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

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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
 
 

[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
See Note 1
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
See Note 1
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
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. 
See http://www.frli.gov.au.