National Health Act 1953 Amendment determination under section 84AF responsible persons (No. PB 99 of 2008) (Cth)
COMMONWEALTH OF AUSTRALIA
Instrument number PB 99 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 2nd OCTOBER 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 November 2008.
2 Amendment of PB 76 of 2008
Schedule 1 amends PB 76 of 2008.
Schedule 1 Amendments
Schedule 1, item dealing with Alendronic acid in the form Tablet
70 mg (as alendronate sodium) (Alendro Once Weekly)
omit from the columns in the order indicated:
| Arrow Pharmaceuticals Pty Ltd | 17 003 144 170 |
and substitute:
| Sigma Pharmaceuticals (Australia) Pty Ltd | 88 004 118 594 |
Schedule 1, item dealing with Alprazolam in the forms Tablet 1 mg (Alprax 1), Tablet 2 mg (Alprax 2), Tablet 250 micrograms (Alprax 0.25) and Tablet 500 micrograms (Alprax 0.5)
omit from the columns in the order indicated:
| Arrow Pharmaceuticals Pty Ltd | 17 003 144 170 |
and substitute:
| Sigma Pharmaceuticals (Australia) Pty Ltd | 88 004 118 594 |
Schedule 1, item dealing with Amiodarone in the forms Tablet containing amiodarone hydrochloride 100 mg (Rithmik 100) and Tablet containing amiodarone hydrochloride 200 mg (Rithmik 200)
omit from the columns in the order indicated:
| Arrow Pharmaceuticals Pty Ltd | 17 003 144 170 |
and substitute:
| Sigma Pharmaceuticals (Australia) Pty Ltd | 88 004 118 594 |
Schedule 1, after item dealing with Amisulpride in the form Tablet
200 mg (Solian 200)
insert in the columns in the order indicated:
| Amisulpride | Tablet 400 mg | Oral | Amipride 400 | Sigma Pharmaceuticals (Australia) Pty Ltd | 88 004 118 594 |
Schedule 1, after item dealing with Amlodipine in the form Tablet
10 mg (as besylate) (Amlodipine-GA)
insert in the columns in the order indicated:
| Amlodipine | Tablet 10 mg (as besylate) | Oral | Amlotrust 10 | Meditech Int. Pty Ltd | 17 069 879 465 |
Schedule 1, after item dealing with Amlodipine in the form Tablet
5 mg (as besylate) (Amlodipine-GA)
insert in the columns in the order indicated:
| Amlodipine | Tablet 5 mg (as besylate) | Oral | Amlotrust 5 | Meditech Int. Pty Ltd | 17 069 879 465 |
Schedule 1, item dealing with Azathioprine in the form Tablet 50 mg (Azapin)
omit from the columns in the order indicated:
| Arrow Pharmaceuticals Pty Ltd | 17 003 144 170 |
and substitute:
| Sigma Pharmaceuticals (Australia) Pty Ltd | 88 004 118 594 |
Schedule 1, item dealing with Baclofen in the forms Tablet 10 mg (Stelax 10) and Tablet 25 mg (Stelax 25)
omit from the columns in the order indicated:
| Arrow Pharmaceuticals Pty Ltd | 17 003 144 170 |
and substitute:
| Sigma Pharmaceuticals (Australia) Pty Ltd | 88 004 118 594 |
Schedule 1, omit item dealing with Cabergoline in the form
Tablet 4 mg
Schedule 1, item dealing with Calcitriol in the form Capsule
0.25 microgram (Kosteo)
omit from the columns in the order indicated:
| Arrow Pharmaceuticals Pty Ltd | 17 003 144 170 |
and substitute:
| Sigma Pharmaceuticals (Australia) Pty Ltd | 88 004 118 594 |
Schedule 1, after item dealing with Carvedilol in the form Tablet
12.5 mg (GenRx Carvedilol)
insert in the columns in the order indicated:
| Carvedilol | Tablet 12.5 mg | Oral | GN-Carvedilol | Genepharm Pty Ltd | 68 118 734 795 |
