National Health (Listing of Pharmaceutical Benefits) Amendment Instrument 2012 (No. 3) (No. PB 27 of 2012) (Cth)

Case

PB 27 of 2012

National Health (Listing of Pharmaceutical Benefits) Amendment Instrument 2012
(No.3)1

National Health Act 1953

I, KIM BESSELL, First Assistant Secretary (Acting), Pharmaceutical Benefits Division, Department of Health and Ageing, delegate of the Minister for Health, make this Instrument under sections 84AF, 85, 85A, 88 and 101 of the National Health Act 1953.

Dated 18 April 2012

KIM BESSELL

First Assistant Secretary (Acting)

Pharmaceutical Benefits Division

Department of Health and Ageing

1          Name of Instrument

(1)        This Instrument is the National Health (Listing of Pharmaceutical Benefits) Amendment Instrument 2012 (No. 3).

(2)        This Instrument may also be cited as PB 27 of 2012.

2          Commencement

This Instrument commences on 1 May 2012.

3          Amendment of the National Health (Listing of Pharmaceutical Benefits) Instrument 2010 (PB 108 of 2010)

Schedule 1 amends the National Health (Listing of Pharmaceutical Benefits) Instrument 2010 (PB 108 of 2010).

Schedule 1     Amendments

  1. Schedule 1, entry for Alendronic Acid in the form Tablet 70 mg (as alendronate sodium)

insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:

Densate 70 DO MP NP C2646 C3070 C3933 4 5

  1. Schedule 1, entry for Anastrozole

(a)          insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:

Anastrozole Synthon ZT MP NP C2213 30 5

(b)          insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:

Arianna AF MP NP C2213 30 5

  1. Schedule 1, entry for Bicalutamide

omit from the column headed “Responsible Person” for the brand “Cosudex”:                  AP          substitute:             SZ

  1. Schedule 1, entry for Bisoprolol in the form Tablet containing bisoprolol fumarate 2.5 mg

insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:

Beprol 2.5 DO MP NP C3234 28 5

  1. Schedule 1, entry for Bisoprolol in the form Tablet containing bisoprolol fumarate 5 mg

insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:

Beprol 5 DO MP NP C3234 28 5

  1. Schedule 1, entry for Bisoprolol in the form Tablet containing bisoprolol fumarate 10 mg

insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:

Beprol 10 DO MP NP C3234 28 5

  1. Schedule 1, entry for Bivalirudin

omit from the column headed “Responsible Person”:                 CS          substitute:             XM

  1. Schedule 1, entry for Carboplatin in the form Solution for I.V. injection 50 mg in 5 mL

omit:

Pfizer Australia Pty Ltd PF MP See Note 3 See Note 3 D

  1. Schedule 1, entry for Carvedilol in the form Tablet 3.125 mg

omit:

Kredex MD MP NP C1735 C3234 30 0

  1. Schedule 1, entry for Cisplatin

omit:

I.V. injection 10 mg in 10 mL Injection Pfizer Australia Pty Ltd PF MP See Note 3 See Note 3 D

  1. Schedule 1, entry for Darunavir

omit:

Tablet 300 mg (as ethanolate) Oral Prezista JC MP
See Note 1 		C3594 C3595 240 5 D

  1. Schedule 1, entry for Doxorubicin in the form Solution for I.V. injection or intravesical administration containing doxorubicin hydrochloride 10 mg in 5 mL single dose vial

omit:

Adriamycin Solution PF MP See Note 3 See Note 3 D

  1. Schedule 1, entry for Doxorubicin

omit:

Solution for I.V. injection or intravesical administration containing doxorubicin hydrochloride 20 mg in 10 mL single dose vial Injection/ intravesical Adriamycin Solution PF MP See Note 3 See Note 3 D

  1. Schedule 1, entry for Doxorubicin – Pegylated Liposomal in the form Suspension for I.V. infusion containing pegylated liposomal doxorubicin hydrochloride 20 mg in 10 mL

insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:

