National Health (Listing of Pharmaceutical Benefits) Amendment Instrument 2013 (No. 1) (No. PB 1 of 2013)

Link to law: https://www.comlaw.gov.au/Details/F2013L00039

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PB 1 of 2013
National Health (Listing of Pharmaceutical Benefits) Amendment Instrument 2013
(No. 1)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 8 January 2013
 
 
 
 
 
 
 
 
 
 
 
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 2013 (No. 1).
            (2)        This Instrument may also be cited as PB 1 of 2013.
2          Commencement
This Instrument commences on 1 February 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, column headed “Determined Quantity”
omit values in all instances where displayed in the column headed “Determined Quantity” for all Listed Drugs, except for:
Methoxyflurane
which retains the value “1” in the column headed “Determined Quantity”
[2]           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”:
 
 
 
Fonat
AL
MP NP
C4122 C4123 C4133
 
4
5
4
 
 
[3]           Schedule 1, entry for Atenolol in the form Tablet 50 mg
omit from the column headed “Brand”:         Atenolol generichealth             substitute:             Atenolol GH
[4]           Schedule 1, entry for Clopidogrel in the form Tablet 75 mg (as hydrogen sulfate)
omit from the column headed “Responsible Person” for the brand “Iscover”:     BQ       substitute:             AV
[5]           Schedule 1, entry for Clopidogrel with aspirin in the form Tablet 75 mg (as hydrogen sulfate)-100 mg
omit from the column headed “Responsible Person” for the brand “DuoCover”:            BQ       substitute:             AV
[6]           Schedule 1, entry for Cyproterone in the form Tablet containing cyproterone acetate 50 mg [Max Quantity 20; Number of Repeats 5]
insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
 
 
 
Cyproterone Sandoz
HX
MP
C1014 C1230 C1404
P1230
20
5
20
 
[7]           Schedule 1, entry for Cyproterone in the form Tablet containing cyproterone acetate 50 mg [Max Quantity 100; Number of Repeats 5]
insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
 
 
 
Cyproterone Sandoz
HX
MP
C1014 C1230 C1404
P1014 P1404
100
5
50
 
 
[8]           Schedule 1, entry for Exemestane
insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
 
 
 
Exemestane-GA
GM
MP NP
C1541 C2457
 
30
5
30
 
 
[9]           Schedule 1, entry for Fludarabine in the form Solution for I.V. injection 50 mg fludarabine phosphate in 2 mL
insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
 
 
 
AS-Fludarabine
YA
MP
C3887
 
See Note 3
See Note 3
5
PB(100)
[10]         Schedule 1, entry for Gabapentin in each of the forms: Capsule 100 mg; Capsule 300 mg; Capsule 400 mg; and Tablet 800 mg
insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
 
 
 
Gabapentin Pfizer
FZ
MP NP
C2664
 
100
5
100
 
 
[11]         Schedule 1, entry for Gemcitabine in each of the forms: Powder for I.V. infusion 200 mg (as hydrochloride); Powder for I.V. infusion 1 g (as hydrochloride); and Powder for I.V. infusion 2 g (as hydrochloride)
insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
 
 
 
AS-Gemcitabine
YA
MP
 
See Note 3
See Note 3
1
 
D(100)
[12]         Schedule 1, entry for Irbesartan in each of the forms: Tablet 75 mg; Tablet 150 mg; and Tablet 300 mg
omit from the column headed “Responsible Person” for the brand “Avapro”:     BQ       substitute:             AV
[13]         Schedule 1, entry for Irbesartan with Hydrochlorothiazide in the form Tablet 150 mg-12.5 mg
omit from the column headed “Responsible Person” for the brand “Avapro HCT 150/12.5”:          BQ       substitute:             AV
[14]         Schedule 1, entry for Irbesartan with Hydrochlorothiazide in the form Tablet 300 mg-12.5 mg
omit from the column headed “Responsible Person” for the brand “Avapro HCT 300/12.5”:          BQ       substitute:             AV
[15]         Schedule 1, entry for Irbesartan with Hydrochlorothiazide in the form Tablet 300 mg-25 mg
omit from the column headed “Responsible Person” for the brand “Avapro HCT 300/25”:             BQ       substitute:             AV
[16]         Schedule 1, entry for Lercanidipine in each of the forms: Tablet containing lercanidipine hydrochloride 10 mg; and Tablet containing lercanidipine hydrochloride 20 mg
insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
 
 
 
Ledip
RA
MP NP
 
28
5
28
 
 
[17]         Schedule 1, entry for Letrozole
insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
 
 
 
Pharmacy Choice Letrozole
RI
MP NP
C1608 C2691 C2692
 
30
5
30
 
 
[18]         Schedule 1, entry for Lisinopril in the form Tablet 5 mg
omit:
 
