National Health (Listing of Pharmaceutical Benefits) Amendment Instrument 2012
(No. 9)1
National Health Act 1953
I, FELICITY McNEILL, First Assistant Secretary, Pharmaceutical Benefits Division, Department of Health and Ageing, delegate of the Minister for Health, make this Instrument under sections 84AF, 84AK, 85, 85A, 88 and 101 of the National Health Act 1953.
Dated 11th December 2012
FELICITY McNEILL
First Assistant Secretary
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. 9).
(2) This Instrument may also be cited as PB 108 of 2012.
2 Commencement
This Instrument commences on 1 January 2013.
3 Amendment of National Health (Listing of Pharmaceutical Benefits) Instrument 2012 (PB 71 of 2012)
Schedule 1 amends the National Health (Listing of Pharmaceutical Benefits) Instrument 2012 (PB 71 of 2012).
Schedule 1 Amendments
[1] Schedule 1, entry for Betamethasone
omit:
| Ointment 500 micrograms (as valerate) per g, 15 g | Application | Betnovate 1/2 | QA | MP NP | C1422 |
| 1 | 1 | 1 |
|
|
|
|
| Cortival 1/2 | FM | MP NP | C1422 |
| 1 | 1 | 1 |
|
|
[2] Schedule 1, entry for Bicalutamide
omit from the column headed “Responsible Person” for the brand “Cosudex”: SZ substitute: AP
[3] Schedule 1, entry for Clopidogrel in the form Tablet 75 mg (as hydrogen sulfate)
omit from the column headed “Circumstances” for the brands “APO-Clopidogrel”, Clopidogrel Winthrop”, “Iscover” and “Plavix”:
C3146 | C3879 |
insert in numerical order:
C4165 | C4166 |
[4] Schedule 1, entry for Clopidogrel in the form Tablet 75 mg (as besilate)
insert in numerical order in the column headed “Circumstances” for the brand “Clovix 75”:
C4165 | C4166 |
[5] Schedule 1, entry for Famciclovir in the form Tablet 500 mg [Max Quantity 56; Number of Repeats 5]
insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
|
|
| Famciclovir generichealth 500 | GQ | MP NP | C3626 C3627 C3628 C3629 | P3626 P3627 P3628 P3629 | 56 | 5 | 56 |
|
|
[6] Schedule 1, entry for Felodipine in each of the forms: Tablet 2.5 mg (extended release); Tablet 5 mg (extended release); and
Tablet 10 mg (extended release)
insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
|
|
| Fendex ER | AF | MP NP |
|
| 30 | 5 | 30 |
|
|
[7] Schedule 1, entry for Fentanyl in the form Transdermal patch 2.063 mg
insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
|
|
| Dutran 12 | GM | MP NP | C1062 |
| 5 | 0 | 5 |
|
|
[8] Schedule 1, entry for Fentanyl in the form Transdermal patch 4.125 mg
insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
|
|
| Dutran 25 | GM | MP NP | C1062 |
| 5 | 0 | 5 |
|
|
[9] Schedule 1, entry for Fentanyl in the form Transdermal patch 8.25 mg
insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
|
|
| Dutran 50 | GM | MP NP | C1062 |
| 5 | 0 | 5 |
|
|
[10] Schedule 1, entry for Fentanyl in the form Transdermal patch 12.375 mg
insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
|
|
| Dutran 75 | GM | MP NP | C1062 |
| 5 | 0 | 5 |
|
|
[11] Schedule 1, entry for Fentanyl in the form Transdermal patch 16.5 mg
insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
|
|
| Dutran 100 | GM | MP NP | C1062 |
| 5 | 0 | 5 |
|
|
