National Health (Listing of Pharmaceutical Benefits) Amendment Instrument 2013 (No. 9) (No. PB 40 of 2013)

Link to law: https://www.comlaw.gov.au/Details/F2013L01460

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PB 40 of 2013
National Health (Listing of Pharmaceutical Benefits) Amendment Instrument 2013
(No. 9)
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, 99AEH and 101 of the National Health Act 1953.
Dated                                          24 July 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. 9).
            (2)        This Instrument may also be cited as PB 40 of 2013.
2          Commencement
This Instrument commences on 1 August 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, after entry for Abciximab
insert:
Abiraterone
Tablet containing abiraterone acetate 250 mg
Oral
Zytiga
JC
MP
C4245
 
120
2
120
 
[2]           Schedule 1, after entry for Amino acid formula with vitamins and minerals without methionine in the form Oral powder 500 g
(XMET Maxamum)
insert in the columns in the order indicated:
 
Oral liquid 87 mL, 30 (HCU cooler 10)
Oral
HCU cooler 10
VF
MP NP
C1314
 
4
5
1
 
 
[3]           Schedule 1, entry for Amino acid formula with vitamins and minerals without methionine in the form Oral liquid 130 mL, 30 (HCU Cooler)
(a)      omit from the column headed “Form”:                                (HCU Cooler)    substitute:             (HCU cooler 15)
(b)      omit from the column headed “Brand”:               HCU Cooler      substitute:             HCU cooler 15
[4]           Schedule 1, after entry for Amino acid formula with vitamins and minerals without methionine in the form Oral liquid 130 mL, 30
(HCU cooler 15)
insert in the columns in the order indicated:
 
Oral liquid 174 mL, 30 (HCU cooler 20)
Oral
HCU cooler 20
VF
MP NP
C1314
 
4
5
1
 
 
[5]           Schedule 1, entry for Amino acid formula with vitamins and minerals without methionine, threonine and valine and low in isoleucine
in the form Oral liquid 130 mL, 30 (MMA/PA cooler)
(a)      omit from the column headed “Form”:                                (MMA/PA cooler)          substitute:             (MMA/PA cooler 15)
(b)      omit from the column headed “Brand”:               MMA/PA cooler            substitute:             MMA/PA cooler 15
[6]           Schedule 1, after entry for Amino acid formula with vitamins and minerals without phenylalanine and tyrosine in the form Oral powder 500 g (XPhen, Tyr Maxamum)
insert in the columns in the order indicated:
 
Oral liquid 87 mL, 30 (TYR cooler 10)
Oral
TYR cooler 10
VF
MP NP
C1453
 
4
5
1
 
 
[7]           Schedule 1, entry for Amino acid formula with vitamins and minerals without phenylalanine and tyrosine in the form Oral liquid
130 mL, 30 (TYR Cooler)
(a)      omit from the column headed “Form”:                                (TYR Cooler)    substitute:             (TYR cooler 15)
(b)      omit from the column headed “Brand”:               TYR Cooler      substitute:             TYR cooler 15
 
[8]           Schedule 1, after entry for Amino acid formula with vitamins and minerals without phenylalanine and tyrosine in the form Oral liquid 130 mL, 30 (TYR cooler 15)
insert in the columns in the order indicated:
 
Oral liquid 174 mL, 30 (TYR cooler 20)
Oral
TYR cooler 20
VF
MP NP
C1453
 
4
5
1
 
 
[9]           Schedule 1, after entry for Amino acid formula with vitamins and minerals without valine, leucine and isoleucine in the form Oral powder 500 g (MSUD Maxamum)
insert in the columns in the order indicated:
 
Oral liquid 87 mL, 30 (MSUD cooler 10)
Oral
MSUD cooler 10
VF
MP NP
C1220
 
4
5
1
 
 
[10]         Schedule 1, entry for Amino acid formula with vitamins and minerals without valine, leucine and isoleucine in the form Oral liquid
130 mL, 30 (MSUD Cooler)
(a)      omit from the column headed “Form”:                                (MSUD Cooler)             substitute:             (MSUD cooler 15)
(b)      omit from the column headed “Brand”:               MSUD Cooler   substitute:             MSUD cooler 15
[11]         Schedule 1, after entry for Amino acid formula with vitamins and minerals without valine, leucine and isoleucine in the form Oral liquid 130 mL, 30 (MSUD cooler 15)
insert in the columns in the order indicated:
 
Oral liquid 174 mL, 30 (MSUD cooler 20)
Oral
MSUD cooler 20
VF
MP NP
C1220
 
4
5
1
 
 
[12]         Schedule 1, entry for Amlodipine in the form Tablet 5 mg (as besylate)
omit:
 
 
 
Pharmacor Amlodipine 5
CR
MP NP
 
30
5
30
 
 
[13]         Schedule 1, entry for Amlodipine in the form Tablet 10 mg (as besylate)
omit:
 
 
 
Pharmacor Amlodipine 10
CR
MP NP
 
30
5
30
 
 
[14]         Schedule 1, entry for Anastrozole
omit:
 
 
 
Anastrozole Synthon
ZT
MP NP
C2213
 
30
5
30
 
 
[15]         Schedule 1, entry for Atorvastatin in the form Tablet 10 mg (as calcium) [Maximum Quantity 30; Number of Repeats 5]
insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
 
 
 
Atorvastatin SZ
HX
MP
C1540 C3047
P1540
30
5
30
 
 

 
 
 
 
 
NP
C1540
 
30
5
30
 
 

[16]         Schedule 1, entry for Atorvastatin in the form Tablet 10 mg (as calcium) [Maximum Quantity 30; Number of Repeats 11]
insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
 
 
 
Atorvastatin SZ
HX
MP
C1540 C3047
P3047
30
11
30
 
 
[17]         Schedule 1, entry for Atorvastatin in the form Tablet 20 mg (as calcium) [Maximum Quantity 30; Number of Repeats 5]
insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
 
 
 
Atorvastatin SZ
HX
MP
C1540 C3047
P1540
30
5
30
 
 

 
 
 
 
 
NP
C1540
 
30
5
30
 
 

[18]         Schedule 1, entry for Atorvastatin in the form Tablet 20 mg (as calcium) [Maximum Quantity 30; Number of Repeats 11]
insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
 
 
 
Atorvastatin SZ
HX
MP
C1540 C3047
P3047
30
11
30
 
 
[19]         Schedule 1, entry for Atorvastatin in the form Tablet 40 mg (as calcium) [Maximum Quantity 30; Number of Repeats 5]
insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
 
 
 
Atorvastatin SZ
HX
MP
C1540 C3047
P1540
30
5
30
 
 

 
 
 
 
 
NP
C1540
 
30
5
30
 
 

[20]         Schedule 1, entry for Atorvastatin in the form Tablet 40 mg (as calcium) [Maximum Quantity 30; Number of Repeats 11]
insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
 
 
 
Atorvastatin SZ
HX
MP
C1540 C3047
P3047
30
11
30
 
 
[21]         Schedule 1, entry for Atorvastatin in the form Tablet 80 mg (as calcium) [Maximum Quantity 30; Number of Repeats 5]
insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
 
 
 
Atorvastatin SZ
HX
MP
C1540 C3047
P1540
30
5
30
 
 

 
 
 
 
 
NP
C1540
 
30
5
30
 
 

[22]         Schedule 1, entry for Atorvastatin in the form Tablet 80 mg (as calcium) [Maximum Quantity 30; Number of Repeats 11]
insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
 
 
 
Atorvastatin SZ
HX
MP
C1540 C3047
P3047
30
11
30
 
 
[23]         Schedule 1, after entry for Azithromycin in the form Powder for oral suspension 200 mg (as dihydrate) per 5 mL, 15 mL
insert:
Bacillus Calmette and Guerin, Connaught strain
Powder for intravesical administration containing 6.6 to 19.2 x 10 8  CFU
Intravesical
ImmuCyst
SW
MP
See Note 1
C1419
 
3
1
1
 
 

Bacillus Calmette and Guerin, Tice strain
Vial containing powder for intravesical administration approximately
5 x 10 8  CFU
Intravesical
OncoTICE
MK
MP
See Note 1
C1290
 
3
1
3
 
 

[24]         Schedule 1, omit entry for “BCG Immunotherapeutic” (Bacillus Calmette-Guérin/Connaught strain)
[25]         Schedule 1, omit entry for “BCG-Tice” (Bacillus Calmette-Guérin/Tice strain)
[26]         Schedule 1, entry for Cabazitaxel
omit from the column headed “Circumstances”:          C4073  C4138    substitute:             C4237  C4262
[27]         Schedule 1, entry for Candesartan
substitute:
Candesartan
Tablet containing candesartan cilexetil 4 mg
Oral
Adesan
AF
MP NP
 
 
30
5
30
 
 

 
 
 
APO-Candesartan
TX
MP NP
 
 
30
5
30
 
 

 
 
 
Atacand
AP
MP NP
 
 
30
5
30
 
 

 
 
 
Candesartan Aspen 4
QA
MP NP
 
 
30
5
30
 
 

 
 
 
Candesartan-GA
GM
MP NP
 
 
30
5
30
 
 

 
 
 
Candesartan GH
GQ
MP NP
 
 
30
5
30
 
 

 
 
 
Candesartan Sandoz
SZ
MP NP
 
 
30
5
30
 
 

 
 
 
STADA Candesartan
TD
MP NP
 
 
30
5
30
 
 

 
Tablet containing candesartan cilexetil 8 mg
Oral
Adesan
AF
MP NP
 
 
30
5
30
 
 

 
 
 
APO-Candesartan
TX
MP NP
 
 
30
5
30
 
 

 
 
 
Atacand
AP
MP NP
 
 
30
5
30
 
 

 
 
 
Candesartan Aspen 8
QA
MP NP
 
 
30
5
30
 
 

 
 
 
Candesartan-GA
GM
MP NP
 
 
30
5
30
 
 

 
 
 
Candesartan GH
GQ
MP NP
 
 
30
5
30
 
 

 
 
 
Candesartan Sandoz
SZ
MP NP
 
 
30
5
30
 
 

 
 
 
STADA Candesartan
TD
MP NP
 
 
30
5
30
 
 

 
Tablet containing candesartan cilexetil 16 mg
Oral
Adesan
AF
MP NP
 
 
30
5
30
 
 

 
 
 
APO-Candesartan
TX
MP NP
 
 
30
5
30
 
 

 
 
 
Atacand
AP
MP NP
 
 
30
5
30
 
 

 
 
 
Candesartan Aspen 16
QA
MP NP
 
 
30
5
30
 
 

 
 
 
Candesartan-GA
GM
MP NP
 
 
30
5
30
 
 

 
 
 
Candesartan GH
GQ
MP NP
 
 
30
5
30
 
 

 
 
 
Candesartan Sandoz
SZ
MP NP
 
 
30
5
30
 
 

 
 
 
STADA Candesartan
TD
MP NP
 
 
30
5
30
 
 

