National Health Act 1953 Amendment determination under section 84AF responsible persons (No. PB 32 of 2008) (Cth)
COMMONWEALTH OF AUSTRALIA
Instrument number PB 32 of 2008
Amendment determination under section 84AF of the National Health Act 1953
I, DIANA MACDONELL, Acting 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 3rd March 2008
DIANA MACDONELL
Acting Assistant Secretary
Pharmaceutical Evaluation Branch
Department of Health and Ageing
Amendment determination – responsible persons
1 Commencement
This instrument commences on 1 April 2008.
2 Amendment of PB 90 of 2007
Schedule 1 amends PB 90 of 2007.
Schedule 1 Amendments
[1] Schedule 1, in the column headed ‘Responsible Person’
omit:
Genepharm Limited (wherever occurring)
and substitute:
Genepharm (Australia) Limited
[2] Schedule 1, after item dealing with Alendronic acid, Tablet 40 mg (as alendronate sodium)
insert in the columns in the order indicated:
| Alendronic acid | Tablet 70 mg (as alendronate sodium) | Oral | Adronat | Alphapharm Pty Limited | 93 002 359 739 |
Schedule 1, after item dealing with Alendronic acid, Tablet 70 mg (as alendronate sodium) (Alendrobell 70 mg)
insert in the columns in the order indicated:
| Alendronic acid | Tablet 70 mg (as alendronate sodium) | Oral | APO-Alendronate | Apotex Pty Ltd | 52 096 916 148 |
| Alendronic acid | Tablet 70 mg (as alendronate sodium) | Oral | Chem mart Alendronate 70mg | Apotex Pty Ltd | 52 096 916 148 |
[4] Schedule 1, after item dealing with Alendronic acid, Tablet 70 mg (as alendronate sodium) (Ossmax 70 mg)
insert in the columns in the order indicated:
| Alendronic acid | Tablet 70 mg (as alendronate sodium) | Oral | Terry White Chemists Alendronate 70mg | Apotex Pty Ltd | 52 096 916 148 |
[5] Schedule 1, after item dealing with Amlodipine, Tablet 10 mg (as besylate) (Amlodipine Sandoz)
insert in the columns in the order indicated:
| Amlodipine | Tablet 10 mg (as besylate) | Oral | APO-Amlodipine | Apotex Pty Ltd | 52 096 916 148 |
| Amlodipine | Tablet 10 mg (as besylate) | Oral | Chem mart Amlodipine | Apotex Pty Ltd | 52 096 916 148 |
[6] Schedule 1, after item dealing with Amlodipine, Tablet 10 mg (as besylate) (Perivasc)
insert in the columns in the order indicated:
| Amlodipine | Tablet 10 mg (as besylate) | Oral | Terry White Chemists Amlodipine | Apotex Pty Ltd | 52 096 916 148 |
[7] Schedule 1, after item dealing with Amlodipine, Tablet 5 mg (as besylate) (Amlodipine Sandoz)
insert in the columns in the order indicated:
| Amlodipine | Tablet 5 mg (as besylate) | Oral | APO-Amlodipine | Apotex Pty Ltd | 52 096 916 148 |
| Amlodipine | Tablet 5 mg (as besylate) | Oral | Chem mart Amlodipine | Apotex Pty Ltd | 52 096 916 148 |
[8] Schedule 1, after item dealing with Amlodipine, Tablet 5 mg (as besylate) (Perivasc)
insert in the columns in the order indicated:
| Amlodipine | Tablet 5 mg (as besylate) | Oral | Terry White Chemists Amlodipine | Apotex Pty Ltd | 52 096 916 148 |
[9] Schedule 1, after items dealing with Beclomethasone, Pressurised inhalation in breath actuated device containing beclomethasone dipropionate 50 micrograms per dose, 200 doses (CFC-free formulation)
