EXPLANATORY STATEMENT
INSTRUMENT NUMBER PB 46 OF 2010
NATIONAL HEALTH ACT 1953
AMENDMENT DETERMINATION UNDER SECTION 84AF
Summary
This legislative instrument in giving effect to recommendations of the Pharmaceutical Benefits Advisory Committee (PBAC) amends the determination under section 84AF made by legislative instrument number PB 16 of 2010 which came into effect on 1 April 2010. The amendments provide for additions and changes to the responsible persons for the brands of pharmaceutical items. These persons are bodies corporate and are identified by their company name and Australian Business Number (ABN). The amendments are set out in the items of Schedule 1 to the instrument.
Purpose and operation
Part VII of the National Health Act 1953 (the Act) is the legislative basis of the Pharmaceutical Benefits Scheme (PBS) by which the Commonwealth provides reliable, timely, and affordable access to a wide range of medicines for all Australians.
Subsection 85(1) provides that benefits are to be provided by the Commonwealth in accordance with Part VII in respect of pharmaceutical benefits.
Drugs and medicinal preparations to which Part VII applies are declared by the Minister by legislative instrument to be so under subsection 85(2). These are listed drugs as defined in subsection 84(1). Part VII also applies to certain extemporaneously-prepared medicinal preparations as a result of declarations under paragraph 85(2)(b).
The Minister by legislative instrument can determine the form or forms of a listed drug by reference to strength, type of unit, size of unit or otherwise (subsection 85(3)); the manner of administration of the form of the listed drug so determined (subsection 85(5)); and a brand of the pharmaceutical item (defined in subsection 84(1)) that has the listed drug in that form with that manner of administration (subsection 85(6)). These determinations govern (except for certain extemporaneously-prepared pharmaceutical benefits) what constitutes the pharmaceutical benefit (defined in subsection 84(1)) under Part VII of the Act.
Section 84AF empowers the Minister to determine that a person is the responsible person for a brand of a pharmaceutical item. The Minister can do this if the person has notified the Minister that the person is or will be the supplier of the brand of the pharmaceutical item to wholesalers or, if not, to approved pharmacists directly. The brand must be a listed brand (defined in subsection 84(1) as a brand in relation to which a determination under subsection 85(6) is in force), and there can be no determination in force that any other person is the responsible person for the brand of the pharmaceutical item or of any other pharmaceutical item.
A responsible person for a brand of pharmaceutical item has various responsibilities or functions under the Act. These include those in relation to entering into price agreements under section 85AD, compliance with price disclosure requirements under Division 3B, and the requirement to supply certain brands of pharmaceutical item for a specified period under Division 3C.
This instrument determines the responsible persons for the brands of pharmaceutical items set out in Schedule 1 to the instrument. These persons are bodies corporate and are identified in Schedule 1 by their company name and Australian Business Number (ABN). The names of the responsible persons were notified before the commencement of section 84AF as permitted by subsection 84AF(2).
A provision-by-provision description of the instrument is contained in the Attachment.
This instrument, expressed to commence on 1 June 2010, was made on 12 May 2010.
Consultations
This instrument affects pharmaceutical companies with medicines listed on the PBS. In relation to the introduction of the responsible person measure, pharmaceutical companies have been consulted during both the policy development and implementation phases. This has occurred through meetings with both peak body organisations and individual companies. Information on this measure has been disseminated through peak industry bodies and during regular meetings with a Stakeholder Reference Group. Particular information on the Responsible Person provisions has been provided by letter to those companies to whom the provisions will apply. Under section 84AF the Minister may only determine a person to be the responsible person for a brand of a pharmaceutical item if the person has notified the Minister that the person is or will be the supplier of the brand of the pharmaceutical item. Each of the persons determined in the instrument to be responsible persons has given the required notification to the Minister.
The PBAC is an independent expert body established by section 100A which makes recommendations to the Minister about which drugs and medicinal preparations should be available as pharmaceutical benefits. PBAC members are appointed following nomination by prescribed organisations and associations from consumers, health economists, practising community pharmacists, general practitioners, clinical pharmacologists and specialists, with at least one member selected from each of those interests or professions. Remaining members are persons whom the Minister is satisfied have qualifications and experience in a field relevant to the functions of the PBAC, and that would enable them to contribute meaningfully to the deliberations of the PBAC. When recommending the listing of a medicine on the PBS, the PBAC takes into account the medical conditions for which the medicine has been approved for use in Australia, its clinical effectiveness, safety and cost-effectiveness compared with other treatments.
ATTACHMENT
Paragraph 1: provides that this instrument commences on 1 June 2010.
Paragraph 2: provides that Schedule 1 amends PB 16 of 2010.
