National Health (Listing of Pharmaceutical Benefits) Amendment Instrument 2014 (No. 11) (PB 82 of 2014)

Link to law: https://www.comlaw.gov.au/Details/F2014L01395

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PB 82 of 2014
National Health (Listing of Pharmaceutical Benefits) Amendment Instrument 2014
(No. 11)
National Health Act 1953
I, FELICITY McNEILL, First Assistant Secretary, Pharmaceutical Benefits Division, Department of Health, 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 20 October 2014
 
 
 
 
 
 
 
 
 
 
 
FELICITY McNEILL
First Assistant Secretary
Pharmaceutical Benefits Division
Department of Health
 
1          Name of Instrument
            (1)        This Instrument is the National Health (Listing of Pharmaceutical                            Benefits) Amendment Instrument 2014 (No. 11).
            (2)        This Instrument may also be cited as PB 82 of 2014.
2          Commencement
This Instrument commences on 1 November 2014.
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 Abiraterone
omit from the column headed “Circumstances”:        C4245   substitute:             C4654
[2]           Schedule 1, after entry for Amino acid formula without phenylalanine in the form Sachets containing oral powder 20 g, 30 (Phlexy-10 Drink Mix)
insert:
Amino acid formula without valine, leucine and isoleucine
Sachets containing oral powder 6 g, 30 (MSUD amino5)
Oral
MSUD amino5
VF
MP NP
C1220
 
12
5
1
 
 
[3]           Schedule 1, entry for Amlodipine with Atorvastatin
substitute:
Amlodipine with Atorvastatin
Tablet 5 mg amlodipine (as besylate) with 10 mg atorvastatin (as calcium)
Oral
APO-Amlodipine/ Atorvastatin 5/10
TX
MP NP
C2449 C2450 C2451
 
30
5
30
 
 

 
 
 
Blooms the Chemist Amlodipine/ Atorvastatin 5/10
IB
MP NP
C2449 C2450 C2451
 
30
5
30
 
 

 
 
 
Cadatin 5/10
FZ
MP NP
C2449 C2450 C2451
 
30
5
30
 
 

 
 
 
Cadivast 5/10
AF
MP NP
C2449 C2450 C2451
 
30
5
30
 
 

 
 
 
Caduet 5/10
PF
MP NP
C2449 C2450 C2451
 
30
5
30
 
 

 
 
 
Chem mart Amlodipine/ Atorvastatin 5/10
CH
MP NP
C2449 C2450 C2451
 
30
5
30
 
 

 
 
 
Terry White Chemists Amlodipine/ Atorvastatin 5/10
TW
MP NP
C2449 C2450 C2451
 
30
5
30
 
 

 
Tablet 5 mg amlodipine (as besylate) with 20 mg atorvastatin (as calcium)
Oral
APO-Amlodipine/ Atorvastatin 5/20
TX
MP NP
C2449 C2450 C2451
 
30
5
30
 
 

 
 
 
Blooms the Chemist Amlodipine/ Atorvastatin 5/20
IB
MP NP
C2449 C2450 C2451
 
30
5
30
 
 

 
 
 
Cadatin 5/20
FZ
MP NP
C2449 C2450 C2451
 
30
5
30
 
 

 
 
 
Cadivast 5/20
AF
MP NP
C2449 C2450 C2451
 
30
5
30
 
 

 
 
 
Caduet 5/20
PF
MP NP
C2449 C2450 C2451
 
30
5
30
 
 

 
 
 
Chem mart Amlodipine/ Atorvastatin 5/20
CH
MP NP
C2449 C2450 C2451
 
30
5
30
 
 

 
 
 
Terry White Chemists Amlodipine/ Atorvastatin 5/20
TW
MP NP
C2449 C2450 C2451
 
30
5
30
 
 

 
Tablet 5 mg amlodipine (as besylate) with 40 mg atorvastatin (as calcium)
Oral
APO-Amlodipine/ Atorvastatin 5/40
TX
MP NP
C2449 C2450 C2451
 
30
5
30
 
 

 
 
 
Blooms the Chemist Amlodipine/ Atorvastatin 5/40
IB
MP NP
C2449 C2450 C2451
 
30
5
30
 
 

