National Health (Listing of Pharmaceutical Benefits) Amendment Instrument 2015 (No. 4) (PB 39 of 2015)

Link to law: https://www.comlaw.gov.au/Details/F2015L00595

Subscribe to a Global-Regulation Premium Membership Today!

Key Benefits:

Subscribe Now
PB 39 of 2015
National Health (Listing of Pharmaceutical Benefits) Amendment Instrument 2015
(No. 4)
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 22 April 2015
 
 
 
 
 
 
 
 
 
 
 
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 2015 (No. 4).
            (2)        This Instrument may also be cited as PB 39 of 2015.
2          Commencement
This Instrument commences on 1 May 2015.
3          Amendment of National Health (Listing of Pharmaceutical Benefits) Instrument 2012 (PB 71 of 2012)
            Schedule 1 amends the National Health (Listing of Pharmaceutical Benefits) Instrument 2012 (PB 71 of 2012).
 
Schedule 1     Amendments
[1]           Schedule 1, column headed Authorised Prescriber
omit:
See Note 1
in all instances where displayed in the column headed “Authorised Prescriber” for Listed Drugs
[2]           Schedule 1, entry for Aciclovir in the form Tablet 200 mg [Maximum Quantity: 50; Number of Repeats: 0]
(a)      omit from the column headed “Circumstances” (all instances):    C3633
(b)      omit from the column headed “Purposes” (all instances):           P3632
[3]           Schedule 1, entry for Aciclovir in the form Tablet 200 mg
omit:
 
 
 
Acihexal
SZ
MP NP
C3632 C3633
P3633
90
5
90
 
 
[4]           Schedule 1, entry for Alendronic Acid
omit from the column headed “Circumstances” (all instances):            C4122  C4123  C4133    substitute:             C4882  C4885  C4889
[5]           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”:
 
 
 
Blooms the Chemist Atorvastatin
IB
MP
C1540 C3047
P1540
30
5
30
 
 

 
 
 
 
 
NP
C1540
 
30
5
30
 
 

[6]           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”:
 
 
 
Blooms the Chemist Atorvastatin
IB
MP
C1540 C3047
P3047
30
11
30
 
 
[7]           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”:
 
 
 
Blooms the Chemist Atorvastatin
IB
MP
C1540 C3047
P1540
30
5
30
 
 

 
 
 
 
 
NP
C1540
 
30
5
30
 
 

[8]           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”:
 
 
 
Blooms the Chemist Atorvastatin
IB
MP
C1540 C3047
P3047
30
11
30
 
 
[9]           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”:
 
 
 
Blooms the Chemist Atorvastatin
IB
MP
C1540 C3047
P1540
30
5
30
 
 

 
 
 
 
 
NP
C1540
 
30
5
30
 
 

[10]         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”:
 
 
 
Blooms the Chemist Atorvastatin
IB
MP
C1540 C3047
P3047
30
11
30
 
 
[11]         Schedule 1, entry for Azathioprine in each of the forms: Tablet 25 mg; and Tablet 50 mg
insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
 
 
 
Azathioprine GH
GQ
MP NP
 
 
100
5
100
 
 
[12]         Schedule 1, entry for Balsalazide
omit from the column headed “Circumstances”:        C1708  C1709    substitute:             C4824
[13]         Schedule 1, entry for Benztropine
omit:
 
Injection containing benztropine mesylate 2 mg in 2 mL vial
Injection
Benztropine Omega
FK
MP NP PDP
 
 
10
0
10
 
 
[14]         Schedule 1, omit entry for Carbomer with Triglyceride Lipids
[15]         Schedule 1, entry for Chloramphenicol in the form Eye ointment 10 mg per g, 4 g
omit:
 
 
 
Chloromycetin
PF
AO MP NP MW
 
 
1
0
1
 
 
 
[16]         Schedule 1, entry for Citalopram in the form Tablet 40 mg (as hydrobromide)
insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
 
 
 
Citalopram Actavis
VN
MP NP
C1211
 
28
5
28
 
 
[17]         Schedule 1, entry for Clindamycin
insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
 
 
 
Clindamycin-Link
LM
MP NP MW PDP
C1145
 
24
0
24
 
 
[18]         Schedule 1, entry for Clopidogrel with aspirin
insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
 
 
 
Piax Plus Aspirin
AF
MP NP
C1722 C3219 C3880
 
30
5
30
 
 
[19]         Schedule 1, entry for Cyclosporin
substitute:
Cyclosporin
Capsule 10 mg
Oral
Neoral 10
NV
MP
 
 
120
3
60
 
 

 
 
 
 
 
MP
 
P1654 P1655 P1656 P1657 P1658 P3328 P3329 P3330 P3331 P3332
120
CN1654 CN1655 CN1656 CN1657 CN1658 CN3328 CN3329 CN3330 CN3331 CN3332
5
CN1654 CN1655 CN1656 CN1657 CN1658 CN3328 CN3329 CN3330 CN3331 CN3332
60
 
C(100)

 
Capsule 25 mg
Oral
Cyclosporin Sandoz
SZ
MP
 
 
60
3
30
 
 

 
 
 
Neoral 25
NV
MP
 
 
60
3
30
 
 

 
 
 
Cyclosporin Sandoz
SZ
MP
 
P1654 P1655 P1656 P1657 P1658 P3328 P3329 P3330 P3331 P3332
120
CN1654 CN1655 CN1656 CN1657 CN1658 CN3328 CN3329 CN3330 CN3331 CN3332
5
CN1654 CN1655 CN1656 CN1657 CN1658 CN3328 CN3329 CN3330 CN3331 CN3332
30
 
C(100)

 
 
 
 