Schedule 1: provides for the following amendments:
SCHEDULE 1
Additions
Listed Drug | Form | Brand | Responsible Person |
Alendronic acid with colecalciferol and calcium | Pack containing 4 tablets containing alendronic acid | Fosamax Plus D-Cal | Merck Sharp & Dohme (Australia) Pty Ltd |
Amlodipine | Tablet 10 mg (as besylate) | Amlodipine-DRLA | Dr Reddy's Laboratories (Australia) Pty Ltd |
Amlodipine | Tablet 5 mg (as besylate) | Amlodipine-DRLA | Dr Reddy's Laboratories (Australia) Pty Ltd |
Amoxycillin | Capsule 500 mg (as trihydrate) | Amoxycillin-GA | Ascent Pharma Pty Ltd |
Cephalexin | Granules for oral suspension 125 mg per 5 mL, 100 mL | APO-Cephalexin | Apotex Pty Ltd |
Cephalexin | Granules for oral suspension 250 mg per 5 mL, 100 mL | APO-Cephalexin | Apotex Pty Ltd |
Ciprofloxacin | Tablet 250 mg (as hydrochloride) | Ciprofloxacin-DRLA | Dr Reddy's Laboratories (Australia) Pty Ltd |
Ciprofloxacin | Tablet 500 mg (as hydrochloride) | Ciprofloxacin-DRLA | Dr Reddy's Laboratories (Australia) Pty Ltd |
Ciprofloxacin | Tablet 750 mg (as hydrochloride) | Ciprofloxacin-DRLA | Dr Reddy's Laboratories (Australia) Pty Ltd |
Clopidogrel | Tablet 75 mg (as besilate) | Clovix 75 | Sigma Pharmaceuticals (Australia) Pty Ltd |
Everolimus | Tablet 1 mg | Certican | Novartis Pharmaceuticals Australia Pty Limited |
Famciclovir | Tablet 125 mg | Ezovir | Alphapharm Pty Ltd |
Famciclovir | Tablet 250 mg | Ezovir | Alphapharm Pty Ltd |
Famciclovir | Tablet 250 mg | Famciclovir Sandoz | Sandoz Pty Ltd |
Famciclovir | Tablet 500 mg | Ezovir | Alphapharm Pty Ltd |
Gabapentin | Tablet 600 mg | Gabatine 600 | Sigma Pharmaceuticals (Australia) Pty Ltd |
Gabapentin | Tablet 800 mg | Gabatine 800 | Sigma Pharmaceuticals (Australia) Pty Ltd |
Gabapentin | Capsule 300 mg | Gabapentin Sandoz | Sandoz Pty Ltd |
Gabapentin | Capsule 400 mg | Gabapentin Sandoz | Sandoz Pty Ltd |
Levetiracetam | Tablet 1 g | APO-Levetiracetam | Apotex Pty Ltd |
Levetiracetam | Tablet 1 g | Chem mart Levetiracetam | Apotex Pty Ltd |
Levetiracetam | Tablet 1 g | Kepcet | Ascent Pharma Pty Ltd |
Levetiracetam | Tablet 1 g | Kevtam | Alphapharm Pty Ltd |
Levetiracetam | Tablet 1 g | Levitam 1000 | Sigma Pharmaceuticals (Australia) Pty Ltd |
Levetiracetam | Tablet 1 g | Terry White Chemists Levetiracetam | Apotex Pty Ltd |
Levetiracetam | Tablet 250 mg | APO-Levetiracetam | Apotex Pty Ltd |
Levetiracetam | Tablet 250 mg | Chem mart Levetiracetam | Apotex Pty Ltd |
Levetiracetam | Tablet 250 mg | Kepcet | Ascent Pharma Pty Ltd |
Levetiracetam | Tablet 250 mg | Kevtam | Alphapharm Pty Ltd |
Levetiracetam | Tablet 250 mg | Levitam 250 | Sigma Pharmaceuticals (Australia) Pty Ltd |
Levetiracetam | Tablet 250 mg | Terry White Chemists Levetiracetam | Apotex Pty Ltd |
Levetiracetam | Tablet 500 mg | APO-Levetiracetam | Apotex Pty Ltd |
Levetiracetam | Tablet 500 mg | Chem mart Levetiracetam | Apotex Pty Ltd |
Levetiracetam | Tablet 500 mg | Kepcet | Ascent Pharma Pty Ltd |
Levetiracetam | Tablet 500 mg | Kevtam | Alphapharm Pty Ltd |
Levetiracetam | Tablet 500 mg | Levitam 500 | Sigma Pharmaceuticals (Australia) Pty Ltd |
Levetiracetam | Tablet 500 mg | Terry White Chemists Levetiracetam | Apotex Pty Ltd |
Lisinopril | Tablet 10 mg | Lisinopril-DRLA | Dr Reddy's Laboratories (Australia) Pty Ltd |
Lisinopril | Tablet 10 mg | Lisinopril-GA | Ascent Pharmaceuticals Limited |
Lisinopril | Tablet 20 mg | Lisinopril-DRLA | Dr Reddy's Laboratories (Australia) Pty Ltd |
Lisinopril | Tablet 5 mg | Lisinopril Sandoz | Sandoz Pty Ltd |
Lisinopril | Tablet 5 mg | Lisinopril-DRLA | Dr Reddy's Laboratories (Australia) Pty Ltd |
Mesalazine | Tablet 1.2 g (prolonged release) | Mezavant | Shire Australia Pty Limited |
Perindopril with amlodipine | Tablet containing 10 mg perindopril arginine with | Coveram | Servier Laboratories (Aust.) Pty Ltd |
Perindopril with amlodipine | Tablet containing 10 mg perindopril arginine with 5 mg amlodipine (as besylate) | Coveram | Servier Laboratories (Aust.) Pty Ltd |