Schedule 1, after item dealing with Carvedilol in the form Tablet
25 mg (GenRx Carvedilol)
insert in the columns in the order indicated:
| Carvedilol | Tablet 25 mg | Oral | GN-Carvedilol | Genepharm Pty Ltd | 68 118 734 795 |
Schedule 1, after item dealing with Carvedilol in the form Tablet
3.125 mg (GenRx Carvedilol)
insert in the columns in the order indicated:
| Carvedilol | Tablet 3.125 mg | Oral | GN-Carvedilol | Genepharm Pty Ltd | 68 118 734 795 |
Schedule 1, after item dealing with Carvedilol in the form Tablet
6.25 mg (GenRx Carvedilol)
insert in the columns in the order indicated:
| Carvedilol | Tablet 6.25 mg | Oral | GN-Carvedilol | Genepharm Pty Ltd | 68 118 734 795 |
Schedule 1, item dealing with Ciprofloxacin in the forms Tablet
250 mg (as hydrochloride) (Ciprol 250), Tablet 500 mg (as hydrochloride) (Ciprol 500) and Tablet 750 mg (as hydrochloride) (Ciprol 750)
omit from the columns in the order indicated:
| Arrow Pharmaceuticals Pty Ltd | 17 003 144 170 |
and substitute:
| Sigma Pharmaceuticals (Australia) Pty Ltd | 88 004 118 594 |
Schedule 1, item dealing with Citalopram in the form Tablet
20 mg (as hydrobromide) (Talam)
omit from the columns in the order indicated:
| Arrow Pharmaceuticals Pty Ltd | 17 003 144 170 |
and substitute:
| Sigma Pharmaceuticals (Australia) Pty Ltd | 88 004 118 594 |
Schedule 1, item dealing with Clarithromycin in the form Tablet
250 mg (Clarithro 250)
omit from the columns in the order indicated:
| Arrow Pharmaceuticals Pty Ltd | 17 003 144 170 |
and substitute:
| Sigma Pharmaceuticals (Australia) Pty Ltd | 88 004 118 594 |
Schedule 1, item dealing with Clomiphene in the form Tablet
containing clomiphene citrate 50 mg (Fermil)
omit from the columns in the order indicated:
| Arrow Pharmaceuticals Pty Ltd | 17 003 144 170 |
and substitute:
| Sigma Pharmaceuticals (Australia) Pty Ltd | 88 004 118 594 |
Schedule 1, item dealing with Diazepam in the forms Tablet
2 mg (Valpam 2) and Tablet 5 mg (Valpam 5)
omit from the columns in the order indicated:
| Arrow Pharmaceuticals Pty Ltd | 17 003 144 170 |
and substitute:
| Sigma Pharmaceuticals (Australia) Pty Ltd | 88 004 118 594 |
Schedule 1, item dealing with Doxycycline in the form Tablet
50 mg (as monohydrate) (Frakas)
omit from the columns in the order indicated:
| Arrow Pharmaceuticals Pty Ltd | 17 003 144 170 |
and substitute:
| Sigma Pharmaceuticals (Australia) Pty Ltd | 88 004 118 594 |
Schedule 1, omit item dealing with Epirubicin in the form Powder for injection containing epirubicin hydrochloride 50 mg (Hospira Pty Limited)
Schedule 1, item dealing with Famotidine in the forms Tablet
20 mg (Ausfam 20) and Tablet 40 mg (Ausfam 40)
omit from the columns in the order indicated:
| Arrow Pharmaceuticals Pty Ltd | 17 003 144 170 |
and substitute:
| Sigma Pharmaceuticals (Australia) Pty Ltd | 88 004 118 594 |
Schedule 1, item dealing with Felodipine in the forms Tablet
10 mg (extended release) (Felodil XR 10) and Tablet 5 mg (extended release) (Felodil XR 5)
omit from the columns in the order indicated:
| Arrow Pharmaceuticals Pty Ltd | 17 003 144 170 |
and substitute:
| Sigma Pharmaceuticals (Australia) Pty Ltd | 88 004 118 594 |