Neoral 25
NV
MP
 
P1654 P1655 P1656 P1657 P1658 P3328 P3329 P3330 P3331 P3332
120
CN1654 CN1655 CN1656 CN1657 CN1658 CN3328 CN3329 CN3330 CN3331 CN3332
5
CN1654 CN1655 CN1656 CN1657 CN1658 CN3328 CN3329 CN3330 CN3331 CN3332
30
 
C(100)

 
Capsule 50 mg
Oral
Cyclosporin Sandoz
SZ
MP
 
 
60
3
30
 
 

 
 
 
Neoral 50
NV
MP
 
 
60
3
30
 
 

 
 
 
Cyclosporin Sandoz
SZ
MP
 
P1654 P1655 P1656 P1657 P1658 P3328 P3329 P3330 P3331 P3332
120
CN1654 CN1655 CN1656 CN1657 CN1658 CN3328 CN3329 CN3330 CN3331 CN3332
5
CN1654 CN1655 CN1656 CN1657 CN1658 CN3328 CN3329 CN3330 CN3331 CN3332
30
 
C(100)

 
 
 
Neoral 50
NV
MP
 
P1654 P1655 P1656 P1657 P1658 P3328 P3329 P3330 P3331 P3332
120
CN1654 CN1655 CN1656 CN1657 CN1658 CN3328 CN3329 CN3330 CN3331 CN3332
5
CN1654 CN1655 CN1656 CN1657 CN1658 CN3328 CN3329 CN3330 CN3331 CN3332
30
 
C(100)

 
Capsule 100 mg
Oral
Cyclosporin Sandoz
SZ
MP
 
 
60
3
30
 
 

 
 
 
Neoral 100
NV
MP
 
 
60
3
30
 
 

 
 
 
Cyclosporin Sandoz
SZ
MP
 
P1654 P1655 P1656 P1657 P1658 P3328 P3329 P3330 P3331 P3332
120
CN1654 CN1655 CN1656 CN1657 CN1658 CN3328 CN3329 CN3330 CN3331 CN3332
5
CN1654 CN1655 CN1656 CN1657 CN1658 CN3328 CN3329 CN3330 CN3331 CN3332
30
 
C(100)

 
 
 
Neoral 100
NV
MP
 
P1654 P1655 P1656 P1657 P1658 P3328 P3329 P3330 P3331 P3332
120
CN1654 CN1655 CN1656 CN1657 CN1658 CN3328 CN3329 CN3330 CN3331 CN3332
5
CN1654 CN1655 CN1656 CN1657 CN1658 CN3328 CN3329 CN3330 CN3331 CN3332
30
 
C(100)

 
Oral liquid 100 mg per mL, 50 mL
Oral
Neoral
NV
MP
 
 
2
3
1
 
 

 
 
 
 
 
MP
 
P1654 P1655 P1656 P1657 P1658 P3328 P3329 P3330 P3331 P3332
4
CN1654 CN1655 CN1656 CN1657 CN1658 CN3328 CN3329 CN3330 CN3331 CN3332
5
CN1654 CN1655 CN1656 CN1657 CN1658 CN3328 CN3329 CN3330 CN3331 CN3332
1
 
C(100)

 
Solution concentrate for I.V. infusion 50 mg in 1 mL
Injection
Sandimmun
NV
MP
C1504 C3333
 
10
0
10
 
PB(100)

[20]         Schedule 1, entry for Doxorubicin in the form Solution for I.V. injection or intravesical administration containing doxorubicin hydrochloride 10 mg in 5 mL single dose vial
omit:
 
 
 
Accord Doxorubicin
GN
MP
 
 
See Note 3
See
Note 3
1
 
D(100)
 
[21]         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:
 
 
 
Fluconazole‑
Claris
AE
MP NP
C3613 C3614 C3615 C3616 C3617 C3618
 
7
0
1
 
 
[22]         Schedule 1, entry for Fludarabine in the form Tablet containing fludarabine phosphate 10 mg  
omit from the column headed “Circumstances”:        C3015
[23]         Schedule 1, entry for Fludarabine in the form Powder for I.V. injection containing fludarabine phosphate 50 mg
(a)      omit:
 
 
 
Farine
GN
MP
C3887
 
See Note 3
See
Note 3
1
 
PB(100)
(b)      omit:
 
 
 
Fludarabine ACT
VN
MP
C3887
 
See Note 3
See
Note 3
1
 
PB(100)
(c)      omit:
 
 
 
Fludarabine Actavis
UA
MP
C3887
 
See Note 3
See
Note 3
1
 
PB(100)
[24]         Schedule 1, entry for Frusemide in each of the forms: Tablet 20 mg; and Tablet 40 mg
omit:
 
 
 