 
 
 
Cadatin 5/40
FZ
MP NP
C2449 C2450 C2451
 
30
5
30
 
 

 
 
 
Cadivast 5/40
AF
MP NP
C2449 C2450 C2451
 
30
5
30
 
 

 
 
 
Caduet 5/40
PF
MP NP
C2449 C2450 C2451
 
30
5
30
 
 

 
 
 
Chem mart Amlodipine/ Atorvastatin 5/40
CH
MP NP
C2449 C2450 C2451
 
30
5
30
 
 

 
 
 
Terry White Chemists Amlodipine/ Atorvastatin 5/40
TW
MP NP
C2449 C2450 C2451
 
30
5
30
 
 

 
Tablet 5 mg amlodipine (as besylate) with 80 mg atorvastatin (as calcium)
Oral
APO-Amlodipine/ Atorvastatin 5/80
TX
MP NP
C2449 C2450 C2451
 
30
5
30
 
 

 
 
 
Blooms the Chemist Amlodipine/ Atorvastatin 5/80
IB
MP NP
C2449 C2450 C2451
 
30
5
30
 
 

 
 
 
Cadatin 5/80
FZ
MP NP
C2449 C2450 C2451
 
30
5
30
 
 

 
 
 
Cadivast 5/80
AF
MP NP
C2449 C2450 C2451
 
30
5
30
 
 

 
 
 
Caduet 5/80
PF
MP NP
C2449 C2450 C2451
 
30
5
30
 
 

 
 
 
Chem mart Amlodipine/ Atorvastatin 5/80
CH
MP NP
C2449 C2450 C2451
 
30
5
30
 
 

 
 
 
Terry White Chemists Amlodipine/ Atorvastatin 5/80
TW
MP NP
C2449 C2450 C2451
 
30
5
30
 
 

 
Tablet 10 mg amlodipine (as besylate) with 10 mg atorvastatin (as calcium)
Oral
APO-Amlodipine/ Atorvastatin 10/10
TX
MP NP
C2449 C2450 C2451
 
30
5
30
 
 

 
 
 
Blooms the Chemist Amlodipine/ Atorvastatin 10/10
IB
MP NP
C2449 C2450 C2451
 
30
5
30
 
 

 
 
 
Cadatin 10/10
FZ
MP NP
C2449 C2450 C2451
 
30
5
30
 
 

 
 
 
Cadivast 10/10
AF
MP NP
C2449 C2450 C2451
 
30
5
30
 
 

 
 
 
Caduet 10/10
PF
MP NP
C2449 C2450 C2451
 
30
5
30
 
 

 
 
 
Chem mart Amlodipine/ Atorvastatin 10/10
CH
MP NP
C2449 C2450 C2451
 
30
5
30
 
 

 
 
 
Terry White Chemists Amlodipine/ Atorvastatin 10/10
TW
MP NP
C2449 C2450 C2451
 
30
5
30
 
 

 
Tablet 10 mg amlodipine (as besylate) with 20 mg atorvastatin (as calcium)
Oral
APO-Amlodipine/ Atorvastatin 10/20
TX
MP NP
C2449 C2450 C2451
 
30
5
30
 
 

 
 
 
Blooms the Chemist Amlodipine/ Atorvastatin 10/20
IB
MP NP
C2449 C2450 C2451
 
30
5
30
 
 

 
 
 
Cadatin 10/20
FZ
MP NP
C2449 C2450 C2451
 
30
5
30
 
 

 
 
 
Cadivast 10/20
AF
MP NP
C2449 C2450 C2451
 
30
5
30
 
 

 
 
 
Caduet 10/20
PF
MP NP
C2449 C2450 C2451
 
30
5
30
 
 

 
 
 
Chem mart Amlodipine/ Atorvastatin 10/20
CH
MP NP
C2449 C2450 C2451
 
30
5
30
 
 

 
 
 
Terry White Chemists Amlodipine/ Atorvastatin 10/20
TW
MP NP
C2449 C2450 C2451
 
30
5
30
 
 