 
Tablet containing candesartan cilexetil 32 mg
Oral
Adesan
AF
MP NP
 
 
30
5
30
 
 

 
 
 
APO-Candesartan
TX
MP NP
 
 
30
5
30
 
 

 
 
 
Atacand
AP
MP NP
 
 
30
5
30
 
 

 
 
 
Candesartan Aspen 32
QA
MP NP
 
 
30
5
30
 
 

 
 
 
Candesartan-GA
GM
MP NP
 
 
30
5
30
 
 

 
 
 
Candesartan GH
GQ
MP NP
 
 
30
5
30
 
 

 
 
 
Candesartan Sandoz
SZ
MP NP
 
 
30
5
30
 
 

 
 
 
STADA Candesartan
TD
MP NP
 
 
30
5
30
 
 

[28]         Schedule 1, entry for Candesartan with Hydrochlorothiazide
substitute:
Candesartan with Hydrochlorothiazide
Tablet containing candesartan cilexetil 16 mg with hydrochlorothiazide 12.5 mg
Oral
Adesan HCT 16/12.5
AF
MP NP
C3307
 
30
5
30
 
 

 
 
 
APO-Candesartan HCTZ 16/12.5
TX
MP NP
C3307
 
30
5
30
 
 

 
 
 
Atacand Plus 16/12.5
AP
MP NP
C3307
 
30
5
30
 
 

 
 
 
Candesartan Combi Aspen 16/12.5
QA
MP NP
C3307
 
30
5
30
 
 

 
 
 
Candesartan HCT GH 16/12.5
GQ
MP NP
C3307
 
30
5
30
 
 

 
 
 
Candesartan HCTZ-GA 16/12.5
GM
MP NP
C3307
 
30
5
30
 
 

 
 
 
STADA Candesartan HCT 16/12.5
TD
MP NP
C3307
 
30
5
30
 
 

 
Tablet containing candesartan cilexetil 32 mg with hydrochlorothiazide 12.5 mg
Oral
APO-Candesartan HCTZ 32/12.5
TX
MP NP
C3307
 
30
5
30
 
 

 
 
 
Atacand Plus 32/12.5
AP
MP NP
C3307
 
30
5
30
 
 

 
 
 
Candesartan Combi Aspen 32/12.5
QA
MP NP
C3307
 
30
5
30
 
 

 
 
 
Candesartan HCT GH 32/12.5
GQ
MP NP
C3307
 
30
5
30
 
 

 
 
 
Candesartan HCTZ-GA 32/12.5
GM
MP NP
C3307
 
30
5
30
 
 

 
 
 
STADA Candesartan HCT 32/12.5
TD
MP NP
C3307
 
30
5
30
 
 

 
Tablet containing candesartan cilexetil 32 mg with hydrochlorothiazide 25 mg
Oral
APO-Candesartan HCTZ 32/25
TX
MP NP
C3307
 
30
5
30
 
 

 
 
 
Atacand Plus 32/25
AP
MP NP
C3307
 
30
5
30
 
 

 
 
 
Candesartan Combi Aspen 32/25
QA
MP NP
C3307
 
30
5
30
 
 

 
 
 
Candesartan HCT GH 32/25
GQ
MP NP
C3307
 
30
5
30
 
 

 
 
 
Candesartan HCTZ-GA 32/25
GM
MP NP
C3307
 
30
5
30
 
 

 
 
 
STADA Candesartan HCT 32/25
TD
MP NP
C3307
 
30
5
30
 
 

[29]         Schedule 1, entry for Carvedilol in the form Tablet 25 mg
omit:
 
 
 
GenRx Carvedilol
GX
MP NP
C1735 C3234
 
60
5
60
 
 
[30]         Schedule 1, entry for Ceftriaxone in the form Powder for injection 1 g (as sodium)
omit from the column headed “Pack Quantity” for the brand “Max Pharma Ceftriaxone”:              1              substitute:             5
 
[31]         Schedule 1, entry for Cephalexin in the form Capsule 250 mg (anhydrous)
(a)      omit:
 
 
 
Cephatrust 250
MI
PDP
 
 
20
0
20
 
 
(b)      omit:
 
 
 
Cephatrust 250
MI
MP NP MW
 
 
20
1
20
 
 
[32]         Schedule 1, after entry for Cephalexin in the form Capsule 250 mg (anhydrous) [Maximum Quantity 20; Number of Repeats 1 (Terry White Chemists Cephalexin)]
insert in the columns in the order indicated:
 
 
 
Cefalexin Sandoz
SZ
MP
C4243
 
40
2
20
 
 

 
 
 
Cephalexin generichealth
GQ
MP
C4243
 
40
2
20
 
 

 
 
 
Chem mart Cephalexin
CH
MP
C4243
 
40
2
20
 
 

 
 
 
Cilex
GM
MP
C4243
 
40
2
20
 
 

 
 
 
GenRx Cephalexin
GX
MP
C4243
 
40
2
20
 
 

 
 
 
Ialex
LN
MP
C4243
 
40
2
20
 
 

 
 
 
Ibilex 250
AF
MP
C4243
 
40
2
20
 
 

 
 
 
Keflex
AS
MP
C4243
 
40
2
20
 
 

 
 
 
Pharmacor Cephalexin 250
CR
MP
C4243
 
40
2
20
 
 

 
 
 
Rancef
RA
MP
C4243
 
40
2
20
 
 

 
 
 
Terry White Chemists Cephalexin
TW
MP
C4243
 
40
2
20
 
 

[33]         Schedule 1, entry for Cephalexin in the form Capsule 500 mg (anhydrous)
(a)      omit:
 
 
 
Cephatrust 500
MI
PDP
 
 
20
0
20
 
 
(b)      omit:
 
 
 
Cephatrust 500
MI
MP NP MW
 
 
20
1
20
 
 
 
 
[34]         Schedule 1, entry for Citalopram in the form Tablet 20 mg (as hydrobromide)
(a)      omit:
 
 
 
Citalopram 20
CR
MP NP
C1211
 
28
5
28
 
 
(b)      omit from the column headed “Responsible Person” for the brand “Pharmacor Citalo 20”:                 MI           substitute:      CR
[35]         Schedule 1, entry for Clopidogrel in the form Tablet 75 mg (as hydrogen sulfate)
omit from the column headed “Responsible Person” for the brand “Plavicor 75”:             MI           substitute:             CR
[36]         Schedule 1, entry for Clopidogrel in the form Tablet 75 mg (as besilate)
insert in numerical order after existing codes in the column headed “Circumstances” for the brand “Clopidogrel-GA”:
C4165  C4166
[37]         Schedule 1, after entry for Diazepam in the form Injection 10 mg in 2 mL
insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
 
Oral liquid 1 mg in 1 mL, 100 mL
Oral
Diazepam Elixir
ON
MP NP
4244
 
1
0
1
 
 
[38]         Schedule 1, entry for Docetaxel in all forms
omit from the column headed “Circumstances” (all instances):               C4155
insert in numerical order:                  C4239
[39]         Schedule 1, entry for Duloxetine in the form Capsule 30 mg (as hydrochloride)
insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
 
 
 
Duloxetine DR GH
GQ
MP NP
C1211
 
28
0
28
 
[40]         Schedule 1, entry for Duloxetine in the form Capsule 60 mg (as hydrochloride)
insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
 
 
 
Duloxetine DR GH
GQ
MP NP
C1211
 
28
5
28
 
[41]         Schedule 1, entry for Famciclovir in the form Tablet 250 mg [Maximum Quantity 21; Number of Repeats 0]
insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
 
 
 
Famlo
RA
MP NP
C3622 C3623
P3622
21
0
21
 
 
[42]         Schedule 1, entry for Famciclovir in the form Tablet 250 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”:
 
 
 
Famlo
RA
MP NP
C3622 C3623
P3623
56
5
56
 
 
[43]         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”:                                ZA          substitute:                TX
[44]         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”:                    ZA          substitute:             TX
[45]         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”:                 ZA          substitute:             TX
[46]         Schedule 1, entry for Fentanyl in the form Lozenge 200 micrograms (as citrate) [Maximum Quantity 9; Number of Repeats 0]
(a)      omit from the column headed “Circumstances”:               C3663  C3664    substitute:             C4250  C4267
(b)      omit from the column headed “Purposes”:         P3663   substitute:             P4250
[47]         Schedule 1, entry for Fentanyl in the form Lozenge 200 micrograms (as citrate) [Maximum Quantity 60; Number of Repeats 0]
(a)      omit from the column headed “Circumstances”:               C3663  C3664    substitute:             C4250  C4267
(b)      omit from the column headed “Purposes”:         P3664   substitute:             P4267
[48]         Schedule 1, entry for Fentanyl in the form Lozenge 400 micrograms (as citrate) [Maximum Quantity 9; Number of Repeats 0]
(a)      omit from the column headed “Circumstances”:               C3663  C3664    substitute:             C4250  C4267
(b)      omit from the column headed “Purposes”:         P3663   substitute:             P4250
[49]         Schedule 1, entry for Fentanyl in the form Lozenge 400 micrograms (as citrate) [Maximum Quantity 60; Number of Repeats 0]
(a)      omit from the column headed “Circumstances”:               C3663  C3664    substitute:             C4250  C4267
(b)      omit from the column headed “Purposes”:         P3664   substitute:             P4267
[50]         Schedule 1, entry for Fentanyl in the form Lozenge 600 micrograms (as citrate) [Maximum Quantity 9; Number of Repeats 0]
(a)      omit from the column headed “Circumstances”:               C3663  C3664    substitute:             C4250  C4267
(b)      omit from the column headed “Purposes”:         P3663   substitute:             P4250
[51]         Schedule 1, entry for Fentanyl in the form Lozenge 600 micrograms (as citrate) [Maximum Quantity 60; Number of Repeats 0]
(a)      omit from the column headed “Circumstances”:               C3663  C3664    substitute:             C4250  C4267
(b)      omit from the column headed “Purposes”:         P3664   substitute:             P4267
[52]         Schedule 1, entry for Fentanyl in the form Lozenge 800 micrograms (as citrate) [Maximum Quantity 9; Number of Repeats 0]
(a)      omit from the column headed “Circumstances”:               C3663  C3664    substitute:             C4250  C4267
(b)      omit from the column headed “Purposes”:         P3663   substitute:             P4250
[53]         Schedule 1, entry for Fentanyl in the form Lozenge 800 micrograms (as citrate) [Maximum Quantity 60; Number of Repeats 0]
(a)      omit from the column headed “Circumstances”:               C3663  C3664    substitute:             C4250  C4267
(b)      omit from the column headed “Purposes”:         P3664   substitute:             P4267
[54]         Schedule 1, entry for Fentanyl in the form Lozenge 1200 micrograms (as citrate) [Maximum Quantity 9; Number of Repeats 0]
(a)      omit from the column headed “Circumstances”:               C3663  C3664    substitute:             C4250  C4267
(b)      omit from the column headed “Purposes”:         P3663   substitute:             P4250
[55]         Schedule 1, entry for Fentanyl in the form Lozenge 1200 micrograms (as citrate) [Maximum Quantity 60; Number of Repeats 0]
(a)      omit from the column headed “Circumstances”:               C3663  C3664    substitute:             C4250  C4267
(b)      omit from the column headed “Purposes”:         P3664   substitute:             P4267
[56]         Schedule 1, entry for Fentanyl in the form Lozenge 1600 micrograms (as citrate) [Maximum Quantity 9; Number of Repeats 0]
(a)      omit from the column headed “Circumstances”:               C3663  C3664    substitute:             C4250  C4267
(b)      omit from the column headed “Purposes”:         P3663   substitute:             P4250
[57]         Schedule 1, entry for Fentanyl in the form Lozenge 1600 micrograms (as citrate) [Maximum Quantity 60; Number of Repeats 0]
(a)      omit from the column headed “Circumstances”:               C3663  C3664    substitute:             C4250  C4267
(b)      omit from the column headed “Purposes”:         P3664   substitute:             P4267
[58]         Schedule 1, entry for Gemcitabine in the form Powder for I.V. infusion 2 g (as hydrochloride)
omit:
 
