National Health (Listing of Pharmaceutical Benefits) Amendment Instrument 2013 (No. 6) (No. PB 29 of 2013)

Link to law: https://www.comlaw.gov.au/Details/F2013L00843

Subscribe to a Global-Regulation Premium Membership Today!

Key Benefits:

Subscribe Now
PB 29 of 2013
National Health (Listing of Pharmaceutical Benefits) Amendment Instrument 2013
(No. 6)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 21 May 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. 6).
            (2)        This Instrument may also be cited as PB 29 of 2013.
2          Commencement
This Instrument commences on 1 June 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 Ampicillin in each of the forms: Powder for injection 500 mg (as sodium); and Powder for injection 1 g (as sodium)
omit from the column headed “Responsible Person” for the brand “Ibimycin” (all instances):        TS          substitute:             WQ
[2]           Schedule 1, entry for Carboplatin in each of the forms: Solution for I.V. injection 50 mg in 5 mL; Solution for I.V. injection 150 mg in 15 mL; and Solution for I.V. injection 450 mg in 45 mL
insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
 
 
 
Carbaccord
WQ
MP
 
See Note 3
See Note 3
1
D(100)
[3]           Schedule 1, entry for Ciprofloxacin in the form Tablet 250 mg (as hydrochloride)
omit:
 
 
 
Profloxin
HX
MP NP
C1143 C1431 C1432 C1572 C1573
 
14
0
14
 
 
[4]           Schedule 1, entry for Citalopram in the form Tablet 10 mg (as hydrobromide)
insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
 
 
 
Citalopram-GA
GN
MP NP
C1211
 
28
5
28
 
 
[5]           Schedule 1, entry for Citalopram in the form Tablet 40 mg (as hydrobromide)
insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
 
 
 
Citalopram-GA
GN
MP NP
C1211
 
28
5
28
 
 
[6]           Schedule 1, entry for Epoetin Beta
omit:
 
Injection 20,000 units in 0.6 mL pre-filled syringe
Injection
NeoRecormon
RO
MP
See Note 1
C1957 C3334
 
12
5
6
D(100)
[7]           Schedule 1, entry for Famciclovir in the form Tablet 500 mg [Maximum Quantity 56; Number of Repeats 5]
insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
 
 
 
Auro-Famciclovir 500
DO
MP NP
C3626 C3627 C3628 C3629
P3626 P3627 P3628 P3629
56
5
56
 
 
[8]           Schedule 1, entry for Felodipine in the form Tablet 2.5 mg (extended release)
omit from the column headed “Responsible Person” for the brand “Felodur ER 2.5 mg”:                                AL          substitute:                ZA
[9]           Schedule 1, entry for Felodipine in the form Tablet 5 mg (extended release)
omit from the column headed “Responsible Person” for the brand “Felodur ER 5 mg”:                   AL          substitute:             ZA
[10]         Schedule 1, entry for Felodipine in the form Tablet 10 mg (extended release)
omit from the column headed “Responsible Person” for the brand “Felodur ER 10 mg”:                 AL          substitute:             ZA
[11]         Schedule 1, entry for Flucloxacillin in each of the forms: Powder for injection 500 mg (as sodium); and Powder for injection 1 g
(as sodium)
omit from the column headed “Responsible Person” for the brand “Flubiclox” (all instances):      TS          substitute:             WQ
[12]         Schedule 1, entry for Gabapentin in the form Tablet 600 mg
insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
 
 
 
Gabapentin Aspen 600
FM
MP NP
C2664
 
100
5
100
 
 
[13]         Schedule 1, entry for Gabapentin in the form Tablet 800 mg
insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
 
 
 
Gabapentin Aspen 800
FM
MP NP
C2664
 
100
5
100
 
 
[14]         Schedule 1, entry for Gemcitabine in the form Powder for I.V. infusion 200 mg (as hydrochloride)
omit from the column headed “Responsible Person” for the brand “Gemcitabine Actavis”:             TA          substitute:             WQ
[15]         Schedule 1, entry for Gemcitabine in the form Powder for I.V. infusion 1 g (as hydrochloride)
omit from the column headed “Responsible Person” for the brand “Gemcitabine Actavis”:             TA          substitute:             WQ
[16]         Schedule 1, entry for Gemcitabine in the form 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”:
 