Perindopril with amlodipine | Tablet containing 5 mg perindopril arginine with 10 mg amlodipine (as besylate) | Coveram | Servier Laboratories (Aust.) Pty Ltd |
Perindopril with amlodipine | Tablet containing 5 mg perindopril arginine with 5 mg amlodipine (as besylate) | Coveram | Servier Laboratories (Aust.) Pty Ltd |
Ramipril | Capsule 1.25 mg | Ramipril-GA | Ascent Pharma Pty Ltd |
Tramadol | Capsule containing tramadol hydrochloride 50 mg | GA Tramadol 50mg | Ascent Pharma Pty Ltd |
Tramadol | Tablet (sustained release) containing tramadol hydrochloride 100 mg | GA Tramadol SR 100mg | Ascent Pharma Pty Ltd |
Tramadol | Tablet (sustained release) containing tramadol hydrochloride 150 mg | GA Tramadol SR 150mg | Ascent Pharma Pty Ltd |
Tramadol | Tablet (sustained release) containing tramadol hydrochloride 200 mg | GA Tramadol SR 200mg | Ascent Pharma Pty Ltd |
Deletions
Listed Drug | Form | Brand | Responsible Person |
Amino acid formula with vitamins and minerals without phenylalanine | Oral powder 400 g (Phenex-2) | Phenex-2 | Abbott Australasia Pty Ltd |
Amino acid formula without methionine, threonine and valine and low in isoleucine | Oral powder 200 g (XMTVI Asadon) | XMTVI Asadon | Nutricia Australia Pty Limited |
Amino acid formula without phenylalanine, tyrosine and methionine | Oral powder 500 g (XPTM Tyrosidon) | XPTM Tyrosidon | Nutricia Australia Pty Limited |
Amoxycillin | Capsule 250 mg (as trihydrate) | Amoxycillin-DP | Genepharm Pty Ltd |
Cetuximab | Solution for I.V. infusion 100 mg in 50 mL | Erbitux | Merck Serono Australia Pty Ltd |
Clotrimazole | Lotion 10 mg per mL, 20 mL | Canesten | Bayer Australia Ltd |
Cromoglycic Acid | Pressurised inhalation containing sodium cromoglycate 1 mg per dose, 200 doses | Intal | sanofi-aventis Australia Pty Ltd |
Follitropin Alfa | Injection set containing 1 vial powder for injection 1,050 i.u. and 1 pre-filled syringe solvent 2 mL | Gonal-f | Merck Serono Australia Pty Ltd |
Follitropin Alfa | Injection set containing 1 vial powder for injection | Gonal-f | Merck Serono Australia Pty Ltd |
Follitropin Alfa | Injection set containing 1 vial powder for injection | Gonal-f 75 | Merck Serono Australia Pty Ltd |
Follitropin Alfa | Injection set containing 10 vials powder for injection 75 i.u. and 10 pre-filled syringes solvent 1 mL | Gonal-f 75 | Merck Serono Australia Pty Ltd |
Gabapentin | Capsule 300 mg | Douglas Gabapentin 300mg | Genepharm Pty Ltd |
Gabapentin | Capsule 300 mg | Gabahexal 300mg | Sandoz Pty Ltd |
Gabapentin | Capsule 400 mg | Pendine 400 | Alphapharm Pty Ltd |
Gabapentin | Capsule 400 mg | Gabahexal 400mg | Sandoz Pty Ltd |
Gliclazide | Tablet 30 mg (modified release) | Diamicron MR | Servier Laboratories (Aust.) Pty Ltd |
Glucose Indicator—Blood | Test strips, 100 (Precision Plus) | Precision Plus | Abbott Australasia Pty Ltd |
Lansoprazole | Capsule 15 mg | Zoton | Wyeth Australia Pty Limited |
Lisinopril | Tablet 5 mg | Lisinopril Hexal | Sandoz Pty Ltd |
Mineral mixture | Oral powder 250 g (Metabolic Mineral Mixture) | Metabolic Mineral Mixture | Nutricia Australia Pty Limited |
Rivaroxaban | Tablets 10 mg, 15 | Xarelto | Bayer Australia Ltd |
Alteration of Form
Listed Drug | Form From: | Form To: | Brand | Responsible Person |
Glucose Indicator—Blood | Test strips, 50 (Accu-Chek Mobile) | Test strips, 100 (Accu-Chek Mobile) | Accu-Chek Mobile | Roche Diagnostics Australia Pty Limited |
Alteration of Brand
Listed Drug | Form | Brand From: | Brand To: | Responsible Person |
Atenolol | Tablet 50 mg | Atehexal | Atenolol Sandoz | Sandoz Pty Ltd |
Captopril | Tablet 50 mg | Captohexal | Captopril Sandoz | Sandoz Pty Ltd |
Diltiazem | Tablet containing diltiazem hydrochloride 60 mg | Diltahexal | Diltiazem Sandoz | Sandoz Pty Ltd |
Alteration of Responsible Person
Listed Drug | Form | Brand | Responsible Person From: | Responsible Person To: |