 
 
Gemcitabine Actavis 2000
WQ
MP
 
See Note 3
See Note 3
1
D(100)
[59]         Schedule 1, entry for Gemfibrozil in the form Tablet 600 mg
(a)      omit:
 
 
 
Pharmacor Gemfibrozil 600
CR
MP
C1540 C3047
P1540
60
5
60
 
 

 
 
 
 
 
NP
C1540
 
60
5
60
 
 

(b)      omit:
 
 
 
Pharmacor Gemfibrozil 600
CR
MP
C1540 C3047
P3047
60
11
60
 
 
[60]         Schedule 1, entry for Glimepiride in the form Tablet 1 mg
omit:
 
 
 
Pharmacor Glimepiride 1
CR
MP NP
 
30
5
30
 
 
[61]         Schedule 1, entry for Glimepiride in the form Tablet 2 mg
omit:
 
 
 
Pharmacor Glimepiride 2
CR
MP NP
 
30
5
30
 
 
[62]         Schedule 1, entry for Glimepiride in the form Tablet 3 mg
omit:
 
 
 
Pharmacor Glimepiride 3
CR
MP NP
 
30
5
30
 
 
[63]         Schedule 1, entry for Glimepiride in the form Tablet 4 mg
omit:
 
 
 
Pharmacor Glimepiride 4
CR
MP NP
 
30
5
30
 
 
[64]         Schedule 1, entry for Glucose Indicator―Blood in all forms of Test strips [Number of Repeats 11]
omit from the column headed “Purposes” (all instances):         P3035    substitute:             P4241
[65]         Schedule 1, after entry for Glucose Indicator―Blood in the form Test strips, 50 (Omnitest EZ)
insert in the columns in the order indicated:
 
Test strips, 50 (OneTouch Select)
For external use
OneTouch Select
JJ
MP NP
 
2
5
1
 
 

 
 
 
 
 
MP
 
P4241
2
11
1
 
 

[66]         Schedule 1, after entry for Glyceryl Trinitrate
insert:
Glycomacropeptide and essential amino acids
Oral liquid 500 mL, 12 (Camino Pro Restore)
Oral
Camino Pro Restore
QH
MP NP
C1286
 
12
5
1
 

Glycomacropeptide and essential amino acids with vitamins and minerals
Bars 54 g, 7 (Camino Pro Complete)
Oral
Camino Pro Complete
QH
MP NP
C1286
 
14
5
1
 
 

 
Bars 81 g, 7 (Camino Pro Complete)
Oral
Camino Pro Complete
QH
MP NP
C1286
 
14
5
1
 
 

 
Sachets containing oral powder 49 g, 28 (Camino Pro Bettermilk)
Oral
Camino Pro Bettermilk
QH
MP NP
C1286
 
4
5
1
 
 

[67]         Schedule 1, after entry for High fat formula with vitamins, minerals and trace elements and low in protein and carbohydrate in the form Oral powder 300 g (KetoCal)
insert in the columns in the order indicated:
 
Oral powder 300 g (KetoCal 3:1)
Oral
KetoCal 3:1
SB
MP NP
C4253
 
24
5
1
 
 
[68]         Schedule 1, after entry for Interferon Gamma-1b
insert:
Ipilimumab
Injection concentrate for I.V. infusion 50 mg in 10 mL
Injection
Yervoy
BQ
MP
C4235 C4236 C4251 C4252 C4254 C4256 C4261 C4265
See Note 3
See Note 3
See Note 3
1
D(100)

 
Injection concentrate for I.V. infusion 200 mg in 40 mL
Injection
Yervoy
BQ
MP
C4235 C4236 C4251 C4252 C4254 C4256 C4261 C4265
See Note 3
See Note 3
See Note 3
1
 
D(100)

[69]         Schedule 1, entry for Lacosamide
substitute:
Lacosamide
Tablet 50 mg
Oral
Vimpat
UC
MP NP
C4271
 
14
1
14
 
 

 
Tablet 100 mg
Oral
Vimpat
UC
MP NP
C4249 C4264 C4271
P4271
14
1
14
 
 

 
 
 
 
 
MP NP
C4249 C4264 C4271
P4249 P4264
56
5
56
 
 

 
Tablet 150 mg
Oral
Vimpat
UC
MP NP
C4240 C4257 C4271
P4271
14
1
14
 
 

 
 
 
 
 
MP NP
C4240 C4257 C4271
P4240 P4257
56
5
56
 
 

 
Tablet 200 mg
Oral
Vimpat
UC
MP NP
C4240 C4257
 
56
5
56
 
 

[70]         Schedule 1, entry for Lamivudine with Zidovudine
insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
 
 
 
Lamivudine 150mg + Zidovudine 300mg Alphapharm
AF
MP
See Note 1
C3586 C3587 C3588 C3589
 
120
5
60
 
D(100)
[71]         Schedule 1, entry for Lamotrigine in the form Tablet 25 mg
omit from the column headed “Responsible Person” for the brand “Lamotrust 25”:          MI           substitute:             CR
[72]         Schedule 1, entry for Lamotrigine in the form Tablet 50 mg
omit from the column headed “Responsible Person” for the brand “Lamotrust 50”:          MI           substitute:             CR
[73]         Schedule 1, entry for Lamotrigine in the form Tablet 100 mg
omit from the column headed “Responsible Person” for the brand “Lamotrust 100”:        MI           substitute:             CR
[74]         Schedule 1, entry for Lamotrigine in the form Tablet 200 mg
omit from the column headed “Responsible Person” for the brand “Lamotrust 200”:        MI           substitute:             CR
[75]         Schedule 1, entry for Letrozole
omit:
 
 
 
Letrozole-Synthon
ZT
MP NP
C1608 C2691 C2692
 
30
5
30
 
 
[76]         Schedule 1, entry for Lisinopril in the form Tablet 5 mg
omit:
 
 
 
Lisinopril 5
CR
MP NP
 
30
5
30
 
 
[77]         Schedule 1, entry for Lisinopril in the form Tablet 10 mg
omit:
 
 
 
Lisinopril 10
CR
MP NP
 
30
5
30
 
 
[78]         Schedule 1, entry for Lisinopril in the form Tablet 20 mg
omit:
 
 
 
Lisinopril 20
CR
MP NP
 
30
5
30
 
 
[79]         Schedule 1, entry for Macrogol 3350
omit:
Macrogol 3350
Sachets containing powder for oral solution 13.125 g with electrolytes, 30
Oral
Movicol
NE
MP NP
See Note 1
C1263 C1613 C2693 C2823 C3642 C3643
See Note 2
P3643
See Note 2
2
See Note 2
0
See Note 2
1
 
 

 
 
 
 
 
MP NP
See Note 1
C1263 C1613 C2693 C2823 C3642 C3643
See Note 2
P3642
See Note 2
2
See Note 2
3
See Note 2
1
 
 

 
 
 
 
 
MP NP
See Note 1
C1263 C1613 C2693 C2823 C3642 C3643
See Note 2
P1263 P1613 P2693 P2823
See Note 2
1
See Note 2
5
See Note 2
1
 
 

substitute:
Macrogol 3350
Sachets containing powder for oral solution 13.125 g with electrolytes, 30
Oral
LaxaCon
GM
MP NP
See Note 1
C1263 C1613 C2693 C2823 C3642 C3643
See Note 2
P3643
See Note 2
2
See Note 2
0
See Note 2
1
 
 

 
 
 
 
 
MP NP
See Note 1
C1263 C1613 C2693 C2823 C3642 C3643
See Note 2
P3642
See Note 2
2
See Note 2
3
See Note 2
1
 
 

 
 
 
 
 
MP NP
See Note 1
C1263 C1613 C2693 C2823 C3642 C3643
See Note 2
P1263 P1613 P2693 P2823
See Note 2
1
See Note 2
5
See Note 2
1
 
 

 
 
 
Movicol
NE
MP NP
See Note 1
C1263 C1613 C2693 C2823 C3642 C3643
See Note 2
P3643
See Note 2
2
See Note 2
0
See Note 2
1
 
 

 
 
 
 
 
MP NP
See Note 1
C1263 C1613 C2693 C2823 C3642 C3643
See Note 2
P3642
See Note 2
2
See Note 2
3
See Note 2
1
 
 

 
 
 
 
 
MP NP
See Note 1
C1263 C1613 C2693 C2823 C3642 C3643
See Note 2
P1263 P1613 P2693 P2823
See Note 2
1
See Note 2
5
See Note 2
1
 
 

[80]         Schedule 1, entry for Macrogol 3350
omit:
 
Powder for oral solution 510 g
Oral
MediHealth ClearLax
ON
MP NP
C4170 C4171 C4173 C4176 C4177 C4179 C4180
P4171 P4173 P4177 P4179 P4180
1
5
1
 
 

 
 
 
OsmoLax
KY
MP NP
C4170 C4171 C4173 C4176 C4177 C4179 C4180
P4171 P4173 P4177 P4179 P4180
1
5
1
 
 

 
 
 
MediHealth ClearLax
ON
MP NP
C4170 C4171 C4173 C4176 C4177 C4179 C4180
P4170
2
0
1
 
 

 
 
 
OsmoLax
KY
MP NP
C4170 C4171 C4173 C4176 C4177 C4179 C4180
P4170
2
0
1
 
 

 
 
 
MediHealth ClearLax
ON
MP NP
C4170 C4171 C4173 C4176 C4177 C4179 C4180
P4176
2
3
1
 
 

 
 
 
OsmoLax
KY
MP NP
C4170 C4171 C4173 C4176 C4177 C4179 C4180
P4176
2
3
1
 
 

 
 
substitute:
 
Powder for oral solution 510 g
Oral
OsmoLax
KY
MP NP
C4170 C4171 C4173 C4176 C4177 C4179 C4180
P4171 P4173 P4177 P4179 P4180
1
5
1
 