Frusemide AN
EA
MP NP
 
 
100
1
100
 
 
[25]         Schedule 1, entry for Glatiramer
(a)      omit from the column headed “Responsible Person”:     CS        substitute:          TB
(b)      omit from the column headed “Circumstances”:            C1175  C1751    substitute:          C4881  C4887
[26]         Schedule 1, entry for Goserelin in the form Subcutaneous implant 3.6 mg (as acetate) in pre-filled injection syringe
omit from the column headed “Circumstances”:        C4799  C4800  C4806  C4807     substitute:             C4874  C4890  C4891  C4892
[27]         Schedule 1, entry for Goserelin in the form Subcutaneous implant (long acting) 10.8 mg (as acetate) in pre-filled injection syringe
omit from the column headed “Circumstances”:        C3229   substitute:             C4890
[28]         Schedule 1, entry for Goserelin and Bicalutamide in each of the forms: Pack containing 1 subcutaneous implant containing goserelin
3.6 mg (as acetate) in pre-filled injection syringe and 28 tablets bicalutamide 50 mg; Pack containing 1 subcutaneous implant containing goserelin 10.8 mg (as acetate) in pre-filled injection syringe and 28 tablets bicalutamide 50 mg; and Pack containing 1 subcutaneous implant containing goserelin 10.8 mg (as acetate) in pre-filled injection syringe and 84 tablets bicalutamide 50 mg
omit from the column headed “Circumstances”:        C3239   substitute:             C4895
[29]         Schedule 1, entry for Hydrocortisone in the form Rectal foam containing hydrocortisone acetate 90 mg per applicatorful, 14 applications, aerosol 21.1 g
omit from the column headed “Circumstances”:        C1294  C1454    substitute:             C4872  C4893
[30]         Schedule 1, entry for Interferon Beta-1a in each of the forms: Injection set comprising 1 vial powder for injection 30 micrograms (6,000,000 I.U.) with diluent; Injection 30 micrograms (6,000,000 I.U.) in 0.5 mL single dose pre-filled syringe; Injection 44 micrograms (12,000,000 I.U.) in 0.5 mL single dose pre-filled syringe; Injection 44 micrograms (12,000,000 I.U.) in 0.5 mL single dose autoinjector; and Solution for injection 132 micrograms in 1.5 mL multidose cartridge
omit from the column headed “Circumstances”:        C1175  C1751    substitute:             C4881  C4887
[31]         Schedule 1, entry for Interferon Beta-1b
omit from the column headed “Circumstances”:        C1175  C1751    substitute:             C4881  C4887
[32]         Schedule 1, entry for Irinotecan in the form I.V. injection containing irinotecan hydrochloride trihydrate 40 mg in 2 mL
omit:
 
 
 
Tecan
GN
MP
 
 
See Note 3
See
Note 3
1
 
D(100)
[33]         Schedule 1, entry for Irinotecan in the form I.V. injection containing irinotecan hydrochloride trihydrate 100 mg in 5 mL
(a)      omit:
 
 
 
Irinotecan Actavis
UA
MP
 
 
See Note 3
See
Note 3
1
 
D(100)
(b)      omit:
 
 
 
Tecan
GN
MP
 
 
See Note 3
See
Note 3
1
 
D(100)
[34]         Schedule 1, entry for Lercanidipine in each of the forms: Tablet containing lercanidipine hydrochloride 10 mg; and Tablet containing lercanidipine hydrochloride 20 mg
omit:
 
 
 
Lercanidipine AN
EA
MP NP
 
 
28
5
28
 
 
[35]         Schedule 1, after entry for Leuprorelin in the form I.M. injection (modified release), powder for injection containing leuprorelin acetate
30 mg with diluent in pre-filled dual-chamber syringe
insert in the columns in the order indicated:
 
I.M. injection (3 month modified release), powder for injection containing leuprorelin acetate
30 mg with diluent in pre-filled dual-chamber syringe
Injection
Lucrin Depot Paediatric 30 mg PDS
VE
MP
C4871 C4884
 
1
1
1
 
 
 
[36]         Schedule 1, entry for Mesalazine in each of the forms: Tablet 250 mg (enteric coated); Tablet 500 mg (enteric coated); Tablet 500 mg (prolonged release); and Tablet 1 g (prolonged release)
omit from the column headed “Circumstances”:        C1708  C1709  C2268  C2269     substitute:             C4873  C4896
[37]         Schedule 1, entry for Mesalazine in the form Tablet 1.2 g (prolonged release)
omit from the column headed “Circumstances”:        C1708  C1709    substitute:             C4824  
[38]         Schedule 1, entry for Mesalazine in each of the forms: Sachet containing prolonged release granules, 1 g per sachet; and Sachet containing prolonged release granules, 2 g per sachet
omit from the column headed “Circumstances”:        C1708  C1709  C2268  C2269     substitute:             C4873  C4896
[39]         Schedule 1, entry for Mesalazine in each of the forms: Sachet containing granules, 500 mg per sachet; Sachet containing granules, 1 g per sachet; and Sachet containing granules, 1.5 g per sachet
omit from the column headed “Circumstances”:        C1708  C1709    substitute:             C4824
[40]         Schedule 1, after entry for Mesalazine in the form Sachet containing granules, 1.5 g per sachet
insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
 
Sachet containing granules, 3 g per sachet
Oral
Salofalk
OA
MP NP
C4824
 
30
5
30
 
 
[41]         Schedule 1, entry for Mesalazine in each of the forms: Suppository 1 g; and Suppository (moulded) 1 g
omit from the column headed “Circumstances”:        C1978   substitute:             C4878
[42]         Schedule 1, entry for Mesalazine in each of the forms: Enemas 1 g in 100 mL, 7; Enemas 2 g in 60 mL, 7; Enemas 4 g in 60 mL, 7; and Rectal foam 1 g per applicatorful, 14 applications, aerosol 80 g
omit from the column headed “Circumstances”:        C1707   substitute:             C4888
[43]         Schedule 1, entry for Mianserin in the form Tablet containing mianserin hydrochloride 10 mg
omit:
 
 
 
Tolvon
MK
MP NP
C1355
 
50
5
50
 
 
[44]         Schedule 1, entry for Mycophenolic Acid
substitute:
Mycophenolic Acid
Capsule containing mycophenolate mofetil 250 mg
Oral
APO‑
Mycophenolate
TX
MP
 
 
300
5
100
 
 

 
 
 
CellCept
RO
MP
 
 
300
5
100
 
 

 
 
 
Ceptolate
AF
MP
 
 
300
5
50
 
 

 
 
 
Mycophenolate Sandoz
SZ
MP
 
 
300
5
100
 
 

 
 
 
 
Pharmacor Mycophenolate 250
CR
MP
 
 
300
5
100
 
 

 
 
 
APO‑
Mycophenolate
TX
MP
 
P1650 P1651 P3355 P3356
600
CN1650 CN1651 CN3355CN3356
5
CN1650 CN1651 CN3355CN3356
100
 
C(100)

 
 