Aciclovir | Tablet 200 mg | Lovir | Genepharm Pty Ltd | Ascent Pharma Pty Ltd |
Aciclovir | Tablet 800 mg | Lovir | Genepharm Pty Ltd | Ascent Pharma Pty Ltd |
Alendronic Acid | Tablet 70 mg (as alendronate sodium) | Alendronate-GA | Genepharm Pty Ltd | Ascent Pharma Pty Ltd |
Alendronic acid with colecalciferol | Tablet 70 mg (as alendronate sodium) with 140 micrograms colecalciferol | Dronalen Plus | Genepharm Pty Ltd | Ascent Pharma Pty Ltd |
Alprazolam | Tablet 1 mg | Alprazolam-GA | Genepharm Pty Ltd | Ascent Pharma Pty Ltd |
Alprazolam | Tablet 2 mg | Alprazolam-GA | Genepharm Pty Ltd | Ascent Pharma Pty Ltd |
Amlodipine | Tablet 10 mg (as besylate) | Amlodipine-GA | Genepharm Pty Ltd | Ascent Pharma Pty Ltd |
Amlodipine | Tablet 10 mg (as besylate) | Norvapine | Genepharm (Australia) Limited | Ascent Pharmaceuticals Limited |
Amlodipine | Tablet 5 mg (as besylate) | Amlodipine-GA | Genepharm Pty Ltd | Ascent Pharma Pty Ltd |
Amlodipine | Tablet 5 mg (as besylate) | Norvapine | Genepharm (Australia) Limited | Ascent Pharmaceuticals Limited |
Amoxycillin | Capsule 250 mg (as trihydrate) | Amoxycillin-GA | Genepharm Pty Ltd | Ascent Pharma Pty Ltd |
Amoxycillin | Capsule 500 mg (as trihydrate) | Amoxycillin-DP | Genepharm Pty Ltd | Ascent Pharmaceuticals Limited |
Amoxycillin | Powder for oral suspension 125 mg (as trihydrate) per 5 mL, 100 mL | Bgramin | Genepharm Pty Ltd | Ascent Pharma Pty Ltd |
Amoxycillin | Powder for oral suspension 250 mg (as trihydrate) per 5 mL, 100 mL | Bgramin | Genepharm Pty Ltd | Ascent Pharma Pty Ltd |
Amoxycillin with Clavulanic Acid | Tablet containing 500 mg amoxycillin (as trihydrate) with 125 mg clavulanic acid (as potassium clavulanate) | GA-Amclav 500/125 | Genepharm Pty Ltd | Ascent Pharma Pty Ltd |
Amoxycillin with Clavulanic Acid | Tablet containing 875 mg amoxycillin (as trihydrate) with 125 mg clavulanic acid (as potassium clavulanate) | GA-Amclav Forte 875/125 | Genepharm Pty Ltd | Ascent Pharma Pty Ltd |
Atenolol | Tablet 50 mg | Atenolol-GA | Genepharm (Australia) Limited | Ascent Pharmaceuticals Limited |
Azathioprine | Tablet 50 mg | Azamun | Genepharm Pty Ltd | Ascent Pharma Pty Ltd |
Balsalazide | Capsule containing balsalazide sodium 750 mg | Colazide | Pharmatel Fresenius Kabi Pty Limited | Fresenius Kabi Australia Pty Limited |
Bicalutamide | Tablet 50 mg | Bicalutamide-GA | Genepharm Pty Ltd | Ascent Pharma Pty Ltd |
Calcitriol | Capsule 0.25 microgram | Calcitriol-DP | Genepharm Pty Ltd | Ascent Pharmaceuticals Limited |
Calcitriol | Capsule 0.25 microgram | Calcitriol-GA | Genepharm (Australia) Limited | Ascent Pharma Pty Ltd |
Carvedilol | Tablet 12.5 mg | GN-Carvedilol | Genepharm Pty Ltd | Ascent Pharma Pty Ltd |
Carvedilol | Tablet 25 mg | GN-Carvedilol | Genepharm Pty Ltd | Ascent Pharma Pty Ltd |
Carvedilol | Tablet 3.125 mg | GN-Carvedilol | Genepharm Pty Ltd | Ascent Pharma Pty Ltd |
Carvedilol | Tablet 6.25 mg | GN-Carvedilol | Genepharm Pty Ltd | Ascent Pharma Pty Ltd |
Cefaclor | Tablet (sustained release) 375 mg (as monohydrate) | Cefaclor-GA | Genepharm (Australia) Limited | Ascent Pharmaceuticals Limited |
Cefaclor | Tablet (sustained release) 375 mg (as monohydrate) | Douglas Cefaclor-CD | Genepharm Pty Ltd | Ascent Pharma Pty Ltd |
Cephalexin | Capsule 250 mg (anhydrous) | Cilex | Genepharm Pty Ltd | Ascent Pharma Pty Ltd |
Cephalexin | Capsule 500 mg (anhydrous) | Cilex | Genepharm Pty Ltd | Ascent Pharma Pty Ltd |
Cephalexin | Granules for oral suspension 125 mg per | Cilex | Genepharm Pty Ltd | Ascent Pharma Pty Ltd |
Cephalexin | Granules for oral suspension 250 mg per | Cilex | Genepharm Pty Ltd | Ascent Pharma Pty Ltd |
Ciprofloxacin | Tablet 500 mg (as hydrochloride) | Ciprofloxacin-GA | Genepharm Pty Ltd | Ascent Pharma Pty Ltd |
Citalopram | Tablet 20 mg (as hydrobromide) | Ciazil | Genepharm Pty Ltd | Ascent Pharma Pty Ltd |