 
 
Gemcitabine Actavis 2000
WQ
MP
 
See Note 3
See Note 3
1
D(100)
[17]         Schedule 1, entry for Glucose Indicator―Blood
omit:
 
Test strips, 50 (TRUEbalance)
For external use
TRUEbalance
NX
MP NP
 
2
5
1
 
 

 
 
 
 
 
MP
 
P3035
2
11
1
 
 

 
Test strips, 50 (TRUEresult)
For external use
TRUEresult
NX
MP NP
 
 
2
5
1
 
 

 
 
 
 
 
MP
 
P3035
2
11
1
 
 

 
Test strips, 50 (TrueTrack)
For external use
TrueTrack
NX
MP NP
 
 
2
5
1
 
 

 
 
 
 
 
MP
 
P3035
2
11
1
 
 

[18]         Schedule 1, after entry for Glucose Indicator―Blood in the form Test strips, 100 (FreeStyle Optium)
insert in the columns in the order indicated:
 
Test strips, 100 (TRUEbalance)
For external use
TRUEbalance
NX
MP NP
 
1
5
1
 
 

 
 
 
 
 
MP
 
P3035
1
11
1
 
 

 
Test strips, 100 (TRUEresult)
For external use
TRUEresult
NX
MP NP
 
 
1
5
1
 
 

 
 
 
 
 
MP
 
P3035
1
11
1
 
 

 
Test strips, 100 (TRUEtrack)
For external use
TRUEtrack
NX
MP NP
 
 
1
5
1
 
 

 
 
 
 
 
MP
 
P3035
1
11
1
 
 

[19]         Schedule 1, entry for Lansoprazole
omit:
Lansoprazole
Tablet 30 mg (orally disintegrating)
Oral
Zoton FasTabs
PF
MP NP
C1177 C1337 C1533
P1177
28
1
28
 
 

 
 
 
 
 
MP NP
C1177 C1337 C1533
P1337 P1533
28
5
28
 
 

substitute:
Lansoprazole
Tablet 30 mg (orally disintegrating)
Oral
Zopral ODT
AF
MP NP
C1177 C1337 C1533
P1177
28
1
28
 
 

 
 
 
Zoton FasTabs
PF
MP NP
C1177 C1337 C1533
P1177
28
1
28
 
 

 
 
 
Zopral ODT
AF
MP NP
C1177 C1337 C1533
P1337 P1533
28
5
28
 
 

 
 
 
Zoton FasTabs
PF
MP NP
C1177 C1337 C1533
P1337 P1533
28
5
28
 
 

[20]         Schedule 1, entry for Lansoprazole in the form Tablet 15 mg (orally disintegrating)
insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
 
 
 
Zopral ODT
AF
MP NP
C1337 C1533
 
28
5
28
 
[21]         Schedule 1, entry for Naltrexone
omit from the column headed “Brand”:         Naltrexone generichealth             substitute:             Naltrexone GH
[22]         Schedule 1, entry for Rosuvastatin
substitute:
Rosuvastatin
Tablet 5 mg (as calcium)
Oral
APO-Rosuvastatin
TX
MP
C4225 C4228
P4228
30
5
30
 
 

 
 
 
 
 
NP
C4228
 
30
5
30
 
 

 
 
 
Cavstat
AF
MP
C1540 C3047 C4225 C4228
P1540 P4228
30
5
30
 
 

 
 
 
 
 
NP
C1540 C4228
 
30
5
30
 
 

 
 
 
Chem mart Rosuvastatin
CH
MP
C4225 C4228
P4228
30
5
30
 
 

 
 
 
 
 
NP
C4228
 
30
5
30
 
 

 
 
 
Crestor
AP
MP
C1540 C3047 C4225 C4228
P1540 P4228
30
5
30
 
 

 
 
 
 
 
NP
C1540 C4228
 
30
5
30
 
 

 
 
 
Rosuvastatin Actavis 5
WQ
MP
C1540 C3047 C4225 C4228
P1540 P4228
30
5
30
 
 

 
 
 
 
 
NP
C1540 C4228
 
30
5
30
 
 

 
 
 
Rosuvastatin GH
GQ
MP
C1540 C3047 C4225 C4228
P1540 P4228
30
5
30
 
 

 
 
