Source: https://www.global-regulation.com/law/australia/228913/national-health-%2528listing-of-pharmaceutical-benefits%2529-amendment-instrument-2012-%2528no.-3%2529-%2528no.-pb-27-of-2012%2529.html
Timestamp: 2018-12-14 12:02:54
Document Index: 312017997

Matched Legal Cases: ['art 1', 'art 1', 'art 1', 'art 1', 'art 1', 'art 1', 'art 1', 'art 1', 'art 1']

National Health (Listing of Pharmaceutical Benefits) Amendment Instrument 2012 (No. 3) (No. PB 27 of 2012) (Australia)
National Health (Listing of Pharmaceutical Benefits) Amendment Instrument 2012 (No. 3) (No. PB 27 of 2012)
Link to law: https://www.comlaw.gov.au/Details/F2012L00935
PB 27 of 2012
(No.3)1
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
(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.
C2646 C3070 C3933
Anastrozole Synthon
[3] Schedule 1, entry for Bicalutamide
omit from the column headed “Responsible Person” for the brand “Cosudex”: AP substitute: SZ
[4] Schedule 1, entry for Bisoprolol in the form Tablet containing bisoprolol fumarate 2.5 mg
[5] Schedule 1, entry for Bisoprolol in the form Tablet containing bisoprolol fumarate 5 mg
[6] Schedule 1, entry for Bisoprolol in the form Tablet containing bisoprolol fumarate 10 mg
[7] Schedule 1, entry for Bivalirudin
omit from the column headed “Responsible Person”: CS substitute: XM
[8] Schedule 1, entry for Carboplatin in the form Solution for I.V. injection 50 mg in 5 mL
[9] Schedule 1, entry for Carvedilol in the form Tablet 3.125 mg
[10] Schedule 1, entry for Cisplatin
[11] Schedule 1, entry for Darunavir
[12] 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
[13] Schedule 1, entry for Doxorubicin
[16] Schedule 1, entry for Enalapril in each of the forms: Tablet containing enalapril maleate 5 mg; and Tablet containing enalapril maleate 10 mg
[17] 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
[18] Schedule 1, entry for Etravirine
[19] Schedule 1, entry for Glucose Indicator—Blood
Test strips, 50 (Advantage II)
[20] Schedule 1, entry for Irinotecan in the form I.V. injection containing irinotecan hydrochloride trihydrate 40 mg in 2 mL
[21] Schedule 1, entry for Letrozole in the form Tablet 2.5 mg
Letrozole-Synthon
[22] Schedule 1, entry for Lisinopril in each of the forms: Tablet 5 mg; Tablet 10 mg; and Tablet 20 mg
[23] Schedule 1, entry for Metformin in the form Tablet containing metformin hydrochloride 500 mg
[24] Schedule 1, entry for Metformin in the form Tablet containing metformin hydrochloride 850 mg
[26] Schedule 1, entry for Mirtazapine in the form Tablet 15 mg (orally disintegrating)
[27] Schedule 1, entry for Mirtazapine in the form Tablet 30 mg
[28] Schedule 1, entry for Mirtazapine in the form Tablet 30 mg (orally disintegrating)
[29] Schedule 1, entry for Mirtazapine in the form Tablet 45 mg
Aurozapine 45
[30] Schedule 1, entry for Mirtazapine in the form Tablet 45 mg (orally disintegrating)
[31] Schedule 1, entry for Mitozantrone
[32] Schedule 1, entry for Mitozantrone in the form Injection 25 mg (as hydrochloride) in 12.5 mL
[33] Schedule 1, entry for Mycophenolic Acid in the form Tablet containing mycophenolate mofetil 500 mg [Max Quantity 150; Number of Repeats 3]
Pharmacor Mycophenolate 500
[34] Schedule 1, entry for Mycophenolic Acid in the form Tablet containing mycophenolate mofetil 500 mg [Max Quantity 300; Number of Repeats 5]
[35] Schedule 1, entry for Naproxen
C2270 C2271 C3647 C3648
P2270 P2271 P3647