Clarithromycin | Tablet 250 mg | Clarac | Genepharm Pty Ltd | Ascent Pharma Pty Ltd |
Coal Tar - Prepared | Gel 10 mg per g, 100 mL | Exorex | Genepharm Pty Ltd | Ascent Pharma Pty Ltd |
Cromoglycic Acid | Capsule containing powder for oral inhalation containing sodium cromoglycate 20 mg (for use in Intal Spinhaler or Intal Halermatic) | Intal Spincaps | Genepharm Pty Ltd | Ascent Pharma Pty Ltd |
Cyproterone | Tablet containing cyproterone acetate | Procur 100 | Genepharm Pty Ltd | Ascent Pharma Pty Ltd |
Cyproterone | Tablet containing cyproterone acetate | Procur | Genepharm Pty Ltd | Ascent Pharma Pty Ltd |
Diazepam | Tablet 5 mg | Diazepam-GA | Genepharm Pty Ltd | Ascent Pharma Pty Ltd |
Diclofenac | Tablet (enteric coated) containing diclofenac sodium 25 mg | Diclofenac-GA | Genepharm (Australia) Limited | Ascent Pharma Pty Ltd |
Diclofenac | Tablet (enteric coated) containing diclofenac sodium 50 mg | Diclofenac-GA | Genepharm (Australia) Limited | Ascent Pharma Pty Ltd |
Diltiazem | Capsule (controlled delivery) containing diltiazem hydrochloride 180 mg | Dilzem CD | Genepharm Pty Ltd | Ascent Pharma Pty Ltd |
Diltiazem | Capsule (controlled delivery) containing diltiazem hydrochloride 240 mg | Dilzem CD | Genepharm Pty Ltd | Ascent Pharma Pty Ltd |
Diltiazem | Tablet containing diltiazem hydrochloride 60 mg | Dilzem 60 mg | Genepharm Pty Ltd | Ascent Pharma Pty Ltd |
Doxycycline | Tablet 100 mg (as hydrochloride) | Doxy-100 | Genepharm Pty Ltd | Ascent Pharma Pty Ltd |
Doxycycline | Tablet 50 mg (as hydrochloride) | Doxy-50 | Genepharm Pty Ltd | Ascent Pharma Pty Ltd |
Electrolyte Replacement, Oral | 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. | Genepharm Pty Ltd | Ascent Pharma Pty Ltd |
Enalapril | Tablet containing enalapril maleate 10 mg | Enalapril-DP 10mg | Genepharm Pty Ltd | Ascent Pharmaceuticals Limited |
Enalapril | Tablet containing enalapril maleate 20 mg | Enalapril-DP 20mg | Genepharm Pty Ltd | Ascent Pharmaceuticals Limited |
Enalapril | Tablet containing enalapril maleate 5 mg | Enalapril-DP 5mg | Genepharm Pty Ltd | Ascent Pharmaceuticals Limited |
Escitalopram | Tablet 10 mg (as oxalate) | Esipram | Genepharm Pty Ltd | Ascent Pharma Pty Ltd |
Escitalopram | Tablet 20 mg (as oxalate) | Esipram | Genepharm Pty Ltd | Ascent Pharma Pty Ltd |
Famotidine | Tablet 20 mg | Pepzan | Genepharm Pty Ltd | Ascent Pharma Pty Ltd |
Famotidine | Tablet 40 mg | Pepzan | Genepharm Pty Ltd | Ascent Pharma Pty Ltd |
Fluoxetine | Capsule 20 mg (as hydrochloride) | Fluoxetine-GA | Genepharm Pty Ltd | Ascent Pharma Pty Ltd |
Frusemide | Tablet 20 mg | Frusid | Genepharm Pty Ltd | Ascent Pharma Pty Ltd |
Frusemide | Tablet 40 mg | Frusid | Genepharm Pty Ltd | Ascent Pharma Pty Ltd |
Gabapentin | Capsule 300 mg | Gabapentin-GA | Genepharm Pty Ltd | Ascent Pharma Pty Ltd |
Gabapentin | Capsule 400 mg | Douglas Gabapentin 400mg | Genepharm Pty Ltd | Ascent Pharmaceuticals Limited |
Gemfibrozil | Tablet 600 mg | Lipazil 600 mg | Genepharm Pty Ltd | Ascent Pharma Pty Ltd |
Glucose | I.V. infusion 69.5 mmol (anhydrous) per 250 mL, 250 mL | Glucose 5% Freeflex | Pharmatel Fresenius Kabi Pty Limited | Fresenius Kabi Australia Pty Limited |
Hydroxyethyl starch 130/0.4 | I.V. infusion 30 g per 500 mL, 500 mL | Voluven 6% | Pharmatel Fresenius Kabi Pty Limited | Fresenius Kabi Australia Pty Limited |
Indapamide | Tablet containing indapamide hemihydrate 2.5 mg | Indapamide-GA | Genepharm Pty Ltd | Ascent Pharma Pty Ltd |
Indapamide | Tablet containing indapamide hemihydrate 2.5 mg | Napamide 2.5 mg | Genepharm Pty Ltd | Ascent Pharmaceuticals Limited |
Isosorbide Mononitrate | Tablet 60 mg (sustained release) | Imtrate 60 mg | Genepharm Pty Ltd | Ascent Pharma Pty Ltd |
Isotretinoin | Capsule 10 mg | Oratane | Genepharm Pty Ltd | Ascent Pharma Pty Ltd |
Isotretinoin | Capsule 20 mg | Oratane | Genepharm Pty Ltd | Ascent Pharma Pty Ltd |
Isotretinoin | Capsule 40 mg | Oratane | Genepharm Pty Ltd | Ascent Pharma Pty Ltd |