 
 
 
NP
C1540 C4228
 
30
5
30
 
 

 
 
 
Rosuvastatin RBX
RA
MP
C4225 C4228
P4228
30
5
30
 
 

 
 
 
 
 
NP
C4228
 
30
5
30
 
 

 
 
 
Rosuvastatin Sandoz
SZ
MP
C4225 C4228
P4228
30
5
30
 
 

 
 
 
 
 
NP
C4228
 
30
5
30
 
 

 
 
 
Terry White Chemists Rosuvastatin
TW
MP
C4225 C4228
P4228
30
5
30
 
 

 
 
 
 
 
NP
C4228
 
30
5
30
 
 

 
 
 
APO-Rosuvastatin
TX
MP
C4225 C4228
P4225
30
11
30
 
 

 
 
 
Cavstat
AF
MP
C1540 C3047 C4225 C4228
P3047 P4225
30
11
30
 
 

 
 
 
Chem mart Rosuvastatin
CH
MP
C4225 C4228
P4225
30
11
30
 
 

 
 
 
Crestor
AP
MP
C1540 C3047 C4225 C4228
P3047 P4225
30
11
30
 
 

 
 
 
Rosuvastatin Actavis 5
WQ
MP
C1540 C3047 C4225 C4228
P3047 P4225
30
11
30
 
 

 
 
 
Rosuvastatin GH
GQ
MP
C1540 C3047 C4225 C4228
P3047 P4225
30
11
30
 
 

 
 
 
Rosuvastatin RBX
RA
MP
C4225 C4228
P4225
30
11
30
 
 

 
 
 
Rosuvastatin Sandoz
SZ
MP
C4225 C4228
P4225
30
11
30
 
 

 
 
 
Terry White Chemists Rosuvastatin
TW
MP
C4225 C4228
P4225
30
11
30
 
 

 
Tablet 10 mg (as calcium)
Oral
APO-Rosuvastatin
TX
MP
C4225 C4228
P4228
30
5
30
 
 

 
 
 
 
 
NP
C4228
 
30
5
30
 
 

 
 
 
Cavstat
AF
MP
C1540 C3047 C4225 C4228
P1540 P4228
30
5
30
 
 

 
 
 
 
 
NP
C1540 C4228
 
30
5
30
 
 

 
 
 
Chem mart Rosuvastatin
CH
MP
C4225 C4228
P4228
30
5
30
 
 

 
 
 
 
 
NP
C4228
 
30
5
30
 
 

 
 
 
Crestor
AP
MP
C1540 C3047 C4225 C4228
P1540 P4228
30
5
30
 
 

 
 
 
 
 
NP
C1540 C4228
 
30
5
30
 
 

 
 
 
Rosuvastatin Actavis 10
WQ
MP
C1540 C3047 C4225 C4228
P1540 P4228
30
5
30
 
 

 
 
 
 
 
NP
C1540 C4228
 
30
5
30
 
 

 
 
 
Rosuvastatin GH
GQ
MP
C1540 C3047 C4225 C4228
P1540 P4228
30
5
30
 
 

 
 
 
 
 
NP
C1540 C4228
 
30
5
30
 
 

 
 
 
Rosuvastatin RBX
RA
MP
C4225 C4228
P4228
30
5
30
 
 

 
 
 
 
 
NP
C4228
 
30
5
30
 
 

 
 
 
Rosuvastatin Sandoz
SZ
MP
C4225 C4228
P4228
30
5
30
 
 

 
 
 
 
 
NP
C4228
 
30
5
30
 
 

 
 
 
Terry White Chemists Rosuvastatin
TW
MP
C4225 C4228
P4228
30
5
30
 
 

 
 
 
 
 
NP
C4228
 
30
5
30
 
 

 
 
 
APO-Rosuvastatin
TX
MP
C4225 C4228
P4225
30
11
30
 
 

 
 
 
Cavstat
AF
MP
C1540 C3047 C4225 C4228
P3047 P4225
30
11
30
 
 

 
 
 
Chem mart Rosuvastatin
CH
MP
C4225 C4228
P4225
30
11
30
 
 

 
 
 
Crestor
AP
MP
C1540 C3047 C4225 C4228
P3047 P4225
30
11
30
 
 

 
 