[12] Schedule 1, entry for Fluoxetine in the form Capsule 20 mg (as hydrochloride)
omit from the column headed “Brand”: Auscap substitute: Auscap Aspen
[13] Schedule 1, entry for Lamotrigine in the form Tablet 25 mg
insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
|
|
| Lamotrigine Aspen 25 | AS | MP NP | C1426 |
| 56 | 5 | 56 |
|
|
[14] Schedule 1, entry for Lamotrigine in the form Tablet 100 mg
insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
|
|
| Lamotrigine Aspen 100 | AS | MP NP | C1426 |
| 56 | 5 | 56 |
|
|
[15] Schedule 1, entry for Macrogol 3350 in the form Powder for oral solution 510 g
(a) omit:
|
|
| your pharmacy Clear Laxative | OY | MP NP | C1263 C1613 C2693 C2823 C3642 C3643 | P3643 | 2 | 0 | 1 |
|
|
(b) omit:
|
|
| your pharmacy Clear Laxative | OY | MP NP | C1263 C1613 C2693 C2823 C3642 C3643 | P3642 | 2 | 3 | 1 |
|
|
(c) omit:
|
|
| your pharmacy Clear Laxative | OY | MP NP | C1263 C1613 C2693 C2823 C3642 C3643 | P1263 P1613 P2693 P2823 | 1 | 5 | 1 |
|
|
[16] Schedule 1, entry for Mirtazapine in each of the forms: Tablet 15 mg (orally disintegrating); Tablet 30 mg (orally disintegrating);
and Tablet 45 mg (orally disintegrating)
omit from the column headed “Brand”: Mirtazapine Pfizer substitute: Mirtazapine Dispersible Pfizer
[17] Schedule 1, entry for Mycophenolic Acid in the form Capsule containing mycophenolate mofetil 250 mg
(a) omit:
|
|
| Cellplant | WQ | MP | C1765 C1766 |
| 300 | 3 | 100 |
|
|
(b) omit:
|
|
| Cellplant | WQ | MP | C1650 C1651 C3355 C3356 |
| 600 | 5 | 100 |
| C(100) |
[18] Schedule 1, entry for Mycophenolic Acid in the form Capsule containing mycophenolate mofetil 500 mg
(a) omit:
|
|
| Cellplant | WQ | MP | C1765 C1766 |
| 150 | 3 | 50 |
|
|
(b) omit:
|
|
| Cellplant | WQ | MP | C1650 C1651 C3355 C3356 |
| 300 | 5 | 50 |
| C(100) |
[19] Schedule 1, entry for Pantoprazole in the form Tablet (enteric coated) 40 mg (as sodium sesquihydrate) [Max Quantity 30; Number of Repeats 2]
(a) omit from the column headed “Responsible Person” for the brand “Panto”: NZ substitute: TK
(b) omit from the column headed “Responsible Person” for the brand “Pantoloc”: NH substitute: TE
[20] Schedule 1, entry for Pantoprazole in the form Tablet (enteric coated) 40 mg (as sodium sesquihydrate) [Max Quantity 30; Number of Repeats 5]
(a) omit from the column headed “Responsible Person” for the brand “Panto”: NZ substitute: TK
(b) omit from the column headed “Responsible Person” for the brand “Pantoloc”: NH substitute: TE
[21] Schedule 1, entry for Pantoprazole in the form Tablet (enteric coated) 20 mg (as sodium sesquihydrate)
(a) omit from the column headed “Responsible Person” for the brand “Panto”: NZ substitute: TK
(b) omit from the column headed “Responsible Person” for the brand “Pantoloc”: NH substitute: TE
[22] Schedule 1, entry for Rabeprazole in the form Tablet containing rabeprazole sodium 10 mg (enteric coated)
(a) omit from the column headed “Brand”: Parzole 10 substitute: Parzol 10
(b) insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
|
|
| Razit 10 | DO | MP NP | C1337 C1533 |
| 28 | 5 | 28 |
|
|