Lipodox ZF MP C1568 C1795 C1796 C3905 C3910 C3911 See Note 3 See Note 3 D
MP
See Note 1 		C1828 C1829 C3348 C3349 4 5 D

  1. Schedule 1, entry for Doxorubicin – Pegylated Liposomal in the form Suspension for I.V. infusion containing pegylated liposomal doxorubicin hydrochloride 50 mg in 25 mL

insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:

Lipodox 50 ZF MP C1568 C1795 C1796 C3905 C3910 C3911 See Note 3 See Note 3 D

  1. Schedule 1, entry for Enalapril in each of the forms: Tablet containing enalapril maleate 5 mg; and Tablet containing enalapril maleate 10 mg

omit:

Enalapril Winthrop WA MP NP 30 5

  1. Schedule 1, entry for Epirubicin in each of the forms: Solution for injection containing epirubicin hydrochloride 10 mg in 5 mL; and Solution for injection containing epirubicin hydrochloride 20 mg in 10 mL

omit:

Pharmorubicin Solution PF MP See Note 3 See Note 3 D

  1. Schedule 1, entry for Etravirine

omit:

Tablet 100 mg Oral Intelence JC MP
See Note 1 		C3596 C3597 240 5 D

  1. Schedule 1, entry for Glucose Indicator—Blood

omit:

Test strips, 50 (Advantage II) For external use Advantage II RD MP NP 2 5
MP P3035 2 11

  1. Schedule 1, entry for Irinotecan in the form I.V. injection containing irinotecan hydrochloride trihydrate 40 mg in 2 mL

omit:

Camptosar PF MP C3184 See Note 3 See Note 3 D

  1. Schedule 1, entry for Letrozole in the form Tablet 2.5 mg

insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:

Letrozole-Synthon ZT MP NP C1608 C2691 C2692 30 5

  1. Schedule 1, entry for Lisinopril in each of the forms: Tablet 5 mg; Tablet 10 mg; and Tablet 20 mg

omit:

Lisinopril Winthrop WA MP NP 30 5

  1. Schedule 1, entry for Metformin in the form Tablet containing metformin hydrochloride 500 mg

insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:

Glucobete 500 DO MP NP 100 5

  1. Schedule 1, entry for Metformin in the form Tablet containing metformin hydrochloride 850 mg

insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:

Glucobete 850 DO MP NP 60 5

  1. Schedule 1, entry for Metformin in the form Tablet containing metformin hydrochloride 1 g

insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:

Glucobete 1000 DO MP NP 90 5

  1. Schedule 1, entry for Mirtazapine in the form Tablet 15 mg (orally disintegrating)

insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:

Milivin OD 15 DO MP NP C1211 30 5

  1. Schedule 1, entry for Mirtazapine in the form Tablet 30 mg

insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:

Aurozapine 30 DO MP NP C1211 30 5

  1. Schedule 1, entry for Mirtazapine in the form Tablet 30 mg (orally disintegrating)

insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:

Milivin OD 30 DO MP NP C1211 30 5

  1. Schedule 1, entry for Mirtazapine in the form Tablet 45 mg

insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:

Aurozapine 45 DO MP NP C1211 30 5

  1. Schedule 1, entry for Mirtazapine in the form Tablet 45 mg (orally disintegrating)

insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:

Milivin OD 45 DO MP NP C1211 30 5

  1. Schedule 1, entry for Mitozantrone

omit:

Injection 10 mg (as hydrochloride) in 5 mL Injection Pfizer Australia Pty Ltd PF MP See Note 3 See Note 3 D

  1. Schedule 1, entry for Mitozantrone in the form Injection 25 mg (as hydrochloride) in 12.5 mL

omit:

Pfizer Australia Pty Ltd PF MP See Note 3 See Note 3 D

  1. Schedule 1, entry for Mycophenolic Acid in the form Tablet containing mycophenolate mofetil 500 mg [Max Quantity 150; Number of Repeats 3]

insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:

Pharmacor Mycophenolate 500 CR MP C1765 C1766 150 3

  1. Schedule 1, entry for Mycophenolic Acid in the form Tablet containing mycophenolate mofetil 500 mg [Max Quantity 300; Number of Repeats 5]

insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:

Pharmacor Mycophenolate 500 CR MP
See Note 1 		C1650 C1651 C3355 C3356 300 5 C

  1. Schedule 1, entry for Naproxen

omit:

Oral suspension 125 mg per 5 mL, 474 mL Oral Naprosyn RO MP NP C2270 C2271 C3647 C3648 P3648 1 0
MP NP C2270 C2271 C3647 C3648 P2270 P2271 P3647 1 3

  1. Schedule 1, entry for Natalizumab 

substitute:

Natalizumab Solution concentrate for I.V. infusion 300 mg in 15 mL Injection Tysabri BD MP
See Note 1 		C3423 C3424 C3425 1 5 D

  1. Schedule 1, entry for Olanzapine in each of the forms: Tablet 2.5 mg (as benzoate); Tablet 5 mg (as benzoate); Tablet 7.5 mg (as benzoate); and Tablet 10 mg (as benzoate)

insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:

Olanzapine-Synthon ZT MP NP C1589 C2044 28 5

  1. Schedule 1, entry for Olanzapine in the form Tablet 5 mg (orally disintegrating)

(a)           insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:

Olanzapine ODT generichealth 5 GQ MP NP C1589 C2044 28 5

(b)           insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:

Olanzapine Sandoz ODT 5 SZ MP NP C1589 C2044 28 5

  1. Schedule 1, entry for Olanzapine in the form Tablet 10 mg (orally disintegrating)

(a)           insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:

Olanzapine ODT generichealth 10 GQ MP NP C1589 C2044 28 5

(b)           insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:

Olanzapine Sandoz ODT 10 SZ MP NP C1589 C2044 28 5

  1. Schedule 1, entry for Ondansetron in the form Tablet 4 mg (as hydrochloride dihydrate)

(a)        omit:

Ondasetron-DRLA RZ MP NP C3050 C3611 P3611 10 1
Ondasetron Tabs Pfizer FZ MP NP C3611 P3611 10 1

substitute:

Ondansetron-DRLA RZ MP NP C3050 C3611 P3611 10 1
Ondansetron Tabs Pfizer FZ MP NP C3050 C3611 P3611 10 1

(b)        insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:

Zilfojim 4 DO MP NP C3050 C3611 P3611 10 1

  1. Schedule 1, entry for Ondansetron in the form Tablet 8 mg (as hydrochloride dihydrate)

(a)        omit:

Ondasetron Tabs Pfizer FZ MP NP C3611 P3611 10 1

substitute:

Ondansetron Tabs Pfizer FZ MP NP C3050 C3611 P3611 10 1

(b)        insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:

Zilfojim 8 DO MP NP C3050 C3611 P3611 10 1

  1. Schedule 1, entry for Ondansetron in the form I.V. injection 4 mg (as hydrochloride dihydrate) in 2 mL

omit:

Pfizer Australia Pty Ltd PF MP NP
See Note 1 		C3050 C3611
See Note 2 		See Note 2 1
See Note 2 		0
See Note 2

  1. Schedule 1, entry for Ondansetron in the form I.V. injection 8 mg (as hydrochloride dihydrate) in 4 mL

omit:

Pfizer Australia Pty Ltd PF MP NP
See Note 1 		C3050 C3611
See Note 2 		See Note 2 1
See Note 2 		0
See Note 2

  1. Schedule 1, entry for Oxaliplatin in the form Powder for I.V. infusion 100 mg

omit:

Winthrop Oxaliplatin WA MP

 C3900 C3901 C3930 C3939 See Note 3 See Note 3 D

  1. Schedule 1, entry for Pantoprazole in the form Tablet (enteric coated) 40 mg (as sodium sesquihydrate) [Max Quantity 30; Number of Repeats 2]

insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:

Torzole 40 TA MP NP C1177 C1337 C1476 C1533 P1177 30 2

  1. Schedule 1, entry for Pantoprazole in the form Tablet (enteric coated) 40 mg (as sodium sesquihydrate) [Max Quantity 30; Number of Repeats 5]

insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:

Torzole 40 TA MP NP C1177 C1337 C1476 C1533 P1337 P1476 P1533 30 5

  1. Schedule 1, entry for Pantoprazole in the form Tablet (enteric coated) 20 mg (as sodium sesquihydrate)

insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:

Torzole 20 TA MP NP C1337 C1476 C1533 30 5

  1. Schedule 1, entry for Pimecrolimus

omit from the column headed “Responsible Person”:                 NV          substitute:             HM

  1. Schedule 1, entry for Pravastatin in the form Tablet containing pravastatin sodium 10 mg [Max Quantity 30; Number of Repeats 5]

insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:

Pravastatin Actavis 10 TA MP C1540 C3047 P1540 30 5
NP C1540 30 5

  1. Schedule 1, entry for Pravastatin in the form Tablet containing pravastatin sodium 10 mg [Max Quantity 30; Number of Repeats 11]

insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:

Pravastatin Actavis 10 TA MP C1540 C3047 P3047 30 11

  1. Schedule 1, entry for Pravastatin in the form Tablet containing pravastatin sodium 20 mg [Max Quantity 30; Number of Repeats 5]

insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:

Pravastatin Actavis 20 TA MP C1540 C3047 P1540 30 5
NP C1540 30 5

  1. Schedule 1, entry for Pravastatin in the form Tablet containing pravastatin sodium 20 mg [Max Quantity 30; Number of Repeats 11]

insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:

Pravastatin Actavis 20 TA MP C1540 C3047 P3047 30 11

  1. Schedule 1, entry for Pravastatin in the form Tablet containing pravastatin sodium 40 mg [Max Quantity 30; Number of Repeats 5]

insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:

Pravastatin Actavis 40 TA MP C1540 C3047 P1540 30 5
NP C1540 30 5

  1. Schedule 1, entry for Pravastatin in the form Tablet containing pravastatin sodium 40 mg [Max Quantity 30; Number of Repeats 11]

insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:

Pravastatin Actavis 40 TA MP C1540 C3047 P3047 30 11

  1. Schedule 1, entry for Promethazine

omit:

Tablet containing promethazine hydrochloride 10 mg Oral Phenergan SW MP NP C3640 C3641 P3641 50 0
MP NP C3640 C3641 P3640 50 3
Tablet containing promethazine hydrochloride 25 mg Oral Phenergan SW MP NP C3640 C3641 P3641 50 0
MP NP C3640 C3641 P3640 50 3
Oral liquid containing promethazine hydrochloride 5 mg per 5 mL, 100 mL Oral Phenergan SW MP NP C3640 C3641 P3641 1 0
MP NP C3640 C3641 P3640 1 3

  1. Schedule 1, entry for Quetiapine in the form Tablet 25 mg (as fumarate)

(a)         insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:

Seronia 25 QA MP NP C1589 C2044 C2765 60 5

(b)         insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:

Syquet AF MP NP C1589 C2044 C2765 60 5

  1. Schedule 1, entry for Quetiapine in the form Tablet 100 mg (as fumarate)

(a)         insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:

Seronia 100 QA MP NP C1589 C2044 C2765 90 5

(b)         insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:

Syquet AF MP NP C1589 C2044 C2765 90 5

  1. Schedule 1, entry for Quetiapine in the form Tablet 200 mg (as fumarate)

(a)         insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:

Seronia 200 QA MP NP C1589 C2044 C2765 60 5

(b)         insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:

Syquet AF MP NP C1589 C2044 C2765 60 5

  1. Schedule 1, entry for Quetiapine in the form Tablet 300 mg (as fumarate)

(a)         insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:

Seronia 300 QA MP NP C1589 C2044 C2765 60 5

(b)         insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:

Syquet AF MP NP C1589 C2044 C2765 60 5

  1. Schedule 1, entry for Quinapril in each of the forms: Tablet 5 mg (as hydrochloride); Tablet 10 mg (as hydrochloride); and Tablet 20 mg (as hydrochloride)

(a)         omit:

Filpril FZ MP NP 30 5

(b)         insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:

Quinapril Pfizer FZ MP NP 30 5

  1. Schedule 1, entry for Ramipril in the form Tablet 1.25 mg

(a)        insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:

Ramipril Tabs Pfizer FZ MP NP 30 5

(b)        insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:

Vascalace 1.25 DO MP NP 30 5

  1. Schedule 1, entry for Ramipril in the form Tablet 2.5 mg

(a)        insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:

Ramipril Tabs Pfizer FZ MP NP 30 5

(b)        insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:

Vascalace 2.5 DO MP NP 30 5

  1. Schedule 1, entry for Ramipril in the form Tablet 5 mg

(a)        insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:

Ramipril Tabs Pfizer FZ MP NP 30 5

(b)        insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:

Vascalace 5 DO MP NP 30 5

  1. Schedule 1, entry for Ramipril in the form Tablet 10 mg

(a)        insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:

Ramipril Tabs Pfizer FZ MP NP 30 5

(b)        insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:

Vascalace 10 DO MP NP 30 5

  1. Schedule 1, entry for Risperidone in the form Tablet 0.5 mg [Max Quantity 60; Number of Repeats 2]

insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:

Risperidone Actavis 0.5 TA MP NP C1589 C2061 C3083 P2061 P3083 60 2

  1. Schedule 1, entry for Risperidone in the form Tablet 0.5 mg [Max Quantity 60; Number of Repeats 5]

insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:

Risperidone Actavis 0.5 TA MP NP C1589 C2061 C3083 P1589 60 5

  1. Schedule 1, entry for Risperidone in the form Tablet 1 mg [Max Quantity 60; Number of Repeats 2]

insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:

Risperidone Actavis 1 TA MP NP C1589 C2061 C2272 C3083 P2061 P3083 60 2

  1. Schedule 1, entry for Risperidone in the form Tablet 1 mg [Max Quantity 60; Number of Repeats 5]

insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:

Risperidone Actavis 1 TA MP NP C1589 C2061 C2272 C3083 P1589 P2272 60 5

  1. Schedule 1, entry for Risperidone in the form Tablet 2 mg [Max Quantity 60; Number of Repeats 2]

insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:

Risperidone Actavis 2 TA MP NP C1589 C2272 C3083 P3083 60 2

  1. Schedule 1, entry for Risperidone in the form Tablet 2 mg [Max Quantity 60; Number of Repeats 5]

insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:

Risperidone Actavis 2 TA MP NP C1589 C2272 C3083 P1589 P2272 60 5

  1. Schedule 1, entry for Risperidone in the form Tablet 3 mg

insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:

Risperidone Actavis 3 TA MP NP C1589 C2272 60 5

  1. Schedule 1, entry for Risperidone in the form Tablet 4 mg

insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:

Risperidone Actavis 4 TA MP NP C1589 C2272 60 5

  1. Schedule 1, entry for Sertraline in the form Tablet 50 mg (as hydrochloride)

omit:

Sertraline Winthrop WA MP NP C1211 30 5

  1. Schedule 1, entry for Simvastatin in the form Tablet 10 mg [Max Quantity 30; Number of Repeats 5]

insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:

Synthon Simvastatin ZT MP C1540 C3047 P1540 30 5
NP C1540 30 5

  1. Schedule 1, entry for Simvastatin in the form Tablet 10 mg [Max Quantity 30; Number of Repeats 11]

insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:

Synthon Simvastatin ZT MP C1540 C3047 P3047 30 11

  1. Schedule 1, entry for Simvastatin in the form Tablet 20 mg [Max Quantity 30; Number of Repeats 5]

insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:

Synthon Simvastatin ZT MP C1540 C3047 P1540 30 5
NP C1540 30 5

  1. Schedule 1, entry for Simvastatin in the form Tablet 20 mg [Max Quantity 30; Number of Repeats 11]

insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:

Synthon Simvastatin ZT MP C1540 C3047 P3047 30 11

  1. Schedule 1, entry for Simvastatin in the form Tablet 40 mg [Max Quantity 30; Number of Repeats 5]

(a)        omit from the column headed “Responsible Person” for the brand “Simvahexal”:   SZ          substitute:                HX

(b)        insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:

Simvastatin Sandoz SZ MP C1540 C3047 P1540 30 5
NP C1540 30 5

(c)          insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:

Synthon Simvastatin ZT MP C1540 C3047 P1540 30 5
NP C1540 30 5

  1. Schedule 1, entry for Simvastatin in the form Tablet 40 mg [Max Quantity 30; Number of Repeats 11]

(a)        omit from the column headed “Responsible Person” for the brand “Simvahexal”:   SZ          substitute:                HX

(b)        insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:

Simvastatin Sandoz SZ MP C1540 C3047 P3047 30 11

(c)          insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:

Synthon Simvastatin ZT MP C1540 C3047 P3047 30 11

  1. Schedule 1, entry for Simvastatin in the form Tablet 80 mg [Max Quantity 30; Number of Repeats 5]

insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:

Synthon Simvastatin ZT MP C1540 C3047 P1540 30 5
NP C1540 30 5

  1. Schedule 1, entry for Simvastatin in the form Tablet 80 mg [Max Quantity 30; Number of Repeats 11]

insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:

Synthon Simvastatin ZT MP C1540 C3047 P3047 30 11

  1. Schedule 1, entry for Topiramate in each of the forms: Tablet 25 mg; and Tablet 50 mg

omit:

Topiramate generichealth GQ MP NP C2797 C2799 60 5

  1. Schedule 1, entry for Topiramate in each of the forms: Tablet 100 mg; and Tablet 200 mg

omit:

Topiramate generichealth GQ MP NP C2797 60 5

  1. Schedule 1, entry for Valaciclovir in the form Tablet 500 mg (as hydrochloride) [Max Quantity 30; Number of Repeats 5]

insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:

Shilova 500 DO MP NP C3622 C3623 C3624 C3631 C3632 P3623 P3624 30 5

  1. Schedule 1, entry for Venlafaxine in the form Capsule (modified release) 37.5 mg (as hydrochloride)

insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:

Altven FZ MP NP C1211 28 0

  1. Schedule 1, entry for Venlafaxine in each of the forms: Capsule (modified release) 75 mg (as hydrochloride); and Capsule (modified release) 150 mg (as hydrochloride)

insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:

Altven FZ MP NP C1211 28 5

  1. Schedule 1, entry for Vincristine in the form I.V. injection containing vincristine sulfate 1 mg in 1 mL

omit:

Pfizer Australia Pty Ltd PF MP See Note 3 See Note 3 D

  1. Schedule 3, details relevant to Responsible person code GZ

omit:

Genzyme Australasia Pty Ltd  24 083 420 526

substitute:

sanofi-aventis Australia Pty Ltd  31 008 558 807

  1. Schedule 3, after details relevant to Responsible person code HL

insert:

HM Meda Pharmaceuticals Pty Ltd  59 155 308 679

  1. Schedule 3, after details relevant to Responsible person code XF

insert:

XM The Medicines Company (Australia) Pty Limited  74 138 555 021

  1. Schedule 3, after details relevant to Responsible person code ZP

insert:

ZT Synthon A.U. Pty Ltd  58 080 948 698

  1. Schedule 4, Part 1, entry for Clopidogrel [Circumstances Code C3879]

omit all text from the column headed “Authority Requirements – Part of Circumstances” and substitute:

Compliance with
Authority Required procedures – Streamlined Authority
Code 3879

  1. Schedule 4, Part 1, entry for Clopidogrel with aspirin [Circumstances Code C3880]

omit all text from the column headed “Authority Requirements – Part of Circumstances” and substitute:

Compliance with
Authority Required procedures – Streamlined Authority
Code 3880

  1. Schedule 4, Part 1, entry for Deferasirox [Circumstances Code C3828]

omit all text from the column headed “Authority Requirements – Part of Circumstances” and substitute:

Compliance with
Written or Telephone
Authority Required procedures – Streamlined Authority
Code 3828

  1. Schedule 4, Part 1, entry for Filgrastim [Circumstances Code C3834]

omit all text from the column headed “Authority Requirements – Part of Circumstances” and substitute:

Compliance with
Written or Telephone
Authority Required procedures – Streamlined Authority
Code 3834

  1. Schedule 4, Part 1, after entry for Naratriptan

insert:

Natalizumab C3423

Where the patient is receiving treatment at/from a private hospital

Initial treatment, as monotherapy, by a neurologist, of clinically definite relapsing-remitting multiple sclerosis in an ambulatory (without assistance or support) patient 18 years of age or older who has experienced at least 2 documented attacks of neurological dysfunction, believed to be due to multiple sclerosis, in the preceding 2 years, and where the diagnosis is confirmed by magnetic resonance imaging of the brain and/or spinal cord and the date of the scan is included in the authority application, unless the authority application is accompanied by written certification provided by a radiologist that a magnetic resonance imaging scan is contraindicated because of the risk of physical (not psychological) injury to the patient

 Compliance with Written or Telephone Authority Required procedures
C3424

Where the patient is receiving treatment at/from a private hospital

Continuing treatment, as monotherapy, of clinically definite relapsing-remitting multiple sclerosis in a patient previously issued with an authority prescription for this drug who does not show continuing progression of disability while on treatment with this drug, and who has demonstrated compliance with, and an ability to tolerate, this therapy.

 Compliance with Written or Telephone Authority Required procedures
C3425

Where the patient is receiving treatment at/from a public hospital

Treatment, as monotherapy, by a neurologist, of clinically definite relapsing-remitting multiple sclerosis in an ambulatory (without assistance or support) patient 18 years of age or older who has experienced at least 2 documented attacks of neurological dysfunction, believed to be due to multiple sclerosis, in the preceding 2 years, and where:
the diagnosis is confirmed by magnetic resonance imaging of the brain and/or spinal cord and the date of the scan is included in the patient's medical notes, unless written certification provided by a radiologist that a magnetic resonance imaging scan is contraindicated because of the risk of physical (not psychological) injury to the patient is included in the patient's medical notes;
natalizumab must be ceased if there is continuing progression of disability while on treatment with natalizumab;
for continued treatment the patient must demonstrate compliance with, and an ability to tolerate, natalizumab

 Compliance with Written or Telephone Authority Required procedures - Streamlined Authority Code 3425

  1. Schedule 4, Part 1, entry for Pegfilgrastim [Circumstances Code C3834]

omit all text from the column headed “Authority Requirements – Part of Circumstances” and substitute:

Compliance with
Written or Telephone
Authority Required procedures – Streamlined Authority
Code 3834

  1. Schedule 4, Part 1, omit entry for Promethazine

  1. Schedule 4, Part 1, entry for Risperidone [Circumstances Code C3841]

omit from the column headed “Authority Requirements – Part of Circumstances”:       C3841    substitute:             3841

  1. Schedule 4, Part 1, entry for Tipranavir [Circumstances Codes C3601; C3602; and C3603]

omit from the column headed “Authority Requirements – Part of Circumstances”:       Authority Authority         substitute:           Authority

1Note

All legislative instruments and compilations are registered on the Federal Register of Legislative Instruments kept under the Legislative Instruments Act 2003.

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