 
CellCept
RO
MP
 
P1650 P1651 P3355 P3356
600
CN1650 CN1651 CN3355CN3356
5
CN1650 CN1651 CN3355CN3356
100
 
C(100)

 
 
 
Ceptolate
AF
MP
 
P1650 P1651 P3355 P3356
600
CN1650 CN1651 CN3355CN3356
5
CN1650 CN1651 CN3355CN3356
50
 
C(100)

 
 
 
Mycophenolate Sandoz
SZ
MP
 
P1650 P1651 P3355 P3356
600
CN1650 CN1651 CN3355CN3356
5
CN1650 CN1651 CN3355CN3356
100
 
C(100)

 
 
 
Pharmacor Mycophenolate 250
CR
MP
 
P1650 P1651 P3355 P3356
600
CN1650 CN1651 CN3355CN3356
5
CN1650 CN1651 CN3355CN3356
100
 
C(100)

 
Tablet (enteric coated) containing mycophenolate sodium equivalent to 180 mg mycophenolic acid
Oral
Myfortic
NV
MP
 
 
120
5
120
 
 

 
 
 
 
 
MP

 
P4084 P4095 P4108 P4146
240
CN4084 CN4095 CN4108 CN4146
55
CN4084 CN4095 CN4108 CN4146
120
 
C(100)

 
Tablet (enteric coated) containing mycophenolate sodium equivalent to 360 mg mycophenolic acid
Oral
Myfortic
NV
MP
 
 
120
5
120
 
 

 
 
 
 
 
MP
 
P4084 P4095 P4108 P4146
240
CN4084 CN4095 CN4108 CN4146
5
CN4084 CN4095 CN4108 CN4146
120
 
C(100)

 
Tablet containing mycophenolate mofetil 500 mg
Oral
APO‑
Mycophenolate
TX
MP
 
 
150
5
50
 
 

 
 
 
CellCept
RO
MP
 
 
150
5
50
 
 

 
 
 
Ceptolate
AF
MP
 
 
150
5
50
 
 

 
 
 
Mycophenolate Sandoz
SZ
MP
 
 
150
5
50
 
 

 
 
 
Pharmacor Mycophenolate 500
CR
MP
 
 
150
5
50
 
 

 
 
 
APO‑
Mycophenolate
TX
MP
 
P1650 P1651 P3355 P3356
300
CN1650 CN1651 CN3355 CN3356
5
CN1650 CN1651 CN3355CN3356
50
 
C(100)

 
 
 
CellCept
RO
MP
 
P1650 P1651 P3355 P3356
300
CN1650 CN1651 CN3355 CN3356
5
CN1650 CN1651 CN3355CN3356
50
 
C(100)

 
 
 
Ceptolate
AF
MP
 
P1650 P1651 P3355 P3356
300
CN1650 CN1651 CN3355 CN3356
5
CN1650 CN1651 CN3355CN3356
50
 
C(100)

 
 
 
Mycophenolate Sandoz
SZ
MP
 
P1650 P1651 P3355 P3356
300
CN1650 CN1651 CN3355 CN3356
5
CN1650 CN1651 CN3355CN3356
50
 
C(100)

 
 
 
Pharmacor Mycophenolate 500
CR
MP
 
P1650 P1651 P3355 P3356
300
CN1650 CN1651 CN3355 CN3356
5
CN1650 CN1651 CN3355CN3356
50
 
C(100)

 
Powder for oral suspension containing mycophenolate mofetil 1 g per 5 mL, 165 mL
Oral
CellCept
RO
MP
 
 
1
5
1
 
 

 
 
 
 
 
MP
 
P1650 P1651 P3355 P3356
2
CN1650 CN1651 CN3355 CN3356
5
CN1650 CN1651 CN3355CN3356
1
 
C(100)

[45]         Schedule 1, entry for Oestradiol
omit:
 
Vaginal tablets 25 micrograms, 15
Vaginal
Vagifem
NO
MP NP
 
 
1
2
1
 
 
 
[46]         Schedule 1, entry for Olsalazine in each of the forms: Capsule containing olsalazine sodium 250 mg; and Tablet containing olsalazine sodium 500 mg
omit from the column headed “Circumstances”:        C1708  C1709    substitute:             C4824
[47]         Schedule 1, entry for Ondansetron in the form Tablet (orally disintegrating) 4 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”:
 
 
 
Zilfojim ODT 4
DO
MP NP
C3611
 
10
1
10
 
 
[48]         Schedule 1, entry for Ondansetron in the form Tablet (orally disintegrating) 8 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”:
 
 
 
Zilfojim ODT 8
DO
MP NP
C3611
 
10
1
10
 
 
[49]         Schedule 1, entry for Oxaliplatin in the form Solution concentrate for I.V. infusion 50 mg in 10 mL
omit:
 
 
 
Oxaliccord
GN
MP
 
 
See Note 3
See
Note 3
1
 
D(100)
[50]         Schedule 1, entry for Oxaliplatin in the form Powder for I.V. infusion 50 mg
omit:
 
 
 
Oxaliplatin Actavis
UA
MP
 
 
See Note 3
See
Note 3
1
 
D(100)
[51]         Schedule 1, entry for Oxaliplatin in the form Powder for I.V. infusion 100 mg
omit:
 
 
 
