National Health Act 1953 Amendment determination under section 84AF responsible persons (No. PB 52 of 2008) (Cth)
COMMONWEALTH OF AUSTRALIA
Instrument number PB 52 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 1st May 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 June 2008.
2 Amendment of PB 90 of 2007
Schedule 1 amends PB 90 of 2007.
Schedule 1 Amendments
[1] Schedule 1, in all instances where Genepharm Australasia Limited appears in the column headed “Responsible Person”
omit from the columns in the order indicated:
| Genepharm Australasia Limited | 52 107 340 367 |
and substitute:
| Genepharm Pty Ltd | 68 118 734 795 |
[2] Schedule 1, in all instances where Genepharm (Australia) Limited appears in the column headed “Responsible Person”
omit from the columns in the order indicated:
| Genepharm (Australia) Limited | 17 003 854 626 |
and substitute:
| Genepharm Pty Ltd | 68 118 734 795 |
[3] Schedule 1, item dealing with Acitretin in the form Capsule 10 mg
omit from the columns in the order indicated:
| Roche Products Pty Ltd | 70 000 132 865 |
and substitute:
| Actavis Australia Pty Ltd | 43 122 896 468 |
[4] Schedule 1, item dealing with Acitretin in the form Capsule 25 mg
omit from the columns in the order indicated:
| Roche Products Pty Ltd | 70 000 132 865 |
and substitute:
| Actavis Australia Pty Ltd | 43 122 896 468 |
[5] Schedule 1, item dealing with Calcium in the form Tablet 250 mg (as citrate)
omit from the columns in the order indicated:
| Key Pharmaceuticals Pty Ltd | 21 001 215 130 |
and substitute:
| Bayer Australia Ltd | 22 000 138 714 |
[6] Schedule 1, items dealing with Captopril in the form Tablet 12.5 mg
omit from the column headed “Brand”:
Genepharm Limited
and substitute:
Genepharm Pty Ltd
[7] Schedule 1, items dealing with Captopril in the form Tablet 25 mg
omit from the column headed “Brand”:
Genepharm Limited
and substitute:
Genepharm Pty Ltd
[8] Schedule 1, items dealing with Captopril in the form Tablet 50 mg
omit from the column headed “Brand”:
Genepharm Limited
and substitute:
Genepharm Pty Ltd
[9] Schedule 1, items dealing with Ciprofloxacin in the form Tablet
500 mg (as hydrochloride)
omit from the column headed “Brand”:
Genepharm Australasia Limited
and substitute:
Genepharm Pty Ltd
[10] Schedule 1, items dealing with Ciprofloxacin in the form Tablet
750 mg (as hydrochloride)
omit from the column headed “Brand”:
Genepharm Australasia Limited
and substitute:
Genepharm Pty Ltd
[11] Schedule 1, after item dealing with Citalopram in the form Tablet
20 mg (as hydrobromide) (Celapram)
insert in the columns in the order indicated:
| Citalopram | Tablet 20 mg (as hydrobromide) | Oral | Celica | Ranbaxy Australia Pty Limited | 17 110 871 826 |
[12] Schedule 1, items dealing with Citalopram in the form Tablet
20 mg (as hydrobromide)
omit from the columns in the order indicated:
| Citalopram | Tablet 20 mg (as hydrobromide) | Oral | Citalopram-RL | GlaxoSmithKline Australia Pty Ltd | 47 100 162 481 |
[13] Schedule 1, items dealing with Codeine with Paracetamol
omit from the columns in the order indicated:
| Codeine with Paracetamol | Tablet containing codeine phosphate 30 mg with paracetamol 500 mg | Oral | Dymadon Forte | GlaxoSmithKline Australia Pty Ltd | 47 100 162 481 |
[14] Schedule 1, after item dealing with Drotrecogin Alfa (Activated)
insert in the columns in the order indicated:
| Duloxetine | Capsule 30 mg (as hydrochloride) | Oral | Cymbalta | Eli Lilly Australia Pty Ltd | 39 000 233 992 |
| Duloxetine | Capsule 60 mg (as hydrochloride) | Oral | Cymbalta | Eli Lilly Australia Pty Ltd | 39 000 233 992 |
[15] Schedule 1, items dealing with Felodipine in the form Tablet
10 mg (extended release)
omit from the column headed “Brand”:
Felodipine XR 10
and substitute:
Felodil XR 10
[16] Schedule 1, items dealing with Felodipine in the form Tablet
5 mg (extended release)
omit from the column headed “Brand”:
Felodipine XR 5
and substitute:
Felodil XR 5
[17] Schedule 1, items dealing with Flucloxacillin
omit from the columns in the order indicated:
| Flucloxacillin | Powder for oral suspension 125 mg (as magnesium) per 5 mL, 100 mL | Oral | Floxapen | GlaxoSmithKline Australia Pty Ltd | 47 100 162 481 |