Schedule 1, item dealing with Fluconazole in the forms Capsule
200 mg (Fluzole 200) and Capsule 50 mg (Fluzole 50)
omit from the columns in the order indicated:
| Arrow Pharmaceuticals Pty Ltd | 17 003 144 170 |
and substitute:
| Sigma Pharmaceuticals (Australia) Pty Ltd | 88 004 118 594 |
Schedule 1, item dealing with Fluvoxamine in the forms Tablet containing fluvoxamine maleate 100 mg (Faverin 100) and Tablet containing fluvoxamine maleate 50 mg (Faverin 50)
omit from the columns in the order indicated:
| Arrow Pharmaceuticals Pty Ltd | 17 003 144 170 |
and substitute:
| Sigma Pharmaceuticals (Australia) Pty Ltd | 88 004 118 594 |
Schedule 1, item dealing with Fosinopril in the forms Tablet containing fosinopril sodium 10 mg (Fosipril 10) and Tablet containing fosinopril sodium 20 mg (Fosipril 20)
omit from the columns in the order indicated:
| Arrow Pharmaceuticals Pty Ltd | 17 003 144 170 |
and substitute:
| Sigma Pharmaceuticals (Australia) Pty Ltd | 88 004 118 594 |
Schedule 1, item dealing with Gabapentin in the forms Capsule
100 mg (Gantin), Capsule 300 mg (Gantin), Capsule 400 mg (Gantin) and Tablet 800 mg (Gantin)
omit from the columns in the order indicated:
| Arrow Pharmaceuticals Pty Ltd | 17 003 144 170 |
and substitute:
| Sigma Pharmaceuticals (Australia) Pty Ltd | 88 004 118 594 |
Schedule 1, item dealing with Gliclazide in the form Tablet 80 mg (Nidem)
omit from the columns in the order indicated:
| Arrow Pharmaceuticals Pty Ltd | 17 003 144 170 |
and substitute:
| Sigma Pharmaceuticals (Australia) Pty Ltd | 88 004 118 594 |
Schedule 1, item dealing with Glimepiride in the forms Tablet 1 mg (Diapride 1), Tablet 2 mg (Diapride 2), Tablet 3 mg (Diapride 3) and Tablet 4 mg (Diapride 4)
omit from the columns in the order indicated:
| Arrow Pharmaceuticals Pty Ltd | 17 003 144 170 |
and substitute:
| Sigma Pharmaceuticals (Australia) Pty Ltd | 88 004 118 594 |
Schedule 1, after items dealing with Insulin Glargine
insert in the columns in the order indicated:
| Insulin Glulisine | Injection (human analogue) 100 units per mL, 10 mL | Injection | Apidra | sanofi-aventis Australia Pty Ltd | 31 008 558 807 |
Schedule 1, item dealing with Ipratropium in the forms Nebuliser solution containing ipratropium bromide 250 micrograms (anhydrous) in 1 mL single dose units, 30 (Aeron 250) and Nebuliser solution containing ipratropium bromide 500 micrograms (anhydrous) in 1 mL single dose units, 30 (Aeron 500)
omit from the columns in the order indicated:
| Arrow Pharmaceuticals Pty Ltd | 17 003 144 170 |
and substitute:
| Sigma Pharmaceuticals (Australia) Pty Ltd | 88 004 118 594 |
Schedule 1, after item dealing with Irinotecan in the form I.V. injection containing irinotecan hydrochloride trihydrate 100 mg in 5 mL (Irinotecan Sandoz)
insert in the columns in the order indicated:
| Irinotecan | I.V. injection containing irinotecan hydrochloride trihydrate 100 mg in | Injection | Irinotecan-GA | Genepharm Pty Ltd | 68 118 734 795 |
Schedule 1, after item dealing with Lamotrigine in the form Tablet
100 mg (Lamotrigine-DP)
insert in the columns in the order indicated:
| Lamotrigine | Tablet 100 mg | Oral | Lamotrigine-GA | Ascent Pharmahealth Ltd | 52 107 340 367 |
