 1            Amendments

[1]Schedule 1, item dealing with Aciclovir in the form Tablet 200 mg (Lovir)

omit from the column headed “Responsible Person”:          Genepharm Pty Ltd

and substitute:               Ascent Pharma Pty Ltd

[2]Schedule 1, item dealing with Aciclovir in the form Tablet 800 mg (Lovir)

omit from the column headed “Responsible Person”:          Genepharm Pty Ltd

and substitute:               Ascent Pharma Pty Ltd

[3]Schedule 1, item dealing with Alendronic acid in the form Tablet 70 mg (as alendronate sodium) (Alendronate-GA)

omit from the column headed “Responsible Person”:          Genepharm Pty Ltd

and substitute:               Ascent Pharma Pty Ltd

[4]Schedule 1, item dealing with Alendronic acid with colecalciferol in the form Tablet 70 mg (as alendronate sodium) with 140 micrograms colecalciferol (Dronalen Plus)

omit from the column headed “Responsible Person”:          Genepharm Pty Ltd

and substitute:               Ascent Pharma Pty Ltd

[5]Schedule 1, after items 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 Fosamax Plus D-Cal Merck Sharp & Dohme (Australia) Pty Ltd  14 000 173 508

[6]Schedule 1, item dealing with Alprazolam in the form Tablet 1 mg (Alprazolam-GA)

omit from the column headed “Responsible Person”:          Genepharm Pty Ltd

and substitute:               Ascent Pharma Pty Ltd

[7]Schedule 1, item dealing with Alprazolam in the form Tablet 2 mg (Alprazolam-GA)

omit from the column headed “Responsible Person”:          Genepharm Pty Ltd

and substitute:               Ascent Pharma Pty Ltd

[8]Schedule 1, items dealing with Amino acid formula with vitamins and minerals without phenylalanine

omit from the columns in the order indicated:

Amino acid formula with vitamins and minerals without phenylalanine Oral powder 400 g (Phenex-2) Oral Phenex-2 Abbott Australasia Pty Ltd  95 000 180 389

[9]Schedule 1, omit item dealing with Amino acid formula without methionine, threonine and valine and low in isoleucine

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

  1. Schedule 1, after item dealing with Amlodipine in the form Tablet 10 mg (as besylate) (Amlodipine Sandoz)

insert in the columns in the order indicated:

Amlodipine Tablet 10 mg (as besylate) Oral Amlodipine-DRLA Dr Reddy’s Laboratories (Australia) Pty Ltd  16 120 092 408

  1. Schedule 1, item dealing with Amlodipine in the form Tablet 10 mg (as besylate) (Amlodipine-GA)

omit from the column headed “Responsible Person”:          Genepharm Pty Ltd

and substitute:              Ascent Pharma Pty Ltd

  1. Schedule 1, item dealing with Amlodipine in the form Tablet 10 mg (as besylate) (Norvapine)

omit from the column headed “Responsible Person”:          Genepharm (Australia) Limited

and substitute:               Ascent Pharmaceuticals Limited

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

insert in the columns in the order indicated:

Amlodipine Tablet 5 mg (as besylate) Oral Amlodipine-DRLA Dr Reddy’s Laboratories (Australia) Pty Ltd  16 120 092 408

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

omit from the column headed “Responsible Person”:          Genepharm Pty Ltd

and substitute:               Ascent Pharma Pty Ltd

  1. Schedule 1, item dealing with Amlodipine in the form Tablet 5 mg (as besylate) (Norvapine)

omit from the column headed “Responsible Person”:          Genepharm (Australia) Limited

and substitute:               Ascent Pharmaceuticals Limited

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

omit from the columns in the order indicated:

Amoxycillin Capsule 250 mg (as trihydrate) Oral Amoxycillin-DP Genepharm Pty Ltd  68 118 734 795

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

omit from the column headed “Responsible Person”:          Genepharm Pty Ltd

and substitute:               Ascent Pharma Pty Ltd

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

omit from the columns in the order indicated:

Genepharm Pty Ltd  68 118 734 795

and substitute:

Ascent Pharmaceuticals Limited  17 003 854 626

  1. Schedule 1, after item dealing with Amoxycillin in the form Capsule 500 mg (as trihydrate) (Amoxycillin-DP)

insert in the columns in the order indicated:

Amoxycillin Capsule 500 mg (as trihydrate) Oral Amoxycillin-GA Ascent Pharma Pty Ltd  68 118 734 795

  1. Schedule 1, item dealing with Amoxycillin in the form Powder for oral suspension 125 mg (as trihydrate) per 5 mL, 100 mL (Bgramin)

omit from the column headed “Responsible Person”:          Genepharm Pty Ltd

and substitute:               Ascent Pharma Pty Ltd

  1. Schedule 1, item dealing with Amoxycillin in the form Powder for oral suspension 250 mg (as trihydrate) per 5 mL, 100 mL (Bgramin)

omit from the column headed “Responsible Person”:          Genepharm Pty Ltd

and substitute:               Ascent Pharma Pty Ltd

  1. 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) (GA-Amclav 500/125)

omit from the column headed “Responsible Person”:          Genepharm Pty Ltd

and substitute:               Ascent Pharma Pty Ltd

  1. 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) (GA-Amclav 875/125)

omit from the column headed “Responsible Person”:          Genepharm Pty Ltd

and substitute:               Ascent Pharma Pty Ltd

  1. Schedule 1, items dealing with Atenolol in the form Tablet 50 mg

omit from the column headed “Brand”:         Atehexal     and substitute:           Atenolol Sandoz

  1. Schedule 1, item dealing with Atenolol in the form Tablet 50 mg (Atenolol-GA)

omit from the column headed “Responsible Person”:          Genepharm (Australia) Limited

and substitute:              Ascent Pharmaceuticals Limited

  1. Schedule 1, item dealing with Azathioprine in the form Tablet 50 mg (Azamun)

omit from the column headed “Responsible Person”:          Genepharm Pty Ltd

and substitute:              Ascent Pharma Pty Ltd

  1. Schedule 1, item dealing with Balsalazide

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

and substitute:              Fresenius Kabi Australia Pty Limited

  1. Schedule 1, item dealing with Bicalutamide in the form Tablet 50 mg (Bicalutamide-GA)

omit from the column headed “Responsible Person”:          Genepharm Pty Ltd

and substitute:              Ascent Pharma Pty Ltd

  1. Schedule 1, item dealing with Calcitriol in the form Capsule 0.25 microgram (Calcitriol-DP)

omit from the columns in the order indicated:

Genepharm Pty Ltd  68 118 734 795

and substitute:

Ascent Pharmaceuticals Limited  17 003 854 626

  1. Schedule 1, item dealing with Calcitriol in the form Capsule 0.25 microgram (Calcitriol-GA)

omit from the columns in the order indicated:

Genepharm (Australia) Limited  17 003 854 626

and substitute:

Ascent Pharma Pty Ltd  68 118 734 795

  1. Schedule 1, after item dealing with Captopril in the form Tablet 12.5 mg (Zedace)

insert in the columns in the order indicated:

Captopril Tablet 25 mg Oral Ascent Pharma Pty Ltd Ascent Pharma Pty Ltd  68 118 734 795

  1. Schedule 1, items dealing with Captopril in the form Tablet 25 mg

omit from the columns in the order indicated:

Captopril Tablet 25 mg Oral Genepharm Pty Ltd Genepharm Pty Ltd  68 118 734 795

  1. Schedule 1, after item dealing with Captopril in the form Tablet 25 mg (Zedace)

insert in the columns in the order indicated:

Captopril Tablet 50 mg Oral Ascent Pharma Pty Ltd Ascent Pharma Pty Ltd  68 118 734 795