Oxaliplatin Actavis
UA
MP
 
 
See Note 3
See
Note 3
1
 
D(100)
[52]         Schedule 1, entry for Pamidronic Acid in the form Concentrated injection containing disodium pamidronate 15 mg in 5 mL
[Maximum Quantity: 4; Number of Repeats: 0]
omit from the column headed “Circumstances”:          C4422   substitute:          C4877
[53]         Schedule 1, entry for Pamidronic Acid in the form Concentrated injection containing disodium pamidronate 30 mg in 10 mL
[Maximum Quantity: 2; Number of Repeats: 0]
omit from the column headed “Circumstances”:          C4420   substitute:          C4883
[54]         Schedule 1, entry for Pamidronic Acid in the form Injection set containing 2 vials powder for I.V. infusion containing disodium pamidronate 30 mg and 2 ampoules solvent 10 mL [Maximum Quantity: 1; Number of Repeats: 0]
omit from the column headed “Circumstances”:          C4420   substitute:          C4883
[55]         Schedule 1, entry for Pamidronic Acid in the form Concentrated injection containing disodium pamidronate 60 mg in 10 mL
[Maximum Quantity: 1; Number of Repeats: 0]
omit from the column headed “Circumstances”:          C4422   substitute:          C4877
[56]         Schedule 1, entry for Paroxetine in the form Tablet 20 mg (as hydrochloride)
insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
 
 
 
Paroxetine Actavis
UA
MP NP
C1211 C1241 C1862
 
30
5
30
 
 
[57]         Schedule 1, entry for Poly-l-lactic acid
omit from the column headed “Responsible Person”:                 SW       substitute:          GA
[58]         Schedule 1, entry for Pramipexole in the form Tablet containing pramipexole hydrochloride 125 micrograms
insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
 
 
 
APO-Pramipexole
TX
MP NP
C3216
 
30
0
30
 
 
[59]         Schedule 1, entry for Pramipexole in the form Tablet containing pramipexole hydrochloride 250 micrograms [Maximum Quantity: 100; Number of Repeats: 5]
insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
 
 
 
APO-Pramipexole
TX
MP NP
C3216
 
100
5
100
 
 
[60]         Schedule 1, entry for Pramipexole in the form Tablet containing pramipexole hydrochloride 1 mg
insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
 
 
 
APO-Pramipexole
TX
MP NP
C3216
 
100
5
100
 
 
[61]         Schedule 1, entry for Pravastatin in the form Tablet containing pravastatin sodium 10 mg [Maximum Quantity: 30; Number of Repeats: 5]
insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
 
 
 
Auro-Pravastatin 10
DO
MP
C1540 C3047
P1540
30
5
30
 
 

 
 
 
 
 
NP
C1540
 
30
5
30
 
 

[62]         Schedule 1, entry for Pravastatin in the form Tablet containing pravastatin sodium 10 mg [Maximum Quantity: 30; Number of Repeats: 11]
insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
 
 
 
Auro-Pravastatin 10
DO
MP
C1540 C3047
P3047
30
11
30
 
 
[63]         Schedule 1, entry for Pravastatin in the form Tablet containing pravastatin sodium 20 mg [Maximum Quantity: 30; Number of Repeats: 5]
insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
 
 
 
Auro-Pravastatin 20
DO
MP
C1540 C3047
P1540
30
5
30
 
 

 
 
 
 
 
NP
C1540
 
30
5
30
 
 

[64]         Schedule 1, entry for Pravastatin in the form Tablet containing pravastatin sodium 20 mg [Maximum Quantity: 30; Number of Repeats: 11]
insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
 
 
 
Auro-Pravastatin 20
DO
MP
C1540 C3047
P3047
30
11
30
 
 
[65]         Schedule 1, entry for Pravastatin in the form Tablet containing pravastatin sodium 40 mg [Maximum Quantity: 30; Number of Repeats: 5]
insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
 
 
 
Auro-Pravastatin 40
DO
MP
C1540 C3047
P1540
30
5
30
 
 

 
 
 
 
 
NP
C1540
 
30
5
30
 
 

[66]         Schedule 1, entry for Pravastatin in the form Tablet containing pravastatin sodium 40 mg [Maximum Quantity: 30; Number of Repeats: 11]
insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
 
 
 
Auro-Pravastatin 40
DO
MP
C1540 C3047
P3047
30
11
30
 
 
[67]         Schedule 1, entry for Pravastatin in the form Tablet containing pravastatin sodium 80 mg [Maximum Quantity: 30; Number of Repeats: 5]
insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
 
 
 
Auro-Pravastatin 80
DO
MP
C1540 C3047
P1540
30
5
30
 
 

 
 
 
 
 
NP
C1540
 
30
5
30
 
 

[68]         Schedule 1, entry for Pravastatin in the form Tablet containing pravastatin sodium 80 mg [Maximum Quantity: 30; Number of Repeats: 11]
insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
 
 
 
Auro-Pravastatin 80
DO
MP
C1540 C3047
P3047
30
11
30
 
 
[69]         Schedule 1, entry for Prednisolone in the form Suppositories 5 mg (as sodium phosphate), 10
omit from the column headed “Circumstances”:        C1294  C1454    substitute:             C4872  C4893
[70]         Schedule 1, entry for Ramipril in the form Capsule 1.25 mg
insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
 
 
 
Vascalace Caps 1.25
DO
MP NP
 
 
30
5
30
 
 
[71]         Schedule 1, entry for Ramipril in the form Capsule 2.5 mg
insert in the columns in the order indicated and in alphabetical order for the column headed “Brand”:
 
 
 
Vascalace Caps 2.5
DO
MP NP
 
 
30
5
30
 
 
[72]         Schedule 1, entry for Ramipril in the form Capsule 5 mg
insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
 
 
 
Vascalace Caps 5
DO
MP NP
 
 
30
5
30
 
 
[73]         Schedule 1, entry for Ramipril in the form Capsule 10 mg
insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
 
 
 