insert in the columns in the order indicated:
| Benzathine benzylpenicillin | Injection 900 mg in 2.3 ml single use pre-filled syringe | Injection | Bicillin L-A | Aspen Pharmacare Australia Pty Limited | 51 096 236 985 |
[10] Schedule 1, item dealing with Benzathine penicillin
omit from the columns in the order indicated:
| Benzathine penicillin | Injection 900 mg in 2 mL cartridge-needle unit (for use with Tubex Injector) | Injection | Bicillin L-A Tubex | Aspen Pharmacare Australia Pty Limited | 51 096 236 985 |
[11] Schedule 1, after item dealing with Captopril, Tablet 12.5 mg (Terry White Chemists Captopril)
omit from the columns in the order indicated:
| Captopril | Tablet 12.5 mg | Oral | Topace | Fawns and McAllan Proprietary Limited | 16 004 296 066 |
[12] Schedule 1, after item dealing with Captopril, Tablet 25 mg (Terry White Chemists Captopril)
omit from the columns in the order indicated:
| Captopril | Tablet 25 mg | Oral | Topace | Fawns and McAllan Proprietary Limited | 16 004 296 066 |
[13] Schedule 1, after item dealing with Captopril, Tablet 50 mg (Terry White Chemists Captopril)
omit from the columns in the order indicated:
| Captopril | Tablet 50 mg | Oral | Topace | Fawns and McAllan Proprietary Limited | 16 004 296 066 |
[14] Schedule 1, after item dealing with Carvedilol, Tablet 12.5 mg (Chem mart Carvedilol 12.5)
insert in the columns in the order indicated:
| Carvedilol | Tablet 12.5 mg | Oral | Dilasig 12.5 | Sigma Pharmaceuticals (Australia) Pty Ltd | 88 004 118 594 |
[15] Schedule 1, after item dealing with Carvedilol, Tablet 25 mg (Chem mart Carvedilol 25 mg)
insert in the columns in the order indicated:
| Carvedilol | Tablet 25 mg | Oral | Dilasig 25 | Sigma Pharmaceuticals (Australia) Pty Ltd | 88 004 118 594 |
[16] Schedule 1, after item dealing with Carvedilol, Tablet 3.125 mg (Chem mart Carvedilol 3.125 mg)
insert in the columns in the order indicated:
| Carvedilol | Tablet 3.125 mg | Oral | Dilasig 3.125 | Sigma Pharmaceuticals (Australia) Pty Ltd | 88 004 118 594 |
[17] Schedule 1, after item dealing with Carvedilol, Tablet 6.25 mg (Chem mart Carvedilol 6.25 mg)
insert in the columns in the order indicated:
| Carvedilol | Tablet 6.25 mg | Oral | Dilasig 6.25 | Sigma Pharmaceuticals (Australia) Pty Ltd | 88 004 118 594 |
[18] Schedule 1, after item dealing with Cefaclor, Powder for oral suspension 125 mg (as monohydrate) per 5 mL, 100 mL (Ceclor)
insert in the columns in the order indicated:
| Cefaclor | Powder for oral suspension 125 mg (as monohydrate) per 5 mL, 100 mL | Oral | Cefaclor Sandoz | Sandoz Pty Ltd | 60 075 449 553 |
[19] Schedule 1, after item dealing with Cefaclor, Powder for oral suspension 250 mg (as monohydrate) per 5 mL, 75 mL (Ceclor)
insert in the columns in the order indicated:
| Cefaclor | Powder for oral suspension 250 mg (as monohydrate) per 5 mL, 75 mL | Oral | Cefaclor Sandoz | Sandoz Pty Ltd | 60 075 449 553 |
[20] Schedule 1, after items dealing with Cephalexin, Capsule 500 mg (anhydrous)
insert in the columns in the order indicated:
| Cephalexin | Granules for oral suspension 125 mg per 5 mL, 100 mL | Oral | Cefalexin Sandoz | Sandoz Pty Ltd | 60 075 449 553 |