[18] Schedule 1, items dealing with Folinic acid in the form Injection containing calcium folinate equivalent to 100 mg folinic acid in 10 mL
omit from the columns in the order indicated:
| Leucovorin Calcium | Pfizer Australia Pty Ltd | 50 008 422 348 |
and substitute:
| Leucovorin Calcium (Pfizer Australia Pty Ltd) | Pfizer Australia Pty Ltd | 50 008 422 348 |
[19] Schedule 1, item dealing with Folinic acid in the form Injection containing calcium folinate equivalent to 300 mg folinic acid in 30 mL
omit from the columns in the order indicated:
| Leucovorin Calcium | Hospira Australia Pty Ltd | 58 097 064 330 |
and substitute:
| Leucovorin Calcium (Hospira Australia Pty Ltd) | Hospira Australia Pty Ltd | 58 097 064 330 |
[20] Schedule 1, items dealing with Folinic acid in the form Injection containing calcium folinate equivalent to 50 mg folinic acid in 5 mL
omit from the columns in the order indicated:
| Leucovorin Calcium | Hospira Australia Pty Ltd | 58 097 064 330 |
| Leucovorin Calcium | Pfizer Australia Pty Ltd | 50 008 422 348 |
and substitute:
| Leucovorin Calcium (Hospira Australia Pty Ltd) | Hospira Australia Pty Ltd | 58 097 064 330 |
| Leucovorin Calcium (Pfizer Australia Pty Ltd) | Pfizer Australia Pty Ltd | 50 008 422 348 |
[21] Schedule 1, item dealing with Folinic acid in the form Tablet containing calcium folinate equivalent to 15 mg folinic acid
omit from the columns in the order indicated:
| Leucovorin Calcium | Hospira Australia Pty Ltd | 58 097 064 330 |
and substitute:
| Leucovorin Calcium (Hospira Australia Pty Ltd) | Hospira Australia Pty Ltd | 58 097 064 330 |
[22] Schedule 1, items dealing with Gabapentin in the form Tablet
600 mg
omit from the columns in the order indicated:
| Gabapentin | Tablet 600 mg | Oral | Pharmacor Gabapentin 600 | Pharmacor Pty Limited | 58 121 020 835 |
[23] Schedule 1, items dealing with Gabapentin in the form Tablet
800 mg
omit from the columns in the order indicated:
| Gabapentin | Tablet 800 mg | Oral | Pharmacor Gabapentin 800 | Pharmacor Pty Limited | 58 121 020 835 |
[24] Schedule 1, after items dealing with Glucose and Ketone Indicator ─ Urine
insert in the columns in the order indicated:
| Glucose Indicator─ Blood | Electrode strips, 100 (FreeStyle Lite) | For external use | FreeStyle Lite | Abbott Australasia Pty Ltd | 95 000 180 389 |
[25] Schedule 1, items dealing with Glucose Indicator—Blood in the form Electrode strips, 50 with the brands Glucocard 01 Sensor, GlucoCare Super Sensor and GlucoOz
omit from the column headed “Responsible Person:
Medical Specialities Australia Unit Trust
and substitute:
Medical Specialties Australia Unit Trust
[26] Schedule 1, items dealing with Hydrochlorothiazide with Amiloride
omit from the columns in the order indicated:
| Hydrochlorothiazide with Amiloride | Tablet containing hydrochlorothiazide 50 mg with amiloride hydrochloride 5 mg | Oral | Amizide | Alphapharm Pty Limited | 93 002 359 739 |
[27] Schedule 1, after item dealing with Meloxicam in the form Tablet
15 mg (Meloxicam Sandoz)
insert in the columns in the order indicated:
| Meloxicam | Tablet 15 mg | Oral | Meloxicam Winthrop | sanofi-aventis Australia Pty Ltd | 31 008 558 807 |
[28] Schedule 1, after item dealing with Meloxicam in the form Tablet
7.5 mg (Meloxicam Sandoz)
insert in the columns in the order indicated:
| Meloxicam | Tablet 7.5 mg | Oral | Meloxicam Winthrop | sanofi-aventis Australia Pty Ltd | 31 008 558 807 |
[29] Schedule 1, items dealing with Metformin in the form Tablet
containing metformin hydrochloride 500 mg
omit from the column headed “Brand”:
Genepharm Australasia Limited
and substitute:
Genepharm Pty Ltd
[30] Schedule 1, items dealing with Metformin in the form Tablet
containing metformin hydrochloride 850 mg
omit from the column headed “Brand”:
Genepharm Australasia Limited
and substitute:
Genepharm Pty Ltd
[31] Schedule 1, items dealing with Norfloxacin
omit from the column headed “Brand”:
Genepharm Limited
and substitute:
Genepharm Pty Ltd
[32] Schedule 1, items dealing with Oxaliplatin
(a)omit from the columns in the order indicated:
| Oxaliplatin | Powder for I.V. infusion 100 mg | Injection | Oxaliplan 100 | Willow Pharmaceuticals Pty Ltd | 80 118 534 704 |