 
Tablet 10 mg amlodipine (as besylate) with 40 mg atorvastatin (as calcium)
Oral
APO-Amlodipine/ Atorvastatin 10/40
TX
MP NP
C2449 C2450 C2451
 
30
5
30
 
 

 
 
 
Blooms the Chemist Amlodipine/ Atorvastatin 10/40
IB
MP NP
C2449 C2450 C2451
 
30
5
30
 
 

 
 
 
Cadatin 10/40
FZ
MP NP
C2449 C2450 C2451
 
30
5
30
 
 

 
 
 
Cadivast 10/40
AF
MP NP
C2449 C2450 C2451
 
30
5
30
 
 

 
 
 
Caduet 10/40
PF
MP NP
C2449 C2450 C2451
 
30
5
30
 
 

 
 
 
Chem mart Amlodipine/ Atorvastatin 10/40
CH
MP NP
C2449 C2450 C2451
 
30
5
30
 
 

 
 
 
Terry White Chemists Amlodipine/ Atorvastatin 10/40
TW
MP NP
C2449 C2450 C2451
 
30
5
30
 
 

 
Tablet 10 mg amlodipine (as besylate) with 80 mg atorvastatin (as calcium)
Oral
APO-Amlodipine/ Atorvastatin 10/80
TX
MP NP
C2449 C2450 C2451
 
30
5
30
 
 

 
 
 
Blooms the Chemist Amlodipine/ Atorvastatin 10/80
IB
MP NP
C2449 C2450 C2451
 
30
5
30
 
 

 
 
 
Cadatin 10/80
FZ
MP NP
C2449 C2450 C2451
 
30
5
30
 
 

 
 
 
Cadivast 10/80
AF
MP NP
C2449 C2450 C2451
 
30
5
30
 
 

 
 
 
Caduet 10/80
PF
MP NP
C2449 C2450 C2451
 
30
5
30
 
 

 
 
 
Chem mart Amlodipine/ Atorvastatin 10/80
CH
MP NP
C2449 C2450 C2451
 
30
5
30
 
 

 
 
 
Terry White Chemists Amlodipine/ Atorvastatin 10/80
TW
MP NP
C2449 C2450 C2451
 
30
5
30
 
 

[4]           Schedule 1, entry for Azathioprine in the form Tablet 50 mg
omit from the column headed “Brand”:       Imazam            substitute:             Imazan
[5]           Schedule 1, entry for Baclofen in the form Tablet 10 mg
(a)      omit:
 
 
 
Chem mart Baclofen
CH
MP NP
 
 
100
5
100
 
 
(b)      omit:
 
 
 
GenRx Baclofen
GX
MP NP
 
 
100
5
100
 
 
(c)      omit:
 
 
 
Terry White Chemists Baclofen
TW
MP NP
 
 
100
5
100
 
 
[6]           Schedule 1, entry for Baclofen in the form Tablet 25 mg
(a)      omit:
 
 
 
Chem mart Baclofen
CH
MP NP
 
 
100
5
100
 
 
(b)      omit:
 
 
 
GenRx Baclofen
GX
MP NP
 
 
100
5
100
 
 
[7]           Schedule 1, entry for Cabazitaxel
omit from the column headed “Circumstances”:        C4237  C4262    substitute:             C4661  C4662
[8]           Schedule 1, entry for Carboplatin in the form Solution for I.V. injection 450 mg in 45 mL
omit:
 
 
 
Pfizer Australia Pty Ltd
PF
MP
 
 
See Note 3
See
Note 3
1
 
D(100)
[9]           Schedule 1, entry for Cefaclor in the form Powder for oral suspension 125 mg (as monohydrate) per 5 mL, 100 mL
(a)      omit:
 
 
 
Chem mart Cefaclor
CH
PDP
 
 
1
0
1
 
 
(b)      omit:
 
 
 
Terry White Chemists Cefaclor
TW
PDP
 
 
1
0
1
 
 
 
(c)      omit:
 
 
 
Chem mart Cefaclor
CH
MP
 
 
1
1
1
 
 
(d)      omit:
 
 
 