Lactulose | Solution BP 3.34 g per 5 mL, 500 mL | Lac-Dol | Genepharm Pty Ltd | Ascent Pharma Pty Ltd |
Lamotrigine | Tablet 100 mg | Lamotrigine-DP | Genepharm Pty Ltd | Ascent Pharma Pty Ltd |
Lamotrigine | Tablet 100 mg | Lamotrigine-GA | Genepharm (Australia) Limited | Ascent Pharmaceuticals Limited |
Lamotrigine | Tablet 200 mg | Lamotrigine-DP | Genepharm Pty Ltd | Ascent Pharma Pty Ltd |
Lamotrigine | Tablet 200 mg | Lamotrigine-GA | Genepharm (Australia) Limited | Ascent Pharmaceuticals Limited |
Lamotrigine | Tablet 25 mg | Lamotrigine-DP | Genepharm Pty Ltd | Ascent Pharma Pty Ltd |
Lamotrigine | Tablet 25 mg | Lamotrigine-GA | Genepharm (Australia) Limited | Ascent Pharmaceuticals Limited |
Lamotrigine | Tablet 50 mg | Lamotrigine-DP | Genepharm Pty Ltd | Ascent Pharma Pty Ltd |
Lamotrigine | Tablet 50 mg | Lamotrigine-GA | Genepharm (Australia) Limited | Ascent Pharmaceuticals Limited |
Lisinopril | Tablet 10 mg | Liprace | Genepharm Pty Ltd | Ascent Pharma Pty Ltd |
Lisinopril | Tablet 20 mg | Liprace | Genepharm Pty Ltd | Ascent Pharma Pty Ltd |
Lisinopril | Tablet 20 mg | Lisinopril-GA | Genepharm (Australia) Limited | Ascent Pharmaceuticals Limited |
Lisinopril | Tablet 5 mg | Liprace | Genepharm Pty Ltd | Ascent Pharma Pty Ltd |
Lisinopril | Tablet 5 mg | Lisinopril-GA | Genepharm (Australia) Limited | Ascent Pharmaceuticals Limited |
Meloxicam | Tablet 15 mg | Meloxicam-GA | Genepharm Pty Ltd | Ascent Pharma Pty Ltd |
Meloxicam | Tablet 7.5 mg | Meloxicam-GA | Genepharm Pty Ltd | Ascent Pharma Pty Ltd |
Metformin | Tablet containing metformin hydrochloride 1 g | Metformin-GA | Genepharm (Australia) Limited | Ascent Pharma Pty Ltd |
Metformin | Tablet containing metformin hydrochloride 500 mg | Metformin-GA | Genepharm Pty Ltd | Ascent Pharma Pty Ltd |
Metformin | Tablet containing metformin hydrochloride 850 mg | Metformin-GA | Genepharm Pty Ltd | Ascent Pharma Pty Ltd |
Mirtazapine | Tablet 30 mg | Mirtazapine-DP | Genepharm Pty Ltd | Ascent Pharma Pty Ltd |
Moclobemide | Tablet 150 mg | Clobemix | Genepharm Pty Ltd | Ascent Pharma Pty Ltd |
Moclobemide | Tablet 300 mg | Clobemix | Genepharm Pty Ltd | Ascent Pharma Pty Ltd |
Omeprazole | Tablet 20 mg | Omeprazole-GA | Genepharm Pty Ltd | Ascent Pharma Pty Ltd |
Ondansetron | I.V. injection 4 mg (as hydrochloride dihydrate) in 2 mL | Onsetron | Sigma Pharmaceuticals (Australia) Pty Ltd | Spirit Pharmaceuticals Pty Ltd |
Ondansetron | I.V. injection 8 mg (as hydrochloride dihydrate) in 4 mL | Onsetron | Sigma Pharmaceuticals (Australia) Pty Ltd | Spirit Pharmaceuticals Pty Ltd |
Ondansetron | Tablet 4 mg (as hydrochloride dihydrate) | Onsetron 4 | Sigma Pharmaceuticals (Australia) Pty Ltd | Spirit Pharmaceuticals Pty Ltd |
Ondansetron | Tablet 8 mg (as hydrochloride dihydrate) | Onsetron 8 | Sigma Pharmaceuticals (Australia) Pty Ltd | Spirit Pharmaceuticals Pty Ltd |
Oxaliplatin | Powder for I.V. infusion 100 mg | Oxaliplatin Link | Pharmatel Fresenius Kabi Pty Limited | Fresenius Kabi Australia Pty Limited |
Pantoprazole | Tablet (enteric coated) 20 mg (as sodium sesquihydrate) | Pantoprazole-GA | Genepharm Pty Ltd | Ascent Pharma Pty Ltd |
Pantoprazole | Tablet (enteric coated) 40 mg (as sodium sesquihydrate) | Pantoprazole-GA | Genepharm Pty Ltd | Ascent Pharma Pty Ltd |
Paracetamol | Tablet 500 mg | Febridol | Genepharm Pty Ltd | Ascent Pharma Pty Ltd |
Paroxetine | Tablet 20 mg (as hydrochloride) | Paroxetine-DP | Genepharm Pty Ltd | Ascent Pharma Pty Ltd |
Paroxetine | Tablet 20 mg (as hydrochloride) | Paroxetine-GA | Genepharm (Australia) Limited | Ascent Pharmaceuticals Limited |
Perindopril | Tablet containing perindopril erbumine | Perindopril-DP | Genepharm Pty Ltd | Ascent Pharmaceuticals Limited |
Perindopril | Tablet containing perindopril erbumine | Perindopril-GA | Genepharm Pty Ltd | Ascent Pharma Pty Ltd |