 

 
 
 
 
 
MP NP
C4170 C4171 C4173 C4176 C4177 C4179 C4180
P4170
2
0
1
 
 

 
 
 
 
 
MP NP
C4170 C4171 C4173 C4176 C4177 C4179 C4180
P4176
2
3
1
 
 

[81]         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”:
 
 
 
APO-Metoprolol
TX
MP NP
 
100
5
100
 
 
[82]         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”:
 
 
 
APO-Metoprolol
TX
MP NP
 
60
5
60
 
 
[83]         Schedule 1, after entry for Miconazole in the form Lotion containing miconazole nitrate 20 mg per mL, 30 g
insert:
Mifepristone
Tablet 200 mg
Oral
Mifepristone Linepharma
XH
MP
C4247
 
1
0
1
 
[84]         Schedule 1, entry for Mirtazapine in the form Tablet 30 mg
insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
 
 
 
Mirtazapine-GA
GN
MP NP
C1211
 
30
5
30
 
 
[85]         Schedule 1, entry for Mirtazapine in the form Tablet 45 mg
insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
 
 
 
Mirtazapine-GA
GM
MP NP
C1211
 
30
5
30
 
 
[86]         Schedule 1, entry for Misoprostol
substitute:
Misoprostol
Tablet 200 micrograms
Oral
GyMiso
XH
MP
C4266
 
4
1
4
 
 

 
 
 
Cytotec
PF
MP
C2630 C2631 C2632
 
120
2
120
 
 

[87]         Schedule 1, entry for Montelukast
substitute:
Montelukast
Tablet, chewable, 4 mg (as sodium)
Oral
APO-Montelukast
TX
MP NP
C2617
 
28
5
28
 
 

 
 
 
Chem mart Montelukast
CH
MP NP
C2617
 
28
5
28
 
 

 
 
 
Lukair
FR
MP NP
C2617
 
28
5
28
 
 

 
 
 
Montair 4
GM
MP NP
C2617
 
28
5
28
 
 

 
 
 
Montelukast GH
GQ
MP NP
C2617
 
28
5
28
 
 

 
 
 
Montelukast RBX
RA
MP NP
C2617
 
28
5
28
 
 

 
 
 
Montelukast Sandoz 4
SZ
MP NP
C2617
 
28
5
28
 
 

 
 
 
Respikast 4
QA
MP NP
C2617
 
28
5
28
 
 

 
 
 
Singulair
MK
MP NP
C2617
 
28
5
28
 
 

 
 
 
Terry White Chemists Montelukast
TW
MP NP
C2617
 
28
5
28
 
 

 
Tablet, chewable, 5 mg (as sodium)
Oral
APO-Montelukast
TX
MP NP
C2618 C3217
 
28
5
28
 
 

 
 
 
Chem mart Montelukast
CH
MP NP
C2618 C3217
 
28
5
28
 
 

 
 
 
Lukair
FR
MP NP
C2618 C3217
 
28
5
28
 
 

 
 
 
Montair 5
GM
MP NP
C2618 C3217
 
28
5
28
 
 

 
 
 
Montelukast GH
GQ
MP NP
C2618 C3217
 
28
5
28
 
 

 
 
 
Montelukast RBX
RA
MP NP
C2618 C3217
 
28
5
28
 
 

 
 
 
Montelukast Sandoz 5
SZ
MP NP
C2618 C3217
 
28
5
28
 
 

 
 
 
Respikast 5
QA
MP NP
C2618 C3217
 
28
5
28
 
 

 
 
 
Singulair
MK
MP NP
C2618 C3217
 
28
5
28
 
 

 
 
 
Terry White Chemists Montelukast
TW
MP NP
C2618 C3217
 
28
5
28
 
 

 
 
[88]         Schedule 1, entry for Norfloxacin
(a)      omit:
 
 
 
Chem mart Norfloxacin
CH
MP NP
C1002 C1070
 
14
1
14
 
 
(b)      omit:
 
 
 
Terry White Chemists Norfloxacin
TW
MP NP
C1002 C1070
 
14
1
14
 
 
[89]         Schedule 1, entry for Olanzapine in each of the forms: Tablet 2.5 mg (as benzoate); Tablet 5 mg (as benzoate); Tablet 7.5 mg
(as benzoate); and Tablet 10 mg (as benzoate)
omit:
 
 
 
Olanzapine-Synthon
ZT
MP NP
C1589 C2044
 
28
5
28
 
 
[90]         Schedule 1, entry for Omeprazole in the form Tablet 20 mg (as magnesium)
omit from the column headed “Responsible Person” for the brand “Omepral” (twice occurring):                  PM         substitute:                TX
[91]         Schedule 1, entry for Paliperidone
omit from the column headed “Circumstances” (all instances):               C1589   substitute:             C4246
[92]         Schedule 1, entry for Paroxetine in the form Tablet 20 mg (as hydrochloride)
omit:
 
 
 
Paroxetine 20
MI
MP NP
C1211 C1241 C1862
 
30
5
30
 
 
[93]         Schedule 1, entry for Paroxetine in the form Tablet 20 mg (as mesilate)
omit:
 
 
 
Paroxetine Synthon
ZT
MP NP
C1211 C1241 C1862
 
30
5
30
 

 
 
 
Pharmacor Paroxo 20
MI
MP NP
C1211 C1241 C1862
 
30
5
30
 
 

[94]         Schedule 1, entry for Perindopril in the form Tablet containing perindopril erbumine 2 mg
omit:
 
 
 
Perindopril 2
CR
MP NP
 
30
5
30
 
 
[95]         Schedule 1, entry for Perindopril in the form Tablet containing perindopril erbumine 4 mg
omit:
 
 
 
Perindopril 4
CR
MP NP
 
30
5
30
 
 
[96]         Schedule 1, entry for Perindopril in the form Tablet containing perindopril erbumine 8 mg
omit:
 
 
 
Perindopril 8
CR
MP NP
 
30
5
30
 
 
[97]         Schedule 1, entry for Pramipexole in the form Tablet containing pramipexole hydrochloride 125 micrograms
(a)      omit from the column headed “Circumstances” for the brand “Simipex 0.125”:
C3088
(b)      omit from the column headed “Purposes” for the brand “Simipex 0.125”:
P3216
[98]         Schedule 1, entry for Pramipexole in the form Tablet containing pramipexole hydrochloride 250 micrograms
(a)      omit from the column headed “Circumstances” for the brand “Simipex 0.25”:
C3088
(b)      omit from the column headed “Purposes” for the brand “Simipex 0.25”:
P3216
[99]         Schedule 1, entry for Progesterone in each of the forms: Pessary 100 mg; and Pessary 200 mg
omit from the column headed “Brand”:         Orion Laboratories Pty Ltd         substitute:             Oripro
[100]       Schedule 1, entry for Quetiapine in the form Tablet 25 mg (as fumarate)
omit:
 
 
 
Quetiapine-Synthon
ZT
MP NP
C1589 C2044 C2765
 
60
5
60
 
 
[101]       Schedule 1, entry for Quetiapine in the form Tablet 100 mg (as fumarate)
omit:
 
 
 
Quetiapine-Synthon
ZT
MP NP
C1589 C2044 C2765
 
90
5
90
 
 
[102]       Schedule 1, entry for Quetiapine in each of the forms: Tablet 200 mg (as fumarate); and Tablet 300 mg (as fumarate)
omit:
 
 
 
Quetiapine-Synthon
ZT
MP NP
C1589 C2044 C2765
 
60
5
60
 
 
[103]       Schedule 1, entry for Quinapril in the form Tablet 5 mg (as hydrochloride)
omit:
 
 
 
Pharmacor Quinapril 5
CR
MP NP
 
30
5
30
 
 
[104]       Schedule 1, entry for Quinapril in the form Tablet 10 mg (as hydrochloride)
omit:
 
 
 
Pharmacor Quinapril 10
CR
MP NP
 
30
5
30
 
 
[105]       Schedule 1, entry for Quinapril in the form Tablet 20 mg (as hydrochloride)
omit:
 
 
 
Pharmacor Quinapril 20
CR
MP NP
 
30
5
30
 
 
[106]       Schedule 1, entry for Ramipril in the form Capsule 1.25 mg
omit:
 
 
 
Pharmacor Ramipril 1.25
CR
MP NP
 
30
5
30
 
 
[107]       Schedule 1, entry for Ramipril in the form Capsule 2.5 mg
omit:
 
 
 
Pharmacor Ramipril 2.5
CR
MP NP
 
30
5
30
 
 
[108]       Schedule 1, entry for Risedronic Acid in each of the forms: Tablet containing risedronate sodium 5 mg; Tablet containing
risedronate sodium 35 mg; Tablet (enteric coated) containing risedronate sodium 35 mg; and Tablet containing risedronate sodium 150 mg
omit from the column headed “Circumstances” (all instances):               C4117
insert in numerical order:                 C4133
[109]       Schedule 1, entry for Risedronic Acid and Calcium in each of the forms: Pack containing 4 tablets risedronate sodium 35 mg and 24 tablets calcium 500 mg (as carbonate); and Pack containing 4 enteric coated tablets risedronate sodium 35 mg and 24 tablets
calcium 500 mg (as carbonate)
omit from the column headed “Circumstances” (all instances):               C4117
insert in numerical order:                 C4133
[110]       Schedule 1, entry for Risedronic acid and calcium with colecalciferol
omit from the column headed “Circumstances” (all instances):               C4117
insert in numerical order:                 C4133
[111]       Schedule 1, entry for Rivaroxaban
omit:
 
Tablet 15 mg
Oral
Xarelto
BN
MP NP
C4098
 
42
0
42
 
 

 
Tablet 20 mg
Oral
Xarelto
BN
MP NP
C4099 C4132
 
28
5
28
 
 

substitute:
 
Tablet 15 mg
Oral
Xarelto
BN
MP NP
C4098 C4260 C4269
P4269
28
5
28
 
 

 
 
 
 
 
MP NP
C4098 C4260 C4269
P4098 P4260
42
0
42
 
 

 
Tablet 20 mg
Oral
Xarelto
BN
MP NP
C4099 C4132 C4268 C4269
 
28
5
28
 
 

[112]       Schedule 1, entry for Rosuvastatin in the form Tablet 5 mg (as calcium) [Maximum Quantity 30; Number of Repeats 5]
insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
 
 
 
Cavstat
AF
MP
C4225 C4228 C4238 C4248
P4228 P4248
30
5
30
 
 

 
 
 
 
 
NP
C4228 C4248
 
30
5
30
 
 

