National Health Act 1953 Amendment determination under section 84AF responsible persons (No. PB 43 of 2008) (Cth)
COMMONWEALTH OF AUSTRALIA
Instrument number PB 43 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 Second of April 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 May 2008.
2 Amendment of PB 90 of 2007
Schedule 1 amends PB 90 of 2007.
Schedule 1 Amendments
[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-GA | Genepharm Pty Ltd | 68 118 734 795 |
[2] 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-GA | Genepharm Pty Ltd | 68 118 734 795 |
[3] Schedule 1, items dealing with Amoxycillin in the form Tablet 1 g (as trihydrate)
omit from the columns in the order indicated:
| Amoxycillin | Tablet 1 g (as trihydrate) | Oral | Amoxil Duo | GlaxoSmithKline Australia Pty Ltd | 47 100 162 481 |
[4] Schedule 1, item dealing with Ethacrynic Acid
omit from the columns in the order indicated:
| Merck Sharp & Dohme (Australia) Pty Ltd | 14 000 173 508 |
and substitute:
| PharmaLink Pty Ltd | 62 116 935 758 |
[5] Schedule 1, items dealing with Flucloxacillin
(a)omit from the columns in the order indicated:
| Flucloxacillin | Capsule 250 mg (as sodium) | Oral | Floxapen | GlaxoSmithKline Australia Pty Ltd | 47 100 162 481 |
(b)omit from the columns in the order indicated:
| Flucloxacillin | Capsule 500 mg (as sodium) | Oral | Floxapen | GlaxoSmithKline Australia Pty Ltd | 47 100 162 481 |
[6] Schedule 1, after item dealing with Flucloxacillin in the form Powder for injection 500 mg (as sodium) (Flucil)
insert in the columns in the order indicated:
| Flucloxacillin | Powder for oral liquid 125 mg (as sodium) per 5 mL, 100 mL | Oral | Aspen Pharmacare Australia Pty Limited | Aspen Pharmacare Australia Pty Limited | 51 096 236 985 |
| Flucloxacillin | Powder for oral liquid 250 mg (as sodium) per 5 mL, 100 mL | Oral | Aspen Pharmacare Australia Pty Limited | Aspen Pharmacare Australia Pty Limited | 51 096 236 985 |
[7] Schedule 1, item dealing with Fluconazole in the form Capsule 100 mg (Fluconazole Winthrop)
omit from the columns in the order indicated:
| Sandoz Pty Ltd | 60 075 449 553 |
and substitute:
| sanofi-aventis Australia Pty Ltd | 31 008 558 807 |
[8] Schedule 1, item dealing with Fluconazole in the form Capsule 200 mg (Fluconazole Winthrop)
omit from the columns in the order indicated:
| Sandoz Pty Ltd | 60 075 449 553 |
and substitute:
| sanofi-aventis Australia Pty Ltd | 31 008 558 807 |
[9] Schedule 1, item dealing with Fosinopril in the form Tablet containing fosinopril sodium 10 mg (Fosinopril Winthrop)
omit from the columns in the order indicated:
| Sandoz Pty Ltd | 60 075 449 553 |
and substitute:
| sanofi-aventis Australia Pty Ltd | 31 008 558 807 |
[10] Schedule 1, item dealing with Fosinopril in the form Tablet containing fosinopril sodium 20 mg (Fosinopril Winthrop)
omit from the columns in the order indicated:
| Sandoz Pty Ltd | 60 075 449 553 |
and substitute:
| sanofi-aventis Australia Pty Ltd | 31 008 558 807 |
[11] Schedule 1, item dealing with Fosinopril with Hydrochlorothiazide in the form Tablet containing fosinopril sodium 10 mg with hydrochlorothiazide 12.5 mg
(Fosinopril/HCT Winthrop 10mg/12.5mg)
omit from the columns in the order indicated:
| Sandoz Pty Ltd | 60 075 449 553 |
and substitute:
| sanofi-aventis Australia Pty Ltd | 31 008 558 807 |
[12] Schedule 1, item dealing with Fosinopril with Hydrochlorothiazide in the form Tablet containing fosinopril sodium 20 mg with hydrochlorothiazide 12.5 mg