Vascalace Caps 10
DO
MP NP
 
 
30
5
30
 
 
[74]         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):               C4122  C4123  C4133    substitute:          C4882  C4885  C4889
[75]         Schedule 1, entry for Risedronic Acid in the form Tablet containing risedronate sodium 30 mg
omit from the column headed “Circumstances”:          C3256   substitute:          C4877
[76]         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 brands: “APO-Rosuvastatin”; “Blooms the Chemist Rosuvastatin”; “Cavstat”; “Chem mart Rosuvastatin”; “Crestor”; and “Crosuva 5” [Authorised Prescriber “MP”]:              
C4228         substitute:             C4226
(b)      omit:            C4248    substitute:             C4263
(c)      omit from the column headed “Purposes” for the brands: “APO-Rosuvastatin” “Blooms the Chemist Rosuvastatin”; “Cavstat”; “Chem mart Rosuvastatin”; “Crestor”; and “Crosuva 5” [Authorised Prescriber “MP”]:              
P4228  P4248           substitute:             P4226  P4263
(d)      omit from the column headed “Circumstances” for the brands: “APO-Rosuvastatin” “Blooms the Chemist Rosuvastatin”; “Cavstat”; “Chem mart Rosuvastatin”; “Crestor”; and “Crosuva 5” [Authorised Prescriber “NP”]:               
C4228  C4248           substitute:             C4226  C4263
(e)      omit from the column headed “Circumstances” for the brand “Rostor 5” [Authorised Prescriber “MP”]:       
C4228         substitute:             C4226
(f)       omit from the column headed “Purposes” for the brand “Rostor 5” [Authorised Prescriber “MP”]: 
P4228         substitute:             P4226
(g)      omit from the column headed “Circumstances” for the brand “Rostor 5” [Authorised Prescriber “NP”]:        
C4228         substitute:             C4226
(h)      omit from the column headed “Circumstances” for the brand “Rosuvastatin Actavis 5” [Authorised Prescriber “MP”]:     
C4228         substitute:             C4226
(i)       omit:            C4248    substitute:             C4263
(j)       omit from the column headed “Purposes” for the brand “Rosuvastatin Actavis 5” [Authorised Prescriber “MP”]:       
P4228  P4248           substitute:             P4226  P4263
(k)      omit from the column headed “Circumstances” for the brand “Rosuvastatin Actavis 5” [Authorised Prescriber “NP”]:     
C4228  C4248           substitute:             C4226  C4263
(l)       omit from the column headed “Circumstances” for the brand “Rosuvastatin AN” [Authorised Prescriber “MP”]:        
C4228         substitute:             C4226
(m)    omit from the column headed “Purposes” for the brand “Rosuvastatin AN” [Authorised Prescriber “MP”]:  
P4228         substitute:             P4226
(n)      omit from the column headed “Circumstances” for the brand “Rosuvastatin AN” [Authorised Prescriber “NP”]:         
C4228         substitute:             C4226
(o)      omit from the column headed “Circumstances” for the brands: “Rosuvastatin-DRLA”; and “Rosuvastatin GH” [Authorised Prescriber “MP”]:  
C4228         substitute:             C4226
(p)      omit:            C4248    substitute:             C4263
(q)      omit from the column headed “Purposes” for the brands: “Rosuvastatin-DRLA”; and “Rosuvastatin GH” [Authorised Prescriber “MP”]:  
P4228  P4248           substitute:             P4226  P4263
(r)       omit from the column headed “Circumstances” for the brands: “Rosuvastatin-DRLA”; and “Rosuvastatin GH” [Authorised Prescriber “NP”]:   
C4228  C4248           substitute:             C4226  C4263
(s)      omit from the column headed “Circumstances” for the brands: “Rosuvastatin RBX”; and Rosuvastatin Sandoz” [Authorised Prescriber “MP”]:           
C4228         substitute:             C4226
(t)       omit from the column headed “Purposes” for the brands: “Rosuvastatin RBX”; and Rosuvastatin Sandoz” [Authorised Prescriber “MP”]:  
P4228         substitute:             P4226
(u)      omit from the column headed “Circumstances” for the brand brands: “Rosuvastatin RBX”; and Rosuvastatin Sandoz” [Authorised Prescriber “NP”]:            
C4228         substitute:             C4226
(v)      omit from the column headed “Circumstances” for the brand “Terry White Chemists Rosuvastatin” [Authorised Prescriber “MP”]:      
C4228         substitute:             C4226
(w)     omit:            C4248    substitute:             C4263
(x)      omit from the column headed “Purposes” for the brand “Terry White Chemists Rosuvastatin” [Authorised Prescriber “MP”]:      
P4228  P4248           substitute:             P4226  P4263
(y)      omit from the column headed “Circumstances” for the brand “Terry White Chemists Rosuvastatin” [Authorised Prescriber “NP”]:       
C4228  C4248           substitute:             C4226  C4263
[77]         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 brands: “APO-Rosuvastatin”; “Blooms the Chemist Rosuvastatin”; “Cavstat”; “Chem mart Rosuvastatin”; “Crestor”; and “Crosuva 5”:       
C4228         substitute:             C4226
(b)      omit:            C4248    substitute:             C4263
(c)      omit from the column headed “Circumstances” for the brand “Rostor 5”:                 C4228    substitute:             C4226
(d)      omit from the column headed “Circumstances” for the brand “Rosuvastatin Actavis 5”:
C4228         substitute:             C4226
(e)      omit:            C4248    substitute:             C4263
(f)       omit from the column headed “Circumstances” for the brand “Rosuvastatin AN”: C4228     substitute:             C4226
(g)      omit from the column headed “Circumstances” for the brands: “Rosuvastatin-DRLA”; and “Rosuvastatin GH”:           
C4228         substitute:             C4226
(h)      omit:            C4248    substitute:             C4263
(i)       omit from the column headed “Circumstances” for the brands: “Rosuvastatin RBX”; and “Rosuvastatin Sandoz”:       