[21] Schedule 1, after items dealing with Cephalexin, Granules for oral suspension 125 mg per 5 mL, 100 mL
insert in the columns in the order indicated:
| Cephalexin | Granules for oral suspension 250 mg per 5 mL, 100 mL | Oral | Cefalexin Sandoz | Sandoz Pty Ltd | 60 075 449 553 |
[22] Schedule 1, after items dealing with Cephazolin
insert in the columns in the order indicated:
| Cetuximab | Solution for I.V. infusion 100 mg in 20 mL | Injection | Erbitux | Merck Serono Australia Pty Ltd | 72 006 900 830 |
[23] Schedule 1, after item dealing with Cetuximab, Solution for I.V. infusion 100 mg in 50 mL (Erbitux)
insert in the columns in the order indicated:
| Cetuximab | Solution for I.V. infusion 500 mg in 100 mL | Injection | Erbitux | Merck Serono Australia Pty Ltd | 72 006 900 830 |
[24] Schedule 1, after items dealing with Doxycycline
omit from the columns in the order indicated:
| Drotrecogin alfa (activated) | Powder for I.V. infusion 20 mg | Injection | Xigris | Eli Lilly Australia Pty Ltd | 39 000 233 992 |
[25] Schedule 1, after items dealing with Enalapril
insert in the columns in the order indicated:
| Enalapril with hydrochlorothiazide | Tablet containing enalapril maleate 20 mg with hydrochlorothiazide 6 mg | Oral | Enalapril/HCT Sandoz | Sandoz Pty Ltd | 60 075 449 553 |
[26] Schedule 1, after items dealing with Famotidine
insert in the columns in the order indicated:
| Felodipine | Tablet 10 mg (extended release) | Oral | Felodipine XR 10 | Arrow Pharmaceuticals Pty Ltd | 17 003 144 170 |
[27] Schedule 1, after items dealing with Felodipine, Tablet 2.5 mg (extended release)
insert in the columns in the order indicated:
| Felodipine | Tablet 5 mg (extended release) | Oral | Felodipine XR 5 | Arrow Pharmaceuticals Pty Ltd | 17 003 144 170 |
[28] Schedule 1, after items dealing with Fenofibrate
insert in the columns in the order indicated:
| Fentanyl | Lozenges 1200 micrograms (as citrate), 3 | Buccal | Actiq | Orphan Australia Pty Ltd | 11 067 189 342 |
| Fentanyl | Lozenges 1600 micrograms (as citrate), 3 | Buccal | Actiq | Orphan Australia Pty Ltd | 11 067 189 342 |
| Fentanyl | Lozenges 200 micrograms (as citrate), 3 | Buccal | Actiq | Orphan Australia Pty Ltd | 11 067 189 342 |
| Fentanyl | Lozenges 400 micrograms (as citrate), 3 | Buccal | Actiq | Orphan Australia Pty Ltd | 11 067 189 342 |
| Fentanyl | Lozenges 600 micrograms (as citrate), 3 | Buccal | Actiq | Orphan Australia Pty Ltd | 11 067 189 342 |
| Fentanyl | Lozenges 800 micrograms (as citrate), 3 | Buccal | Actiq | Orphan Australia Pty Ltd | 11 067 189 342 |
[29] Schedule 1, after items dealing with Flucloxacillin, Capsule 500 mg (as sodium)
omit from the columns in the order indicated:
| Flucloxacillin | Powder for injection 1 g (as sodium) | Injection | Aspen Flucil | Aspen Pharmacare Australia Pty Limited | 51 096 236 985 |
| Flucloxacillin | Powder for injection 1 g (as sodium) | Injection | Flopen | Aspen Pharmacare Australia Pty Limited | 51 096 236 985 |
[30] Schedule 1, after item dealing with Flucloxacillin, Powder for injection 1 g (as sodium) (Flubiclox)