Schedule 1, item dealing with Lamotrigine in the form Tablet 100 mg (Seaze 100)
omit from the columns in the order indicated:
| Arrow Pharmaceuticals Pty Ltd | 17 003 144 170 |
and substitute:
| Sigma Pharmaceuticals (Australia) Pty Ltd | 88 004 118 594 |
Schedule 1, after item dealing with Lamotrigine in the form Tablet
200 mg (Lamotrigine-DP)
insert in the columns in the order indicated:
| Lamotrigine | Tablet 200 mg | Oral | Lamotrigine-GA | Ascent Pharmahealth Ltd | 52 107 340 367 |
Schedule 1, item dealing with Lamotrigine in the form Tablet 200 mg (Seaze 200)
omit from the columns in the order indicated:
| Arrow Pharmaceuticals Pty Ltd | 17 003 144 170 |
and substitute:
| Sigma Pharmaceuticals (Australia) Pty Ltd | 88 004 118 594 |
Schedule 1, after item dealing with Lamotrigine in the form Tablet
25 mg (Lamotrigine-DP)
insert in the columns in the order indicated:
| Lamotrigine | Tablet 25 mg | Oral | Lamotrigine-GA | Ascent Pharmahealth Ltd | 52 107 340 367 |
Schedule 1, item dealing with Lamotrigine in the form Tablet 25 mg (Seaze 25)
omit from the columns in the order indicated:
| Arrow Pharmaceuticals Pty Ltd | 17 003 144 170 |
and substitute:
| Sigma Pharmaceuticals (Australia) Pty Ltd | 88 004 118 594 |
Schedule 1, item dealing with Lamotrigine in the form Tablet 5 mg (Seaze 5)
omit from the columns in the order indicated:
| Arrow Pharmaceuticals Pty Ltd | 17 003 144 170 |
and substitute:
| Sigma Pharmaceuticals (Australia) Pty Ltd | 88 004 118 594 |
Schedule 1, after item dealing with Lamotrigine in the form Tablet
50 mg (Lamotrigine-DP)
insert in the columns in the order indicated:
| Lamotrigine | Tablet 50 mg | Oral | Lamotrigine-GA | Ascent Pharmahealth Ltd | 52 107 340 367 |
Schedule 1, item dealing with Lamotrigine in the form Tablet 50 mg (Seaze 50)
omit from the columns in the order indicated:
| Arrow Pharmaceuticals Pty Ltd | 17 003 144 170 |
and substitute:
| Sigma Pharmaceuticals (Australia) Pty Ltd | 88 004 118 594 |
Schedule 1, item dealing with Lisinopril in the form Tablet 10 mg (Fibsol 10)
omit from the columns in the order indicated:
| Arrow Pharmaceuticals Pty Ltd | 17 003 144 170 |
and substitute:
| Sigma Pharmaceuticals (Australia) Pty Ltd | 88 004 118 594 |
Schedule 1, item dealing with Lisinopril in the form Tablet 10 mg
omit from the columns in the order indicated:
| Lisinopril | Tablet 10 mg | Oral | Lisinotrust 10 | Meditech Int. Pty Ltd | 17 069 879 465 |
Schedule 1, item dealing with Lisinopril in the form Tablet 20 mg (Fibsol 20)
omit from the columns in the order indicated:
| Arrow Pharmaceuticals Pty Ltd | 17 003 144 170 |
and substitute:
| Sigma Pharmaceuticals (Australia) Pty Ltd | 88 004 118 594 |
Schedule 1, item dealing with Lisinopril in the form Tablet 20 mg
omit from the columns in the order indicated:
| Lisinopril | Tablet 20 mg | Oral | Lisinotrust 20 | Meditech Int. Pty Ltd | 17 069 879 465 |
Schedule 1, item dealing with Lisinopril in the form Tablet 5 mg (Fibsol 5)
omit from the columns in the order indicated:
| Arrow Pharmaceuticals Pty Ltd | 17 003 144 170 |
and substitute:
| Sigma Pharmaceuticals (Australia) Pty Ltd | 88 004 118 594 |
Schedule 1, item dealing with Lisinopril in the form Tablet 5 mg