C4228         substitute:             C4226
(j)       omit from the column headed “Circumstances” for the brand “Terry White Chemists Rosuvastatin”:
C4228         substitute:             C4226
(k)      omit:            C4248    substitute:             C4263
[78]         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 brands: “APO-Rosuvastatin”; “Blooms the Chemist Rosuvastatin”; “Cavstat”; “Chem mart Rosuvastatin”; “Crestor”; and “Crosuva 10” [Authorised Prescriber “MP”]:            
C4228         substitute:             C4226
(b)      omit:            C4248    substitute:             C4263
(c)      omit from the column headed “Purposes” for the brands: “APO-Rosuvastatin” “Blooms the Chemist Rosuvastatin”; “Cavstat”; “Chem mart Rosuvastatin”; “Crestor”; and “Crosuva 10” [Authorised Prescriber “MP”]:            
P4228  P4248           substitute:             P4226  P4263
(d)      omit from the column headed “Circumstances” for the brands: “APO-Rosuvastatin” “Blooms the Chemist Rosuvastatin”; “Cavstat”; “Chem mart Rosuvastatin”; “Crestor”; and “Crosuva 10” [Authorised Prescriber “NP”]:             
C4228  C4248           substitute:             C4226  C4263
(e)      omit from the column headed “Circumstances” for the brand “Rostor 10” [Authorised Prescriber “MP”]:     
C4228         substitute:             C4226
(f)       omit from the column headed “Purposes” for the brand “Rostor 10” [Authorised Prescriber “MP”]:               
P4228         substitute:             P4226
(g)      omit from the column headed “Circumstances” for the brand “Rostor 10” [Authorised Prescriber “NP”]:      
C4228         substitute:             C4226
(h)      omit from the column headed “Circumstances” for the brand “Rosuvastatin Actavis 10” [Authorised Prescriber “MP”]:     
C4228         substitute:             C4226
(i)       omit:            C4248    substitute:             C4263
(j)       omit from the column headed “Purposes” for the brand “Rosuvastatin Actavis 10” [Authorised Prescriber “MP”]:     
P4228  P4248        substitute:          P4226  P4263
(k)      omit from the column headed “Circumstances” for the brand “Rosuvastatin Actavis 10” [Authorised Prescriber “NP”]:     
C4228  C4248           substitute:             C4226  C4263
(l)       omit from the column headed “Circumstances” for the brand “Rosuvastatin AN” [Authorised Prescriber “MP”]:        
C4228         substitute:             C4226
(m)    omit from the column headed “Purposes” for the brand “Rosuvastatin AN” [Authorised Prescriber “MP”]:  
P4228         substitute:             P4226
(n)      omit from the column headed “Circumstances” for the brand “Rosuvastatin AN” [Authorised Prescriber “NP”]:         
C4228         substitute:             C4226
(o)      omit from the column headed “Circumstances” for the brands: “Rosuvastatin-DRLA”; and “Rosuvastatin GH” [Authorised Prescriber “MP”]:  
C4228         substitute:             C4226
(p)      omit:            C4248    substitute:             C4263
(q)      omit from the column headed “Purposes” for the brands: “Rosuvastatin-DRLA”; and “Rosuvastatin GH” [Authorised Prescriber “MP”]:  
P4228  P4248           substitute:             P4226  P4263
(r)       omit from the column headed “Circumstances” for the brands: “Rosuvastatin-DRLA”; and “Rosuvastatin GH” [Authorised Prescriber “NP”]:   
C4228  C4248           substitute:             C4226  C4263
(s)      omit from the column headed “Circumstances” for the brands: “Rosuvastatin RBX”; and Rosuvastatin Sandoz” [Authorised Prescriber “MP”]:           
C4228         substitute:             C4226
(t)       omit from the column headed “Purposes” for the brands: “Rosuvastatin RBX”; and Rosuvastatin Sandoz” [Authorised Prescriber “MP”]:  
P4228         substitute:             P4226
(u)      omit from the column headed “Circumstances” for the brand brands: “Rosuvastatin RBX”; and Rosuvastatin Sandoz” [Authorised Prescriber “NP”]:            
C4228         substitute:             C4226
(v)      omit from the column headed “Circumstances” for the brand “Terry White Chemists Rosuvastatin” [Authorised Prescriber “MP”]:      
C4228         substitute:             C4226
(w)     omit:            C4248    substitute:             C4263
(x)      omit from the column headed “Purposes” for the brand “Terry White Chemists Rosuvastatin” [Authorised Prescriber “MP”]:      
P4228  P4248           substitute:             P4226  P4263
(y)      omit from the column headed “Circumstances” for the brand “Terry White Chemists Rosuvastatin” [Authorised Prescriber “NP”]:       
C4228  C4248           substitute:             C4226  C4263
[79]         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 brands: “APO-Rosuvastatin”; “Blooms the Chemist Rosuvastatin”; “Cavstat”; “Chem mart Rosuvastatin”; “Crestor”; and “Crosuva 10”:     
C4228         substitute:             C4226
(b)      omit:            C4248    substitute:             C4263
(c)      omit from the column headed “Circumstances” for the brand “Rostor 10”:               C4228    substitute:             C4226
(d)      omit from the column headed “Circumstances” for the brand “Rosuvastatin Actavis 10”:
C4228         substitute:             C4226
(e)      omit:            C4248    substitute:             C4263
(f)       omit from the column headed “Circumstances” for the brand “Rosuvastatin AN”: C4228     substitute:             C4226
(g)      omit from the column headed “Circumstances” for the brands: “Rosuvastatin-DRLA”; and “Rosuvastatin GH”:           
C4228         substitute:             C4226
(h)      omit:            C4248    substitute:             C4263
(i)       omit from the column headed “Circumstances” for the brands: “Rosuvastatin RBX”; and “Rosuvastatin Sandoz”:       
C4228         substitute:             C4226
 