Perindopril | Tablet containing perindopril erbumine | Perindopril-DP | Genepharm Pty Ltd | Ascent Pharmaceuticals Limited |
Perindopril | Tablet containing perindopril erbumine 4 mg | Perindopril-GA | Genepharm Pty Ltd | Ascent Pharma Pty Ltd |
Perindopril | Tablet containing perindopril erbumine | Perindopril-DP | Genepharm Pty Ltd | Ascent Pharmaceuticals Limited |
Perindopril | Tablet containing perindopril erbumine | Perindopril-GA | Genepharm Pty Ltd | Ascent Pharma Pty Ltd |
Phenoxymethylpenicillin | Capsule 250 mg phenoxymethylpenicillin (as potassium) | Cilopen VK | Genepharm Pty Ltd | Ascent Pharma Pty Ltd |
Phenoxymethylpenicillin | Capsule 500 mg phenoxymethylpenicillin (as potassium) | Cilopen VK | Genepharm Pty Ltd | Ascent Pharma Pty Ltd |
Pravastatin | Tablet containing pravastatin sodium | Pravastatin-GA 10 | Genepharm (Australia) Limited | Ascent Pharma Pty Ltd |
Pravastatin | Tablet containing pravastatin sodium | Pravastatin-GA 20 | Genepharm (Australia) Limited | Ascent Pharma Pty Ltd |
Pravastatin | Tablet containing pravastatin sodium | Pravastatin-GA 40 | Genepharm (Australia) Limited | Ascent Pharma Pty Ltd |
Pravastatin | Tablet containing pravastatin sodium | Pravastatin-GA 80 | Genepharm (Australia) Limited | Ascent Pharma Pty Ltd |
Quinapril | Tablet 10 mg (as hydrochloride) | Quinapril-DP | Genepharm Pty Ltd | Ascent Pharmaceuticals Limited |
Quinapril | Tablet 20 mg (as hydrochloride) | Quinapril-GA | Genepharm Pty Ltd | Ascent Pharma Pty Ltd |
Quinapril | Tablet 5 mg (as hydrochloride) | Quinapril-DP | Genepharm Pty Ltd | Ascent Pharmaceuticals Limited |
Ramipril | Capsule 1.25 mg | Ramipril-DP | Genepharm Pty Ltd | Ascent Pharmaceuticals Limited |
Ramipril | Capsule 10 mg | Ramipril-DP | Genepharm Pty Ltd | Ascent Pharmaceuticals Limited |
Ramipril | Capsule 2.5 mg | Ramipril-DP | Genepharm Pty Ltd | Ascent Pharmaceuticals Limited |
Ramipril | Capsule 5 mg | Ramipril-DP | Genepharm Pty Ltd | Ascent Pharmaceuticals Limited |
Ranitidine | Tablet 150 mg (as hydrochloride) | Ranoxyl | Genepharm Pty Ltd | Ascent Pharma Pty Ltd |
Risperidone | Tablet 0.5 mg | Risperidone-GA | Genepharm Pty Ltd | Ascent Pharma Pty Ltd |
Risperidone | Tablet 1 mg | Risperidone-GA | Genepharm Pty Ltd | Ascent Pharma Pty Ltd |
Risperidone | Tablet 2 mg | Risperidone-GA | Genepharm Pty Ltd | Ascent Pharma Pty Ltd |
Risperidone | Tablet 3 mg | Risperidone-GA | Genepharm Pty Ltd | Ascent Pharma Pty Ltd |
Risperidone | Tablet 4 mg | Risperidone-GA | Genepharm Pty Ltd | Ascent Pharma Pty Ltd |
Roxithromycin | Tablet 150 mg | Roxithromycin-GA | Genepharm Pty Ltd | Ascent Pharma Pty Ltd |
Roxithromycin | Tablet 300 mg | Roxithromycin-GA | Genepharm Pty Ltd | Ascent Pharma Pty Ltd |
Salbutamol | Nebuliser solution 2.5 mg (as sulfate) in | Salbutamol-GA | Genepharm Pty Ltd | Ascent Pharma Pty Ltd |
Salbutamol | Nebuliser solution 5 mg (as sulfate) in | Salbutamol-GA | Genepharm Pty Ltd | Ascent Pharma Pty Ltd |
Sertraline | Tablet 100 mg (as hydrochloride) | Sertraline-GA | Genepharm Pty Ltd | Ascent Pharma Pty Ltd |
Sertraline | Tablet 50 mg (as hydrochloride) | Sertraline-GA | Genepharm Pty Ltd | Ascent Pharma Pty Ltd |
Simvastatin | Tablet 10 mg | Simvastatin-DP | Genepharm Pty Ltd | Ascent Pharma Pty Ltd |
Simvastatin | Tablet 10 mg | Simvastatin-GA 10 | Genepharm (Australia) Limited | Ascent Pharmaceuticals Limited |
Simvastatin | Tablet 20 mg | Simvastatin-DP | Genepharm Pty Ltd | Ascent Pharma Pty Ltd |
Simvastatin | Tablet 20 mg | Simvastatin-GA 20 | Genepharm (Australia) Limited | Ascent Pharmaceuticals Limited |
Simvastatin | Tablet 40 mg | Simvastatin-DP | Genepharm Pty Ltd | Ascent Pharma Pty Ltd |
Simvastatin | Tablet 40 mg | Simvastatin-GA 40 | Genepharm (Australia) Limited | Ascent Pharmaceuticals Limited |
Simvastatin | Tablet 80 mg | Simvastatin-DP | Genepharm Pty Ltd | Ascent Pharma Pty Ltd |
Simvastatin | Tablet 80 mg | Simvastatin-GA 80 | Genepharm (Australia) Limited | Ascent Pharmaceuticals Limited |