  1. Schedule 1, items dealing with Captopril in the form Tablet 50 mg

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

  1. Schedule 1, items dealing with Captopril in the form Tablet 50 mg

omit from the columns in the order indicated:

Captopril Tablet 50 mg Oral Genepharm Pty Ltd Genepharm Pty Ltd  68 118 734 795

  1. Schedule 1, item dealing with Carvedilol in the form Tablet 12.5 mg (GN-Carvedilol)

omit from the column headed “Responsible Person”:          Genepharm Pty Ltd

and substitute:              Ascent Pharma Pty Ltd

  1. Schedule 1, item dealing with Carvedilol in the form Tablet 25 mg (GN-Carvedilol)

omit from the column headed “Responsible Person”:          Genepharm Pty Ltd

and substitute:              Ascent Pharma Pty Ltd

  1. Schedule 1, item dealing with Carvedilol in the form Tablet 3.125 mg (GN-Carvedilol)

omit from the column headed “Responsible Person”:          Genepharm Pty Ltd

and substitute:              Ascent Pharma Pty Ltd

  1. Schedule 1, item dealing with Carvedilol in the form Tablet 6.25 mg (GN-Carvedilol)

omit from the column headed “Responsible Person”:          Genepharm Pty Ltd

and substitute:              Ascent Pharma Pty Ltd

  1. Schedule 1, item dealing with Cefaclor in the form Tablet (sustained release) 375 mg (as monohydrate) (Cefaclor-GA)

omit from the column headed “Responsible Person”:          Genepharm (Australia) Limited

and substitute:              Ascent Pharmaceuticals Limited

  1. Schedule 1, item dealing with Cefaclor in the form Tablet (sustained release) 375 mg (as monohydrate) (Douglas Cefaclor-CD)

omit from the column headed “Responsible Person”:          Genepharm Pty Ltd

and substitute:              Ascent Pharma Pty Ltd

  1. Schedule 1, item dealing with Cephalexin in the form Capsule 250 mg (anhydrous) (Cilex)

omit from the column headed “Responsible Person”:          Genepharm Pty Ltd

and substitute:              Ascent Pharma Pty Ltd

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

omit from the column headed “Responsible Person”:          Genepharm Pty Ltd

and substitute:              Ascent Pharma Pty Ltd

  1. Schedule 1, after item dealing with Cephalexin in the form Capsule 500 mg (anhydrous) (Terry White Chemists Cephalexin)

insert in the columns in the order indicated:

Cephalexin Granules for oral suspension 125 mg per 5 mL, 100 mL Oral APO-Cephalexin Apotex Pty Ltd  52 096 916 148

  1. Schedule 1, item dealing with Cephalexin in the form Granules for oral suspension 125 mg per 5 mL, 100 mL (Cilex)

omit from the column headed “Responsible Person”:          Genepharm Pty Ltd

and substitute:              Ascent Pharma Pty Ltd

  1. Schedule 1, after item dealing with Cephalexin in the form Granules for oral suspension 125 mg per 5 mL, 100 mL (Terry White
    Chemists Cephalexin)

insert in the columns in the order indicated:

Cephalexin Granules for oral suspension 250 mg per 5 mL, 100 mL Oral APO-Cephalexin Apotex Pty Ltd  52 096 916 148

  1. Schedule 1, item dealing with Cephalexin in the form Granules for oral suspension 250 mg per 5 mL, 100 mL (Cilex)

omit from the column headed “Responsible Person”:          Genepharm Pty Ltd

and substitute:              Ascent Pharma Pty Ltd

  1. Schedule 1, items dealing with Cetuximab

omit from the columns in the order indicated:

Cetuximab Solution for I.V. infusion 100 mg in 50 mL Injection Erbitux Merck Serono Australia Pty Ltd  72 006 900 830

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

insert in the columns in the order indicated:

Ciprofloxacin Tablet 250 mg (as hydrochloride) Oral Ciprofloxacin-DRLA Dr Reddy’s Laboratories (Australia) Pty Ltd  16 120 092 408

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

insert in the columns in the order indicated:

Ciprofloxacin Tablet 500 mg (as hydrochloride) Oral Ascent Pharmaceuticals Limited Ascent Pharmaceuticals Limited  17 003 854 626

  1. Schedule 1, after item dealing with Ciprofloxacin in the form Tablet 500 mg (as hydrochloride) (Ciprofloxacin-BW)

insert in the columns in the order indicated:

Ciprofloxacin Tablet 500 mg (as hydrochloride) Oral Ciprofloxacin-DRLA Dr Reddy’s Laboratories (Australia) Pty Ltd  16 120 092 408

  1. Schedule 1, item dealing with Ciprofloxacin in the form Tablet 500 mg (as hydrochloride) (Ciprofloxacin-GA)

omit from the column headed “Responsible Person”:          Genepharm Pty Ltd

and substitute:              Ascent Pharma Pty Ltd

  1. Schedule 1, items dealing with Ciprofloxacin in the form Tablet 500 mg (as hydrochloride)

omit from the columns in the order indicated:

Ciprofloxacin Tablet 500 mg (as hydrochloride) Oral Genepharm (Australia) Limited Genepharm (Australia) Limited  17 003 854 626

  1. Schedule 1, after item dealing with Ciprofloxacin in the form Tablet 500 mg (as hydrochloride) (Profloxin)

insert in the columns in the order indicated:

Ciprofloxacin Tablet 750 mg (as hydrochloride) Oral Ascent Pharmaceuticals Limited Ascent Pharmaceuticals Limited  17 003 854 626

  1. Schedule 1, after item dealing with Ciprofloxacin in the form Tablet 750 mg (as hydrochloride) (Ciprofloxacin-BW)

insert in the columns in the order indicated:

Ciprofloxacin Tablet 750 mg (as hydrochloride) Oral Ciprofloxacin-DRLA Dr Reddy’s Laboratories (Australia) Pty Ltd  16 120 092 408

  1. Schedule 1, items dealing with Ciprofloxacin in the form Tablet 750 mg (as hydrochloride)

omit from the columns in the order indicated:

Ciprofloxacin Tablet 750 mg (as hydrochloride) Oral Genepharm (Australia) Limited Genepharm (Australia) Limited  17 003 854 626

  1. Schedule 1, item dealing with Citalopram in the form Tablet 20 mg (as hydrobromide) (Ciazil)

omit from the column headed “Responsible Person”:          Genepharm Pty Ltd

and substitute:              Ascent Pharma Pty Ltd

  1. Schedule 1, item dealing with Clarithromycin in the form Tablet 250 mg (Clarac)

omit from the column headed “Responsible Person”:          Genepharm Pty Ltd

and substitute:              Ascent Pharma Pty Ltd

  1. Schedule 1, after items dealing with Clonidine

insert in the columns in the order indicated:

Clopidogrel Tablet 75 mg (as besilate) Oral Clovix 75 Sigma Pharmaceuticals (Australia) Pty Ltd  88 004 118 594

  1. Schedule 1, items dealing with Clotrimazole

omit from the columns in the order indicated:

Clotrimazole Lotion 10 mg per mL, 20 mL Application Canesten Bayer Australia Ltd  22 000 138 714

  1. Schedule 1, item dealing with Coal Tar ─ Prepared

omit from the column headed “Responsible Person”:          Genepharm Pty Ltd

and substitute:              Ascent Pharma Pty Ltd

  1. Schedule 1, item dealing with Cromoglycic Acid in the form Capsule containing powder for oral inhalation containing sodium cromoglycate
    20 mg (for use in Intal Spinhaler or Intal Halermatic)

omit from the column headed “Responsible Person”:          Genepharm Pty Ltd

and substitute:              Ascent Pharma Pty Ltd

  1. Schedule 1, items dealing with Cromoglycic Acid

omit from the columns in the order indicated:

Cromoglycic Acid Pressurised inhalation containing sodium cromoglycate 1 mg per dose, 200 doses Inhalation by mouth Intal sanofi-aventis Australia Pty Ltd  31 008 558 807

  1. Schedule 1, item dealing with Cyproterone in the form Tablet containing cyproterone acetate 100 mg (Procur 100)

omit from the column headed “Responsible Person”:          Genepharm Pty Ltd

and substitute:              Ascent Pharma Pty Ltd

  1. Schedule 1, item dealing with Cyproterone in the form Tablet containing cyproterone acetate 50 mg (Procur)

omit from the column headed “Responsible Person”:          Genepharm Pty Ltd

and substitute:              Ascent Pharma Pty Ltd

  1. Schedule 1, item dealing with Diazepam in the form Tablet 5 mg (Diazepam-GA)

omit from the column headed “Responsible Person”:          Genepharm Pty Ltd

and substitute:              Ascent Pharma Pty Ltd

  1. Schedule 1, item dealing with Diclofenac in the form Tablet (enteric coated) containing diclofenac sodium 25 mg (Diclofenac-GA)

omit from the columns in the order indicated:

Genepharm (Australia) Limited  17 003 854 626

and substitute:

Ascent Pharma Pty Ltd  68 118 734 795

  1. Schedule 1, item dealing with Diclofenac in the form Tablet (enteric coated) containing diclofenac sodium 50 mg (Diclofenac-GA)

omit from the columns in the order indicated:

Genepharm (Australia) Limited  17 003 854 626

and substitute:

Ascent Pharma Pty Ltd  68 118 734 795

  1. Schedule 1, item dealing with Diltiazem in the form Capsule (controlled delivery) containing diltiazem hydrochloride 180 mg (Dilzem CD)

omit from the column headed “Responsible Person”:          Genepharm Pty Ltd

and substitute:              Ascent Pharma Pty Ltd

  1. Schedule 1, item dealing with Diltiazem in the form Capsule (controlled delivery) containing diltiazem hydrochloride 240 mg (Dilzem CD)

omit from the column headed “Responsible Person”:          Genepharm Pty Ltd

and substitute:              Ascent Pharma Pty Ltd

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

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

  1. Schedule 1, item dealing with Diltiazem in the form Tablet containing diltiazem hydrochloride 60 mg (Dilzem 60 mg)

omit from the column headed “Responsible Person”:          Genepharm Pty Ltd

and substitute:              Ascent Pharma Pty Ltd

  1. Schedule 1, item dealing with Doxycycline in the form Tablet 100 mg (as hydrochloride) (Doxy-100)

omit from the column headed “Responsible Person”:          Genepharm Pty Ltd

and substitute:              Ascent Pharma Pty Ltd

  1. Schedule 1, item dealing with Doxycycline in the form Tablet 50 mg (as hydrochloride) (Doxy-50)

omit from the column headed “Responsible Person”:          Genepharm Pty Ltd

and substitute:              Ascent Pharma Pty Ltd

  1. Schedule 1, item dealing with Electrolyte Replacement, Oral in the form Oral rehydration salts containing glucose 3.56 g, sodium chloride
    470 mg, potassium chloride 300 mg and sodium acid citrate 530 mg per sachet, 10 (restore O.R.S.)

omit from the column headed “Responsible Person”:          Genepharm Pty Ltd

and substitute:              Ascent Pharma Pty Ltd

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

omit from the columns in the order indicated:

Genepharm Pty Ltd  68 118 734 795

and substitute:

Ascent Pharmaceuticals Limited  17 003 854 626

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

omit from the columns in the order indicated:

Genepharm Pty Ltd  68 118 734 795

and substitute:

Ascent Pharmaceuticals Limited  17 003 854 626

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

omit from the columns in the order indicated:

Genepharm Pty Ltd  68 118 734 795

and substitute:

Ascent Pharmaceuticals Limited  17 003 854 626

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

omit from the column headed “Responsible Person”:          Genepharm Pty Ltd

and substitute:              Ascent Pharma Pty Ltd

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

omit from the column headed “Responsible Person”:          Genepharm Pty Ltd

and substitute:              Ascent Pharma Pty Ltd

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

insert in the columns in the order indicated:

Everolimus Tablet 1 mg Oral Certican Novartis Pharmaceuticals Australia Pty Limited  18 004 244 160

  1. Schedule 1, omit items dealing with Famciclovir

and substitute in the columns in the order indicated:

Famciclovir Tablet 125 mg Oral Ezovir Alphapharm Pty Ltd  93 002 359 739
Famciclovir Tablet 125 mg Oral Famvir Novartis Pharmaceuticals Australia Pty Limited  18 004 244 160
Famciclovir Tablet 250 mg Oral Ezovir Alphapharm Pty Ltd  93 002 359 739
Famciclovir Tablet 250 mg Oral Famciclovir Sandoz Sandoz Pty Ltd  60 075 449 553
Famciclovir Tablet 250 mg Oral Famvir Novartis Pharmaceuticals Australia Pty Limited  18 004 244 160
Famciclovir Tablet 500 mg Oral Ezovir Alphapharm Pty Ltd  93 002 359 739
Famciclovir Tablet 500 mg Oral Famvir Novartis Pharmaceuticals Australia Pty Limited  18 004 244 160

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

omit from the column headed “Responsible Person”:          Genepharm Pty Ltd

and substitute:              Ascent Pharma Pty Ltd

  1. Schedule 1, item dealing with Famotidine in the form Tablet 40 mg (Pepzan)

omit from the column headed “Responsible Person”:          Genepharm Pty Ltd

and substitute:              Ascent Pharma Pty Ltd

  1. Schedule 1, item dealing with Fluoxetine in the form Capsule 20 mg (as hydrochloride) (Fluoxetine-GA)

omit from the column headed “Responsible Person”:          Genepharm Pty Ltd

and substitute:              Ascent Pharma Pty Ltd

  1. Schedule 1, items dealing with Follitropin Alfa

omit from the columns in the order indicated:

Follitropin Alfa Injection set containing 1 vial powder for injection 1,050 I.U. and 1 pre-filled syringe solvent 2 mL Injection Gonal-f Merck Serono Australia Pty Ltd  72 006 900 830
Follitropin Alfa Injection set containing 1 vial powder for injection 450 I.U. and 1 pre-filled syringe solvent 1 mL Injection Gonal-f Merck Serono Australia Pty Ltd  72 006 900 830
Follitropin Alfa Injection set containing 1 vial powder for injection 75 I.U. and 1 pre-filled syringe solvent 1 mL Injection Gonal-f 75 Merck Serono Australia Pty Ltd  72 006 900 830
Follitropin Alfa Injection set containing 10 vials powder for injection 75 I.U. and 10 pre-filled syringes solvent 1 mL Injection Gonal-f 75 Merck Serono Australia Pty Ltd  72 006 900 830

  1. Schedule 1, item dealing with Frusemide in the form Tablet 20 mg (Frusid)

omit from the column headed “Responsible Person”:          Genepharm Pty Ltd

and substitute:              Ascent Pharma Pty Ltd

  1. Schedule 1, item dealing with Frusemide in the form Tablet 40 mg (Frusid)

omit from the column headed “Responsible Person”:          Genepharm Pty Ltd

and substitute:              Ascent Pharma Pty Ltd

  1. Schedule 1, items dealing with Gabapentin in the form Capsule 300 mg

omit from the columns in the order indicated:

Gabapentin Capsule 300 mg Oral Douglas Gabapentin 300mg Genepharm Pty Ltd  68 118 734 795
Gabapentin Capsule 300 mg Oral Gabahexal 300mg Sandoz Pty Ltd  60 075 449 553