(Fosinopril/HCT Winthrop 20mg/12.5mg)
omit from the columns in the order indicated:
| Sandoz Pty Ltd | 60 075 449 553 |
and substitute:
| sanofi-aventis Australia Pty Ltd | 31 008 558 807 |
[13] Schedule 1, after item dealing with Gabapentin in the form Tablet
600 mg (Neurontin)
insert in the columns in the order indicated:
| Gabapentin | Tablet 600 mg | Oral | Pharmacor Gabapentin 600 | Pharmacor Pty Limited | 58 121 020 835 |
[14] Schedule 1, after item dealing with Gabapentin in the form Tablet
800 mg (Pendine 800)
insert in the columns in the order indicated:
| Gabapentin | Tablet 800 mg | Oral | Pharmacor Gabapentin 800 | Pharmacor Pty Limited | 58 121 020 835 |
[15] Schedule 1, items dealing with Isosorbide Dinitrate
omit from the columns in the order indicated:
| Isosorbide Dinitrate | Tablet 10 mg | Oral | Isordil | Sigma Pharmaceuticals (Australia) Pty Ltd | 88 004 118 594 |
[16] Schedule 1, after item dealing with Lamotrigine in the form Tablet
100 mg (Lamogine)
insert in the columns in the order indicated:
| Lamotrigine | Tablet 100 mg | Oral | Lamotrigine generichealth | Generic Health Pty Ltd | 93 110 617 859 |
[17] Schedule 1, after item dealing with Lamotrigine in the form Tablet
200 mg (Lamogine)
insert in the columns in the order indicated:
| Lamotrigine | Tablet 200 mg | Oral | Lamotrigine generichealth | Generic Health Pty Ltd | 93 110 617 859 |
[18] Schedule 1, after item dealing with Lamotrigine in the form Tablet
25 mg (Lamogine)
insert in the columns in the order indicated:
| Lamotrigine | Tablet 25 mg | Oral | Lamotrigine generichealth | Generic Health Pty Ltd | 93 110 617 859 |
[19] Schedule 1, after item dealing with Lamotrigine in the form Tablet
50 mg (Lamogine)
insert in the columns in the order indicated:
| Lamotrigine | Tablet 50 mg | Oral | Lamotrigine generichealth | Generic Health Pty Ltd | 93 110 617 859 |
[20] Schedule 1, after items dealing with Lansoprazole
insert in the columns in the order indicated:
| Lapatinib | Tablet 250 mg (as ditosylate monohydrate) | Oral | Tykerb | GlaxoSmithKline Australia Pty Ltd | 47 100 162 481 |
[21] Schedule 1, after items dealing with Lercanidipine
insert in the columns in the order indicated:
| Lercanidipine with enalapril | Tablet containing lercanidipine hydrochloride 10 mg with enalapril maleate 10 mg | Oral | Zan-Extra 10/10 | Solvay Biosciences Pty Ltd | 41 007 401 201 |
| Lercanidipine with enalapril | Tablet containing lercanidipine hydrochloride 10 mg with enalapril maleate 20 mg | Oral | Zan-Extra 10/20 | Solvay Biosciences Pty Ltd | 41 007 401 201 |
[22] Schedule 1, item dealing with Lisinopril in the form Tablet 10 mg (Lisinopril Winthrop)
omit from the columns in the order indicated:
| Sandoz Pty Ltd | 60 075 449 553 |
and substitute:
| sanofi-aventis Australia Pty Ltd | 31 008 558 807 |
[23] Schedule 1, after item dealing with Lisinopril in the form Tablet 20 mg (Lisinopril 20)
insert in the columns in the order indicated:
| Lisinopril | Tablet 20 mg | Oral | Lisinopril generichealth | Generic Health Pty Ltd | 93 110 617 859 |
[24] Schedule 1, item dealing with Lisinopril in the form Tablet 20 mg (Lisinopril Winthrop)
omit from the columns in the order indicated:
| Sandoz Pty Ltd | 60 075 449 553 |
and substitute:
| sanofi-aventis Australia Pty Ltd | 31 008 558 807 |
[25] Schedule 1, item dealing with Lisinopril in the form Tablet 5 mg (Lisinopril Winthrop)