[113]       Schedule 1, entry for Rosuvastatin in the form Tablet 5 mg (as calcium) [Maximum Quantity 30; Number of Repeats 5]
(a)      omit from the column headed “Circumstances” for the brand “Crestor” with Authorised Prescriber “MP”:
C1540  C3047  C4225  C4228            substitute:             C4225  C4228  C4238  C4248
(b)      omit from the column headed “Purposes” for the brand “Crestor” with Authorised Prescriber “MP”:
P1540  P4228          substitute:             P4228  P4248
(c)      omit from the column headed “Circumstances” for the brand “Crestor” with Authorised Prescriber “NP”:
C1540  C4228          substitute:             C4228  C4248
[114]       Schedule 1, entry for Rosuvastatin in the form Tablet 5 mg (as calcium) [Maximum Quantity 30; Number of Repeats 5]
insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
 
 
 
Rostor 5
DO
MP
C4225 C4228
P4228
30
5
30
 
 

 
 
 
 
 
NP
C4228
 
30
5
30
 
 

[115]       Schedule 1, entry for Rosuvastatin in the form Tablet 5 mg (as calcium) [Maximum Quantity 30; Number of Repeats 5]
(a)      omit from the column headed “Circumstances” for the brand “Rosuvastatin Actavis 5” with Authorised Prescriber “MP”:
C1540  C3047  C4225  C4228            substitute:             C4225  C4228  C4238  C4248
(b)      omit from the column headed “Purposes” for the brand “Rosuvastatin Actavis 5” with Authorised Prescriber “MP”:
P1540  P4228          substitute:             P4228  P4248
(c)      omit from the column headed “Circumstances” for the brand “Rosuvastatin Actavis 5” with Authorised Prescriber “NP”:
C1540  C4228          substitute:             C4228  C4248
[116]       Schedule 1, entry for Rosuvastatin in the form Tablet 5 mg (as calcium) [Maximum Quantity 30; Number of Repeats 5]
insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
 
 
 
Rosuvastatin GH
GQ
MP
C4225 C4228 C4238 C4248
P4228 P4248
30
5
30
 
 

 
 
 
 
 
NP
C4228 C4248
 
30
5
30
 
 

[117]       Schedule 1, entry for Rosuvastatin in the form Tablet 5 mg (as calcium) [Maximum Quantity 30; Number of Repeats 11]
insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
 
 
 
Cavstat
AF
MP
C4225 C4228 C4238 C4248
P4225 P4238
30
11
30
 
 
[118]       Schedule 1, entry for Rosuvastatin in the form Tablet 5 mg (as calcium) [Maximum Quantity 30; Number of Repeats 11]
(a)      omit from the column headed “Circumstances” for the brand “Crestor”:
C1540  C3047  C4225  C4228            substitute:             C4225  C4228  C4238  C4248
(b)      omit from the column headed “Purposes” for the brand “Crestor”:
P3047  P4225          substitute:             P4225  P4238
[119]       Schedule 1, entry for Rosuvastatin in the form Tablet 5 mg (as calcium) [Maximum Quantity 30; Number of Repeats 11]
insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
 
 
 
Rostor 5
DO
MP
C4225 C4228
P4225
30
11
30
 
 
[120]       Schedule 1, entry for Rosuvastatin in the form Tablet 5 mg (as calcium) [Maximum Quantity 30; Number of Repeats 11]
(a)      omit from the column headed “Circumstances” for the brand “Rosuvastatin Actavis 5”:
C1540  C3047  C4225  C4228            substitute:             C4225  C4228  C4238  C4248
(b)      omit from the column headed “Purposes” for the brand “Rosuvastatin Actavis 5”:
P3047  P4225          substitute:             P4225  P4238
 
[121]       Schedule 1, entry for Rosuvastatin in the form Tablet 5 mg (as calcium) [Maximum Quantity 30; Number of Repeats 11]
insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
 
 
 
Rosuvastatin GH
GQ
MP
C4225 C4228 C4238 C4248
P4225 P4238
30
11
30
 
 
[122]       Schedule 1, entry for Rosuvastatin in the form Tablet 10 mg (as calcium) [Maximum Quantity 30; Number of Repeats 5]
insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
 
 
 
Cavstat
AF
MP
C4225 C4228 C4238 C4248
P4228 P4248
30
5
30
 
 

 
 
 
 
 
NP
C4228 C4248
 
30
5
30
 
 

[123]       Schedule 1, entry for Rosuvastatin in the form Tablet 10 mg (as calcium) [Maximum Quantity 30; Number of Repeats 5]
(a)      omit from the column headed “Circumstances” for the brand “Crestor” with Authorised Prescriber “MP”:
C1540  C3047  C4225  C4228            substitute:             C4225  C4228  C4238  C4248
(b)      omit from the column headed “Purposes” for the brand “Crestor” with Authorised Prescriber “MP”:
P1540  P4228          substitute:             P4228  P4248
(c)      omit from the column headed “Circumstances” for the brand “Crestor” with Authorised Prescriber “NP”:
C1540  C4228          substitute:             C4228  C4248
[124]       Schedule 1, entry for Rosuvastatin in the form Tablet 10 mg (as calcium) [Maximum Quantity 30; Number of Repeats 5]
insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
 
 
 
Rostor 10
DO
MP
C4225 C4228
P4228
30
5
30
 
 

 
 
 
 
 
NP
C4228
 
30
5
30
 
 

[125]       Schedule 1, entry for Rosuvastatin in the form Tablet 10 mg (as calcium) [Maximum Quantity 30; Number of Repeats 5]
(a)      omit from the column headed “Circumstances” for the brand “Rosuvastatin Actavis 10” with Authorised Prescriber “MP”:
C1540  C3047  C4225  C4228            substitute:             C4225  C4228  C4238  C4248
(b)      omit from the column headed “Purposes” for the brand “Rosuvastatin Actavis 10” with Authorised Prescriber “MP”:
P1540  P4228          substitute:             P4228  P4248
(c)      omit from the column headed “Circumstances” for the brand “Rosuvastatin Actavis 10” with Authorised Prescriber “NP”:
C1540  C4228          substitute:             C4228  C4248
[126]       Schedule 1, entry for Rosuvastatin in the form Tablet 10 mg (as calcium) [Maximum Quantity 30; Number of Repeats 5]
insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
 
 
 
Rosuvastatin GH
GQ
MP
C4225 C4228 C4238 C4248
P4228 P4248
30
5
30
 
 

 
 
 
 
 
NP
C4228 C4248
 
30
5
30
 
 

[127]       Schedule 1, entry for Rosuvastatin in the form Tablet 10 mg (as calcium) [Maximum Quantity 30; Number of Repeats 11]
insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
 
 
 
Cavstat
AF
MP
C4225 C4228 C4238 C4248
P4225 P4238
30
11
30
 
 
[128]       Schedule 1, entry for Rosuvastatin in the form Tablet 10 mg (as calcium) [Maximum Quantity 30; Number of Repeats 11]
(a)      omit from the column headed “Circumstances” for the brand “Crestor”:
C1540  C3047  C4225  C4228            substitute:             C4225  C4228  C4238  C4248
(b)      omit from the column headed “Purposes” for the brand “Crestor”:
P3047  P4225          substitute:             P4225  P4238
[129]       Schedule 1, entry for Rosuvastatin in the form Tablet 10 mg (as calcium) [Maximum Quantity 30; Number of Repeats 11]
insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
 
 
 
Rostor 10
DO
MP
C4225 C4228
P4225
30
11
30
 
 
[130]       Schedule 1, entry for Rosuvastatin in the form Tablet 10 mg (as calcium) [Maximum Quantity 30; Number of Repeats 11]
(a)      omit from the column headed “Circumstances” for the brand “Rosuvastatin Actavis 10”:
C1540  C3047  C4225  C4228            substitute:             C4225  C4228  C4238  C4248
(b)      omit from the column headed “Purposes” for the brand “Rosuvastatin Actavis 10”:
P3047  P4225          substitute:             P4225  P4238
[131]       Schedule 1, entry for Rosuvastatin in the form Tablet 10 mg (as calcium) [Maximum Quantity 30; Number of Repeats 11]
insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
 
 
 
Rosuvastatin GH
GQ
MP
C4225 C4228 C4238 C4248
P4225 P4238
30
11
30
 
 
[132]       Schedule 1, entry for Rosuvastatin in the form Tablet 20 mg (as calcium) [Maximum Quantity 30; Number of Repeats 5]
insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
 
 
 
Cavstat
AF
MP
C4225 C4227 C4238 C4259
P4227 P4259
30
5
30
 
 

 
 
 
 
 
NP
C4227 C4259
 
30
5
30
 
 

[133]       Schedule 1, entry for Rosuvastatin in the form Tablet 20 mg (as calcium) [Maximum Quantity 30; Number of Repeats 5]
(a)      omit from the column headed “Circumstances” for the brand “Crestor” with Authorised Prescriber “MP”:
C1540  C3047  C4225  C4227            substitute:             C4225  C4227  C4238  C4259
(b)      omit from the column headed “Purposes” for the brand “Crestor” with Authorised Prescriber “MP”:
P1540  P4227          substitute:             P4227  P4259
(c)      omit from the column headed “Circumstances” for the brand “Crestor” with Authorised Prescriber “NP”:
C1540  C4227          substitute:             C4227  C4259
[134]       Schedule 1, entry for Rosuvastatin in the form Tablet 20 mg (as calcium) [Maximum Quantity 30; Number of Repeats 5]
insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
 
 
 
Rostor 20
DO
MP
C4225 C4227
P4227
30
5
30
 
 

 
 
 
 
 
NP
C4227
 
30
5
30
 
 

[135]       Schedule 1, entry for Rosuvastatin in the form Tablet 20 mg (as calcium) [Maximum Quantity 30; Number of Repeats 5]
(a)      omit from the column headed “Circumstances” for the brand “Rosuvastatin Actavis 20” with Authorised Prescriber “MP”:
C1540  C3047  C4225  C4227            substitute:             C4225  C4227  C4238  C4259
(b)      omit from the column headed “Purposes” for the brand “Rosuvastatin Actavis 20” with Authorised Prescriber “MP”:
P1540  P4227          substitute:             P4227  P4259
(c)      omit from the column headed “Circumstances” for the brand “Rosuvastatin Actavis 20” with Authorised Prescriber “NP”:
C1540  C4227          substitute:             C4227  C4259
[136]       Schedule 1, entry for Rosuvastatin in the form Tablet 20 mg (as calcium) [Maximum Quantity 30; Number of Repeats 5]
insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
 
 
 
Rosuvastatin GH
GQ
MP
C4225 C4227 C4238 C4259
P4227 P4259
30
5
30
 
 

 
 
 
 
 
NP
C4227 C4259
 
30
5
30
 
 

[137]       Schedule 1, entry for Rosuvastatin in the form Tablet 20 mg (as calcium) [Maximum Quantity 30; Number of Repeats 11]
insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
 
 
 