 
 
Prinivil 5
MK
MP NP
 
30
5
30
 
 
[19]         Schedule 1, entry for Metronidazole
omit:
 
I.V. infusion 500 mg in 100 mL
Injection
Baxter Healthcare Pty Ltd
BX
MP NP
C1300 C1448
 
10
0
10
 
 

 
 
 
 
 
PDP
1448
 
10
0
10
 
 

 
 
 
DBL Metronidazole Intravenous Infusion
HH
MP NP
C1300 C1448
 
10
0
10
 
 

 
 
 
 
 
PDP
1448
 
10
0
10
 
 

substitute:
 
I.V. infusion 500 mg in 100 mL
Injection
Baxter Healthcare Pty Ltd
BX
MP NP
C4167 C4168 C4169
 
10
0
1
 
 

 
 
 
 
 
PDP
C4169
 
10
0
1
 
 

 
 
 
DBL Metronidazole Intravenous Infusion
HH
MP NP
C4167 C4168 C4169
 
10
0
10
 
 

 
 
 
 
 
PDP
C4169
 
10
0
10
 
 

 
 
 
Metronidazole-Claris
AE
MP NP
C4167 C4168 C4169
 
10
0
5
 
 

 
 
 
 
 
PDP
C4169
 
10
0
5
 
 

[20]         Schedule 1, entry for Nebivolol
omit from the column headed “Responsible Person” (all instances):      CS        substitute:             FK
[21]         Schedule 1, entry for Oxaliplatin in each of the forms: Solution concentrate for I.V. infusion 50 mg in 10 mL; Solution concentrate for I.V. infusion 100 mg in 20 mL; and Solution concentrate for I.V. infusion 200 mg in 40 mL
insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
 
 
 
AS-Oxaliplatin
YA
MP
C3900 C3901 C3930 C3939
 
See Note 3
See Note 3
1
 
D(100)
[22]         Schedule 1, entry for Oxybutynin in the form Transdermal patches 36 mg, 8
omit from the column headed “Responsible Person”:             HH        substitute:             GM
[23]         Schedule 1, entry for Paclitaxel in each of the forms: Solution concentrate for I.V. infusion 30 mg in 5 mL; Solution concentrate for I.V. infusion 100 mg in 16.7 mL; and Solution concentrate for I.V. infusion 300 mg in 50 mL
insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
 
 
 
GN-Paclitaxel
YA
MP
C3186 C3890 C3902 C3917 C3955 C3956
 
See Note 3
See Note 3
1
 
D(100)
[24]         Schedule 1, entry for Pravastatin in the form Tablet containing pravastatin sodium 10 mg [Max Quantity 30; Number of Repeats 5]
omit:
 
 
 
Pravastatin Winthrop
WA
MP
C1540 C3047
P1540
30
5
30
 

 
 
 
 
 
NP
C1540
 
30
5
30
 
 

[25]         Schedule 1, entry for Pravastatin in the form Tablet containing pravastatin sodium 10 mg [Max Quantity 30; Number of Repeats 11]
omit:
 
 
 
Pravastatin Winthrop
WA
MP
C1540 C3047
P3047
30
11
30
 
 
[26]         Schedule 1, entry for Pravastatin in the form Tablet containing pravastatin sodium 20 mg [Max Quantity 30; Number of Repeats 5]
omit:
 
 
 
Pravastatin Winthrop
WA
MP
C1540 C3047
P1540
30
5
30
 
 

 
 
 
 
 
NP
C1540
 
30
5
30
 
 

[27]         Schedule 1, entry for Pravastatin in the form Tablet containing pravastatin sodium 20 mg [Max Quantity 30; Number of Repeats 11]
omit:
 
 
 
Pravastatin Winthrop
WA
MP
C1540 C3047
P3047
30
11
30
 
 
[28]         Schedule 1, entry for Pravastatin in the form Tablet containing pravastatin sodium 40 mg [Max Quantity 30; Number of Repeats 5]
omit:
 
 
 
Pravastatin Winthrop
WA
MP
C1540 C3047
P1540
30
5
30
 
 

 
 
 
 
 
NP
C1540
 
30
5
30
 
 

[29]         Schedule 1, entry for Pravastatin in the form Tablet containing pravastatin sodium 40 mg [Max Quantity 30; Number of Repeats 11]
omit:
 
 
 
Pravastatin Winthrop
WA
MP
C1540 C3047
P3047
30
11
30
 
 
[30]         Schedule 1, entry for Simvastatin in the form Tablet 10 mg [Max Quantity 30; Number of Repeats 5]
omit:
 
 
 
Simvastatin Winthrop
WA
MP
C1540 C3047
P1540
30
5
30
 
 

