COMMONWEALTH OF AUSTRALIA
Instrument number PB 77 of 2009
Amendment determination under section 84AF of the National Health Act 1953
I, LINDA JACKSON, 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 31 July 2009
LINDA JACKSON
Assistant Secretary
Pharmaceutical Evaluation Branch
Department of Health and Ageing
Amendment determination – responsible persons
1 Commencement
This instrument commences on 1 September 2009.
2 Amendment of PB 115 of 2008
Schedule 1 amends PB 115 of 2008.
Schedule 1 Amendments
[1]Schedule 1, items dealing with Amoxycillin
omit from the columns in the order indicated:
Amoxycillin
Capsule 250 mg (as trihydrate)
Oral
Amohexal
Sandoz Pty Ltd
60 075 449 553
[2]Schedule 1, item dealing with Amoxycillin with Clavulanic Acid in the form Tablet containing 500 mg amoxycillin (as trihydrate) with 125 mg clavulanic acid (as potassium clavulanate)
omit from the column headed “Brand”:
Curam 500/125
and substitute:
Curam Duo 500/125
[3]Schedule 1, item dealing with Amoxycillin with Clavulanic Acid in the form Tablet containing 875 mg amoxycillin (as trihydrate) with 125 mg clavulanic acid (as potassium clavulanate)
omit from the column headed “Brand”:
Curam 875/125
and substitute:
Curam Duo Forte 875/125
[4]Schedule 1, item dealing with Anakinra
omit from the columns in the order indicated:
Amgen Australia Pty Limited
31 051 057 428
and substitute:
PharmaLink Pty Ltd
62 116 935 758
[5]Schedule 1, item dealing with Atenolol in the form Tablet 50 mg (Atenolol-GA)
omit from the columns in the order indicated:
Ascent Pharmahealth Ltd
52 107 340 367
and substitute:
Genepharm (Australia) Limited
17 003 854 626
[6]Schedule 1, items dealing with Carboplatin
omit from the columns in the order indicated:
Carboplatin
Solution for I.V. injection 450 mg in 45 mL
Injection
Baxter Carboplatin
Baxter Healthcare Pty Ltd
43 000 392 781
[7]Schedule 1, item dealing with Cefaclor in the form Tablet (sustained release) 375 mg (as monohydrate) (Cefaclor-GA)
omit from the columns in the order indicated:
Genepharm Pty Ltd
68 118 734 795
and substitute:
Genepharm (Australia) Limited
17 003 854 626
[8]Schedule 1, after item dealing with Cephalexin in the form Capsule 500 mg (anhydrous) (Cephabell)
insert in the columns in the order indicated:
Cephalexin
Capsule 500 mg (anhydrous)
Oral
Cephalexin generichealth
Generic Health Pty Ltd
93 110 617 859
[9]Schedule 1, item dealing with Ciprofloxacin in the forms Tablet
500 mg (as hydrochloride) and Tablet 750 mg (as hydrochloride)
omit from the columns in the order indicated:
Genepharm Pty Ltd
Genepharm Pty Ltd
68 118 734 795
and substitute:
Genepharm (Australia) Limited
Genepharm (Australia) Limited
17 003 854 626
[10] Schedule 1, item dealing with Cladribine in the form Injection 10 mg in 5 mL vial
omit from the column headed “Form”:
vial
[11] Schedule 1, after items dealing with Clopidogrel
insert in the columns in the order indicated:
Clotrimazole
Cream 10 mg per g, 20 g
Application
Clonea
Alphapharm Pty Ltd
93 002 359 739
[12] Schedule 1, item dealing with Diclofenac in the form Tablet (enteric coated) containing diclofenac sodium 25 mg (Diclofenac-GA)
omit from the columns in the order indicated:
Ascent Pharmahealth Ltd
52 107 340 367
and substitute:
Genepharm (Australia) Limited
17 003 854 626
[13] Schedule 1, item dealing with Escitalopram in the form Tablet 10 mg (as oxalate) (Esipram)
omit from the columns in the order indicated:
CNS Pharma Pty Ltd
76 121 515 400
and substitute:
Genepharm Pty Ltd
68 118 734 795