 
Rosuvastatin Actavis 10
WQ
MP
C1540 C3047 C4225 C4228
P3047 P4225
30
11
30
 
 

 
 
 
Rosuvastatin GH
GQ
MP
C1540 C3047 C4225 C4228
P3047 P4225
30
11
30
 
 

 
 
 
Rosuvastatin RBX
RA
MP
C4225 C4228
P4225
30
11
30
 
 

 
 
 
Rosuvastatin Sandoz
SZ
MP
C4225 C4228
P4225
30
11
30
 
 

 
 
 
Terry White Chemists Rosuvastatin
TW
MP
C4225 C4228
P4225
30
11
30
 
 

 
Tablet 20 mg (as calcium)
Oral
APO-Rosuvastatin
TX
MP
C4225 C4227
P4227
30
5
30
 
 

 
 
 
 
 
NP
C4227
 
30
5
30
 
 

 
 
 
Cavstat
AF
MP
C1540 C3047 C4225 C4227
P1540 P4227
30
5
30
 
 

 
 
 
 
 
NP
C1540 C4227
 
30
5
30
 
 

 
 
 
Chem mart Rosuvastatin
CH
MP
C4225 C4227
P4227
30
5
30
 
 

 
 
 
 
 
NP
C4227
 
30
5
30
 
 

 
 
 
Crestor
AP
MP
C1540 C3047 C4225 C4227
P1540 P4227
30
5
30
 
 

 
 
 
 
 
NP
C1540 C4227
 
30
5
30
 
 

 
 
 
Rosuvastatin Actavis 20
WQ
MP
C1540 C3047 C4225 C4227
P1540 P4227
30
5
30
 
 

 
 
 
 
 
NP
C1540 C4227
 
30
5
30
 
 

 
 
 
Rosuvastatin GH
GQ
MP
C1540 C3047 C4225 C4227
P1540 P4227
30
5
30
 
 

 
 
 
 
 
NP
C1540 C4227
 
30
5
30
 
 

 
 
 
Rosuvastatin RBX
RA
MP
C4225 C4227
P4227
30
5
30
 
 

 
 
 
 
 
NP
C4227
 
30
5
30
 
 

 
 
 
Rosuvastatin Sandoz
SZ
MP
C4225 C4227
P4227
30
5
30
 
 

 
 
 
 
 
NP
C4227
 
30
5
30
 
 

 
 
 
Terry White Chemists Rosuvastatin
TW
MP
C4225 C4227
P4227
30
5
30
 
 

 
 
 
 
 
NP
C4227
 
30
5
30
 
 

 
 
 
APO-Rosuvastatin
TX
MP
C4225 C4227
P4225
30
11
30
 
 

 
 
 
Cavstat
AF
MP
C1540 C3047 C4225 C4227
P3047 P4225
30
11
30
 
 

 
 
 
Chem mart Rosuvastatin
CH
MP
C4225 C4227
P4225
30
11
30
 
 

 
 
 
Crestor
AP
MP
C1540 C3047 C4225 C4227
P3047 P4225
30
11
30
 
 

 
 
 
Rosuvastatin Actavis 20
WQ
MP
C1540 C3047 C4225 C4227
P3047 P4225
30
11
30
 
 

 
 
 
Rosuvastatin GH
GQ
MP
C1540 C3047 C4225 C4227
P3047 P4225
30
11
30
 
 

 
 
 
Rosuvastatin RBX
RA
MP
C4225 C4227
P4225
30
11
30
 
 

 
 
 
Rosuvastatin Sandoz
SZ
MP
C4225 C4227
P4225
30
11
30
 
 

 
 
 
Terry White Chemists Rosuvastatin
TW
MP
C4225 C4227
P4225
30
11
30
 
 

 
Tablet 40 mg (as calcium)
Oral
APO-Rosuvastatin
TX
MP
C4225 C4226
P4226
30
5
30
 
 

 
 
 
 
 
NP
C4226
 
30
5
30
 
 

 
 
 
Cavstat
AF
MP
C1540 C3047 C4225 C4226
P1540 P4226
30
5
30
 
 

 
 
 
 
 
NP
C1540 C4226
 
30
5
30
 
 

 
 
 
Chem mart Rosuvastatin
CH
MP
C4225 C4226
P4226
30
5
30
 
 

 
 
 
 