Terry White Chemists Cefaclor
TW
MP
 
 
1
1
1
 
 
[10]         Schedule 1, entry for Cefaclor in the form Powder for oral suspension 250 mg (as monohydrate) per 5 mL, 75 mL
(a)      omit:
 
 
 
Chem mart Cefaclor
CH
PDP
 
 
1
0
1
 
 
(b)      omit:
 
 
 
Terry White Chemists Cefaclor
TW
PDP
 
 
1
0
1
 
 
(c)      omit:
 
 
 
Chem mart Cefaclor
CH
MP
 
 
1
1
1
 
 
(d)      omit:
 
 
 
Terry White Chemists Cefaclor
TW
MP
 
 
1
1
1
 
 
[11]         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 Actavis
UA
MP NP
C1211
 
28
5
28
 
 
[12]         Schedule 1, entry for Diclofenac in the form Tablet (enteric coated) containing diclofenac sodium 25 mg [Maximum Quantity: 100;
Number of Repeats: 0]
insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
 
 
 
Diclofenac AN
EA
MP NP
C1036 C1054 C3645 C3646
P3646
100
0
50
 
 

 
 
 
 
 
PDP
C1036 C1054
 
100
0
50
 
 

 
[13]         Schedule 1, entry for Diclofenac in the form Tablet (enteric coated) containing diclofenac sodium 25 mg [Maximum Quantity: 100;
Number of Repeats: 3]
insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
 
 
 
Diclofenac AN
EA
MP NP
C1036 C1054 C3645 C3646
P1036 P1054 P3645
100
3
50
 
 
[14]         Schedule 1, entry for Diclofenac in the form Tablet (enteric coated) containing diclofenac sodium 50 mg [Maximum Quantity: 50;
Number of Repeats: 0]
insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
 
 
 
Diclofenac AN
EA
MP NP
C1036 C1054 C3645 C3646
P3646
50
0
50
 
 

 
 
 
 
 
PDP
C1036 C1054
 
50
0
50
 
 

[15]         Schedule 1, entry for Diclofenac in the form Tablet (enteric coated) containing diclofenac sodium 50 mg [Maximum Quantity: 50;
Number of Repeats: 3]
insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
 
 
 
Diclofenac AN
EA
MP NP
C1036 C1054 C3645 C3646
P1036 P1054 P3645
50
3
50
 
 
[16]         Schedule 1, entry for Diltiazem in the form Tablet containing diltiazem hydrochloride 60 mg
(a)      omit:
 
 
 
Chem mart Diltiazem
CH
MP NP
 
 
90
5
90
 
 
(b)      omit:
 
 
 
GenRx Diltiazem
GX
MP NP
 
 
90
5
90
 
 
(c)      omit:
 
 
 
Terry White Chemists Diltiazem
TW
MP NP
 
 
90
5
90
 
 
[17]         Schedule 1, entry for Docetaxel in each of the forms: Solution concentrate for I.V. infusion 140 mg in 7 mL; and Solution concentrate for I.V. infusion 160 mg in 16 mL
omit from the column headed “Circumstances”:        C3888  C3892  C3916  C3956  C4078  C4140  C4160  C4239
[18]         Schedule 1, entry for Docetaxel in each of the forms: Powder for I.V. infusion 20 mg with solvent; and Powder for I.V. infusion 80 mg
with solvent
omit from the column headed “Circumstances”:        C4078  C4140  C4160  C4239
 
[19]         Schedule 1, entry for Docetaxel in each of the forms: Solution concentrate for I.V. infusion 20 mg in 1 mL; Solution concentrate for I.V. infusion 20 mg in 2 mL; Solution concentrate for I.V. infusion 80 mg in 4 mL; and Solution concentrate for I.V. infusion 80 mg in 8 mL
omit from the column headed “Circumstances” (all instances):            C3888  C3892  C3916  C3956  C4078  C4140  C4160  C4239
[20]         Schedule 1, entry for Donepezil in the form Tablet containing donepezil hydrochloride 5 mg
insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
 
 
 