Cavstat
AF
MP
C4225 C4227 C4238 C4259
P4225 P4238
30
11
30
 
 
[138]       Schedule 1, entry for Rosuvastatin in the form Tablet 20 mg (as calcium) [Maximum Quantity 30; Number of Repeats 11]
(a)      omit from the column headed “Circumstances” for the brand “Crestor”:
C1540  C3047  C4225  C4227            substitute:             C4225  C4227  C4238  C4259
(b)      omit from the column headed “Purposes” for the brand “Crestor”:
P3047  P4225          substitute:             P4225  P4238
[139]       Schedule 1, entry for Rosuvastatin in the form Tablet 20 mg (as calcium) [Maximum Quantity 30; Number of Repeats 11]
insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
 
 
 
Rostor 20
DO
MP
C4225 C4227
P4225
30
11
30
 
 
[140]       Schedule 1, entry for Rosuvastatin in the form Tablet 20 mg (as calcium) [Maximum Quantity 30; Number of Repeats 11]
(a)      omit from the column headed “Circumstances” for the brand “Rosuvastatin Actavis 20”:
C1540  C3047  C4225  C4227            substitute:             C4225  C4227  C4238  C4259
(b)      omit from the column headed “Purposes” for the brand “Rosuvastatin Actavis 20”:
P3047  P4225          substitute:             P4225  P4238
[141]       Schedule 1, entry for Rosuvastatin in the form Tablet 20 mg (as calcium) [Maximum Quantity 30; Number of Repeats 11]
insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
 
 
 
Rosuvastatin GH
GQ
MP
C4225 C4227 C4238 C4259
P4225 P4238
30
11
30
 
 
[142]       Schedule 1, entry for Rosuvastatin in the form Tablet 40 mg (as calcium) [Maximum Quantity 30; Number of Repeats 5]
insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
 
 
 
Cavstat
AF
MP
C4225 C4226 C4238 C4263
P4226 P4263
30
5
30
 
 

 
 
 
 
 
NP
C4226 C4263
 
30
5
30
 
 

[143]       Schedule 1, entry for Rosuvastatin in the form Tablet 40 mg (as calcium) [Maximum Quantity 30; Number of Repeats 5]
(a)      omit from the column headed “Circumstances” for the brand “Crestor” with Authorised Prescriber “MP”:
C1540  C3047  C4225  C4226            substitute:             C4225  C4226  C4238  C4263
(b)      omit from the column headed “Purposes” for the brand “Crestor” with Authorised Prescriber “MP”:
P1540  P4226          substitute:             P4226  P4263
(c)      omit from the column headed “Circumstances” for the brand “Crestor” with Authorised Prescriber “NP”:
C1540  C4226          substitute:             C4226  C4263
 
[144]       Schedule 1, entry for Rosuvastatin in the form Tablet 40 mg (as calcium) [Maximum Quantity 30; Number of Repeats 5]
insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
 
 
 
Rostor 40
DO
MP
C4225 C4226
P4226
30
5
30
 
 

 
 
 
 
 
NP
C4226
 
30
5
30
 
 

[145]       Schedule 1, entry for Rosuvastatin in the form Tablet 40 mg (as calcium) [Maximum Quantity 30; Number of Repeats 5]
(a)      omit from the column headed “Circumstances” for the brand “Rosuvastatin Actavis 40” with Authorised Prescriber “MP”:
C1540  C3047  C4225  C4226            substitute:             C4225  C4226  C4238  C4263
(b)      omit from the column headed “Purposes” for the brand “Rosuvastatin Actavis 40” with Authorised Prescriber “MP”:
P1540  P4226          substitute:             P4226  P4263
(c)      omit from the column headed “Circumstances” for the brand “Rosuvastatin Actavis 40” with Authorised Prescriber “NP”:
C1540  C4226          substitute:             C4226  C4263
[146]       Schedule 1, entry for Rosuvastatin in the form Tablet 40 mg (as calcium) [Maximum Quantity 30; Number of Repeats 5]
insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
 
 
 
Rosuvastatin GH
GQ
MP
C4225 C4226 C4238 C4263
P4226 P4263
30
5
30
 
 

 
 
 
 
 
NP
C4226 C4263
 
30
5
30
 
 

[147]       Schedule 1, entry for Rosuvastatin in the form Tablet 40 mg (as calcium) [Maximum Quantity 30; Number of Repeats 11]
insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
 
 
 
Cavstat
AF
MP
C4225 C4226 C4238 C4263
P4225 P4238
30
11
30
 
 
[148]       Schedule 1, entry for Rosuvastatin in the form Tablet 40 mg (as calcium) [Maximum Quantity 30; Number of Repeats 11]
(a)      omit from the column headed “Circumstances” for the brand “Crestor”:
C1540  C3047  C4225  C4226            substitute:             C4225  C4226  C4238  C4263
(b)      omit from the column headed “Purposes” for the brand “Crestor”:
P3047  P4225          substitute:             P4225  P4238
[149]       Schedule 1, entry for Rosuvastatin in the form Tablet 40 mg (as calcium) [Maximum Quantity 30; Number of Repeats 11]
insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
 
 
 
Rostor 40
DO
MP
C4225 C4226
P4225
30
11
30
 
 
[150]       Schedule 1, entry for Rosuvastatin in the form Tablet 40 mg (as calcium) [Maximum Quantity 30; Number of Repeats 11]
(a)      omit from the column headed “Circumstances” for the brand “Rosuvastatin Actavis 40”:
C1540  C3047  C4225  C4226            substitute:             C4225  C4226  C4238  C4263
(b)      omit from the column headed “Purposes” for the brand “Rosuvastatin Actavis 40”:
P3047  P4225          substitute:             P4225  P4238
[151]       Schedule 1, entry for Rosuvastatin in the form Tablet 40 mg (as calcium) [Maximum Quantity 30; Number of Repeats 11]
insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
 
 
 
Rosuvastatin GH
GQ
MP
C4225 C4226 C4238 C4263
P4225 P4238
30
11
30
 
 
[152]       Schedule 1, entry for Sertraline in the form Tablet 50 mg (as hydrochloride)
(a)      omit from the column headed “Responsible Person” for the brand “Sertracor 50”:                 MI           substitute:             CR
(b)      omit:
 
 
 
Sertraline 50
CR
MP NP
C1211
 
30
5
30
 
 
[153]       Schedule 1, entry for Sertraline in the form Tablet 100 mg (as hydrochloride)
(a)      omit from the column headed “Responsible Person” for the brand “Sertracor 100”:                              MI           substitute:      CR
(b)      omit:
 
 
 
Sertraline 100
CR
MP NP
C1211
 
30
5
30
 
 
[154]       Schedule 1, entry for Simvastatin in the form Tablet 10 mg
(a)      omit:
 
 
 
Pharmacor Simvastatin 10
MI
MP
C1540 C3047
P1540
30
5
30
 
 

 
 
 
 
 
NP
C1540
 
30
5
30
 
 

(b)      omit:
 
 
 
Synthon Simvastatin
ZT
MP
C1540 C3047
P1540
30
5
30
 
 

 
 
 
 
 
NP
C1540
 
30
5
30
 
 

(c)      omit:
 
 
 
Pharmacor Simvastatin 10
MI
MP
C1540 C3047
P3047
30
11
30
 
 
(d)      omit:
 
 
 
Synthon Simvastatin
ZT
MP
C1540 C3047
P3047
30
11
30
 
 
[155]       Schedule 1, entry for Simvastatin in the form Tablet 20 mg
(a)      omit:
 
 
 
Pharmacor Simvastatin 20
MI
MP
C1540 C3047
P1540
30
5
30
 
 

 
 
 
 
 
NP
C1540
 
30
5
30
 
 

(b)      omit:
 
 
 
Synthon Simvastatin
ZT
MP
C1540 C3047
P1540
30
5
30
 
 

 
 
 
 
 
NP
C1540
 
30
5
30
 
 

(c)      omit:
 
 
 
Pharmacor Simvastatin 20
MI
MP
C1540 C3047
P3047
30
11
30
 
 
(d)      omit:
 
 
 
Synthon Simvastatin
ZT
MP
C1540 C3047
P3047
30
11
30
 
 
[156]       Schedule 1, entry for Simvastatin in the form Tablet 40 mg
(a)      omit:
 
 
 
Pharmacor Simvastatin 40
MI
MP
C1540 C3047
P1540
30
5
30
 
 

 
 
 
 
 
NP
C1540
 
30
5
30
 
 

(b)      omit:
 
 
 
Synthon Simvastatin
ZT
MP
C1540 C3047
P1540
30
5
30
 
 

 
 
 
 
 
NP
C1540
 
30
5
30
 
 

(c)      omit:
 
 
 
Pharmacor Simvastatin 40
MI
MP
C1540 C3047
P3047
30
11
30
 
 
(d)      omit:
 
 
 
Synthon Simvastatin
ZT
MP
C1540 C3047
P3047
30
11
30
 
 
[157]       Schedule 1, entry for Simvastatin in the form Tablet 80 mg
(a)      omit:
 
 
 
Pharmacor Simvastatin 80
MI
MP
C1540 C3047
P1540
30
5
30
 
 

 
 
 
 
 
NP
C1540
 
30
5
30
 
 

(b)      omit:
 
 
 
Synthon Simvastatin
ZT
MP
C1540 C3047
P1540
30
5
30
 
 

 
 
 
 
 
NP
C1540
 
30
5
30
 
 

(c)      omit:
 
 
 
Pharmacor Simvastatin 80
MI
MP
C1540 C3047
P3047
30
11
30
 
 
(d)      omit:
 
 
 
Synthon Simvastatin
ZT
MP
C1540 C3047
P3047
30
11
30
 
 
[158]       Schedule 1, entry for Strontium
omit from the column headed “Circumstances”:
C4117
[159]       Schedule 1, entry for Telmisartan with Hydrochlorothiazide in the form Tablet 40 mg-12.5 mg
insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
 
 
 
Pritor Plus 40/12.5 mg
FI
MP NP
C3307
 
28
5
28
 
 
[160]       Schedule 1, entry for Telmisartan with Hydrochlorothiazide in the form Tablet 80 mg-12.5 mg
insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
 
 
 
Pritor Plus 80/12.5 mg
FI
MP NP
C3307
 
28
5
28
 
 
[161]       Schedule 1, entry for Telmisartan with Hydrochlorothiazide in the form Tablet 80 mg-25 mg
insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
 
 
 
Pritor Plus 80/25 mg
FI
MP NP
C3307
 
28
5
28
 
 
 
 
[162]       Schedule 1, entry for Terbinafine in the form Tablet 250 mg (as hydrochloride)
(a)      omit:
 
 
 
Terbinafine 250
CR
MP NP
C2191 C2865 C3244
P2865 P3244
42
0
42
 
 
(b)      omit:
 
 
 
Terbinafine 250
CR
MP NP
C2191 C2865 C3244
P2191
42
1
42
 
 
[163]       Schedule 1, after entry for Trimethoprim in the form Tablet 300 mg [Triprim]
insert in the columns in the order indicated:
 
 
 
Alprim
AF
MP
C4243
 
14
2
7
 
 

 
 
 
Triprim
QA
MP
C4243
 
14
2
7
 
 

