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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-   Injection        Anapen Junior      Link Medical Products Pty Ltd               73 010 971 516
                        injector (Anapen Junior)
Adrenaline              I.M. injection 150 micrograms in 0.3 mL single dose syringe auto-   Injection        EpiPen Jr.         Alphapharm Pty Ltd                          93 002 359 739
                        injector (EpiPen Jr.)
Adrenaline              I.M. injection 300 micrograms in 0.3 mL single dose syringe auto-   Injection        Anapen             Link Medical Products Pty Ltd               73 010 971 516
                        injector (Anapen)
Adrenaline              I.M. injection 300 micrograms in 0.3 mL single dose syringe auto-   Injection        EpiPen             Alphapharm Pty Ltd                          93 002 359 739
                        injector (EpiPen)

[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.     Injection        Taxotere           sanofi-aventis Australia Pty Ltd            31 008 558 807
                        infusion 20 mg (anhydrous) in 0.5 mL with solvent
Docetaxel               Injection set containing 1 single use vial concentrate for I.V.     Injection        Taxotere           sanofi-aventis Australia Pty Ltd            31 008 558 807
                        infusion 80 mg (anhydrous) in 2 mL with solvent


[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




Instrument Number PB 56 of 2010
                                                                                                        2
[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—       Test strips, 100 (Accu-Chek Active)            For external use    Accu-Chek Active   Roche Diagnostics Australia Pty Limited     29 003 001 205
Blood

[13]          Schedule 1, items dealing with Glucose Indicator—Blood
              omit from the columns in the order indicated:
Glucose Indicator—       Test strips, 100 (SofTact)                     For external use    SofTact            Abbott Australasia Pty Ltd                  95 000 180 389
Blood

[14]          Schedule 1, items dealing with Glucose Indicator—Blood
              omit from the columns in the order indicated:
Glucose Indicator—       Test strips, 50 (Accu-Chek Active)             For external use    Accu-Chek Active   Roche Diagnostics Australia Pty Limited     29 003 001 205
Blood

[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—       Test strips, 50 (CareSens N)                   For external use    CareSens N         Life Bioscience Pty Ltd                     13 108 135 191
Blood




Instrument Number PB 56 of 2010
                                                                                   3
[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    Oral            Diabex XR          Alphapharm Pty Ltd                          93 002 359 739
                         500 mg, 120
Metformin                Tablets (extended release) containing metformin hydrochloride    Oral            Diaformin XR       Alphapharm Pty Ltd                          93 002 359 739
                         500 mg, 120
Metformin                Tablets (extended release) containing metformin hydrochloride    Oral            Metex XR           Sigma Pharmaceuticals (Australia) Pty Ltd   88 004 118 594
                         500 mg, 120

[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      18 004 244 160
                                                                                                                             Limited



Instrument Number PB 56 of 2010
                                                                                                      4
[24]              Schedule 1, item dealing with Oestradiol and Oestradiol with Norethisterone
                  omit from the columns in the order indicated:
Oestradiol and             Pack containing 4 transdermal patches oestradiol 4 mg and 4           Transdermal     Estracombi         Novartis Pharmaceuticals Australia Pty   18 004 244 160
Oestradiol with            transdermal patches oestradiol 10 mg with norethisterone acetate 30                                      Limited
Norethisterone             mg


[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




Instrument Number PB 56 of 2010
                                                                                                             5
[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   Apotex Pty Ltd                     52 096 916 148
                                                                                        Tamoxifen

[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



Instrument Number PB 56 of 2010
                                                                                6

				
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