[36] Schedule 1, entry for Natalizumab
Solution concentrate for I.V. infusion 300 mg in 15 mL
C3423 C3424 C3425
[37] 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)
Olanzapine ODT generichealth 5
Olanzapine Sandoz ODT 5
Olanzapine ODT generichealth 10
Olanzapine Sandoz ODT 10
[40] Schedule 1, entry for Ondansetron in the form Tablet 4 mg (as hydrochloride dihydrate)
Ondasetron-DRLA
Ondansetron Tabs Pfizer
Zilfojim 4
[41] Schedule 1, entry for Ondansetron in the form Tablet 8 mg (as hydrochloride dihydrate)
Zilfojim 8
[42] Schedule 1, entry for Ondansetron in the form I.V. injection 4 mg (as hydrochloride dihydrate) in 2 mL
[43] Schedule 1, entry for Ondansetron in the form I.V. injection 8 mg (as hydrochloride dihydrate) in 4 mL
[44] Schedule 1, entry for Oxaliplatin in the form Powder for I.V. infusion 100 mg
[45] Schedule 1, entry for Pantoprazole in the form Tablet (enteric coated) 40 mg (as sodium sesquihydrate) [Max Quantity 30; Number of Repeats 2]
Torzole 40
[46] Schedule 1, entry for Pantoprazole in the form Tablet (enteric coated) 40 mg (as sodium sesquihydrate) [Max Quantity 30; Number of Repeats 5]
[47] Schedule 1, entry for Pantoprazole in the form Tablet (enteric coated) 20 mg (as sodium sesquihydrate)
Torzole 20
[48] Schedule 1, entry for Pimecrolimus
omit from the column headed “Responsible Person”: NV substitute: HM
[49] Schedule 1, entry for Pravastatin in the form Tablet containing pravastatin sodium 10 mg [Max Quantity 30; Number of Repeats 5]
Pravastatin Actavis 10
[50] Schedule 1, entry for Pravastatin in the form Tablet containing pravastatin sodium 10 mg [Max Quantity 30; Number of Repeats 11]
[51] Schedule 1, entry for Pravastatin in the form Tablet containing pravastatin sodium 20 mg [Max Quantity 30; Number of Repeats 5]
Pravastatin Actavis 20
[52] Schedule 1, entry for Pravastatin in the form Tablet containing pravastatin sodium 20 mg [Max Quantity 30; Number of Repeats 11]
[53] Schedule 1, entry for Pravastatin in the form Tablet containing pravastatin sodium 40 mg [Max Quantity 30; Number of Repeats 5]
Pravastatin Actavis 40
[54] Schedule 1, entry for Pravastatin in the form Tablet containing pravastatin sodium 40 mg [Max Quantity 30; Number of Repeats 11]
[55] Schedule 1, entry for Promethazine
Tablet containing promethazine hydrochloride 10 mg
C3640 C3641
Tablet containing promethazine hydrochloride 25 mg
Oral liquid containing promethazine hydrochloride 5 mg per 5 mL, 100 mL
[56] Schedule 1, entry for Quetiapine in the form Tablet 25 mg (as fumarate)
Seronia 25
[57] Schedule 1, entry for Quetiapine in the form Tablet 100 mg (as fumarate)
Seronia 100
[58] Schedule 1, entry for Quetiapine in the form Tablet 200 mg (as fumarate)
Seronia 200
[59] Schedule 1, entry for Quetiapine in the form Tablet 300 mg (as fumarate)
Seronia 300
[60] 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)
Filpril
[61] Schedule 1, entry for Ramipril in the form Tablet 1.25 mg
Ramipril Tabs Pfizer
Vascalace 1.25
[62] Schedule 1, entry for Ramipril in the form Tablet 2.5 mg
Vascalace 2.5
[63] Schedule 1, entry for Ramipril in the form Tablet 5 mg
Vascalace 5
[64] Schedule 1, entry for Ramipril in the form Tablet 10 mg
Vascalace 10
[65] Schedule 1, entry for Risperidone in the form Tablet 0.5 mg [Max Quantity 60; Number of Repeats 2]
Risperidone Actavis 0.5
[66] Schedule 1, entry for Risperidone in the form Tablet 0.5 mg [Max Quantity 60; Number of Repeats 5]