[164]       Schedule 1, entry for Vinorelbine in each of the forms: Capsule 20 mg (as tartrate); and Capsule 30 mg (as tartrate)
omit from the column headed “Circumstances”:          C1194   substitute:             C4242  C4272
[165]       Schedule 3, after details relevant to Responsible Person Code FB
insert:
FI
Boehringer Ingelheim Pty Ltd
 52 000 452 308
[166]       Schedule 3, after details relevant to Responsible Person Code QB
insert:
QH
Cortex Health Pty Ltd
 17 144 062 386
[167]       Schedule 3, after details relevant to Responsible Person Code XA
insert:
XH
MS Health Pty Ltd
 33 155 182 586
[168]       Schedule 3
omit:
ZA
AstraZeneca Pty Ltd
 54 009 682 311
[169]       Schedule 3
omit:
ZT
Synthon A.U. Pty Ltd
 58 080 948 698
[170]       Schedule 4, Part 1, after entry for Abciximab
insert:
Abiraterone
C4245
 
 
Castration resistant metastatic carcinoma of the prostate
The treatment must be in combination with prednisone or prednisolone;
The treatment must not be used in combination with chemotherapy;
Patient must have failed treatment with docetaxel due to resistance or intolerance;
Patient must have a WHO performance status of 2 or less;
Patient must not receive PBS-subsidised abiraterone if progressive disease develops while on abiraterone
Compliance with Authority Required procedures
[171]       Schedule 4, Part 1, after entry for Azithromycin
insert:

Bacillus Calmette and Guerin, Connaught strain
C1419
 
 
Treatment of carcinoma in situ of the urinary bladder
 

Bacillus Calmette and Guerin, Tice strain
C1290
 
 
Primary and relapsing superficial urothelial carcinoma of the bladder
 

[172]       Schedule 4, Part 1, omit entry for “BCG Immunotherapeutic” (Bacillus Calmette-Guérin/Connaught strain)
[173]       Schedule 4, Part 1, omit entry for “BCG-Tice” (Bacillus Calmette-Guérin/Tice strain)
[174]       Schedule 4, Part 1, entry for Cabazitaxel
substitute:

Cabazitaxel
C4237
 
 
Castration resistant metastatic carcinoma of the prostate
The treatment must be in combination with prednisone or prednisolone;
The treatment must not be used in combination with abiraterone;
Patient must have failed treatment with docetaxel due to resistance or intolerance;
Patient must have a WHO performance status of 2 or less;
Patient must not receive PBS-subsidised cabazitaxel if progressive disease develops while on cabazitaxel
Compliance with Authority Required procedures


 
C4262
 
 
Castration resistant metastatic carcinoma of the prostate
The treatment must be in combination with prednisone or prednisolone;
The treatment must not be used in combination with abiraterone;
Patient must have failed treatment with docetaxel due to resistance or intolerance;
Patient must have a WHO performance status of 2 or less;
Patient must not receive PBS-subsidised cabazitaxel if progressive disease develops while on cabazitaxel
Compliance with Authority Required procedures - Streamlined Authority Code 4262


[175]       Schedule 4, Part 1, after entry for Celecoxib
insert:
Cephalexin
C4243
 
 
Prophylaxis of urinary tract infection
Compliance with Authority Required procedures - Streamlined Authority Code 4243
[176]       Schedule 4, Part 1, entry for Diazepam
insert in numerical order after existing text:
 
C4244
 
 
Chronic spasticity
Patient must be under 18 years of age
Compliance with Authority Required procedures
[177]       Schedule 4, Part 1, entry for Docetaxel
(a)      omit:
 
C4155
 
 
Androgen independent (castration resistant) metastatic carcinoma of the prostate
Patient must have a Karnofsky performance status score of at least 60%;
The treatment must be used as first-line chemotherapy;
The treatment must be administered in three weekly cycles;
Patient must not receive more than 10 cycles of treatment with docetaxel under this restriction
Compliance with Authority Required procedures - Streamlined Authority Code 4155

(b)      insert in numerical order following existing text:
 
C4239
 
 
Androgen independent (castration resistant) metastatic carcinoma of the prostate
Patient must have a Karnofsky performance status score of at least 60%;
The treatment must be used as first-line chemotherapy;
The treatment must be administered in three weekly cycles;
Patient must not receive more than 10 cycles of treatment with docetaxel under this restriction
Compliance with Authority Required procedures - Streamlined Authority Code 4239

[178]       Schedule 4, Part 1, entry for Fentanyl
(a)      omit:

 
C3663
P3663
 
Initial supply for dose titration for breakthrough pain in a palliative care patient with cancer who is receiving opioids for their persistent pain and where further escalation in the dose of morphine for breakthrough pain results in intolerable adverse effects
Compliance with Authority Required procedures

 
C3664
P3664
 
Continuing supply for breakthrough pain in a palliative care patient with cancer who is receiving opioids for their persistent pain and where further escalation in the dose of morphine for breakthrough pain results in intolerable adverse effects
Compliance with Authority Required procedures

(b)      insert in numerical order following existing text:

 
C4250
P4250
 
Breakthrough pain
Initial treatment for dose titration
Patient must be undergoing palliative care;
Patient must have cancer;
Patient must be receiving opioids for their persistent pain;
Patient must be unable to tolerate further escalation in the dose of morphine for breakthrough pain due to adverse effects
Compliance with Authority Required procedures

 
C4267
P4267
 
Breakthrough pain
Continuing treatment
Patient must be undergoing palliative care;
Patient must have cancer;
Patient must be receiving opioids for their persistent pain;
Patient must be unable to tolerate further escalation in the dose of morphine for breakthrough pain due to adverse effects
Compliance with Authority Required procedures

[179]       Schedule 4, Part 1, entry for Glucose Indicator―Blood
(a)      omit:
 
 
P3035
 
For use in patients who are 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
 
(b)      insert in numerical order following existing text:
 
 
P4241
 
Blood glucose monitoring
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
 
[180]       Schedule 4, Part 1, after entry for Glycerol
insert:

Glycomacropeptide and essential amino acids
C1286
 
 
Phenylketonuria

 

Glycomacropeptide and essential amino acids with vitamins and minerals
C1286
 
 
Phenylketonuria

 

[181]       Schedule 4, Part 1, entry for High fat formula with vitamins, minerals and trace elements and low in protein and carbohydrate
insert in numerical order following existing text:
 
C4253
 
 
Ketogenic diet
Patient must have intractable seizures requiring treatment with a ketogenic diet; OR
Patient must have a glucose transport protein defect; OR
Patient must have pyruvate dehydrogenase deficiency
KetoCal 3:1 should only be used under strict supervision of a dietician, together with a metabolic physician and/or neurologist
 
[182]       Schedule 4, Part 1, after entry for Interferon Gamma-1b
insert:

Ipilimumab
C4235
 
 
Unresectable Stage III or Stage IV malignant melanoma
Induction treatment
The treatment must be as monotherapy;
Patient must not have received prior treatment with ipilimumab;
The treatment must not exceed a total of 4 doses at a maximum dose of 3 mg per kg every 3 weeks
The patient's body weight must be documented in the patient's medical records at the time treatment is initiated
Compliance with Authority Required procedures

 
C4236
 
 
Unresectable Stage III or Stage IV malignant melanoma
Re-induction treatment
The treatment must be as monotherapy;
Patient must have progressive disease after achieving an initial objective response to the most recent course of ipilimumab treatment (induction or re-induction);
The treatment must not exceed a total of 4 doses at a maximum dose of 3 mg per kg every 3 weeks
An initial objective response to treatment is defined as either:
(i) sustained stable disease of greater than or equal to 3 months duration measured from at least 2 weeks after the date of completion of the most recent course of ipilimumab; or
(ii) a partial or complete response
The patient's body weight must be documented in the patient's medical records at the time treatment with ipilimumab is initiated
Compliance with Authority Required procedures

 
C4251
 
 
Unresectable Stage III or Stage IV malignant melanoma
Completion of induction treatment
The treatment must be as monotherapy;
The treatment must be for completion of induction treatment in a patient who commenced induction treatment with ipilimumab prior to 1 August 2013;
The treatment must not exceed a total of 4 doses (combined PBS-subsidised and non-PBS-subsidised) at a maximum dose of 3 mg per kg every 3 weeks
The patient's body weight must be documented in the patient's medical records at the time treatment is initiated
For patients who commenced induction treatment with ipilimumab prior to 1 August 2013 prescribers should request the appropriate number of repeats to provide a total of 4 doses of ipilimumab (combined PBS-subsidised and non-PBS subsidised)
Compliance with Authority Required procedures - Streamlined Authority Code 4251

 
C4252
 
 
Unresectable Stage III or Stage IV malignant melanoma
Completion of re-induction treatment
The treatment must be as monotherapy;
Patient must have progressive disease after achieving an initial objective response to the most recent course of ipilimumab treatment (induction or re-induction) received prior to 1 August 2013;
The treatment must be for completion of re-induction treatment in a patient who commenced re-induction treatment with ipilimumab prior to 1 August 2013;
The treatment must not exceed a total of 4 doses (combined PBS-subsidised and non-PBS-subsidised) at a maximum dose of 3 mg per kg every 3 weeks
An initial objective response to treatment is defined as either:
(i) sustained stable disease of greater than or equal to 3 months duration measured from at least 2 weeks after the date of completion of the most recent course of ipilimumab; or
(ii) a partial or complete response
The patient's body weight must be documented in the patient's medical records at the time treatment with ipilimumab is initiated
For patients who commenced re-induction treatment with ipilimumab prior to 1 August 2013 prescribers should request the appropriate number of repeats to provide a maximum of 4 doses of ipilimumab (combined PBS-subsidised and non-PBS-subsidised)
Compliance with Authority Required procedures - Streamlined Authority Code 4252

 
C4254
 
 
Unresectable Stage III or Stage IV malignant melanoma
Induction treatment
The treatment must be as monotherapy;
Patient must not have received prior treatment with ipilimumab;
The treatment must not exceed a total of 4 doses at a maximum dose of 3 mg per kg every 3 weeks
The patient's body weight must be documented in the patient's medical records at the time treatment is initiated
Compliance with Authority Required procedures - Streamlined Authority Code 4254

 
C4256
 
 
Unresectable Stage III or Stage IV malignant melanoma
Completion of re-induction treatment
The treatment must be as monotherapy;
Patient must have progressive disease after achieving an initial objective response to the most recent course of ipilimumab treatment (induction or re-induction) received prior to 1 August 2013;
The treatment must be for completion of re-induction treatment in a patient who commenced re-induction treatment with ipilimumab prior to 1 August 2013;
The treatment must not exceed a total of 4 doses (combined PBS-subsidised and non-PBS-subsidised) at a maximum dose of 3 mg per kg every 3 weeks
An initial objective response to treatment is defined as either:
(i) sustained stable disease of greater than or equal to 3 months duration measured from at least 2 weeks after the date of completion of the most recent course of ipilimumab; or
(ii) a partial or complete response
The patient's body weight must be documented in the patient's medical records at the time treatment with ipilimumab is initiated
For patients who commenced re-induction treatment with ipilimumab prior to 1 August 2013 prescribers should request the appropriate number of repeats to provide a maximum of 4 doses of ipilimumab (combined PBS-subsidised and non-PBS-subsidised)
Compliance with Authority Required procedures