(b)omit from the columns in the order indicated:
| Oxaliplatin | Powder for I.V. infusion 50 mg | Injection | Oxaliplan 50 | Willow Pharmaceuticals Pty Ltd | 80 118 534 704 |
[33] Schedule 1, after items dealing with Potassium Chloride with Potassium Bicarbonate
insert in the columns in the order indicated:
| Pramipexole | Tablet containing pramipexole hydrochloride 1 mg | Oral | Sifrol | Boehringer Ingelheim Pty Ltd | 52 000 452 308 |
| Pramipexole | Tablet containing pramipexole hydrochloride 125 micrograms | Oral | Sifrol | Boehringer Ingelheim Pty Ltd | 52 000 452 308 |
| Pramipexole | Tablet containing pramipexole hydrochloride 250 micrograms | Oral | Sifrol | Boehringer Ingelheim Pty Ltd | 52 000 452 308 |
[34] Schedule 1, items dealing with Pravastatin in the form Tablet
containing pravastatin sodium 10 mg
omit from the columns in the order indicated:
| Pravastatin | Tablet containing pravastatin sodium 10 mg | Oral | Pravastatin-RL | GlaxoSmithKline Australia Pty Ltd | 47 100 162 481 |
[35] Schedule 1, items dealing with Pravastatin in the form Tablet
containing pravastatin sodium 20 mg
omit from the columns in the order indicated:
| Pravastatin | Tablet containing pravastatin sodium 20 mg | Oral | Pravastatin-RL | GlaxoSmithKline Australia Pty Ltd | 47 100 162 481 |
[36] Schedule 1, items dealing with Pravastatin in the form Tablet
containing pravastatin sodium 40 mg
omit from the columns in the order indicated:
| Pravastatin | Tablet containing pravastatin sodium 40 mg | Oral | Pravastatin-RL | GlaxoSmithKline Australia Pty Ltd | 47 100 162 481 |
[37] Schedule 1, after item dealing with Quinapril in the form Tablet
20 mg (as hydrochloride) (Pharmacor Quinapril 20)
insert in the columns in the order indicated:
| Quinapril | Tablet 20 mg (as hydrochloride) | Oral | Quinapril Sandoz | Sandoz Pty Ltd | 60 075 449 553 |
[38] Schedule 1, item dealing with Raltitrexed
omit from the columns in the order indicated:
| AstraZeneca Pty Ltd | 54 009 682 311 |
and substitute:
| Hospira Pty Ltd | 13 107 058 328 |
[39] Schedule 1, items dealing with Roxithromycin in the form Tablet
150 mg
omit from the columns in the order indicated:
| Roxithromycin | Tablet 150 mg | Oral | Roxithromycin-RL | GlaxoSmithKline Australia Pty Ltd | 47 100 162 481 |
[40] Schedule 1, items dealing with Roxithromycin in the form Tablet
300 mg
omit from the columns in the order indicated:
| Roxithromycin | Tablet 300 mg | Oral | Roxithromycin-RL | GlaxoSmithKline Australia Pty Ltd | 47 100 162 481 |
[41] Schedule 1, items dealing with Simvastatin in the form Tablet 10 mg
(a) omit from the column headed “Brand”:
Genepharm Australasia Limited
and substitute:
Genepharm Pty Ltd
(b)omit from the columns in the order indicated:
| Simvastatin | Tablet 10 mg | Oral | Simvastatin-RL | GlaxoSmithKline Australia Pty Ltd | 47 100 162 481 |
[42] Schedule 1, items dealing with Simvastatin in the form Tablet 20 mg
(a) omit from the column headed “Brand”:
Genepharm Australasia Limited
and substitute:
Genepharm Pty Ltd
(b)omit from the columns in the order indicated:
| Simvastatin | Tablet 20 mg | Oral | Simvastatin-RL | GlaxoSmithKline Australia Pty Ltd | 47 100 162 481 |
[43] Schedule 1, items dealing with Simvastatin in the form Tablet 40 mg
(a) omit from the column headed “Brand”:
Genepharm Australasia Limited
and substitute:
Genepharm Pty Ltd
(b)omit from the columns in the order indicated:
| Simvastatin | Tablet 40 mg | Oral | Simvastatin-RL | GlaxoSmithKline Australia Pty Ltd | 47 100 162 481 |
[44] Schedule 1, items dealing with Simvastatin in the form Tablet 5 mg
omit from the columns in the order indicated:
| Simvastatin | Tablet 5 mg | Oral | Simvastatin-RL | GlaxoSmithKline Australia Pty Ltd | 47 100 162 481 |
[45] Schedule 1, items dealing with Simvastatin in the form Tablet 80 mg
(a) omit from the column headed “Brand”:
Genepharm Australasia Limited
and substitute:
Genepharm Pty Ltd
(b)omit from the columns in the order indicated:
| Simvastatin | Tablet 80 mg | Oral | Simvastatin-RL | GlaxoSmithKline Australia Pty Ltd | 47 100 162 481 |
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