[67] Schedule 1, entry for Risperidone in the form Tablet 1 mg [Max Quantity 60; Number of Repeats 2]
Risperidone Actavis 1
[68] Schedule 1, entry for Risperidone in the form Tablet 1 mg [Max Quantity 60; Number of Repeats 5]
[69] Schedule 1, entry for Risperidone in the form Tablet 2 mg [Max Quantity 60; Number of Repeats 2]
Risperidone Actavis 2
[70] Schedule 1, entry for Risperidone in the form Tablet 2 mg [Max Quantity 60; Number of Repeats 5]
[71] Schedule 1, entry for Risperidone in the form Tablet 3 mg
Risperidone Actavis 3
[72] Schedule 1, entry for Risperidone in the form Tablet 4 mg
Risperidone Actavis 4
[73] Schedule 1, entry for Sertraline in the form Tablet 50 mg (as hydrochloride)
[74] Schedule 1, entry for Simvastatin in the form Tablet 10 mg [Max Quantity 30; Number of Repeats 5]
Synthon Simvastatin
[75] Schedule 1, entry for Simvastatin in the form Tablet 10 mg [Max Quantity 30; Number of Repeats 11]
[76] Schedule 1, entry for Simvastatin in the form Tablet 20 mg [Max Quantity 30; Number of Repeats 5]
[77] Schedule 1, entry for Simvastatin in the form Tablet 20 mg [Max Quantity 30; Number of Repeats 11]
[78] 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
[79] Schedule 1, entry for Simvastatin in the form Tablet 40 mg [Max Quantity 30; Number of Repeats 11]
[80] Schedule 1, entry for Simvastatin in the form Tablet 80 mg [Max Quantity 30; Number of Repeats 5]
[81] Schedule 1, entry for Simvastatin in the form Tablet 80 mg [Max Quantity 30; Number of Repeats 11]
[82] Schedule 1, entry for Topiramate in each of the forms: Tablet 25 mg; and Tablet 50 mg
Topiramate generichealth
[83] Schedule 1, entry for Topiramate in each of the forms: Tablet 100 mg; and Tablet 200 mg
C3622 C3623 C3624 C3631 C3632
[85] Schedule 1, entry for Venlafaxine in the form Capsule (modified release) 37.5 mg (as hydrochloride)
[86] 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)
[87] Schedule 1, entry for Vincristine in the form I.V. injection containing vincristine sulfate 1 mg in 1 mL
[88] Schedule 3, details relevant to Responsible person code GZ
[89] Schedule 3, after details relevant to Responsible person code HL
59 155 308 679
[90] Schedule 3, after details relevant to Responsible person code XF
The Medicines Company (Australia) Pty Limited
74 138 555 021
[91] Schedule 3, after details relevant to Responsible person code ZP
Synthon A.U. Pty Ltd
58 080 948 698
[92] Schedule 4, Part 1, entry for Clopidogrel [Circumstances Code C3879]
omit all text from the column headed “Authority Requirements – Part of Circumstances” and substitute:
Authority Required procedures – Streamlined Authority
[93] Schedule 4, Part 1, entry for Clopidogrel with aspirin [Circumstances Code C3880]
[94] Schedule 4, Part 1, entry for Deferasirox [Circumstances Code C3828]
Written or Telephone
[95] Schedule 4, Part 1, entry for Filgrastim [Circumstances Code C3834]
[96] Schedule 4, Part 1, after entry for Naratriptan
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
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.
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
[97] Schedule 4, Part 1, entry for Pegfilgrastim [Circumstances Code C3834]
[98] Schedule 4, Part 1, omit entry for Promethazine
[99] Schedule 4, Part 1, entry for Risperidone [Circumstances Code C3841]
omit from the column headed “Authority Requirements – Part of Circumstances”: C3841 substitute: 3841
[100] 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