Aridon APN 5
FM
MP NP
C4219 C4220 C4224
 
28
5
28
 
 
[21]         Schedule 1, entry for Donepezil in the form Tablet containing donepezil hydrochloride 10 mg
insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
 
 
 
Aridon APN 10
FM
MP NP
C4219 C4220 C4224
 
28
5
28
 
 
[22]         Schedule 1, entry for Doxorubicin in the form Solution for I.V. injection or intravesical administration containing doxorubicin hydrochloride 50 mg in 25 mL single dose vial
omit:
 
 
 
Adriamycin Solution
PF
MP
 
 
See Note 3
See
Note 3
1
 
D(100)
[23]         Schedule 1, entry for Doxorubicin in the form Solution for I.V. injection or intravesical administration containing doxorubicin hydrochloride 200 mg in 100 mL single dose vial
omit:
 
 
 
Adriamycin
PF
MP
 
 
See Note 3
See
Note 3
1
 
D(100)
[24]         Schedule 1, entry for Enalapril in each of the forms: Tablet containing enalapril maleate 5 mg; Tablet containing enalapril maleate 10 mg; and Tablet containing enalapril maleate 20 mg
insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
 
 
 
Enalapril AN
EA
MP NP
 
 
30
5
30
 
 
[25]         Schedule 1, entry for Epirubicin in the form Solution for injection containing epirubicin hydrochloride 50 mg in 25 mL
omit:
 
 
 
Pharmorubicin Solution
PF
MP
 
 
See Note 3
See
Note 3
1
 
D(100)
 
[26]         Schedule 1, entry for Fluconazole in each of the forms: Solution for I.V. infusion 100 mg in 50 mL; and Solution for I.V. infusion 200 mg
in 100 mL
omit:
 
 
 
Diflucan
PF
MP NP
C3613 C3614 C3615 C3616 C3617 C3618
 
7
0
1
 
 
[27]         Schedule 1, after entry for Glucose Indicator—Blood in the form Test strips, 100 (Contour)
insert in the columns in the order indicated:
 
Test strips, 100 (Contour next)
For external use
Contour next
IK
MP NP
 
 
1
5
1
 
 

 
 
 
 
 
MP
 
P4241
1
11
1
 
 

[28]         Schedule 1, after entry for Indacaterol in the form Capsule containing powder for oral inhalation 300 micrograms (as maleate) (for use in Breezhaler)
insert:
Indacaterol with glycopyrronium
Capsule containing powder for oral inhalation indacaterol 110 micrograms (as maleate) with glycopyrronium 50 micrograms (as bromide) (for use in Breezhaler)
Inhalation by mouth
ultibro breezhaler 110/50
NV
MP NP
C4655
 
30
5
30
 
 
[29]         Schedule 1, entry for Indapamide
omit:
 
Tablet containing indapamide hemihydrate 1.5 mg (sustained release)
Oral
Natrilix SR
SE
MP NP
 
 
90
1
90
 
 
substitute:
 
Tablet containing indapamide hemihydrate 1.5 mg (sustained release)
Oral
APO-Indapamide SR
TX
MP NP
 
 
90
1
90
 
 

 
 
 
Chem mart Indapamide SR
CH
MP NP
 
 
90
1
90
 
 

 
 
 
Natrilix SR
SE
MP NP
 
 
90
1
90
 
 

 
 
 
Terry White Chemists Indapamide SR
TW
MP NP
 
 
90
1
90
 
 

 
[30]         Schedule 1, entry for Interferon Beta-1b
omit:
 
 
 
Extavia
NV
MP
C1175 C1751
 
15
5
15
 
 
[31]         Schedule 1, entry for Ipratropium in each of the forms: Nebuliser solution containing ipratropium bromide 250 micrograms (anhydrous) in 1 mL single dose units, 30; and Nebuliser solution containing ipratropium bromide 500 micrograms (anhydrous) in 1 mL single dose units, 30
omit:
 
 
 
Ipravent
PF
MP NP
C1754 C1755
 
2
5
1
 
 
[32]         Schedule 1, entry for Irbesartan in the form Tablet 75 mg
insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
 
 
 