omit from the columns in the order indicated:
| Sandoz Pty Ltd | 60 075 449 553 |
and substitute:
| sanofi-aventis Australia Pty Ltd | 31 008 558 807 |
[26] Schedule 1, after item dealing with Macrogol 3350
insert in the columns in the order indicated:
| Macrogol 3350 | Sachets containing powder for oral solution 6.563 g with electrolytes, 30 | Oral | Movicol-Half | Norgine Pty Ltd | 78 005 022 882 |
[27] Schedule 1, item dealing with Paroxetine in the form Tablet 20 mg
(as hydrochloride) (Paroxetine Winthrop)
omit from the columns in the order indicated:
| Sandoz Pty Ltd | 60 075 449 553 |
and substitute:
| sanofi-aventis Australia Pty Ltd | 31 008 558 807 |
[28] Schedule 1, after item dealing with Risedronic Acid and Calcium
insert in the columns in the order indicated:
| Risedronic acid and calcium with colecalciferol | Pack containing 4 tablets risedronate sodium 35 mg and 24 sachets containing granules of calcium carbonate 2.5 g with colecalciferol 22 micrograms | Oral | Actonel Combi D | sanofi-aventis Australia Pty Ltd | 31 008 558 807 |
[29] Schedule 1, items dealing with Salmeterol
omit from the columns in the order indicated:
| Salmeterol | Pressurised inhalation 25 micrograms (as xinafoate) per dose, 120 doses | Inhalation by mouth | Serevent | GlaxoSmithKline Australia Pty Ltd | 47 100 162 481 |
[30] Schedule 1, after item dealing with Sertraline in the form Tablet
100 mg (as hydrochloride) (GenRx Sertraline)
insert in the columns in the order indicated:
| Sertraline | Tablet 100 mg (as hydrochloride) | Oral | Sertra 100 | Sigma Pharmaceuticals (Australia) Pty Ltd | 88 004 118 594 |
[31] Schedule 1, after item dealing with Sertraline in the form Tablet 50 mg (as hydrochloride) (GenRx Sertraline)
insert in the columns in the order indicated:
| Sertraline | Tablet 50 mg (as hydrochloride) | Oral | Sertra 50 | Sigma Pharmaceuticals (Australia) Pty Ltd | 88 004 118 594 |
[32] Schedule 1, items dealing with Tiagabine in the forms Tablet 10 mg (as hydrochloride), Tablet 15 mg (as hydrochloride) and Tablet 5 mg (as hydrochloride)
omit from the columns in the order indicated:
| Hospira Australia Pty Ltd | 58 097 064 330 |
| Hospira Australia Pty Ltd | 58 097 064 330 |
| Hospira Australia Pty Ltd | 58 097 064 330 |
and substitute:
| Orphan Australia Pty Ltd | 11 067 189 342 |
| Orphan Australia Pty Ltd | 11 067 189 342 |
| Orphan Australia Pty Ltd | 11 067 189 342 |
[33] Schedule 1, after item dealing with Tramadol in the form Tablet containing tramadol hydrochloride 100 mg (sustained release)
(Tramal SR 100)
insert in the columns in the order indicated:
| Tramadol | Tablet containing tramadol hydrochloride 100 mg (sustained release) | Oral | Tramedo SR 100 | Alphapharm Pty Limited | 93 002 359 739 |
[34] Schedule 1, after item dealing with Tramadol in the form Tablet containing tramadol hydrochloride 150 mg (sustained release)
(Tramal SR 150)
insert in the columns in the order indicated:
| Tramadol | Tablet containing tramadol hydrochloride 150 mg (sustained release) | Oral | Tramedo SR 150 | Alphapharm Pty Limited | 93 002 359 739 |
[35] Schedule 1, after item dealing with Tramadol in the form Tablet containing tramadol hydrochloride 200 mg (sustained release)
(Tramal SR 200)
insert in the columns in the order indicated:
| Tramadol | Tablet containing tramadol hydrochloride 200 mg (sustained release) | Oral | Tramedo SR 200 | Alphapharm Pty Limited | 93 002 359 739 |
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