National Health Act 1953 - Amendment determination under section 84AF - responsible persons (No. PB 56 of 2010) (Australia)

National Health Act 1953 - Amendment determination under section 84AF - responsible persons (No. PB 56 of 2010)

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COMMONWEALTH OF AUSTRALIA
Instrument number PB 56 of 2010
Amendment determination under section 84AF of the National Health Act 1953
I, FELICITY McNEILL, 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 June 2010

FELICITY McNEILL
Assistant Secretary
Pharmaceutical Evaluation Branch
Department of Health and Ageing

Amendment determination – responsible persons
1              Commencement
                This instrument commences on 1 July 2010.
2              Amendment of PB 16 of 2010
                Schedule 1 amends PB 16 of 2010.
Schedule 1            Amendments

[1]Schedule 1, items dealing with Aciclovir in the form Tablet 800 mg (Zovirax 800 mg)
                 omit from the columns in the order indicated:
Aciclovir
Tablet 800 mg
Oral
Zovirax 800 mg
GlaxoSmithKline Australia Pty Ltd
47 100 162 481
[2]Schedule 1, omit items dealing with Adrenaline in the forms I.M. injection 150 micrograms in 0.3 mL single dose syringe auto-injector and
I.M. injection 300 micrograms in 0.3 mL single dose syringe auto-injector
   and substitute in the columns in the order indicated:
Adrenaline
I.M. injection 150 micrograms in 0.3 mL single dose syringe auto-injector (Anapen Junior)
Injection
Anapen Junior
Link Medical Products Pty Ltd
73 010 971 516

Adrenaline
I.M. injection 150 micrograms in 0.3 mL single dose syringe auto-injector (EpiPen Jr.)
Injection
EpiPen Jr.
Alphapharm Pty Ltd
93 002 359 739

Adrenaline
I.M. injection 300 micrograms in 0.3 mL single dose syringe auto-injector (Anapen)
Injection
Anapen
Link Medical Products Pty Ltd
73 010 971 516

Adrenaline
I.M. injection 300 micrograms in 0.3 mL single dose syringe auto-injector (EpiPen)
Injection
EpiPen
Alphapharm Pty Ltd
93 002 359 739

[3]Schedule 1, items dealing with Atenolol in the form Tablet 50 mg
                 omit from the columns in the order indicated:
Atenolol
Tablet 50 mg
Oral
GenRx Atenolol
Apotex Pty Ltd
52 096 916 148
[4]Schedule 1, items dealing with Captopril in the form Tablet 12.5 mg
omit from the column headed “Brand”:         Captohexal          and substitute:           Captopril Sandoz
[5]Schedule 1, items dealing with Diclofenac in the form Tablet (enteric coated) containing diclofenac sodium 50 mg
omit from the columns in the order indicated:
Diclofenac
Tablet (enteric coated) containing diclofenac sodium 50 mg
Oral
GenRx Diclofenac
Apotex Pty Ltd
52 096 916 148
[6]Schedule 1, omit items dealing with Docetaxel
   and substitute in the columns in the order indicated:
Docetaxel
Injection set containing 1 single use vial concentrate for I.V. infusion 20 mg (anhydrous) in 0.5 mL with solvent
Injection
Taxotere
sanofi-aventis Australia Pty Ltd
31 008 558 807

Docetaxel
Injection set containing 1 single use vial concentrate for I.V. infusion 80 mg (anhydrous) in 2 mL with solvent
Injection
Taxotere
sanofi-aventis Australia Pty Ltd
31 008 558 807

[7]Schedule 1, after item dealing with Famciclovir in the form Tablet 125 mg (Famvir)
insert in the columns in the order indicated:
Famciclovir
Tablet 125 mg
Oral
Favic 125
Sigma Pharmaceuticals (Australia) Pty Ltd
88 004 118 594

[8]Schedule 1, after item dealing with Famciclovir in the form Tablet 250 mg (Famvir)
insert in the columns in the order indicated:
Famciclovir
Tablet 250 mg
Oral
Favic 250
Sigma Pharmaceuticals (Australia) Pty Ltd
88 004 118 594
[9]Schedule 1, after item dealing with Famciclovir in the form Tablet 500 mg (Famvir)
insert in the columns in the order indicated:
Famciclovir
Tablet 500 mg
Oral
Favic 500
Sigma Pharmaceuticals (Australia) Pty Ltd
88 004 118 594
[10]                   Schedule 1, items dealing with Famotidine in the form Tablet 40 mg
omit from the column headed “Brand”:         Famohexal and substitute:           Famotidine Sandoz
[11]            Schedule 1, item dealing with Gemfibrozil in the form Tablet 600 mg (Jezil)
omit from the columns in the order indicated:

Alphapharm Pty Ltd
93 002 359 739
and substitute:

Ascent Pharmaceuticals Limited
17 003 854 626
[12]                   Schedule 1, after items dealing with Glucose and Ketone Indicator—Urine
insert in the columns in the order indicated:
Glucose Indicator—Blood
Test strips, 100 (Accu-Chek Active)
For external use
Accu-Chek Active
Roche Diagnostics Australia Pty Limited
29 003 001 205
[13]                   Schedule 1, items dealing with Glucose Indicator—Blood
omit from the columns in the order indicated:
Glucose Indicator—Blood
Test strips, 100 (SofTact)
For external use
SofTact
Abbott Australasia Pty Ltd
95 000 180 389
[14]                   Schedule 1, items dealing with Glucose Indicator—Blood
omit from the columns in the order indicated:
Glucose Indicator—Blood
Test strips, 50 (Accu-Chek Active)
For external use
Accu-Chek Active
Roche Diagnostics Australia Pty Limited
29 003 001 205
[15]                   Schedule 1, after item dealing with Glucose Indicator—Blood in the form Test strips, 50 (Bionime Rightest)
insert in the columns in the order indicated:
Glucose Indicator—Blood
Test strips, 50 (CareSens N)
For external use
CareSens N
Life Bioscience Pty Ltd
13 108 135 191
[16]                   Schedule 1, items dealing with Indapamide in the form Tablet containing indapamide hemihydrate 2.5 mg
omit from the columns in the order indicated:
Indapamide
Tablet containing indapamide hemihydrate 2.5 mg
Oral
Napamide 2.5 mg
Ascent Pharmaceuticals Limited
17 003 854 626
[17]                   Schedule 1, after item dealing with Lamotrigine in the form Tablet 100 mg (Seaze 100)
insert in the columns in the order indicated:
Lamotrigine
Tablet 200 mg
Oral
APO- Lamotrigine
Apotex Pty Ltd
52 096 916 148
[18]                   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
Lisinopril Hexal
Sandoz Pty Ltd
60 075 449 553
[19]                   Schedule 1, items dealing with Medroxyprogesterone
omit from the columns in the order indicated:
Medroxyprogesterone
Injection containing medroxyprogesterone acetate 50 mg in 1 mL
Injection
Depo-Provera
Pfizer Australia Pty Ltd
50 008 422 348
[20]                   Schedule 1, item dealing with Mesalazine
omit from the columns in the order indicated:
Mesalazine
Suppositories 1 g, 28
Rectal
Pentasa
Ferring Pharmaceuticals Pty Limited
87 003 037 170
and substitute:
Mesalazine
Suppository 1 g
Rectal
Pentasa
Ferring Pharmaceuticals Pty Limited
87 003 037 170
[21]                   Schedule 1, items dealing with Metformin
                 omit from the columns in the order indicated:
Metformin
Tablets (extended release) containing metformin hydrochloride
500 mg, 120
Oral
Diabex XR
Alphapharm Pty Ltd
93 002 359 739