[23] Schedule 1, entry for Rabeprazole in the form Tablet containing rabeprazole sodium 20 mg (enteric coated) [Max Quantity 30; Number of Repeats 2]
(a) omit from the column headed “Brand”: Parzole 20 substitute: Parzol 20
(b) insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
|
|
| Razit 20 | DO | MP NP | C1177 C1337 C1533 | P1177 | 30 | 2 | 30 |
|
|
(c) insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
|
|
| STADA Rabeprazole | TD | MP NP | C1177 C1337 C1533 | P1177 | 30 | 2 | 30 |
|
|
[24] Schedule 1, entry for Rabeprazole in the form Tablet containing rabeprazole sodium 20 mg (enteric coated) [Max Quantity 30; Number of Repeats 5]
(a) omit from the column headed “Brand”: Parzole 20 substitute: Parzol 20
(b) insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
|
|
| Razit 20 | DO | MP NP | C1177 C1337 C1533 | P1337 P1533 | 30 | 5 | 30 |
|
|
(c) insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
|
|
| STADA Rabeprazole | TD | MP NP | C1177 C1337 C1533 | P1337 P1533 | 30 | 5 | 30 |
|
|
[25] Schedule 1, entry for Risperidone in the form Tablet 0.5 mg [Max Quantity 60; Number of Repeats 2]
(a) omit:
|
|
| Resdone 0.5 | CR | MP NP | C1589 C2061 C3083 | P2061 P3083 | 60 | 2 | 60 |
|
|
(b) insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
|
|
| Rispericor 0.5 | CR | MP NP | C1589 C2061 C3083 | P2061 P3083 | 60 | 2 | 60 |
|
|
[26] Schedule 1, entry for Risperidone in the form Tablet 0.5 mg [Max Quantity 60; Number of Repeats 5]
(a) omit:
|
|
| Resdone 0.5 | CR | MP NP | C1589 C2061 C3083 | P1589 | 60 | 5 | 60 |
|
|
(b) insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
|
|
| Rispericor 0.5 | CR | MP NP | C1589 C2061 C3083 | P1589 | 60 | 5 | 60 |
|
|
[27] Schedule 1, entry for Risperidone in the form Tablet 1 mg [Max Quantity 60; Number of Repeats 2]
(a) omit:
|
|
| Resdone 1 | CR | MP NP | C1589 C2061 C2272 C3083 | P2061 P3083 | 60 | 2 | 60 |
|
|
(b) insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
|
|
| Rispericor 1 | CR | MP NP | C1589 C2061 C2272 C3083 | P2061 P3083 | 60 | 2 | 60 |
|
|
[28] Schedule 1, entry for Risperidone in the form Tablet 1 mg [Max Quantity 60; Number of Repeats 5]
(a) omit:
|
|
| Resdone 1 | CR | MP NP | C1589 C2061 C2272 C3083 | P1589 P2272 | 60 | 5 | 60 |
|
|
(b) insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
|
|
| Rispericor 1 | CR | MP NP | C1589 C2061 C2272 C3083 | P1589 P2272 | 60 | 5 | 60 |
|
|
[29] Schedule 1, entry for Risperidone in the form Tablet 2 mg [Max Quantity 60; Number of Repeats 2]
(a) omit:
|
|
| Resdone 2 | CR | MP NP | C1589 C2272 C3083 | P3083 | 60 | 2 | 60 |
|
|
(b) insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
|
|
| Rispericor 2 | CR | MP NP | C1589 C2272 C3083 | P3083 | 60 | 2 | 60 |
|
|
[30] Schedule 1, entry for Risperidone in the form Tablet 2 mg [Max Quantity 60; Number of Repeats 5]
(a) omit:
|
|
| Resdone 2 | CR | MP NP | C1589 C2272 C3083 | P1589 P2272 | 60 | 5 | 60 |
|
|
(b) insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
|
|
| Rispericor 2 | CR | MP NP | C1589 C2272 C3083 | P1589 P2272 | 60 | 5 | 60 |
|
|
[31] Schedule 1, entry for Risperidone in the form Tablet 3 mg
(a) omit:
|
|
| Resdone 3 | CR | MP NP | C1589 C2272 |