  1. Schedule 1, after item dealing with Gabapentin in the form Capsule 300 mg (Gabapentin 300)

insert in the columns in the order indicated:

Gabapentin Capsule 300 mg Oral Gabapentin Sandoz Sandoz Pty Ltd  60 075 449 553

  1. Schedule 1, item dealing with Gabapentin in the form Capsule 300 mg (Gabapentin-GA)

omit from the column headed “Responsible Person”:          Genepharm Pty Ltd

and substitute:              Ascent Pharma Pty Ltd

  1. Schedule 1, item dealing with Gabapentin in the form Capsule 400 mg (Douglas Gabapentin 400mg)

omit from the columns in the order indicated:

Genepharm Pty Ltd  68 118 734 795

and substitute:

Ascent Pharmaceuticals Limited  17 003 854 626

  1. Schedule 1, items dealing with Gabapentin in the form Capsule 400 mg

omit from the columns in the order indicated:

Gabapentin Capsule 400 mg Oral Gabahexal 400mg Sandoz Pty Ltd  60 075 449 553

  1. Schedule 1, after item dealing with Gabapentin in the form Capsule 400 mg (Gabapentin 400)

insert in the columns in the order indicated:

Gabapentin Capsule 400 mg Oral Gabapentin Sandoz Sandoz Pty Ltd  60 075 449 553

  1. Schedule 1, items dealing with Gabapentin in the form Capsule 400 mg

omit from the columns in the order indicated:

Gabapentin Capsule 400 mg Oral Pendine 400 Alphapharm Pty Ltd  93 002 359 739

  1. Schedule 1, after item dealing with Gabapentin in the form Tablet 600 mg (Gabaran)

insert in the columns in the order indicated:

Gabapentin Tablet 600 mg Oral Gabatine 600 Sigma Pharmaceuticals (Australia) Pty Ltd  88 004 118 594

  1. Schedule 1, after item dealing with Gabapentin in the form Tablet 800 mg (Gabaran)

insert in the columns in the order indicated:

Gabapentin Tablet 800 mg Oral Gabatine 800 Sigma Pharmaceuticals (Australia) Pty Ltd  88 004 118 594

  1. Schedule 1, item dealing with Gemfibrozil in the form Tablet 600 mg (Lipazil 600 mg)

omit from the column headed “Responsible Person”:          Genepharm Pty Ltd

and substitute:              Ascent Pharma Pty Ltd

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

omit from the columns in the order indicated:

Gliclazide Tablet 30 mg (modified release) Oral Diamicron MR Servier Laboratories (Aust.) Pty Ltd  54 004 838 500

  1. Schedule 1, items dealing with Glucose in the form I.V. infusion 139 mmol (anhydrous) per 500 mL, 500 mL

omit from the columns in the order indicated:

Pharmatel Fresenius Kabi Pty Limited Pharmatel Fresenius Kabi Pty Limited

and substitute:

Fresenius Kabi Australia Pty Limited Fresenius Kabi Australia Pty Limited

  1. Schedule 1, item dealing with Glucose in the form I.V. infusion 278 mmol (anhydrous) per 500 mL, 500 mL

omit from the columns in the order indicated:

Pharmatel Fresenius Kabi Pty Limited Pharmatel Fresenius Kabi Pty Limited

and substitute:

Fresenius Kabi Australia Pty Limited Fresenius Kabi Australia Pty Limited

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

omit from the columns in the order indicated:

Pharmatel Fresenius Kabi Pty Limited Pharmatel Fresenius Kabi Pty Limited

and substitute:

Fresenius Kabi Australia Pty Limited Fresenius Kabi Australia Pty Limited

  1. Schedule 1, items dealing with Glucose in the form I.V. infusion 69.5 mmol (anhydrous) per 250 mL, 250 mL

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

and substitute:              Fresenius Kabi Australia Pty Limited

  1. Schedule 1, after items dealing with Glucose and Ketone Indicator—Urine

insert in the columns in the order indicated:

Glucose Indicator—Blood Test strips, 100 (Accu-Chek Mobile) For external use Accu-Chek Mobile Roche Diagnostics Australia Pty Limited  29 003 001 205

  1. Schedule 1, items dealing with Glucose Indicator—Blood

omit from the columns in the order indicated:

Glucose Indicator—Blood Test strips, 100 (Precision Plus) For external use Precision Plus Abbott Australasia Pty Ltd  95 000 180 389

  1. Schedule 1, items dealing with Glucose Indicator—Blood

omit from the columns in the order indicated:

Glucose Indicator—Blood Test strips, 50 (Accu-Chek Mobile) For external use Accu-Chek Mobile Roche Diagnostics Australia Pty Limited  29 003 001 205

  1. Schedule 1, item dealing with Hydroxyethyl starch 130/0.4

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

and substitute:              Fresenius Kabi Australia Pty Limited

  1. Schedule 1, item dealing with Imipramine in the forms Tablet containing imipramine hydrochloride 10 mg and Tablet containing imipramine hydrochloride 25 mg

omit from the column headed “ABN”:            11 463  31 1 7

and substitute:              39 114 633 117

  1. Schedule 1, item dealing with Indapamide in the form Tablet containing indapamide hemihydrate 2.5 mg (Indapamide-GA)

omit from the column headed “Responsible Person”:          Genepharm Pty Ltd

and substitute:              Ascent Pharma Pty Ltd

  1. Schedule 1, item dealing with Indapamide in the form Tablet containing indapamide hemihydrate 2.5 mg (Napamide 2.5 mg)

omit from the columns in the order indicated:

Genepharm Pty Ltd  68 118 734 795

and substitute:

Ascent Pharmaceuticals Limited  17 003 854 626

  1. Schedule 1, item dealing with Isosorbide Mononitrate in the form Tablet 60 mg (sustained release) (Imtrate 60 mg)

omit from the column headed “Responsible Person”:          Genepharm Pty Ltd

and substitute:              Ascent Pharma Pty Ltd

  1. Schedule 1, item dealing with Isotretinoin in the form Capsule 10 mg (Oratane)

omit from the column headed “Responsible Person”:          Genepharm Pty Ltd

and substitute:              Ascent Pharma Pty Ltd

  1. Schedule 1, item dealing with Isotretinoin in the form Capsule 20 mg (Oratane)

omit from the column headed “Responsible Person”:          Genepharm Pty Ltd

and substitute:              Ascent Pharma Pty Ltd

  1. Schedule 1, item dealing with Isotretinoin in the form Capsule 40 mg

omit from the column headed “Responsible Person”:          Genepharm Pty Ltd

and substitute:              Ascent Pharma Pty Ltd

  1. Schedule 1, item dealing with Lactulose in the form Solution BP 3.34 g per 5 mL, 500 mL (Lac-Dol)

omit from the column headed “Responsible Person”:          Genepharm Pty Ltd

and substitute:              Ascent Pharma Pty Ltd

  1. Schedule 1, item dealing with Lamotrigine in the form Tablet 100 mg (Lamotrigine-DP)

omit from the column headed “Responsible Person”:          Genepharm Pty Ltd

and substitute:              Ascent Pharma Pty Ltd

  1. Schedule 1, item dealing with Lamotrigine in the form Tablet 100 mg (Lamotrigine-GA)

omit from the column headed “Responsible Person”:          Genepharm (Australia) Limited

and substitute:              Ascent Pharmaceuticals Limited

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

omit from the column headed “Responsible Person”:          Genepharm Pty Ltd

and substitute:              Ascent Pharma Pty Ltd

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

omit from the column headed “Responsible Person”:          Genepharm (Australia) Limited

and substitute:              Ascent Pharmaceuticals Limited

  1. Schedule 1, item dealing with Lamotrigine in the form Tablet 25 mg (Lamotrigine-DP)

omit from the column headed “Responsible Person”:          Genepharm Pty Ltd

and substitute:              Ascent Pharma Pty Ltd

  1. Schedule 1, item dealing with Lamotrigine in the form Tablet 25 mg (Lamotrigine-GA)

omit from the column headed “Responsible Person”:          Genepharm (Australia) Limited

and substitute:              Ascent Pharmaceuticals Limited

  1. Schedule 1, item dealing with Lamotrigine in the form Tablet 50 mg (Lamotrigine-DP)

omit from the column headed “Responsible Person”:          Genepharm Pty Ltd

and substitute:              Ascent Pharma Pty Ltd

  1. Schedule 1, item dealing with Lamotrigine in the form Tablet 50 mg (Lamotrigine-GA)

omit from the column headed “Responsible Person”:          Genepharm (Australia) Limited

and substitute:              Ascent Pharmaceuticals Limited

  1. Schedule 1, items dealing with Lansoprazole in the form Capsule 15 mg

omit from the columns in the order indicated:

Lansoprazole Capsule 15 mg Oral Zoton Wyeth Australia Pty Limited  16 000 296 211

  1. Schedule 1, omit items dealing with Levetiracetam

and substitute in the columns in the order indicated:

Levetiracetam Oral solution 100 mg per mL, 300 mL Oral Keppra UCB Australia Proprietary Limited  48 005 799 208
Levetiracetam Tablet 1 g Oral APO-Levetiracetam Apotex Pty Ltd  52 096 916 148
Levetiracetam Tablet 1 g Oral Chem mart Levetiracetam Apotex Pty Ltd  52 096 916 148
Levetiracetam Tablet 1 g Oral Kepcet Ascent Pharma Pty Ltd  68 118 734 795
Levetiracetam Tablet 1 g Oral Keppra UCB Australia Proprietary Limited  48 005 799 208
Levetiracetam Tablet 1 g Oral Kevtam Alphapharm Pty Ltd  93 002 359 739
Levetiracetam Tablet 1 g Oral Levitam 1000 Sigma Pharmaceuticals (Australia) Pty Ltd  88 004 118 594
Levetiracetam Tablet 1 g Oral Terry White Chemists Levetiracetam Apotex Pty Ltd  52 096 916 148
Levetiracetam Tablet 250 mg Oral APO-Levetiracetam Apotex Pty Ltd  52 096 916 148
Levetiracetam Tablet 250 mg Oral Chem mart Levetiracetam Apotex Pty Ltd  52 096 916 148
Levetiracetam Tablet 250 mg Oral Kepcet Ascent Pharma Pty Ltd  68 118 734 795
Levetiracetam Tablet 250 mg Oral Keppra UCB Australia Proprietary Limited  48 005 799 208
Levetiracetam Tablet 250 mg Oral Kevtam Alphapharm Pty Ltd  93 002 359 739
Levetiracetam Tablet 250 mg Oral Levitam 250 Sigma Pharmaceuticals (Australia) Pty Ltd  88 004 118 594
Levetiracetam Tablet 250 mg Oral Terry White Chemists Levetiracetam Apotex Pty Ltd  52 096 916 148
Levetiracetam Tablet 500 mg Oral APO-Levetiracetam Apotex Pty Ltd  52 096 916 148
Levetiracetam Tablet 500 mg Oral Chem mart Levetiracetam Apotex Pty Ltd  52 096 916 148
Levetiracetam Tablet 500 mg Oral Kepcet Ascent Pharma Pty Ltd  68 118 734 795
Levetiracetam Tablet 500 mg Oral Keppra UCB Australia Proprietary Limited  48 005 799 208
Levetiracetam Tablet 500 mg Oral Kevtam Alphapharm Pty Ltd  93 002 359 739
Levetiracetam Tablet 500 mg Oral Levitam 500 Sigma Pharmaceuticals (Australia) Pty Ltd  88 004 118 594
Levetiracetam Tablet 500 mg Oral Terry White Chemists Levetiracetam Apotex Pty Ltd  52 096 916 148

  1. Schedule 1, item dealing with Lisinopril in the form Tablet 10 mg (Liprace)

omit from the column headed “Responsible Person”:          Genepharm Pty Ltd

and substitute:              Ascent Pharma Pty Ltd

  1. Schedule 1, after item dealing with Lisinopril in the form Tablet 10 mg (Lisinopril Winthrop)

insert in the columns in the order indicated:

Lisinopril Tablet 10 mg Oral Lisinopril-DRLA Dr Reddy’s Laboratories (Australia) Pty Ltd  16 120 092 408
Lisinopril Tablet 10 mg Oral Lisinopril-GA Ascent Pharmaceuticals Limited  17 003 854 626

  1. Schedule 1, item dealing with Lisinopril in the form Tablet 20 mg (Liprace)

omit from the column headed “Responsible Person”:          Genepharm Pty Ltd

and substitute:              Ascent Pharma Pty Ltd

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

insert in the columns in the order indicated:

Lisinopril Tablet 20 mg Oral Lisinopril-DRLA Dr Reddy’s Laboratories (Australia) Pty Ltd  16 120 092 408

  1. Schedule 1, item dealing with Lisinopril in the form Tablet 20 mg (Lisinopril-GA)

omit from the column headed “Responsible Person”:          Genepharm (Australia) Limited

and substitute:              Ascent Pharmaceuticals Limited

  1. Schedule 1, item dealing with Lisinopril in the form Tablet 5 mg (Liprace)

omit from the column headed “Responsible Person”:          Genepharm Pty Ltd

and substitute:              Ascent Pharma Pty Ltd

  1. Schedule 1, items dealing with Lisinopril in the form Tablet 5 mg

omit from the columns in the order indicated:

Lisinopril Tablet 5 mg Oral Lisinopril Hexal Sandoz Pty Ltd  60 075 449 553

  1. Schedule 1, after item dealing with Lisinopril in the form Tablet 5 mg (Lisinopril Ranbaxy)

insert in the columns in the order indicated:

Lisinopril Tablet 5 mg Oral Lisinopril Sandoz Sandoz Pty Ltd  60 075 449 553

  1. Schedule 1, after item dealing with Lisinopril in the form Tablet 5 mg (Lisinopril Winthrop)

insert in the columns in the order indicated:

Lisinopril Tablet 5 mg Oral Lisinopril-DRLA Dr Reddy’s Laboratories (Australia) Pty Ltd  16 120 092 408

  1. Schedule 1, item dealing with Lisinopril in the form Tablet 5 mg (Lisinopril-GA)

omit from the column headed “Responsible Person”:          Genepharm (Australia) Limited

and substitute:              Ascent Pharmaceuticals Limited

  1. Schedule 1, item dealing with Meloxicam in the form Tablet 15 mg (Meloxicam-GA)

omit from the column headed “Responsible Person”:          Genepharm Pty Ltd

and substitute:              Ascent Pharma Pty Ltd

  1. Schedule 1, item dealing with Meloxicam in the form Tablet 7.5 mg (Meloxicam-GA)

omit from the column headed “Responsible Person”:          Genepharm Pty Ltd

and substitute:              Ascent Pharma Pty Ltd

  1. Schedule 1, after item dealing with Mesalazine in the form Suppositories 1 g, 28

insert in the columns in the order indicated:

Mesalazine Tablet 1.2 g (prolonged release) Oral Mezavant Shire Australia Pty Limited  29 128 941 819

  1. Schedule 1, item dealing with Metformin in the form Tablet containing metformin hydrochloride 1 g (Metformin-GA)

omit from the columns in the order indicated:

Genepharm (Australia) Limited  17 003 854 626

and substitute:

Ascent Pharma Pty Ltd  68 118 734 795

  1. Schedule 1, after item dealing with Metformin in the form Tablet containing metformin hydrochloride 1 g (Metformin-GA)

insert in the columns in the order indicated:

Metformin Tablet containing metformin hydrochloride 500 mg Oral Ascent Pharmaceuticals Limited Ascent Pharmaceuticals Limited  17 003 854 626

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

omit from the columns in the order indicated:

Metformin Tablet containing metformin hydrochloride 500 mg Oral Genepharm (Australia) Limited Genepharm (Australia) Limited  17 003 854 626

  1. Schedule 1, item dealing with Metformin in the form Tablet containing metformin hydrochloride 500 mg (Metformin-GA)

omit from the column headed “Responsible Person”:          Genepharm Pty Ltd

and substitute:              Ascent Pharma Pty Ltd

  1. Schedule 1, after item dealing with Metformin in the form Tablet containing metformin hydrochloride 500 mg (Terry White
    Chemists Metformin)

insert in the columns in the order indicated:

Metformin Tablet containing metformin hydrochloride 850 mg Oral Ascent Pharmaceuticals Limited Ascent Pharmaceuticals Limited  17 003 854 626

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

omit from the columns in the order indicated:

Metformin Tablet containing metformin hydrochloride 850 mg Oral Genepharm (Australia) Limited Genepharm (Australia) Limited  17 003 854 626

  1. Schedule 1, item dealing with Metformin in the form Tablet containing metformin hydrochloride 850 mg (Metformin-GA)

omit from the column headed “Responsible Person”:          Genepharm Pty Ltd

and substitute:              Ascent Pharma Pty Ltd

  1. Schedule 1, omit item dealing with Mineral mixture

  1. Schedule 1, item dealing with Mirtazapine in the form Tablet 30 mg (Mirtazapine-DP)

omit from the column headed “Responsible Person”:          Genepharm Pty Ltd

and substitute:              Ascent Pharma Pty Ltd

  1. Schedule 1, item dealing with Moclobemide in the form Tablet 150 mg (Clobemix)

omit from the column headed “Responsible Person”:          Genepharm Pty Ltd

and substitute:              Ascent Pharma Pty Ltd

  1. Schedule 1, item dealing with Moclobemide in the form Tablet 300 mg (Clobemix)

omit from the column headed “Responsible Person”:          Genepharm Pty Ltd

and substitute:              Ascent Pharma Pty Ltd

  1. Schedule 1, after items dealing with Norethisterone with Mestranol

insert in the columns in the order indicated:

Norfloxacin Tablet 400 mg Oral Ascent Pharmaceuticals Limited Ascent Pharmaceuticals Limited  17 003 854 626

  1. Schedule 1, items dealing with Norfloxacin in the form Tablet 400 mg

omit from the columns in the order indicated:

Norfloxacin Tablet 400 mg Oral Genepharm Pty Ltd Genepharm Pty Ltd  68 118 734 795

  1. Schedule 1, item dealing with Omeprazole in the form Tablet 20 mg (Omeprazole-GA)

omit from the column headed “Responsible Person”:          Genepharm Pty Ltd

and substitute:              Ascent Pharma Pty Ltd

  1. Schedule 1, item dealing with Ondansetron in the form I.V. injection 4 mg (as hydrochloride dihydrate) in 2 mL (Onsetron)

omit from the columns in the order indicated:

Sigma Pharmaceuticals (Australia) Pty Ltd  88 004 118 594

and substitute:

Spirit Pharmaceuticals Pty Ltd  67 109 225 747

  1. Schedule 1, item dealing with Ondansetron in the form I.V. injection 8 mg (as hydrochloride dihydrate) in 4 mL (Onsetron)

omit from the columns in the order indicated:

Sigma Pharmaceuticals (Australia) Pty Ltd  88 004 118 594

and substitute:

Spirit Pharmaceuticals Pty Ltd  67 109 225 747

  1. Schedule 1, item dealing with Ondansetron in the form Tablet 4 mg (as hydrochloride dihydrate) (Onsetron 4)

omit from the columns in the order indicated:

Sigma Pharmaceuticals (Australia) Pty Ltd  88 004 118 594

and substitute:

Spirit Pharmaceuticals Pty Ltd  67 109 225 747

  1. Schedule 1, item dealing with Ondansetron in the form Tablet 8 mg (as hydrochloride dihydrate) (Onsetron 8)

omit from the columns in the order indicated:

Sigma Pharmaceuticals (Australia) Pty Ltd  88 004 118 594

and substitute:

Spirit Pharmaceuticals Pty Ltd  67 109 225 747

  1. Schedule 1, item dealing with Oxaliplatin in the form Powder for I.V. infusion 100 mg (Oxaliplatin Link)

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

and substitute:              Fresenius Kabi Australia Pty Limited

  1. Schedule 1, item dealing with Pantoprazole in the form Tablet (enteric coated) 20 mg (as sodium sesquihydrate) (Pantoprazole-GA)

omit from the column headed “Responsible Person”:          Genepharm Pty Ltd

and substitute:              Ascent Pharma Pty Ltd

  1. Schedule 1, item dealing with Pantoprazole in the form Tablet (enteric coated) 40 mg (as sodium sesquihydrate) (Pantoprazole-GA)

omit from the column headed “Responsible Person”:          Genepharm Pty Ltd

and substitute:              Ascent Pharma Pty Ltd

  1. Schedule 1, item dealing with Paracetamol in the form Tablet 500 mg (Febridol)

omit from the column headed “Responsible Person”:          Genepharm Pty Ltd

and substitute:              Ascent Pharma Pty Ltd

  1. Schedule 1, item dealing with Paroxetine in the form Tablet 20 mg (as hydrochloride) (Paroxetine-DP)

omit from the column headed “Responsible Person”:          Genepharm Pty Ltd

and substitute:              Ascent Pharma Pty Ltd

  1. Schedule 1, item dealing with Paroxetine in the form Tablet 20 mg (as hydrochloride) (Paroxetine-GA)

omit from the column headed “Responsible Person”:          Genepharm (Australia) Limited

and substitute:              Ascent Pharmaceuticals Limited

  1. Schedule 1, item dealing with Perindopril in the form Tablet containing perindopril erbumine 2 mg (Perindopril-DP)

omit from the columns in the order indicated:

Genepharm Pty Ltd  68 118 734 795

and substitute:

Ascent Pharmaceuticals Limited  17 003 854 626

  1. Schedule 1, item dealing with Perindopril in the form Tablet containing perindopril erbumine 2 mg (Perindopril-GA)

omit from the column headed “Responsible Person”:          Genepharm Pty Ltd

and substitute:              Ascent Pharma Pty Ltd

  1. Schedule 1, item dealing with Perindopril in the form Tablet containing perindopril erbumine 4 mg (Perindopril-DP)

omit from the columns in the order indicated:

Genepharm Pty Ltd  68 118 734 795

and substitute:

Ascent Pharmaceuticals Limited  17 003 854 626

  1. Schedule 1, item dealing with Perindopril in the form Tablet containing perindopril erbumine 4 mg (Perindopril-GA)

omit from the column headed “Responsible Person”:          Genepharm Pty Ltd

and substitute:              Ascent Pharma Pty Ltd

  1. Schedule 1, item dealing with Perindopril in the form Tablet containing perindopril erbumine 8 mg (Perindopril-DP)

omit from the columns in the order indicated:

Genepharm Pty Ltd  68 118 734 795

and substitute:

Ascent Pharmaceuticals Limited  17 003 854 626

  1. Schedule 1, item dealing with Perindopril in the form Tablet containing perindopril erbumine 8 mg (Perindopril-GA)

omit from the column headed “Responsible Person”:          Genepharm Pty Ltd

and substitute:              Ascent Pharma Pty Ltd

  1. Schedule 1, after items dealing with Perindopril

insert in the columns in the order indicated:

Perindopril with amlodipine Tablet containing 10 mg perindopril arginine with 10 mg amlodipine (as besylate) Oral Coveram Servier Laboratories (Aust.) Pty Ltd  54 004 838 500
Perindopril with amlodipine Tablet containing 10 mg perindopril arginine with 5 mg amlodipine (as besylate) Oral Coveram Servier Laboratories (Aust.) Pty Ltd  54 004 838 500
Perindopril with amlodipine Tablet containing 5 mg perindopril arginine with 10 mg amlodipine (as besylate) Oral Coveram Servier Laboratories (Aust.) Pty Ltd  54 004 838 500
Perindopril with amlodipine Tablet containing 5 mg perindopril arginine with 5 mg amlodipine (as besylate) Oral Coveram Servier Laboratories (Aust.) Pty Ltd  54 004 838 500

  1. Schedule 1, item dealing with Phenoxymethylpenicillin in the form Capsule 250 mg phenoxymethylpenicillin (as potassium) (Cilopen VK)

omit from the column headed “Responsible Person”:          Genepharm Pty Ltd

and substitute:              Ascent Pharma Pty Ltd

  1. Schedule 1, item dealing with Phenoxymethylpenicillin in the form Capsule 500 mg phenoxymethylpenicillin (as potassium) (Cilopen VK)

omit from the column headed “Responsible Person”:          Genepharm Pty Ltd

and substitute:              Ascent Pharma Pty Ltd

  1. Schedule 1, item dealing with Pravastatin in the form Tablet containing pravastatin sodium 10 mg (Pravastatin-GA 10)

omit from the columns in the order indicated:

Genepharm (Australia) Limited  17 003 854 626

and substitute:

Ascent Pharma Pty Ltd  68 118 734 795

  1. Schedule 1, item dealing with Pravastatin in the form Tablet containing pravastatin sodium 20 mg (Pravastatin-GA 20)

omit from the columns in the order indicated:

Genepharm (Australia) Limited  17 003 854 626

and substitute:

Ascent Pharma Pty Ltd  68 118 734 795

  1. Schedule 1, item dealing with Pravastatin in the form Tablet containing pravastatin sodium 40 mg (Pravastatin-GA 40)

omit from the columns in the order indicated:

Genepharm (Australia) Limited  17 003 854 626

and substitute:

Ascent Pharma Pty Ltd  68 118 734 795

  1. Schedule 1, item dealing with Pravastatin in the form Tablet containing pravastatin sodium 80 mg (Pravastatin-GA 80)

omit from the columns in the order indicated:

Genepharm (Australia) Limited  17 003 854 626

and substitute:

Ascent Pharma Pty Ltd  68 118 734 795

  1. Schedule 1, item dealing with Quinapril in the form Tablet 10 mg (as hydrochloride) (Quinapril-DP)

omit from the columns in the order indicated:

Genepharm Pty Ltd  68 118 734 795

and substitute:

Ascent Pharmaceuticals Limited  17 003 854 626

  1. Schedule 1, item dealing with Quinapril in the form Tablet 20 mg (as hydrochloride) (Quinapril-GA)

omit from the column headed “Responsible Person”:          Genepharm Pty Ltd

and substitute:              Ascent Pharma Pty Ltd

  1. Schedule 1, item dealing with Quinapril in the form Tablet 5 mg (as hydrochloride) (Quinapril-DP)

omit from the columns in the order indicated:

Genepharm Pty Ltd  68 118 734 795

and substitute:

Ascent Pharmaceuticals Limited  17 003 854 626

  1. Schedule 1, item dealing with Ramipril in the form Capsule 1.25 mg (Ramipril-DP)

omit from the columns in the order indicated:

Genepharm Pty Ltd  68 118 734 795

and substitute:

Ascent Pharmaceuticals Limited  17 003 854 626

  1. Schedule 1, after item dealing with Ramipril in the form Capsule 1.25 mg (Ramipril-DP)

insert in the columns in the order indicated:

Ramipril Capsule 1.25 mg Oral Ramipril-GA Ascent Pharma Pty Ltd 68 118 734 795

  1. Schedule 1, item dealing with Ramipril in the form Capsule 10 mg (Ramipril-DP)

omit from the columns in the order indicated:

Genepharm Pty Ltd  68 118 734 795

and substitute:

Ascent Pharmaceuticals Limited  17 003 854 626

  1. Schedule 1, item dealing with Ramipril in the form Capsule 2.5 mg (Ramipril-DP)

omit from the columns in the order indicated:

Genepharm Pty Ltd  68 118 734 795

and substitute:

Ascent Pharmaceuticals Limited  17 003 854 626

  1. Schedule 1, item dealing with Ramipril in the form Capsule 5 mg (Ramipril-DP)

omit from the columns in the order indicated:

Genepharm Pty Ltd  68 118 734 795

and substitute:

Ascent Pharmaceuticals Limited  17 003 854 626

  1. Schedule 1, item dealing with Ranitidine in the form Tablet 150 mg (as hydrochloride) (Ranoxyl)

omit from the column headed “Responsible Person”:          Genepharm Pty Ltd

and substitute:              Ascent Pharma Pty Ltd

  1. Schedule 1, item dealing with Risperidone in the form Tablet 0.5 mg (Risperidone-GA)

omit from the column headed “Responsible Person”:          Genepharm Pty Ltd

and substitute:              Ascent Pharma Pty Ltd

  1. Schedule 1, item dealing with Risperidone in the form Tablet 1 mg (Risperidone-GA)

omit from the column headed “Responsible Person”:          Genepharm Pty Ltd

and substitute:              Ascent Pharma Pty Ltd

  1. Schedule 1, item dealing with Risperidone in the form Tablet 2 mg (Risperidone-GA)

omit from the column headed “Responsible Person”:          Genepharm Pty Ltd

and substitute:              Ascent Pharma Pty Ltd

  1. Schedule 1, item dealing with Risperidone in the form Tablet 3 mg (Risperidone-GA)

omit from the column headed “Responsible Person”:          Genepharm Pty Ltd

and substitute:               Ascent Pharma Pty Ltd

  1. Schedule 1, item dealing with Risperidone in the form Tablet 4 mg (Risperidone-GA)

omit from the column headed “Responsible Person”:          Genepharm Pty Ltd

and substitute:              Ascent Pharma Pty Ltd

  1. Schedule 1, items dealing with Rivaroxaban

omit from the columns in the order indicated:

Rivaroxaban Tablets 10 mg, 15 Oral Xarelto Bayer Australia Ltd  22 000 138 714

  1. Schedule 1, item dealing with Roxithromycin in the form Tablet 150 mg (Roxithromycin-GA)

omit from the column headed “Responsible Person”:          Genepharm Pty Ltd

and substitute:              Ascent Pharma Pty Ltd

  1. Schedule 1, item dealing with Roxithromycin in the form Tablet 300 mg (Roxithromycin-GA)

omit from the column headed “Responsible Person”:          Genepharm Pty Ltd

and substitute:              Ascent Pharma Pty Ltd

  1. Schedule 1, item dealing with Salbutamol in the form Nebuliser solution 2.5 mg (as sulfate) in 2.5 mL single dose units, 30 (Salbutamol-GA)

omit from the column headed “Responsible Person”:          Genepharm Pty Ltd

and substitute:              Ascent Pharma Pty Ltd

  1. Schedule 1, item dealing with Salbutamol in the form Nebuliser solution 5 mg (as sulfate) in 2.5 mL single dose units, 30 (Salbutamol-GA)