omit from the columns in the order indicated:
| Lisinopril | Tablet 5 mg | Oral | Lisinotrust 5 | Meditech Int. Pty Ltd | 17 069 879 465 |
Schedule 1, item dealing with Meloxicam in the forms Tablet 15 mg (Movalis 15) and Tablet 7.5 mg (Movalis 7.5)
omit from the columns in the order indicated:
| Arrow Pharmaceuticals Pty Ltd | 17 003 144 170 |
and substitute:
| Sigma Pharmaceuticals (Australia) Pty Ltd | 88 004 118 594 |
Schedule 1, after item dealing with Mesalazine in the form Sachet containing granules, 1 g per sachet
insert in the columns in the order indicated:
| Mesalazine | Sachet containing granules, 1.5 g per sachet | Oral | Salofalk | Orphan Australia Pty Ltd | 11 067 189 342 |
Schedule 1, item dealing with Metformin in the forms Tablet containing metformin hydrochloride 1 g (Formet 1000), Tablet containing metformin hydrochloride 500 mg (Formet 500) and Tablet containing metformin hydrochloride 850 mg (Formet 850)
omit from the columns in the order indicated:
| Arrow Pharmaceuticals Pty Ltd | 17 003 144 170 |
and substitute:
| Sigma Pharmaceuticals (Australia) Pty Ltd | 88 004 118 594 |
Schedule 1, item dealing with Metoprolol in the forms Tablet containing metoprolol tartrate 100 mg (Metrol 100) and Tablet containing metoprolol tartrate 50 mg (Metrol 50)
omit from the columns in the order indicated:
| Arrow Pharmaceuticals Pty Ltd | 17 003 144 170 |
and substitute:
| Sigma Pharmaceuticals (Australia) Pty Ltd | 88 004 118 594 |
Schedule 1, item dealing with Mirtazapine in the forms Tablet 30 mg (Mirtazon) and Tablet 45 mg (Mirtazon)
omit from the columns in the order indicated:
| Arrow Pharmaceuticals Pty Ltd | 17 003 144 170 |
and substitute:
| Sigma Pharmaceuticals (Australia) Pty Ltd | 88 004 118 594 |
Schedule 1, item dealing with Nifedipine in the forms Tablet 30 mg (controlled release) (Addos XR 30) and Tablet 60 mg (controlled release) (Addos XR 60)
omit from the columns in the order indicated:
| Arrow Pharmaceuticals Pty Ltd | 17 003 144 170 |
and substitute:
| Sigma Pharmaceuticals (Australia) Pty Ltd | 88 004 118 594 |
Schedule 1, item dealing with Norfloxacin in the form Tablet 400 mg (Roxin)
omit from the columns in the order indicated:
| Arrow Pharmaceuticals Pty Ltd | 17 003 144 170 |
and substitute:
| Sigma Pharmaceuticals (Australia) Pty Ltd | 88 004 118 594 |
Schedule 1, item dealing with Ondansetron in the forms I.V. injection
4 mg (as hydrochloride dihydrate) in 2 mL (Onsetron), I.V. injection
8 mg (as hydrochloride dihydrate) in 4 mL (Onsetron), Tablet 4 mg (as hydrochloride dihydrate) (Onsetron 4) and Tablet 8 mg (as hydrochloride dihydrate) (Onsetron 8)
omit from the columns in the order indicated:
| Arrow Pharmaceuticals Pty Ltd | 17 003 144 170 |
and substitute:
| Sigma Pharmaceuticals (Australia) Pty Ltd | 88 004 118 594 |
Schedule 1, item dealing with Pancreatic Extract in the form Capsule (containing enteric coated minimicrospheres) providing not less than 10,000 BP units of lipase activity
omit from the column headed “Brand”:
Creon
and substitute:
Creon 10,000
Schedule 1, item dealing with Pancreatic Extract in the form Capsule (containing enteric coated minimicrospheres) providing not less than 25,000 BP units of lipase activity
