National Health (Listing of Pharmaceutical Benefits) Amendment Instrument 2012 (No. 9) (No. PB 108 of 2012) (Cth)

Case

PB 108 of 2012

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

  1. Schedule 1, entry for Bicalutamide

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

  1. 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

  1. 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

  1. 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

  1. 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

  1. 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

  1. 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

  1. 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

  1. 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

  1. 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

  1. Schedule 1, entry for Fluoxetine in the form Capsule 20 mg (as hydrochloride)

omit from the column headed “Brand”:         Auscap substitute:             Auscap Aspen

  1. 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

  1. 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

  1. 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

  1. 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

  1. 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
See Note 1 		C1650 C1651 C3355 C3356 600 5 100 C(100)

  1. 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
See Note 1 		C1650 C1651 C3355 C3356 300 5 50 C(100)

  1. 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

  1. 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

  1. 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

  1. 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

  1. 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

  1. 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

  1. 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

  1. 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

  1. 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

  1. 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

  1. 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

  1. 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

  1. 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

  1. 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

  1. 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

  1. 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

  1. 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

  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)

omit from the column headed “Brand”:         STADA Venlafaxine SR substitute:          STADA Venlafaxine-SR

  1. Schedule 3

omit:

NH Nycomed Healthcare Pty Limited  55 140 659 374

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

omit:       Nycomed Pty Ltd             substitute:             Takeda Pharmaceuticals Australia Pty Ltd

  1. Schedule 3

omit:

NZ Nycomed Services Pty Limited  15 140 661 123

  1. 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

  1. 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
Authority Required procedures – Streamlined Authority
Code 3879

(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.

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