insert in the columns in the order indicated:
| Flucloxacillin | Powder for injection 1 g (as sodium) | Injection | Flucil | Aspen Pharmacare Australia Pty Limited | 51 096 236 985 |
[31] Schedule 1, after item dealing with Flucloxacillin, Powder for injection 1 g (as sodium) (Hospira Australia Pty Ltd)
omit from the columns in the order indicated:
| Flucloxacillin | Powder for injection 500 mg (as sodium) | Injection | Flopen | Aspen Pharmacare Australia Pty Limited | 51 096 236 985 |
[32] Schedule 1, after item dealing with Flucloxacillin, Powder for injection 500 g (as sodium) (Flubiclox)
insert in the columns in the order indicated:
| Flucloxacillin | Powder for injection 500 g (as sodium) | Injection | Flucil | Aspen Pharmacare Australia Pty Limited | 51 096 236 985 |
[33] Schedule 1, after item dealing with Flucloxacillin, Powder for oral suspension 250 mg (as magnesium) per 5 mL, 100 mL (Flopen)
omit from the columns in the order indicated:
| Flucloxacillin | Powder for oral suspension 250 mg (as magnesium) per 5 mL, 100 mL | Oral | Floxapen | GlaxoSmithKline Australia Pty Ltd | 47 100 162 481 |
[34] Schedule 1, after item dealing with Gemfibrozil, Tablet 600 mg (Lopid)
insert in the columns in the order indicated:
| Gemfibrozil | Tablet 600 mg | Oral | Pharmacor Gemfibrozil 600 | Pharmacor Pty Limited | 58 121 020 835 |
[35] Schedule 1, after item dealing with Hypromellose, Eye drops 3 mg per mL, 15 mL (In a Wink Moisturising)
omit from the columns in the order indicated:
| Hypromellose | Eye drops 5 mg per mL, 15 mL | Application to the eye | Isopto Tears | Alcon Laboratories (Australia) Pty Ltd | 88 000 740 830 |
[36] Schedule 1, after item dealing with Irinotecan, I.V. injection containing irinotecan hydrochloride trihydrate 100 mg in 5 mL (Hospira Australia Pty Ltd)
insert in the columns in the order indicated:
| Irinotecan | I.V. injection containing irinotecan hydrochloride trihydrate 100 mg in 5 mL | Injection | Irinotecan Sandoz | Sandoz Pty Ltd | 60 075 449 553 |
[37] Schedule 1, after item dealing with Irinotecan, I.V. injection containing irinotecan hydrochloride trihydrate 40 mg in 2 mL (Hospira Australia Pty Ltd)
insert in the columns in the order indicated:
| Irinotecan | I.V. injection containing irinotecan hydrochloride trihydrate 40 mg in 2 mL | Injection | Irinotecan Sandoz | Sandoz Pty Ltd | 60 075 449 553 |
[38] Schedule 1, after items dealing with Methyldopa
insert in the columns in the order indicated:
| Methylphenidate | Capsule containing methylphenidate hydrochloride 20 mg (modified release) | Oral | Ritalin LA | Novartis Pharmaceuticals Australia Pty Limited | 18 004 244 160 |
| Methylphenidate | Capsule containing methylphenidate hydrochloride 30 mg (modified release) | Oral | Ritalin LA | Novartis Pharmaceuticals Australia Pty Limited | 18 004 244 160 |
| Methylphenidate | Capsule containing methylphenidate hydrochloride 40 mg (modified release) | Oral | Ritalin LA | Novartis Pharmaceuticals Australia Pty Limited | 18 004 244 160 |
[39] Schedule 1, after item dealing with Metronidazole, I.V. infusion 500 mg in 100 mL (Baxter Healthcare Pty Ltd)
insert in the columns in the order indicated:
| Metronidazole | I.V. infusion 500 mg in 100 mL | Injection | Metronidazole Sandoz | Sandoz Pty Ltd | 60 075 449 553 |
[40] Schedule 1, item dealing with Oestradiol
omit from the columns in the order indicated:
| Oestradiol | Nasal spray containing oestradiol hemihydrate 150 micrograms per actuation, 60 actuations, 4.2 mL | Nasal | Aerodiol | Servier Laboratories (Aust.) Pty Ltd | 54 004 838 500 |
[41] Schedule 1, after items dealing with Paclitaxel
insert in the columns in the order indicated:
| Paliperidone | Tablet 3 mg (prolonged release) | Oral | Invega | Janssen-Cilag Pty Ltd | 47 000 129 975 |
| Paliperidone | Tablet 6 mg (prolonged release) | Oral | Invega | Janssen-Cilag Pty Ltd | 47 000 129 975 |
| Paliperidone | Tablet 9 mg (prolonged release) | Oral | Invega | Janssen-Cilag Pty Ltd | 47 000 129 975 |
[42] Schedule 1, after item dealing with Phenoxymethylpenicillin, Oral suspension 125 mg (as benzathine) per 5 mL, 100 mL (Cilicaine V)
insert in the columns in the order indicated:
| Phenoxymethylpenicillin | Oral suspension 150 mg (as benzathine) per 5 mL, 100 mL | Oral | Abbocillin-V | Sigma Pharmaceuticals (Australia) Pty Ltd | 88 004 118 594 |
| Phenoxymethylpenicillin | Oral suspension 150 mg (as benzathine) per 5 mL, 100 mL | Oral | Cilicaine V | Sigma Pharmaceuticals (Australia) Pty Ltd | 88 004 118 594 |
[43] Schedule 1, after item dealing with Prochlorperazine, Suppositories containing prochlorperazine equivalent to 25 mg prochlorperazine maleate, 5 (Stemetil)
omit from the columns in the order indicated:
| Prochlorperazine | Suppositories containing prochlorperazine equivalent to 5 mg prochlorperazine maleate, 5 | Rectal | Stemetil | sanofi-aventis Australia Pty Ltd | 31 008 558 807 |
[44] Schedule 1, after item dealing with Salbutamol, Nebuliser solution
2.5 mg (as sulfate) in 2.5 mL single dose units, 30 (Pfizer Australia Pty Ltd)
insert in the columns in the order indicated:
| Salbutamol | Nebuliser solution 2.5 mg (as sulfate) in 2.5 mL single dose units, 30 | Inhalation | Pharmacor Salbutamol 2.5 | Pharmacor Pty Limited | 58 121 020 835 |
| Salbutamol | Nebuliser solution 2.5 mg (as sulfate) in 2.5 mL single dose units, 30 | Inhalation | Salbutamol Sandoz | Sandoz Pty Ltd | 60 075 449 553 |
| Salbutamol | Nebuliser solution 2.5 mg (as sulfate) in 2.5 mL single dose units, 30 | Inhalation | Salbutamol-GA | Genepharm (Australia) Limited | 17 003 854 626 |
[45] Schedule 1, after item dealing with Salbutamol, Nebuliser solution
5 mg (as sulfate) in 2.5 mL single dose units, 30 (GenRx Salbutamol)
insert in the columns in the order indicated:
| Salbutamol | Nebuliser solution 5 mg (as sulfate) in 2.5 mL single dose units, 30 | Inhalation | Pharmacor Salbutamol 5 | Pharmacor Pty Limited | 58 121 020 835 |
| Salbutamol | Nebuliser solution 5 mg (as sulfate) in 2.5 mL single dose units, 30 | Inhalation | Salbutamol Sandoz | Sandoz Pty Ltd | 60 075 449 553 |
| Salbutamol | Nebuliser solution 5 mg (as sulfate) in 2.5 mL single dose units, 30 | Inhalation | Salbutamol-GA | Genepharm (Australia) Limited | 17 003 854 626 |
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