omit from the column headed “Brand”:
Creon Forte
and substitute:
Creon 25,000
Schedule 1, item dealing with Paracetamol in the form Tablet 500 mg (Parmol)
omit from the columns in the order indicated:
| Arrow Pharmaceuticals Pty Ltd | 17 003 144 170 |
and substitute:
| Sigma Pharmaceuticals (Australia) Pty Ltd | 88 004 118 594 |
Schedule 1, item dealing with Paroxetine in the form Tablet 20 mg
(as hydrochloride) (Extine 20)
omit from the columns in the order indicated:
| Arrow Pharmaceuticals Pty Ltd | 17 003 144 170 |
and substitute:
| Sigma Pharmaceuticals (Australia) Pty Ltd | 88 004 118 594 |
Schedule 1, after item dealing with Paroxetine in the form Tablet
20 mg (as hydrochloride) (Terry White Chemists Paroxetine)
insert in the columns in the order indicated:
| Paroxetine | Tablet 20 mg (as mesilate) | Oral | Paroxetine generichealth | Generic Health Pty Ltd | 93 110 617 859 |
Schedule 1, item dealing with Pravastatin in the forms Tablet containing pravastatin sodium 10 mg (Lipostat 10), Tablet containing pravastatin sodium 20 mg (Lipostat 20), Tablet containing pravastatin sodium 40 mg (Lipostat 40) and Tablet containing pravastatin sodium 80 mg (Lipostat 80)
omit from the columns in the order indicated:
| Arrow Pharmaceuticals Pty Ltd | 17 003 144 170 |
and substitute:
| Sigma Pharmaceuticals (Australia) Pty Ltd | 88 004 118 594 |
Schedule 1, after item dealing with Pyrimethamine
insert in the columns in the order indicated:
| Quetiapine | Tablet (modified release) 200 mg (as fumarate) | Oral | Seroquel XR | AstraZeneca Pty Ltd | 54 009 682 311 |
| Quetiapine | Tablet (modified release) 300 mg (as fumarate) | Oral | Seroquel XR | AstraZeneca Pty Ltd | 54 009 682 311 |
| Quetiapine | Tablet (modified release) 400 mg (as fumarate) | Oral | Seroquel XR | AstraZeneca Pty Ltd | 54 009 682 311 |
| Quetiapine | Tablet (modified release) 50 mg (as fumarate) | Oral | Seroquel XR | AstraZeneca Pty Ltd | 54 009 682 311 |
Schedule 1, item dealing with Quinapril in the forms Tablet 10 mg (as hydrochloride) (Acquin 10), Tablet 20 mg (as hydrochloride)
(Acquin 20) and Tablet 5 mg (as hydrochloride) (Acquin 5)
omit from the columns in the order indicated:
| Arrow Pharmaceuticals Pty Ltd | 17 003 144 170 |
and substitute:
| Sigma Pharmaceuticals (Australia) Pty Ltd | 88 004 118 594 |
Schedule 1, item dealing with Ramipril in the forms Capsule 10 mg (Prilace 10), Tablet 1.25 mg (Prilace 1.25), Tablet 2.5 mg (Prilace 2.5) and Tablet 5 mg (Prilace 5)
omit from the columns in the order indicated:
| Arrow Pharmaceuticals Pty Ltd | 17 003 144 170 |
and substitute:
| Sigma Pharmaceuticals (Australia) Pty Ltd | 88 004 118 594 |
Schedule 1, item dealing with Roxithromycin in the forms Tablet
150 mg (Roxar 150), and Tablet 300 mg (Roxar 300)
omit from the columns in the order indicated:
| Arrow Pharmaceuticals Pty Ltd | 17 003 144 170 |
and substitute:
| Sigma Pharmaceuticals (Australia) Pty Ltd | 88 004 118 594 |
Schedule 1, item dealing with Salbutamol in the forms Nebuliser solution 2.5 mg (as sulfate) in 2.5 mL single dose units, 30
(Butamol 2.5) and Nebuliser solution 5 mg (as sulfate) in 2.5 mL single dose units, 30 (Butamol 5)