Irbesartan Actavis 75
UA
MP NP
 
 
30
5
30
 
 
[33]         Schedule 1, entry for Irbesartan in the form Tablet 300 mg
insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
 
 
 
Irbesartan Actavis 300
UA
MP NP
 
 
30
5
30
 
 
[34]         Schedule 1, entry for Irinotecan in the form I.V. injection containing irinotecan hydrochloride trihydrate 300 mg in 15 mL
omit:
 
 
 
Camptosar
PF
MP
 
 
See Note 3
See
Note 3
1
 
D(100)
[35]         Schedule 1, entry for Lactulose
(a)      omit:
 
 
 
GenRx Lactulose
GX
MP NP
C1150 C1613 C3642 C3643
P3643
3
0
1
 
 
(b)      omit:
 
 
 
GenRx Lactulose
GX
MP NP
C1150 C1613 C3642 C3643
P3642
3
3
1
 
 
(c)      omit:
 
 
 
GenRx Lactulose
GX
MP NP
C1150 C1613 C3642 C3643
P1150 P1613
1
5
1
 
 
 
[36]         Schedule 1, entry for Metformin in the form Tablet (extended release) containing metformin hydrochloride 1 g
insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
 
 
 
Diaformin XR 1000
AF
MP NP
 
 
60
5
60
 
 
[37]         Schedule 1, entry for Methotrexate in the form Injection 50 mg in 2 mL vial
omit:
 
 
 
Pfizer Australia Pty Ltd
PF
MP
 
See Note 2
5
See Note 2
5
See
Note 2
5
 
 
[38]         Schedule 1, entry for Metoclopramide in the form Tablet containing metoclopramide hydrochloride 10 mg
insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
 
 
 
Metoclopramide AN
EA
MP NP MW PDP
 
 
25
0
25
 
 
[39]         Schedule 1, entry for Metoprolol in the form Tablet containing metoprolol tartrate 50 mg
insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
 
 
 
Metoprolol AN
EA
MP NP
 
 
100
5
100
 
 
[40]         Schedule 1, entry for Metoprolol in the form Tablet containing metoprolol tartrate 100 mg
insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
 
 
 
Metoprolol AN
EA
MP NP
 
 
60
5
60
 
 
[41]         Schedule 1, entry for Mometasone in the form Cream containing mometasone furoate 1 mg per g, 15 g
insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
 
 
 
Momasone
QA
MP NP
C1422
 
1
0
1
 
 
[42]         Schedule 1, entry for Norethisterone with Ethinyloestradiol
omit:
 
Pack containing 12 tablets 500 micrograms‑35 micrograms, 9 tablets 1 mg‑35 micrograms and 7 inert tablets
Oral
Improvil 28 Day
FZ
MP NP
 
 
4
2
4
 
 
[43]         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; Solution concentrate for I.V. infusion 150 mg in 25 mL; and Solution concentrate for I.V. infusion 300 mg
in 50 mL
omit from the column headed “Circumstances” (all instances):            C3186  C3890  C3902  C3917  C3955  C3956        
[44]         Schedule 1, entry for Paclitaxel, nanoparticle albumin-bound
insert in numerical order in the column headed “Circumstances”:       C4657
[45]         Schedule 1, after entry for Penicillamine in the form Tablet 250 mg
insert:
Perampanel
Tablet 2 mg (as hemisesquihydrate)
Oral
Fycompa
EI
MP
C4656
 
14
1
7
 
 

 
Tablet 4 mg (as hemisesquihydrate)
Oral
Fycompa
EI
MP NP
C4658
 
28
5
28
 
 

 
Tablet 6 mg (as hemisesquihydrate)
Oral
Fycompa
EI
MP NP
C4658
 
28
5
28
 
 

 
Tablet 8 mg (as hemisesquihydrate)
Oral
Fycompa
EI
MP NP
C4658
 
28
5
28
 
 

 
Tablet 10 mg (as hemisesquihydrate)
Oral
Fycompa
EI
MP NP
C4658
 
28
5
28
 
 

 
Tablet 12 mg (as hemisesquihydrate)
Oral
Fycompa
EI
MP NP
C4658
 
28
5
28
 
 