omit from the column headed “Responsible Person”:          Genepharm Pty Ltd

and substitute:              Ascent Pharma Pty Ltd

  1. Schedule 1, item dealing with Sertraline in the form Tablet 100 mg (as hydrochloride) (Sertraline-GA)

omit from the column headed “Responsible Person”:          Genepharm Pty Ltd

and substitute:              Ascent Pharma Pty Ltd

  1. Schedule 1, item dealing with Sertraline in the form Tablet 50 mg (as hydrochloride) (Sertraline-GA)

omit from the column headed “Responsible Person”:          Genepharm Pty Ltd

and substitute:              Ascent Pharma Pty Ltd

  1. Schedule 1, item dealing with Simvastatin in the form Tablet 10 mg (Simvastatin-DP)

omit from the column headed “Responsible Person”:          Genepharm Pty Ltd

and substitute:              Ascent Pharma Pty Ltd

  1. Schedule 1, item dealing with Simvastatin in the form Tablet 10 mg (Simvastatin-GA 10)

omit from the column headed “Responsible Person”:          Genepharm (Australia) Limited

and substitute:              Ascent Pharmaceuticals Limited

  1. Schedule 1, item dealing with Simvastatin in the form Tablet 20 mg (Simvastatin-DP)

omit from the column headed “Responsible Person”:          Genepharm Pty Ltd

and substitute:              Ascent Pharma Pty Ltd

  1. Schedule 1, item dealing with Simvastatin in the form Tablet 20 mg (Simvastatin-GA 20)

omit from the column headed “Responsible Person”:          Genepharm (Australia) Limited

and substitute:              Ascent Pharmaceuticals Limited

  1. Schedule 1, item dealing with Simvastatin in the form Tablet 40 mg (Simvastatin-DP)

omit from the column headed “Responsible Person”:          Genepharm Pty Ltd

and substitute:              Ascent Pharma Pty Ltd

  1. Schedule 1, item dealing with Simvastatin in the form Tablet 40 mg (Simvastatin-GA 40)

omit from the column headed “Responsible Person”:          Genepharm (Australia) Limited

and substitute:              Ascent Pharmaceuticals Limited

  1. Schedule 1, item dealing with Simvastatin in the form Tablet 80 mg (Simvastatin-DP)

omit from the column headed “Responsible Person”:          Genepharm Pty Ltd

and substitute:              Ascent Pharma Pty Ltd

  1. Schedule 1, item dealing with Simvastatin in the form Tablet 80 mg (Simvastatin-GA 80)

omit from the column headed “Responsible Person”:          Genepharm (Australia) Limited

and substitute:              Ascent Pharmaceuticals Limited

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

omit from the columns in the order indicated:

Pharmatel Fresenius Kabi Pty Limited Pharmatel Fresenius Kabi Pty Limited

and substitute:

Fresenius Kabi Australia Pty Limited Fresenius Kabi Australia Pty Limited

  1. Schedule 1, item dealing with Sodium Chloride in the form I.V. infusion 38.5 mmol per 250 mL, 250 mL (Sodium Chloride 0.9% Freeflex)

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

and substitute:              Fresenius Kabi Australia Pty Limited

  1. Schedule 1, items dealing with Sodium Chloride in the form I.V. infusion 77 mmol per 500 mL, 500 mL

omit from the columns in the order indicated:

Pharmatel Fresenius Kabi Pty Limited Pharmatel Fresenius Kabi Pty Limited

and substitute:

Fresenius Kabi Australia Pty Limited Fresenius Kabi Australia Pty Limited

  1. Schedule 1, items 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

omit from the columns in the order indicated:

Pharmatel Fresenius Kabi Pty Limited Pharmatel Fresenius Kabi Pty Limited

and substitute:

Fresenius Kabi Australia Pty Limited Fresenius Kabi Australia Pty Limited

  1. Schedule 1, items dealing with Sodium Lactate Compound in the form 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

omit from the columns in the order indicated:

Pharmatel Fresenius Kabi Pty Limited Pharmatel Fresenius Kabi Pty Limited

and substitute:

Fresenius Kabi Australia Pty Limited Fresenius Kabi Australia Pty Limited

  1. Schedule 1, item dealing with Tamoxifen in the form Tablet 20 mg (as citrate) (Tamoxen 20 mg)

omit from the column headed “Responsible Person”:          Genepharm Pty Ltd

and substitute:              Ascent Pharma Pty Ltd

  1. Schedule 1, item dealing with Terbinafine in the form Tablet 250 mg (as hydrochloride) (Terbinafine-DP)

omit from the columns in the order indicated:

Genepharm Pty Ltd  68 118 734 795

and substitute:

Ascent Pharmaceuticals Limited  17 003 854 626

  1. Schedule 1, after item dealing with Tramadol in the form Capsule containing tramadol hydrochloride 50 mg (Chem mart Tramadol)

insert in the columns in the order indicated:

Tramadol Capsule containing tramadol hydrochloride 50 mg Oral GA Tramadol 50mg Ascent Pharma Pty Ltd  68 118 734 795

  1. Schedule 1, after item dealing with Tramadol in the form Tablet (sustained release) containing tramadol hydrochloride 100 mg (Chem mart Tramadol SR)

insert in the columns in the order indicated:

Tramadol Tablet (sustained release) containing tramadol hydrochloride 100 mg Oral GA Tramadol SR 100mg Ascent Pharma Pty Ltd  68 118 734 795

  1. Schedule 1, after item dealing with Tramadol in the form Tablet (sustained release) containing tramadol hydrochloride 150 mg (Chem mart Tramadol SR)

insert in the columns in the order indicated:

Tramadol Tablet (sustained release) containing tramadol hydrochloride 150 mg Oral GA Tramadol SR 150mg Ascent Pharma Pty Ltd  68 118 734 795

  1. Schedule 1, after item dealing with Tramadol in the form Tablet (sustained release) containing tramadol hydrochloride 200 mg (Chem mart Tramadol SR)

insert in the columns in the order indicated:

Tramadol Tablet (sustained release) containing tramadol hydrochloride 200 mg Oral GA Tramadol SR 200mg Ascent Pharma Pty Ltd  68 118 734 795

  1. Schedule 1, item dealing with Trandolapril in the form Capsule 1 mg (Trandolapril-DP)

omit from the columns in the order indicated:

Genepharm Pty Ltd  68 118 734 795

and substitute:

Ascent Pharmaceuticals Limited  17 003 854 626

  1. Schedule 1, item dealing with Trandolapril in the form Capsule 2 mg (Trandolapril-DP)

omit from the columns in the order indicated:

Genepharm Pty Ltd  68 118 734 795

and substitute:

Ascent Pharmaceuticals Limited  17 003 854 626

  1. Schedule 1, item dealing with Trandolapril in the form Capsule 4 mg (Trandolapril-DP)

omit from the columns in the order indicated:

Genepharm Pty Ltd  68 118 734 795

and substitute:

Ascent Pharmaceuticals Limited  17 003 854 626

  1. Schedule 1, item dealing with Trandolapril in the form Capsule 500 micrograms (Trandolapril-DP)

omit from the columns in the order indicated:

Genepharm Pty Ltd  68 118 734 795

and substitute:

Ascent Pharmaceuticals Limited  17 003 854 626

  1. Schedule 1, item dealing with Vinorelbine in the form Solution for I.V. infusion 10 mg (as tartrate) in 1 mL (Vinorelbine Link)

omit from the columns in the order indicated:

Link Medical Products Pty Ltd  73 010 971 516

and substitute:

Fresenius Kabi Australia Pty Limited  39 109 383 593

  1. Schedule 1, item dealing with Vinorelbine in the form Solution for I.V. infusion 50 mg (as tartrate) in 5 mL (Vinorelbine Link)

omit from the columns in the order indicated:

Link Medical Products Pty Ltd  73 010 971 516

and substitute:

Fresenius Kabi Australia Pty Limited  39 109 383 593
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