 
C4261
 
 
Unresectable Stage III or Stage IV malignant melanoma
Re-induction treatment
The treatment must be as monotherapy;
Patient must have progressive disease after achieving an initial objective response to the most recent course of ipilimumab treatment (induction or re-induction);
The treatment must not exceed a total of 4 doses at a maximum dose of 3 mg per kg every 3 weeks
An initial objective response to treatment is defined as either:
(i) sustained stable disease of greater than or equal to 3 months duration measured from at least 2 weeks after the date of completion of the most recent course of ipilimumab; or
(ii) a partial or complete response
The patient's body weight must be documented in the patient's medical records at the time treatment with ipilimumab is initiated
Compliance with Authority Required procedures - Streamlined Authority Code 4261

 
C4265
 
 
Unresectable Stage III or Stage IV malignant melanoma
Completion of induction treatment
The treatment must be as monotherapy;
The treatment must be for completion of induction treatment in a patient who commenced induction treatment with ipilimumab prior to 1 August 2013;
The treatment must not exceed a total of 4 doses (combined PBS-subsidised and non-PBS-subsidised) at a maximum dose of 3 mg per kg every 3 weeks
The patient's body weight must be documented in the patient's medical records at the time treatment is initiated
For patients who commenced induction treatment with ipilimumab prior to 1 August 2013 prescribers should request the appropriate number of repeats to provide a total of 4 doses of ipilimumab (combined PBS-subsidised and non-PBS subsidised)
Compliance with Authority Required procedures

[183]       Schedule 4, Part 1, entry for Lacosamide
substitute:

Lacosamide
C4240
 
 
Intractable partial epileptic seizures
Initial treatment
Must be treated by a neurologist;
The treatment must be in combination with two or more anti-epileptic drugs which includes one second-line adjunctive agent;
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
Patient must be aged 16 years or older
Compliance with Authority Required procedures - Streamlined Authority Code 4240

 
C4249
 
 
Intractable partial epileptic seizures
Continuing treatment
Patient must have previously been treated with PBS-subsidised lacosamide
Patient must be aged 16 years or older
Compliance with Authority Required procedures - Streamlined Authority Code 4249

 

 
C4257
 
 
Intractable partial epileptic seizures
Continuing treatment
Patient must have previously been treated with PBS-subsidised lacosamide
Patient must be aged 16 years or older
Compliance with Authority Required procedures - Streamlined Authority Code 4257

 
C4264
 
 
Intractable partial epileptic seizures
Initial treatment
Must be treated by a neurologist;
The treatment must be in combination with two or more anti-epileptic drugs which includes one second-line adjunctive agent;
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
Patient must be aged 16 years or older
Compliance with Authority Required procedures - Streamlined Authority Code 4264

 
C4271
 
 
Intractable partial epileptic seizures
Initial treatment
Must be treated by a neurologist;
The treatment must be in combination with two or more anti-epileptic drugs which includes one second-line adjunctive agent;
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;
The treatment must be for dose titration purposes
Patient must be aged 16 years or older
Compliance with Authority Required procedures - Streamlined Authority Code 4271

[184]       Schedule 4, Part 1, after entry for Miconazole
insert:
Mifepristone
C4247
 
 
Termination of an intra-uterine pregnancy
Must be treated by a prescriber who is registered with the MS 2 Step Prescribing Program;
The condition must be an intra-uterine pregnancy of up to 49 days of gestation;
The treatment must be in sequential combination with misoprostol 800 micrograms
An authority prescription for misoprostol 200 microgram tablets must be sought at the time of authority application
Compliance with Authority Required procedures
[185]       Schedule 4, Part 1, entry for Misoprostol
insert in numerical order following existing text:
 
C4266
 
 
Termination of an intra-uterine pregnancy
Must be treated by a prescriber who is registered with the MS 2 Step Prescribing Program;
The condition must be an intra-uterine pregnancy of up to 49 days of gestation;
The treatment must be in sequential combination with mifepristone 200 mg
An authority prescription for mifepristone 200 mg tablet must be sought at the time of authority application
Compliance with Authority Required procedures
[186]       Schedule 4, Part 1, entry for Paliperidone
substitute:
Paliperidone
C4246
 
 
Schizophrenia
Compliance with Authority Required procedures - Streamlined Authority Code 4246
[187]       Schedule 4, Part 1, entry for Risedronic Acid
(a)      omit:
 
C4117
 
 
Osteoporosis
Patient must be aged 70 years or older;
Patient must have a Bone Mineral Density (BMD) T-score of -3.0 or less;
Patient must not receive concomitant treatment with any other PBS-subsidised anti-resorptive agent for this condition
The date, site (femoral neck or lumbar spine) and score of the qualifying BMD measurement must be documented in the patient's medical records when treatment is initiated
Compliance with Authority Required procedures - Streamlined Authority Code 4117

(b)      insert in numerical order following existing text:
 
C4133
 
 
Osteoporosis
Patient must be aged 70 years or older;
Patient must have a Bone Mineral Density (BMD) T-score of -2.5 or less;
Patient must not receive concomitant treatment with any other PBS-subsidised anti-resorptive agent for this condition
The date, site (femoral neck or lumbar spine) and score of the qualifying BMD measurement must be documented in the patient's medical records when treatment is initiated
Compliance with Authority Required procedures - Streamlined Authority Code 4133
[188]       Schedule 4, Part 1, entry for Risedronic Acid and Calcium
(a)      omit:
 
C4117
 
 
Osteoporosis
Patient must be aged 70 years or older;
Patient must have a Bone Mineral Density (BMD) T-score of -3.0 or less;
Patient must not receive concomitant treatment with any other PBS-subsidised anti-resorptive agent for this condition
The date, site (femoral neck or lumbar spine) and score of the qualifying BMD measurement must be documented in the patient's medical records when treatment is initiated
Compliance with Authority Required procedures - Streamlined Authority Code 4117

(b)      insert in numerical order following existing text:
 
C4133
 
 
Osteoporosis
Patient must be aged 70 years or older;
Patient must have a Bone Mineral Density (BMD) T-score of -2.5 or less;
Patient must not receive concomitant treatment with any other PBS-subsidised anti-resorptive agent for this condition
The date, site (femoral neck or lumbar spine) and score of the qualifying BMD measurement must be documented in the patient's medical records when treatment is initiated
Compliance with Authority Required procedures - Streamlined Authority Code 4133
[189]       Schedule 4, Part 1, entry for Risedronic acid and calcium with colecalciferol
(a)      omit:
 
C4117
 
 
Osteoporosis
Patient must be aged 70 years or older;
Patient must have a Bone Mineral Density (BMD) T-score of -3.0 or less;
Patient must not receive concomitant treatment with any other PBS-subsidised anti-resorptive agent for this condition
The date, site (femoral neck or lumbar spine) and score of the qualifying BMD measurement must be documented in the patient's medical records when treatment is initiated
Compliance with Authority Required procedures - Streamlined Authority Code 4117

(b)      insert in numerical order following existing text:
 
C4133
 
 
Osteoporosis
Patient must be aged 70 years or older;
Patient must have a Bone Mineral Density (BMD) T-score of -2.5 or less;
Patient must not receive concomitant treatment with any other PBS-subsidised anti-resorptive agent for this condition
The date, site (femoral neck or lumbar spine) and score of the qualifying BMD measurement must be documented in the patient's medical records when treatment is initiated
Compliance with Authority Required procedures - Streamlined Authority Code 4133
[190]       Schedule 4, Part 1, entry for Rivaroxaban
insert in numerical order following existing text:

 
C4260
P4260
 
Pulmonary embolism
Initial treatment
Patient must have confirmed acute symptomatic pulmonary embolism
Compliance with Authority Required procedures - Streamlined Authority Code 4260

 
C4268
 
 
Pulmonary embolism
Continuing treatment
Patient must have confirmed acute symptomatic pulmonary embolism
Compliance with Authority Required procedures - Streamlined Authority Code 4268

 
C4269
P4269
 
Prevention of stroke or systemic embolism
Patient must have non-valvular atrial fibrillation;
Patient must have one or more risk factors for developing stroke or systemic embolism
Risk factors for developing stroke or systemic ischaemic embolism are:
(i) Prior stroke (ischaemic or unknown type), transient ischaemic attack or non-central nervous system (CNS) systemic embolism;
(ii) age 75 years or older;
(iii) hypertension;
(iv) diabetes mellitus;
(v) heart failure and/or left ventricular ejection fraction 35% or less
Compliance with Authority Required procedures - Streamlined Authority Code 4269

[191]       Schedule 4, Part 1, entry for Rosuvastatin
(a)      omit:

 
C1540
P1540
 
For use in patients that meet the criteria set out in the General Statement for Lipid-Lowering Drugs
 

 
C3047
P3047
 
For use in patients who meet the criteria set out in the General Statement for Lipid-Lowering Drugs, and who are 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
 

(b)      insert in numerical order following existing text:

 
C4238
P4238
 
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
 

 
C4248
P4248
 
For use in patients who meet the criteria set out in the General Statement for Lipid-Lowering Drugs
 

 
C4259
P4259
 
For use in patients who meet the criteria set out in the General Statement for Lipid-Lowering Drugs
 

 
C4263
P4263
 
For use in patients who meet the criteria set out in the General Statement for Lipid-Lowering Drugs
 

[192]       Schedule 4, Part 1, entry for Strontium
omit:
 
C4117
 
 
Osteoporosis
Patient must be aged 70 years or older;
Patient must have a Bone Mineral Density (BMD) T-score of -3.0 or less;
Patient must not receive concomitant treatment with any other PBS-subsidised anti-resorptive agent for this condition
The date, site (femoral neck or lumbar spine) and score of the qualifying BMD measurement must be documented in the patient's medical records when treatment is initiated
Compliance with Authority Required procedures - Streamlined Authority Code 4117

[193]       Schedule 4, Part 1, after entry for Triglycerides, medium chain and long chain with glucose polymer
insert:
Trimethoprim
C4243
 
 
Prophylaxis of urinary tract infection
Compliance with Authority Required procedures - Streamlined Authority Code 4243
[194]       Schedule 4, Part 1, entry for Vinorelbine
(a)      omit:
 
C1194
 
 
Locally advanced or metastatic non-small cell lung cancer
Compliance with Authority Required procedures
(b)      insert in numerical order following existing text:

 
C4242
 
 
Locally advanced or metastatic non-small cell lung cancer
Compliance with Authority Required procedures

 
C4272
 
 
Advanced breast cancer
Patient must have failed standard prior therapy, which includes an anthracycline
Compliance with Authority Required procedures