[46]         Schedule 1, entry for Perindopril with Indapamide in the form Tablet containing perindopril erbumine 4 mg with indapamide hemihydrate 1.25 mg
insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
 
 
 
Perindopril Combi Actavis 4/1.25
GN
MP NP
C4375
 
30
5
30
 
 
[47]         Schedule 1, entry for Ranitidine in the form Tablet 150 mg (as hydrochloride)
insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
 
 
 
APO-Ranitidine
TX
MP NP MW
 
 
60
5
60
 
 
[48]         Schedule 1, entry for Ranitidine in the form Tablet 300 mg (as hydrochloride)
insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
 
 
 
APO-Ranitidine
TX
MP NP
 
 
30
5
30
 
 
[49]         Schedule 1, entry for Roxithromycin in the form Tablet 150 mg [Maximum Quantity: 10; Number of Repeats: 0]
insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
 
 
 
Roxithromycin AN
EA
PDP
 
 
10
0
10
 
 
[50]         Schedule 1, entry for Roxithromycin in the form Tablet 150 mg [Maximum Quantity: 10; Number of Repeats: 1]
insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
 
 
 
Roxithromycin AN
EA
MP NP
 
 
10
1
10
 
 
[51]         Schedule 1, entry for Roxithromycin in the form Tablet 300 mg [Maximum Quantity: 5; Number of Repeats: 0]
insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
 
 
 
Roxithromycin AN
EA
PDP
 
 
5
0
5
 
 
[52]         Schedule 1, entry for Roxithromycin in the form Tablet 300 mg [Maximum Quantity: 5; Number of Repeats: 1]
insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
 
 
 
Roxithromycin AN
EA
MP NP
 
 
5
1
5
 
 
[53]         Schedule 1, entry for Sertraline in each of the forms: Tablet 50 mg (as hydrochloride); and Tablet 100 mg (as hydrochloride)
insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
 
 
 
Sertraline AN
EA
MP NP
C1211 C1241 C1975
 
30
5
30
 
 
[54]         Schedule 1, entry for Triglycerides―medium chain, formula in each of the forms: Oral powder 400 g (Lipistart); and Oral powder 400 g (Monogen)
omit from the column headed “Circumstances”:          C1068  C1511  C1513  C1670  C1671
substitute:             C4651  C4652  C4653  C4659  C4660
[55]         Schedule 1, after entry for Triglycerides―medium chain, formula in the form Oral powder 400 g (Monogen)
insert in the columns in the order indicated:
 
Oral powder 400 g (Peptamen Junior)
Oral
Peptamen Junior
NT
MP NP
C4660
 
8
5
1
 
 
[56]         Schedule 1, after entry for Vitamins, minerals and trace elements with carbohydrate in the form Oral powder 200 g (Paediatric Seravit)
insert in the columns in the order indicated:
 
Sachets containing oral powder 6 g, 30 (FruitiVits)
Oral
FruitiVits
VF
MP NP
C4663
 
1
5
1
 
 
[57]         Schedule 1, entry for Zolmitriptan
insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
 
 
 
APO-Zolmitriptan
TX
MP NP
C4573
 
4
5
2
 
 
[58]         Schedule 3, after details relevant to Responsible Person code IA
insert:
IB
Apotex Pty Ltd
 52 096 916 148
[59]         Schedule 4, Part 1, entry for Abiraterone
substitute:
Abiraterone
C4654
 
 
Castration resistant metastatic carcinoma of the prostate
The treatment must be in combination with prednisone or prednisolone; AND
The treatment must not be used in combination with chemotherapy; AND
Patient must have failed treatment with docetaxel due to resistance or intolerance; AND
Patient must have a WHO performance status of 2 or less; AND
Patient must not receive PBS-subsidised abiraterone if progressive disease develops while on abiraterone
Compliance with Authority Required procedures

[60]         Schedule 4, Part 1, entry for Cabazitaxel
substitute:

Cabazitaxel
C4661
 
 
Where the patient is receiving treatment in the community setting or at/from a Private Hospital
Castration resistant metastatic carcinoma of the prostate
The treatment must be in combination with prednisone or prednisolone; AND
The treatment must not be used in combination with abiraterone; AND
Patient must have failed treatment with docetaxel due to resistance or intolerance; AND
Patient must have a WHO performance status of 2 or less; AND
Patient must not receive PBS-subsidised cabazitaxel if progressive disease develops while on cabazitaxel
Compliance with Authority Required procedures


 
C4662
 
 
Where the patient is receiving treatment at/from a Public Hospital
Castration resistant metastatic carcinoma of the prostate
The treatment must be in combination with prednisone or prednisolone; AND
The treatment must not be used in combination with abiraterone; AND
Patient must have failed treatment with docetaxel due to resistance or intolerance; AND
Patient must have a WHO performance status of 2 or less; AND
Patient must not receive PBS-subsidised cabazitaxel if progressive disease develops while on cabazitaxel
Compliance with Authority Required procedures - Streamlined Authority Code 4662


[61]         Schedule 4, Part 1, omit entry for Docetaxel
[62]         Schedule 4, Part 1, after entry for Indacaterol
insert:
Indacaterol with glycopyrronium
C4655
 
 
Chronic obstructive pulmonary disease (COPD)
Patient must have been stabilised on a combination of a long acting muscarinic antagonist and long acting beta-2 agonist.

Compliance with Authority Required procedures - Streamlined Authority Code 4655
[63]         Schedule 4, Part 1, omit entry for Paclitaxel
[64]         Schedule 4, Part 1, entry for Paclitaxel, nanoparticle albumin-bound
insert in numerical order following existing text:
 
C4657
 
 
Stage IV (metastatic) adenocarcinoma of the pancreas
The treatment must be in combination with gemcitabine; AND
The condition must not have been treated previously with PBS-subsidised therapy; AND
Patient must have an Eastern Cooperative Oncology Group (ECOG) performance status score of 2 or less
A patient who has progressive disease when treated with this drug is no longer eligible for PBS-subsidised treatment with this drug
Compliance with Authority Required procedures - Streamlined Authority Code 4657

[65]         Schedule 4, Part 1, after entry for Pemetrexed
insert:

Perampanel
C4656
 
 
Intractable partial epileptic seizures
Initial treatment
The treatment must be in combination with two or more anti-epileptic drugs which includes one second-line adjunctive agent; AND
The condition must have failed to be controlled satisfactorily by other anti-epileptic drugs, which includes at least one first-line anti-epileptic agent and at least two second-line adjunctive anti-epileptic agents
Must be treated by a neurologist
Compliance with Authority Required procedures - Streamlined Authority Code 4656


 
C4658
 
 
Intractable partial epileptic seizures
Continuing treatment
Patient must have previously been issued with an authority prescription for this drug
Compliance with Authority Required procedures - Streamlined Authority Code 4658


[66]         Schedule 4, Part 1, omit entry for Polyethylene glycol 400
[67]         Schedule 4, Part 1, entry for Triglycerides―medium chain, formula
insert in numerical order following existing text:

 
C4651
 
 
Hyperlipoproteinaemia type 1
 

 
C4652
 
 
Chylous ascites
 

 
C4653
 
 
Chylothorax
 

 
C4659
 
 
Long chain fatty acid oxidation disorders
 

 
C4660
 
 
Dietary management of conditions requiring a source of medium chain triglycerides
Patient must have fat malabsorption due to liver disease; OR
Patient must have fat malabsorption due to short gut syndrome; OR
Patient must have fat malabsorption due to cystic fibrosis; OR
Patient must have fat malabsorption due to gastrointestinal disorders
 

[68]         Schedule 4, Part 1, entry for Vitamins, minerals and trace elements with carbohydrate
insert in numerical order following existing text:
 
C4663
 
 
Dietary management of conditions requiring a highly restrictive therapeutic diet
Patient must have insufficient vitamin and mineral intake due to a specific diagnosis requiring a highly restrictive therapeutic diet; AND
Patient must be unable to adequately meet vitamin, mineral and trace element needs with other proprietary vitamin and mineral preparations
Patient must be aged 3 years or older
Compliance with Authority Required procedures