[14] Schedule 1, after item dealing with Escitalopram in the form Tablet
10 mg (as oxalate) (Lexapro)
insert in the columns in the order indicated:
Escitalopram
Tablet 10 mg (as oxalate)
Oral
LoxaLate
Alphapharm Pty Ltd
93 002 359 739
[15] Schedule 1, item dealing with Escitalopram in the form Tablet 20 mg (as oxalate) (Esipram)
omit from the columns in the order indicated:
CNS Pharma Pty Ltd
76 121 515 400
and substitute:
Genepharm Pty Ltd
68 118 734 795
[16] Schedule 1, after item dealing with Escitalopram in the form Tablet
20 mg (as oxalate) (Lexapro)
insert in the columns in the order indicated:
Escitalopram
Tablet 20 mg (as oxalate)
Oral
LoxaLate
Alphapharm Pty Ltd
93 002 359 739
[17] Schedule 1, items dealing with Etanercept
omit from the columns in the order indicated:
Etanercept
Injection set containing 4 vials powder for injection 50 mg and 4 pre-filled syringes solvent 1 mL
Injection
Enbrel
Wyeth Australia Pty Limited
16 000 296 211
[18] Schedule 1, after item dealing with Fludarabine in the form Powder for I.V. injection containing fludarabine phosphate 50 mg
insert in the columns in the order indicated:
Fludarabine
Powder for I.V. injection containing fludarabine phosphate 50 mg
Injection
Fludarabine Actavis
Generic Health Pty Ltd
93 110 617 859
[19] Schedule 1, after items dealing with Glibenclamide
insert in the columns in the order indicated:
Gliclazide
Tablet 30 mg (modified release)
Oral
APO-Gliclazide MR
Apotex Pty Ltd
52 096 916 148
Gliclazide
Tablet 30 mg (modified release)
Oral
Chem mart Gliclazide MR
Apotex Pty Ltd
52 096 916 148
[20] Schedule 1, after item dealing with Gliclazide in the form Tablet
30 mg (modified release) (Oziclide MR)
insert in the columns in the order indicated:
Gliclazide
Tablet 30 mg (modified release)
Oral
Terry White Chemists Gliclazide MR
Apotex Pty Ltd
52 096 916 148
[21] Schedule 1, after item dealing with Glimepiride in the form Tablet 1 mg (Amaryl)
insert in the columns in the order indicated:
Glimepiride
Tablet 1 mg
Oral
APO-Glimepiride
Apotex Pty Ltd
52 096 916 148
[22] Schedule 1, after item dealing with Glimepiride in the form Tablet 2 mg (Amaryl)
insert in the columns in the order indicated:
Glimepiride
Tablet 2 mg
Oral
APO-Glimepiride
Apotex Pty Ltd
52 096 916 148
[23] Schedule 1, after item dealing with Glimepiride in the form Tablet 3 mg (Amaryl)
insert in the columns in the order indicated:
Glimepiride
Tablet 3 mg
Oral
APO-Glimepiride
Apotex Pty Ltd
52 096 916 148
[24] Schedule 1, after item dealing with Glimepiride in the form Tablet 4 mg (Amaryl)
insert in the columns in the order indicated:
Glimepiride
Tablet 4 mg
Oral
APO-Glimepiride
Apotex Pty Ltd
52 096 916 148
[25] Schedule 1, after item dealing with Glucose in the form I.V. infusion 278 mmol (anhydrous) per L, 1 L (Baxter Healthcare Pty Ltd)
insert in the columns in the order indicated:
Glucose
I.V. infusion 278 mmol (anhydrous) per L, 1 L
Injection
Pharmatel Fresenius Kabi Pty Limited
Pharmatel Fresenius Kabi Pty Limited
39 109 383 593
[26] Schedule 1, item dealing with Lamotrigine in the forms Tablet 100 mg, Tablet 200 mg, Tablet 25 mg and Tablet 50 mg (Lamotrigine-GA)
omit from the columns in the order indicated:
Ascent Pharmahealth Ltd
52 107 340 367
and substitute:
Genepharm (Australia) Limited
17 003 854 626
[27] Schedule 1, after item dealing with Lansoprazole in the form Sachet containing granules for oral suspension, 30 mg per sachet
insert in the columns in the order indicated:
Lansoprazole
Tablet 30 mg (orally disintegrating)
Oral
Zoton FasTabs
Wyeth Australia Pty Limited
16 000 296 211