| 60 | 5 | 60 |
|
|
(b) insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
|
|
| Rispericor 3 | CR | MP NP | C1589 C2272 |
| 60 | 5 | 60 |
|
|
[32] Schedule 1, entry for Risperidone in the form Tablet 4 mg
(a) omit:
|
|
| Resdone 4 | CR | MP NP | C1589 C2272 |
| 60 | 5 | 60 |
|
|
(b) insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
|
|
| Rispericor 4 | CR | MP NP | C1589 C2272 |
| 60 | 5 | 60 |
|
|
[33] Schedule 1, entry for Terbinafine in the form Tablet 250 mg (as hydrochloride)
(a) omit:
|
|
| Terbix 250 | MI | MP NP | C2191 C2865 C3244 | P2865 P3244 | 42 | 0 | 42 |
|
|
(b) omit:
|
|
| Terbix 250 | MI | MP NP | C2191 C2865 C3244 | P2191 | 42 | 1 | 42 |
|
|
[34] Schedule 1, entry for Tramadol in the form Capsule containing tramadol hydrochloride 50 mg
(a) omit:
|
|
| GenRx Tramadol | GX | MP NP | C1497 C1615 | P1497 | 20 | 0 | 20 |
|
|
|
|
|
|
| PDP | C1497 C1615 |
| 20 | 0 | 20 |
|
|
(b) omit:
|
|
| GenRx Tramadol | GX | MP NP | C1497 C1615 | P1615 | 20 | 2 | 20 |
|
|
[35] Schedule 1, entry for Tramadol
(a) omit:
| Tablet (extended release) containing tramadol hydrochloride 100 mg | Oral | Durotram XR | IA | MP NP | C1537 |
| 10 | 0 | 10 |
|
|
(b) omit:
| Tablet (extended release) containing tramadol hydrochloride 200 mg | Oral | Durotram XR | IA | MP NP | C1537 |
| 10 | 0 | 10 |
|
|
(c) omit:
| Tablet (extended release) containing tramadol hydrochloride 300 mg | Oral | Durotram XR | IA | MP NP | C1537 |
| 10 | 0 | 10 |
|
|
[36] 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)
omit from the column headed “Brand”: STADA Venlafaxine SR substitute: STADA Venlafaxine-SR
[37] Schedule 3
omit:
NH | Nycomed Healthcare Pty Limited | 55 140 659 374 |
[38] Schedule 3, details relevant to Responsible person code NQ
omit: Nycomed Pty Ltd substitute: Takeda Pharmaceuticals Australia Pty Ltd
[39] Schedule 3
omit:
NZ | Nycomed Services Pty Limited | 15 140 661 123 |
[40] Schedule 3, after details relevant to Responsible person code TD
insert:
TE | Takeda Pharmaceuticals Australia Pty Ltd | 71 095 610 870 |
TK | Takeda Pharmaceuticals Australia Pty Ltd | 71 095 610 870 |
[41] Schedule 4, Part 1, entry for Clopidogrel
(a) omit:
| C3146 |
|
| Treatment in combination with aspirin following cardiac stent insertion | Compliance with Authority Required procedures - Streamlined Authority Code 3146 |
| C3879 |
|
| Treatment of acute coronary syndrome (myocardial infarction or unstable angina) in combination with aspirin | Compliance with |
(b) insert in numerical order following existing text:
| C4165 |
|
| Cardiac stent insertion The treatment must be in combination with aspirin; The treatment must follow insertion of a cardiac stent | Compliance with Authority Required procedures - Streamlined Authority Code 4165 |
| C4166 |
|
| Acute coronary syndrome (myocardial infarction or unstable angina) The treatment must be in combination with aspirin
| Compliance with Authority Required procedures - Streamlined Authority Code 4166 |
1Note
All legislative instruments and compilations are registered on the Federal Register of Legislative Instruments kept under the Legislative Instruments Act 2003.