Sodium Chloride | I.V. infusion 38.5 mmol per 250 mL, | Sodium Chloride 0.9% Freeflex | Pharmatel Fresenius Kabi Pty Limited | Fresenius Kabi Australia Pty Limited |
Tamoxifen | Tablet 20 mg (as citrate) | Tamoxen 20 mg | Genepharm Pty Ltd | Ascent Pharma Pty Ltd |
Terbinafine | Tablet 250 mg (as hydrochloride) | Terbinafine-DP | Genepharm Pty Ltd | Ascent Pharmaceuticals Limited |
Trandolapril | Capsule 1 mg | Trandolapril-DP | Genepharm Pty Ltd | Ascent Pharmaceuticals Limited |
Trandolapril | Capsule 2 mg | Trandolapril-DP | Genepharm Pty Ltd | Ascent Pharmaceuticals Limited |
Trandolapril | Capsule 4 mg | Trandolapril-DP | Genepharm Pty Ltd | Ascent Pharmaceuticals Limited |
Trandolapril | Capsule 500 micrograms | Trandolapril-DP | Genepharm Pty Ltd | Ascent Pharmaceuticals Limited |
Vinorelbine | Solution for I.V. infusion 10 mg (as tartrate) in 1 mL | Vinorelbine Link | Link Medical Products Pty Ltd | Fresenius Kabi Australia Pty Limited |
Vinorelbine | Solution for I.V. infusion 50 mg (as tartrate) in 5 mL | Vinorelbine Link | Link Medical Products Pty Ltd | Fresenius Kabi Australia Pty Limited |
Alteration of Brand and Responsible Person
Listed Drug | Form | Brand From: | Brand To: | Responsible Person From: | Responsible Person To: |
Captopril | Tablet 25 mg | Genepharm Pty Ltd | Ascent Pharma Pty Ltd | Genepharm Pty Ltd | Ascent Pharma Pty Ltd |
Captopril | Tablet 50 mg | Genepharm Pty Ltd | Ascent Pharma Pty Ltd | Genepharm Pty Ltd | Ascent Pharma Pty Ltd |
Ciprofloxacin | Tablet 500 mg (as hydrochloride) | Genepharm (Australia) Limited | Ascent Pharmaceuticals Limited | Genepharm (Australia) Limited | Ascent Pharmaceuticals Limited |
Ciprofloxacin | Tablet 750 mg (as hydrochloride) | Genepharm (Australia) Limited | Ascent Pharmaceuticals Limited | Genepharm (Australia) Limited | Ascent Pharmaceuticals Limited |
Glucose | I.V. infusion 278 mmol (anhydrous) per 500 mL, 500 mL | Pharmatel Fresenius Kabi Pty Limited | Fresenius Kabi Australia Pty Limited | Pharmatel Fresenius Kabi Pty Limited | Fresenius Kabi Australia Pty Limited |
Glucose | I.V. infusion 278 mmol (anhydrous) per L, 1 L | Pharmatel Fresenius Kabi Pty Limited | Fresenius Kabi Australia Pty Limited | Pharmatel Fresenius Kabi Pty Limited | Fresenius Kabi Australia Pty Limited |
Glucose | I.V. infusion 139 mmol (anhydrous) per 500 mL, 500 mL | Pharmatel Fresenius Kabi Pty Limited | Fresenius Kabi Australia Pty Limited | Pharmatel Fresenius Kabi Pty Limited | Fresenius Kabi Australia Pty Limited |
Metformin | Tablet containing metformin hydrochloride 500 mg | Genepharm (Australia) Limited | Ascent Pharmaceuticals Limited | Genepharm (Australia) Limited | Ascent Pharmaceuticals Limited |
Metformin | Tablet containing metformin hydrochloride 850 mg | Genepharm (Australia) Limited | Ascent Pharmaceuticals Limited | Genepharm (Australia) Limited | Ascent Pharmaceuticals Limited |
Norfloxacin | Tablet 400 mg | Genepharm Pty Ltd | Ascent Pharmaceuticals Limited | Genepharm Pty Ltd | Ascent Pharmaceuticals Limited |
Sodium Chloride | I.V. infusion 154 mmol per L, 1 L | Pharmatel Fresenius Kabi Pty Limited | Fresenius Kabi Australia Pty Limited | Pharmatel Fresenius Kabi Pty Limited | Fresenius Kabi Australia Pty Limited |
Sodium Chloride | I.V. infusion 77 mmol per 500 mL, 500 mL | Pharmatel Fresenius Kabi Pty Limited | Fresenius Kabi Australia Pty Limited | Pharmatel Fresenius Kabi Pty Limited | Fresenius Kabi Australia Pty Limited |
Sodium Lactate Compound | 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 | Pharmatel Fresenius Kabi Pty Limited | Fresenius Kabi Australia Pty Limited | Pharmatel Fresenius Kabi Pty Limited | Fresenius Kabi Australia Pty Limited |
Sodium Lactate Compound | 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 | Pharmatel Fresenius Kabi Pty Limited | Fresenius Kabi Australia Pty Limited | Pharmatel Fresenius Kabi Pty Limited | Fresenius Kabi Australia Pty Limited |