[28] Schedule 1, item dealing with Lisinopril in the form Tablet 20 mg (Lisinopril-GA)
omit from the columns in the order indicated:
Ascent Pharmahealth Ltd
52 107 340 367
and substitute:
Genepharm (Australia) Limited
17 003 854 626
[29] Schedule 1, item dealing with Metformin in the form Tablet containing metformin hydrochloride 1 g (Metformin-GA)
omit from the columns in the order indicated:
Ascent Pharmahealth Ltd
52 107 340 367
and substitute:
Genepharm (Australia) Limited
17 003 854 626
[30] Schedule 1, item dealing with Metformin in the forms Tablet containing metformin hydrochloride 500 mg and Tablet containing metformin hydrochloride 850 mg
omit from the columns in the order indicated:
Genepharm Pty Ltd
Genepharm Pty Ltd
68 118 734 795
and substitute:
Genepharm (Australia) Limited
Genepharm (Australia) Limited
17 003 854 626
[31] Schedule 1, after item dealing with Metformin in the form Tablets (extended release) containing metformin hydrochloride 500 mg, 120 (Diabex XR)
insert in the columns in the order indicated:
Metformin
Tablets (extended release) containing metformin hydrochloride 500 mg, 120
Oral
Diaformin XR
Alphapharm Pty Ltd
93 002 359 739
Metformin
Tablets (extended release) containing metformin hydrochloride 500 mg, 120
Oral
Metex XR
Sigma Pharmaceuticals (Australia) Pty Ltd
88 004 118 594
[32] Schedule 1, items dealing with Paclitaxel
(a) omit from the columns in the order indicated:
Paclitaxel
Solution concentrate for I.V. infusion 100 mg in
16.7 mL
Injection
Baxter Paclitaxel
Baxter Healthcare Pty Ltd
43 000 392 781
(b) omit from the columns in the order indicated:
Paclitaxel
Solution concentrate for I.V. infusion 30 mg in 5 mL
Injection
Baxter Paclitaxel
Baxter Healthcare Pty Ltd
43 000 392 781
(c) omit from the columns in the order indicated:
Paclitaxel
Solution concentrate for I.V. infusion 300 mg in 50 mL
Injection
Baxter Paclitaxel
Baxter Healthcare Pty Ltd
43 000 392 781
[33] Schedule 1, item dealing with Paroxetine in the form Tablet 20 mg (as hydrochloride) (Paroxetine-GA)
omit from the columns in the order indicated:
Ascent Pharmahealth Ltd
52 107 340 367
and substitute:
Genepharm (Australia) Limited
17 003 854 626
[34] Schedule 1, after item dealing with Polygeline
insert in the columns in the order indicated:
Poly-l-lactic acid
Powder for injection
150 mg
Injection
Sculptra
sanofi-aventis Australia Pty Ltd
31 008 558 807
[35] Schedule 1, after items dealing with Pramipexole
insert in the columns in the order indicated:
Pravastatin
Tablet containing pravastatin sodium 10 mg
Oral
APO-Pravastatin
Apotex Pty Ltd
52 096 916 148
[36] Schedule 1, item dealing with Pravastatin in the form Tablet containing pravastatin sodium 10 mg (Pravastatin-GA 10)
omit from the columns in the order indicated:
Ascent Pharmahealth Ltd
52 107 340 367
and substitute:
Genepharm (Australia) Limited
17 003 854 626
[37] Schedule 1, item dealing with Pravastatin in the form Tablet containing pravastatin sodium 20 mg (Pravastatin-GA 20)
omit from the columns in the order indicated:
Ascent Pharmahealth Ltd
52 107 340 367
and substitute:
Genepharm (Australia) Limited
17 003 854 626
[38] Schedule 1, item dealing with Pravastatin in the form Tablet containing pravastatin sodium 40 mg (Pravastatin-GA 40)
omit from the columns in the order indicated:
Ascent Pharmahealth Ltd
52 107 340 367
and substitute:
Genepharm (Australia) Limited
17 003 854 626
[39] Schedule 1, item dealing with Pravastatin in the form Tablet containing pravastatin sodium 80 mg (Pravastatin-GA 80)
omit from the columns in the order indicated:
Ascent Pharmahealth Ltd
52 107 340 367
and substitute:
Genepharm (Australia) Limited
17 003 854 626
[40] Schedule 1, after item dealing with Roxithromycin in the form Tablet 150 mg (Roximycin)
insert in the columns in the order indicated:
Roxithromycin
Tablet 150 mg
Oral
Roxithromycin-GA
Genepharm Pty Ltd
68 118 734 795
[41] Schedule 1, after item dealing with Roxithromycin in the form Tablet 300 mg (Roximycin)
insert in the columns in the order indicated:
Roxithromycin
Tablet 300 mg
Oral
Roxithromycin-GA
Genepharm Pty Ltd
68 118 734 795
[42] Schedule 1, after item dealing with Sevelamer
insert in the columns in the order indicated:
Silver sulfadiazine
Cream 10 mg per g, 50 g
Application
Flamazine
Smith & Nephew Pty Limited
68 000 087 507
[43] Schedule 1, items dealing with Simvastatin
(a) omit from the columns in the order indicated:
Simvastatin
Tablet 10 mg
Oral
Genepharm Pty Ltd
Genepharm Pty Ltd
68 118 734 795
(b) omit from the columns in the order indicated:
Simvastatin
Tablet 20 mg
Oral
Genepharm Pty Ltd
Genepharm Pty Ltd
68 118 734 795
(c) omit from the columns in the order indicated:
Simvastatin
Tablet 40 mg
Oral
Genepharm Pty Ltd
Genepharm Pty Ltd
68 118 734 795
(d) omit from the columns in the order indicated:
Simvastatin
Tablet 80 mg
Oral
Genepharm Pty Ltd
Genepharm Pty Ltd
68 118 734 795
[44] Schedule 1, after item dealing with Sodium Acid Phosphate
insert in the columns in the order indicated:
Sodium bicarbonate
Capsule 840 mg
Oral
Sodibic
Aspen Pharmacare Australia Pty Limited
51 096 236 985
[45] Schedule 1, after item dealing with Sodium Chloride in the form
I.V. infusion 154 mmol per L, 1 L (Baxter Healthcare Pty Ltd)
insert in the columns in the order indicated:
Sodium Chloride
I.V. infusion 154 mmol per L, 1 L
Injection
Pharmatel Fresenius Kabi Pty Limited
Pharmatel Fresenius Kabi Pty Limited
39 109 383 593
[46] Schedule 1, after item dealing with Sodium Lactate Compound in the form 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 (Baxter Healthcare Pty Ltd)
insert in the columns in the order indicated:
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
Injection
Pharmatel Fresenius Kabi Pty Limited
Pharmatel Fresenius Kabi Pty Limited
39 109 383 593
[47] Schedule 1, after item dealing with Tramadol in the form Capsule containing tramadol hydrochloride 50 mg (GenRx Tramadol)
insert in the columns in the order indicated:
Tramadol
Capsule containing tramadol hydrochloride
50 mg
Oral
Lodam 50
Spirit Pharmaceuticals Pty Ltd
67 109 225 747
[48] Schedule 1, after item dealing with Tramadol in the form Tablet (sustained release) containing tramadol hydrochloride 100 mg
(Chem mart Tramadol SR)
insert in the columns in the order indicated:
Tramadol
Tablet (sustained release) containing tramadol hydrochloride 100 mg
Oral
Lodam SR 100
Spirit Pharmaceuticals Pty Ltd
67 109 225 747
[49] Schedule 1, after item dealing with Tramadol in the form Tablet (sustained release) containing tramadol hydrochloride 150 mg
(Chem mart Tramadol SR)
insert in the columns in the order indicated:
Tramadol
Tablet (sustained release) containing tramadol hydrochloride 150 mg
Oral
Lodam SR 150
Spirit Pharmaceuticals Pty Ltd
67 109 225 747
[50] Schedule 1, after item dealing with Tramadol in the form Tablet (sustained release) containing tramadol hydrochloride 200 mg
(Chem mart Tramadol SR)
insert in the columns in the order indicated:
Tramadol
Tablet (sustained release) containing tramadol hydrochloride 200 mg
Oral
Lodam SR 200
Spirit Pharmaceuticals Pty Ltd
67 109 225 747