 
NP
C4226
 
30
5
30
 
 

 
 
 
Crestor
AP
MP
C1540 C3047 C4225 C4226
P1540 P4226
30
5
30
 
 

 
 
 
 
 
NP
C1540 C4226
 
30
5
30
 
 

 
 
 
Rosuvastatin Actavis 40
WQ
MP
C1540 C3047 C4225 C4226
P1540 P4226
30
5
30
 
 

 
 
 
 
 
NP
C1540 C4226
 
30
5
30
 
 

 
 
 
Rosuvastatin GH
GQ
MP
C1540 C3047 C4225 C4226
P1540 P4226
30
5
30
 
 

 
 
 
 
 
NP
C1540 C4226
 
30
5
30
 
 

 
 
 
Rosuvastatin RBX
RA
MP
C4225 C4226
P4226
30
5
30
 
 

 
 
 
 
 
NP
C4226
 
30
5
30
 
 

 
 
 
Rosuvastatin Sandoz
SZ
MP
C4225 C4226
P4226
30
5
30
 
 

 
 
 
 
 
NP
C4226
 
30
5
30
 
 

 
 
 
Terry White Chemists Rosuvastatin
TW
MP
C4225 C4226
P4226
30
5
30
 
 

 
 
 
 
 
NP
C4226
 
30
5
30
 
 

 
 
 
APO-Rosuvastatin
TX
MP
C4225 C4226
P4225
30
11
30
 
 

 
 
 
Cavstat
AF
MP
C1540 C3047 C4225 C4226
P3047 P4225
30
11
30
 
 

 
 
 
Chem mart Rosuvastatin
CH
MP
C4225 C4226
P4225
30
11
30
 
 

 
 
 
Crestor
AP
MP
C1540 C3047 C4225 C4226
P3047 P4225
30
11
30
 
 

 
 
 
Rosuvastatin Actavis 40
WQ
MP
C1540 C3047 C4225 C4226
P3047 P4225
30
11
30
 
 

 
 
 
Rosuvastatin GH
GQ
MP
C1540 C3047 C4225 C4226
P3047 P4225
30
11
30
 
 

 
 
 
Rosuvastatin RBX
RA
MP
C4225 C4226
P4225
30
11
30
 
 

 
 
 
Rosuvastatin Sandoz
SZ
MP
C4225 C4226
P4225
30
11
30
 
 

 
 
 
Terry White Chemists Rosuvastatin
TW
MP
C4225 C4226
P4225
30
11
30
 
 

[23]         Schedule 1, entry for Temozolomide in the form Capsule 180 mg
insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
 
 
 
Astromide
WQ
MP
C1736 C1737 C2101
 
5
5
5
 
[24]         Schedule 3, after details relevant to Responsible person code YT
insert:
ZA
AstraZeneca Pty Ltd
 54 009 682 311
[25]         Schedule 4, Part 1, entry for Rosuvastatin
(a)      insert in the column headed “Purposes Code” for the Circumstances Code “C1540”             P1540
(b)      insert in the column headed “Purposes Code” for the Circumstances Code “C3047”             P3047
(c)      insert in numerical order following existing text:

 
C4225
P4225
 
For use in patients who meet the criteria set out in the General Statement for Lipid-Lowering Drugs
Patient must be receiving treatment under a GP Management Plan or Team Care Arrangements where Medicare benefits were or are payable for the preparation of the Plan or coordination of the Arrangements;
The treatment must not be prescribed for hypercholesterolaemia if the patient has heterozygous familial hypercholesterolaemia
 

 
C4226
P4226
 
For use in patients who meet the criteria set out in the General Statement for Lipid-Lowering Drugs
The treatment must not be prescribed for hypercholesterolaemia if the patient has heterozygous familial hypercholesterolaemia
 

 
C4227
P4227
 
For use in patients who meet the criteria set out in the General Statement for Lipid-Lowering Drugs
The treatment must not be prescribed for hypercholesterolaemia if the patient has heterozygous familial hypercholesterolaemia
 

 
C4228
P4228
 
For use in patients who meet the criteria set out in the General Statement for Lipid-Lowering Drugs
The treatment must not be prescribed for hypercholesterolaemia if the patient has heterozygous familial hypercholesterolaemia
 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
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.comlaw.gov.au