 
 
 
 
 
NP
C1540
 
30
5
30
 
 

[31]         Schedule 1, entry for Simvastatin in the form Tablet 10 mg [Max Quantity 30; Number of Repeats 11]
omit:
 
 
 
Simvastatin Winthrop
WA
MP
C1540 C3047
P3047
30
11
30
 
 
[32]         Schedule 1, entry for Simvastatin in the form Tablet 20 mg [Max Quantity 30; Number of Repeats 5]
omit:
 
 
 
Simvastatin Winthrop
WA
MP
C1540 C3047
P1540
30
5
30
 
 

 
 
 
 
 
NP
C1540
 
30
5
30
 
 

[33]         Schedule 1, entry for Simvastatin in the form Tablet 20 mg [Max Quantity 30; Number of Repeats 11]
omit:
 
 
 
Simvastatin Winthrop
WA
MP
C1540 C3047
P3047
30
11
30
 
 
[34]         Schedule 1, entry for Simvastatin in the form Tablet 40 mg [Max Quantity 30; Number of Repeats 5]
omit:
 
 
 
Simvastatin Winthrop
WA
MP
C1540 C3047
P1540
30
5
30
 
 

 
 
 
 
 
NP
C1540
 
30
5
30
 
 

[35]         Schedule 1, entry for Simvastatin in the form Tablet 40 mg [Max Quantity 30; Number of Repeats 11]
omit:
 
 
 
Simvastatin Winthrop
WA
MP
C1540 C3047
P3047
30
11
30
 
 
[36]         Schedule 1, entry for Simvastatin in the form Tablet 80 mg [Max Quantity 30; Number of Repeats 5]
omit:
 
 
 
Simvastatin Winthrop
WA
MP
C1540 C3047
P1540
30
5
30
 
 

 
 
 
 
 
NP
C1540
 
30
5
30
 
 

[37]         Schedule 1, entry for Simvastatin in the form Tablet 80 mg [Max Quantity 30; Number of Repeats 11]
omit:
 
 
 
Simvastatin Winthrop
WA
MP
C1540 C3047
P3047
30
11
30
 
 
[38]         Schedule 1, entry for Sumatriptan in the form Tablet 50 mg (as succinate) for the following brands only:
APO-Sumatriptan; Chem mart Sumatriptan; Imigran; Sumagran 50; Sumagran Aspen 50; Sumatab;
and Terry White Chemists Sumatriptan
omit from the column headed “Pack Quantity”:          4          substitute:             2
[39]         Schedule 1, entry for Testosterone in each of the forms: Transdermal patches 12.2 mg, 60; and Transdermal patches 24.3 mg, 30
omit from the column headed “Responsible Person”:             HH        substitute:             GM
[40]         Schedule 1, entry for Topotecan
insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
 
 
 
Topotecan Agila
YA
MP
C3186
 
See Note 3
See Note 3
5
D(100)
[41]         Schedule 1, entry for Tramadol in each of the forms: Tablet (sustained release) containing tramadol hydrochloride 100 mg; Tablet (sustained release) containing tramadol hydrochloride 150 mg; and Tablet (sustained release) containing tramadol hydrochloride 200 mg
insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
 
 
 
Tramadol SR generichealth
GQ
MP NP
C1537
 
20
0
20
 
[42]         Schedule 1, entry for Tramadol in the form Injection containing tramadol hydrochloride 100 mg in 2 mL
omit from the column headed “Brand”:         Tramahexal      substitute:             Tramadol Sandoz
[43]         Schedule 1, entry for Vinorelbine in each of the forms: Solution for I.V. infusion 10 mg (as tartrate) in 1 mL; and Solution for I.V. infusion 50 mg (as tartrate) in 5 mL
insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
 
 
 
AS-Vinorelbine
YA
MP
C3890 C3907
 
See Note 3
See Note 3
1
PB(100)
[44]         Schedule 3, details relevant to Responsible person code FK
omit:       Invida Australia Pty Ltd            substitute:             A.Menarini Australia Pty Ltd
[45]         Schedule 3, after details relevant to Responsible person code XM
insert:
YA
Agila Australasia Pty Ltd
 12 154 055 339
[46]         Schedule 4, Part 1, entry for Metronidazole
substitute:

Metronidazole
 
P1416
 
Treatment of anaerobic infections
 

 
C4167
 
 
Acute anaerobic sepsis
Must be treated in a hospital
 

 
C4168
 
 
Prophylaxis to prevent infection
Patient must be undergoing large bowel surgery
 

 
C4169
 
 
Acute anaerobic sepsis
Must be treated in a hospital
 

 
 
 
 
 
 
 
 
 
 
1Note
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See http://www.comlaw.gov.au