omit from the columns in the order indicated:
| Arrow Pharmaceuticals Pty Ltd | 17 003 144 170 |
and substitute:
| Sigma Pharmaceuticals (Australia) Pty Ltd | 88 004 118 594 |
Schedule 1, item dealing with Sertraline in the form Tablet 100 mg (as hydrochloride)
omit from the columns in the order indicated:
| Sertraline | Tablet 100 mg (as hydrochloride) | Oral | Sertratrust 100 | Meditech Int. Pty Ltd | 17 069 879 465 |
Schedule 1, item dealing with Sertraline in the form Tablet 100 mg (as hydrochloride) (Xydep 100)
omit from the columns in the order indicated:
| Arrow Pharmaceuticals Pty Ltd | 17 003 144 170 |
and substitute:
| Sigma Pharmaceuticals (Australia) Pty Ltd | 88 004 118 594 |
Schedule 1, item dealing with Sertraline in the form Tablet 50 mg (as hydrochloride)
omit from the columns in the order indicated:
| Sertraline | Tablet 50 mg (as hydrochloride) | Oral | Sertratrust 50 | Meditech Int. Pty Ltd | 17 069 879 465 |
Schedule 1, item dealing with Sertraline in the form Tablet 50 mg (as hydrochloride) (Xydep 50)
omit from the columns in the order indicated:
| Arrow Pharmaceuticals Pty Ltd | 17 003 144 170 |
and substitute:
| Sigma Pharmaceuticals (Australia) Pty Ltd | 88 004 118 594 |
Schedule 1, item dealing with Simvastatin in the form Tablet 10 mg
omit from the columns in the order indicated:
| Simvastatin | Tablet 10 mg | Oral | Simvatrust 10 | Meditech Int. Pty Ltd | 17 069 879 465 |
Schedule 1, item dealing with Simvastatin in the form Tablet 20 mg
omit from the columns in the order indicated:
| Simvastatin | Tablet 20 mg | Oral | Simvatrust 20 | Meditech Int. Pty Ltd | 17 069 879 465 |
Schedule 1, item dealing with Simvastatin in the form Tablet 40 mg
omit from the columns in the order indicated:
| Simvastatin | Tablet 40 mg | Oral | Simvatrust 40 | Meditech Int. Pty Ltd | 17 069 879 465 |
Schedule 1, item dealing with Simvastatin in the form Tablet 80 mg
omit from the columns in the order indicated:
| Simvastatin | Tablet 80 mg | Oral | Simvatrust 80 | Meditech Int. Pty Ltd | 17 069 879 465 |
Schedule 1, item dealing with Sotalol in the forms Tablet containing sotalol hydrochloride 160 mg (Solavert) and Tablet containing sotalol hydrochloride 80 mg (Solavert)
omit from the columns in the order indicated:
| Arrow Pharmaceuticals Pty Ltd | 17 003 144 170 |
and substitute:
| Sigma Pharmaceuticals (Australia) Pty Ltd | 88 004 118 594 |
Schedule 1, item dealing with Sumatriptan in the form Tablet
50 mg (as succinate) (Sumagran 50)
omit from the columns in the order indicated:
| Arrow Pharmaceuticals Pty Ltd | 17 003 144 170 |
and substitute:
| Sigma Pharmaceuticals (Australia) Pty Ltd | 88 004 118 594 |
Schedule 1, item dealing with Terbinafine in the form Tablet
250 mg (as hydrochloride) (Tamsil)
omit from the columns in the order indicated:
| Arrow Pharmaceuticals Pty Ltd | 17 003 144 170 |
and substitute:
| Sigma Pharmaceuticals (Australia) Pty Ltd | 88 004 118 594 |
Schedule 1, after item dealing with Tramadol in the form Oral drops containing tramadol hydrochloride 100 mg per mL, 10 mL (Tramal)
insert in the columns in the order indicated:
| Tramadol | Tablet (extended release) containing tramadol hydrochloride 100 mg | Oral | Durotram XR | iNova Pharmaceuticals (Australia) Pty Limited | 88 000 222 408 |