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

[22]                   Schedule 1, items dealing with Moclobemide in the form Tablet 300 mg
omit from the column headed “Brand”:         Mohexal     and substitute:        Moclobemide Sandoz
[23]                   Schedule 1, item dealing with Oestradiol
omit from the columns in the order indicated:
Oestradiol
Transdermal patches 4 mg, 8
Transdermal
Estraderm 50
Novartis Pharmaceuticals Australia Pty Limited
18 004 244 160
[24]                   Schedule 1, item dealing with Oestradiol and Oestradiol with Norethisterone
omit from the columns in the order indicated:
Oestradiol and Oestradiol with Norethisterone
Pack containing 4 transdermal patches oestradiol 4 mg and 4 transdermal patches oestradiol 10 mg with norethisterone acetate 30 mg
Transdermal
Estracombi
Novartis Pharmaceuticals Australia Pty Limited
18 004 244 160
[25]                   Schedule 1, after item dealing with Oxaliplatin in the form Powder for I.V. infusion 50 mg (Oxaliplatin Ebewe)
insert in the columns in the order indicated:
Oxaliplatin
Powder for I.V. infusion 50 mg
Injection
Oxaliplatin Link
Fresenius Kabi Australia Pty Ltd
39 109 383 593
[26]                   Schedule 1, after item dealing with Paclitaxel in the form Solution concentrate for I.V. infusion 100 mg in 16.7 mL (Paclitaxel Ebewe)
insert in the columns in the order indicated:
Paclitaxel
Solution concentrate for I.V. infusion 100 mg in 16.7 mL
Injection
Plaxel
Willow Pharmaceuticals Pty Ltd
80 118 534 704
[27]                   Schedule 1, after item dealing with Paclitaxel in the form Solution concentrate for I.V. infusion 150 mg in 25 mL (Paclitaxel Ebewe)
insert in the columns in the order indicated:
Paclitaxel
Solution concentrate for I.V. infusion 150 mg in 25 mL
Injection
Plaxel
Willow Pharmaceuticals Pty Ltd
80 118 534 704
[28]                   Schedule 1, after item dealing with Paclitaxel in the form Solution concentrate for I.V. infusion 30 mg in 5 mL (Paclitaxel Ebewe)
insert in the columns in the order indicated:
Paclitaxel
Solution concentrate for I.V. infusion 30 mg in 5 mL
Injection
Plaxel
Willow Pharmaceuticals Pty Ltd
80 118 534 704
[29]                   Schedule 1, after item dealing with Paclitaxel in the form Solution concentrate for I.V. infusion 300 mg in 50 mL (Paclitaxel Ebewe)
insert in the columns in the order indicated:
Paclitaxel
Solution concentrate for I.V. infusion 300 mg in 50 mL
Injection
Plaxel
Willow Pharmaceuticals Pty Ltd
80 118 534 704
[30]                   Schedule 1, items dealing with Paracetamol in the form Tablet 500 mg
omit from the columns in the order indicated:
Paracetamol
Tablet 500 mg
Oral
Dymadon P
Johnson & Johnson Pacific Pty Limited
73 001 121 446
[31]                   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
Liprachol
Sandoz Pty Ltd
60 075 449 553
[32]                   Schedule 1, after item dealing with Pravastatin in the form Tablet containing pravastatin sodium 20 mg (Pravastatin generichealth)
insert in the columns in the order indicated:
Pravastatin
Tablet containing pravastatin sodium 20 mg
Oral
Pravastatin Sandoz
Sandoz Pty Ltd
60 075 449 553
[33]                   Schedule 1, item dealing with Tamoxifen in the form Tablet 20 mg (as citrate)
(a) omit from the columns in the order indicated:
Tamoxifen
Tablet 20 mg (as citrate)
Oral
Chem mart Tamoxifen
Apotex Pty Ltd
52 096 916 148
(b) omit from the columns in the order indicated:
Tamoxifen
Tablet 20 mg (as citrate)
Oral
Terry White Chemists Tamoxifen
Apotex Pty Ltd
52 096 916 148
[34]                   Schedule 1, after item dealing with Terbinafine in the form Tablet 250 mg (as hydrochloride) (Terbinafine-DP)
insert in the columns in the order indicated:
Terbinafine
Tablet 250 mg (as hydrochloride)
Oral
Terbinafine-GA
Ascent Pharma Pty Ltd
68 118 734 795
[35]                   Schedule 1, item dealing with Tiludronic Acid
omit from the columns in the order indicated:

Hospira Pty Limited
13 107 058 328
and substitute:

sanofi-aventis Australia Pty Ltd
31 008 558 807
[36]                   Schedule 1, after item dealing with Topiramate in the form Tablet 100 mg (Topiramate Sandoz)
insert in the columns in the order indicated:
Topiramate
Tablet 100 mg
Oral
Topiramate-GA
Ascent Pharma Pty Ltd
68 118 734 795
[37]                   Schedule 1, after item dealing with Topiramate in the form Tablet 200 mg (Topiramate Sandoz)
insert in the columns in the order indicated:
Topiramate
Tablet 200 mg
Oral
Topiramate-GA
Ascent Pharma Pty Ltd
68 118 734 795
[38]                   Schedule 1, after item dealing with Topiramate in the form Tablet 25 mg (Topiramate Sandoz)
insert in the columns in the order indicated:
Topiramate
Tablet 25 mg
Oral
Topiramate-GA
Ascent Pharma Pty Ltd
68 118 734 795
[39]                   Schedule 1, after item dealing with Topiramate in the form Tablet 50mg (Topiramate Sandoz)
insert in the columns in the order indicated:
Topiramate
Tablet 50 mg
Oral
Topiramate-GA
Ascent Pharma Pty Ltd
68 118 734 795