| Tramadol | Tablet (extended release) containing tramadol hydrochloride 200 mg | Oral | Durotram XR | iNova Pharmaceuticals (Australia) Pty Limited | 88 000 222 408 |
| Tramadol | Tablet (extended release) containing tramadol hydrochloride 300 mg | Oral | Durotram XR | iNova Pharmaceuticals (Australia) Pty Limited | 88 000 222 408 |
Schedule 1, items dealing with Tramadol
omit from the columns in the order indicated:
| Tablet containing tramadol hydrochloride 100 mg (sustained release) | Tramahexal SR |
| Tablet containing tramadol hydrochloride 100 mg (sustained release) | Tramal SR 100 |
| Tablet containing tramadol hydrochloride 100 mg (sustained release) | Tramedo SR 100 |
| Tablet containing tramadol hydrochloride 100 mg (sustained release) | Zydol SR 100 |
| Tablet containing tramadol hydrochloride 150 mg (sustained release) | Tramahexal SR |
| Tablet containing tramadol hydrochloride 150 mg (sustained release) | Tramal SR 150 |
| Tablet containing tramadol hydrochloride 150 mg (sustained release) | Tramedo SR 150 |
| Tablet containing tramadol hydrochloride 150 mg (sustained release) | Zydol SR 150 |
| Tablet containing tramadol hydrochloride 200 mg (sustained release) | Tramahexal SR |
| Tablet containing tramadol hydrochloride 200 mg (sustained release) | Tramal SR 200 |
| Tablet containing tramadol hydrochloride 200 mg (sustained release) | Tramedo SR 200 |
| Tablet containing tramadol hydrochloride 200 mg (sustained release) | Zydol SR 200 |
| Tablet containing tramadol hydrochloride 50 mg (sustained release) | Tramal SR 50 |
and substitute:
| Tablet (sustained release) containing tramadol hydrochloride 100 mg | Tramahexal SR |
| Tablet (sustained release) containing tramadol hydrochloride 100 mg | Tramal SR 100 |
| Tablet (sustained release) containing tramadol hydrochloride 100 mg | Tramedo SR 100 |
| Tablet (sustained release) containing tramadol hydrochloride 100 mg | Zydol SR 100 |
| Tablet (sustained release) containing tramadol hydrochloride 150 mg | Tramahexal SR |
| Tablet (sustained release) containing tramadol hydrochloride 150 mg | Tramal SR 150 |
| Tablet (sustained release) containing tramadol hydrochloride 150 mg | Tramedo SR 150 |
| Tablet (sustained release) containing tramadol hydrochloride 150 mg | Zydol SR 150 |
| Tablet (sustained release) containing tramadol hydrochloride 200 mg | Tramahexal SR |
| Tablet (sustained release) containing tramadol hydrochloride 200 mg | Tramal SR 200 |
| Tablet (sustained release) containing tramadol hydrochloride 200 mg | Tramedo SR 200 |
| Tablet (sustained release) containing tramadol hydrochloride 200 mg | Zydol SR 200 |
| Tablet (sustained release) containing tramadol hydrochloride 50 mg | Tramal SR 50 |
Schedule 1, item dealing with Trandolapril in the forms Capsule
1 mg (Dolapril 1), Capsule 2 mg (Dolapril 2), Capsule 4 mg (Dolapril 4) and Capsule 500 micrograms (Dolapril 0.5)
omit from the columns in the order indicated:
| Arrow Pharmaceuticals Pty Ltd | 17 003 144 170 |
and substitute:
| Sigma Pharmaceuticals (Australia) Pty Ltd | 88 004 118 594 |
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0
0