(j)       omit from the column headed “Circumstances” for the brand “Terry White Chemists Rosuvastatin”:
C4228         substitute:             C4226
(k)      omit:            C4248    substitute:             C4263
[80]         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 brands: “APO-Rosuvastatin”; “Blooms the Chemist Rosuvastatin”; “Cavstat”; “Chem mart Rosuvastatin”; “Crestor”; and “Crosuva 20” [Authorised Prescriber “MP”]:            
C4227         substitute:             C4226
(b)      omit:            C4259    substitute:             C4263
(c)      omit from the column headed “Purposes” for the brands: “APO-Rosuvastatin” “Blooms the Chemist Rosuvastatin”; “Cavstat”; “Chem mart Rosuvastatin”; “Crestor”; and “Crosuva 20” [Authorised Prescriber “MP”]:            
P4227  P4259           substitute:             P4226  P4263
(d)      omit from the column headed “Circumstances” for the brands: “APO-Rosuvastatin” “Blooms the Chemist Rosuvastatin”; “Cavstat”; “Chem mart Rosuvastatin”; “Crestor”; and “Crosuva 20” [Authorised Prescriber “NP”]:             
C4227  C4259           substitute:             C4226  C4263
(e)      omit from the column headed “Circumstances” for the brand “Rostor 20” [Authorised Prescriber “MP”]:     
C4227         substitute:             C4226
(f)       omit from the column headed “Purposes” for the brand “Rostor 20” [Authorised Prescriber “MP”]:               
P4227         substitute:             P4226
(g)      omit from the column headed “Circumstances” for the brand “Rostor 20” [Authorised Prescriber “NP”]:      
C4227         substitute:             C4226
(h)      omit from the column headed “Circumstances” for the brand “Rosuvastatin Actavis 20” [Authorised Prescriber “MP”]:     
C4227         substitute:             C4226
(i)       omit:            C4259    substitute:             C4263
(j)       omit from the column headed “Purposes” for the brand “Rosuvastatin Actavis 20” [Authorised Prescriber “MP”]:     
P4227  P4259           substitute:             P4226  P4263
(k)      omit from the column headed “Circumstances” for the brand “Rosuvastatin Actavis 20” [Authorised Prescriber “NP”]:     
C4227  C4259           substitute:             C4226  C4263
(l)       omit from the column headed “Circumstances” for the brand “Rosuvastatin AN” [Authorised Prescriber “MP”]:        
C4227         substitute:             C4226
(m)    omit from the column headed “Purposes” for the brand “Rosuvastatin AN” [Authorised Prescriber “MP”]:  
P4227         substitute:             P4226
(n)      omit from the column headed “Circumstances” for the brand “Rosuvastatin AN” [Authorised Prescriber “NP”]:         
C4227         substitute:             C4226
(o)      omit from the column headed “Circumstances” for the brands: “Rosuvastatin-DRLA”; and “Rosuvastatin GH” [Authorised Prescriber “MP”]:  
C4227         substitute:             C4226
(p)      omit:            C4259    substitute:             C4263
(q)      omit from the column headed “Purposes” for the brands: “Rosuvastatin-DRLA”; and “Rosuvastatin GH” [Authorised Prescriber “MP”]:  
P4227  P4259           substitute:             P4226  P4263
(r)       omit from the column headed “Circumstances” for the brands: “Rosuvastatin-DRLA”; and “Rosuvastatin GH” [Authorised Prescriber “NP”]:   
C4227  C4259           substitute:             C4226  C4263
(s)      omit from the column headed “Circumstances” for the brands: “Rosuvastatin RBX”; and Rosuvastatin Sandoz” [Authorised Prescriber “MP”]:           
C4227         substitute:             C4226
(t)       omit from the column headed “Purposes” for the brands: “Rosuvastatin RBX”; and Rosuvastatin Sandoz” [Authorised Prescriber “MP”]:  
P4227         substitute:             P4226
(u)      omit from the column headed “Circumstances” for the brand brands: “Rosuvastatin RBX”; and Rosuvastatin Sandoz” [Authorised Prescriber “NP”]:            
C4227         substitute:             C4226
(v)      omit from the column headed “Circumstances” for the brand “Terry White Chemists Rosuvastatin” [Authorised Prescriber “MP”]:      
C4227         substitute:             C4226
(w)     omit:            C4259    substitute:             C4263
(x)      omit from the column headed “Purposes” for the brand “Terry White Chemists Rosuvastatin” [Authorised Prescriber “MP”]:      
P4227  P4258           substitute:             P4226  P4263
(y)      omit from the column headed “Circumstances” for the brand “Terry White Chemists Rosuvastatin” [Authorised Prescriber “NP”]:       
C4227  C4259           substitute:             C4226  C4263
[81]         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 brands: “APO-Rosuvastatin”; “Blooms the Chemist Rosuvastatin”; “Cavstat”; “Chem mart Rosuvastatin”; “Crestor”; and “Crosuva 20”:     
C4227         substitute:             C4226
(b)      omit:            C4259    substitute:             C4263
(c)      omit from the column headed “Circumstances” for the brand “Rostor 20”:               C4227    substitute:             C4226
(d)      omit from the column headed “Circumstances” for the brand “Rosuvastatin Actavis 20”:
C4227         substitute:             C4226
(e)      omit:            C4259    substitute:             C4263
(f)       omit from the column headed “Circumstances” for the brand “Rosuvastatin AN”:  C4227    substitute:             C4226
(g)      omit from the column headed “Circumstances” for the brands: “Rosuvastatin-DRLA”; and “Rosuvastatin GH”:           
C4227         substitute:             C4226
(h)      omit:            C4259    substitute:             C4263
(i)       omit from the column headed “Circumstances” for the brands: “Rosuvastatin RBX”; and “Rosuvastatin Sandoz”:       
C4227         substitute:             C4226
(j)       omit from the column headed “Circumstances” for the brand “Terry White Chemists Rosuvastatin”:
C4227         substitute:             C4226
(k)      omit:            C4259    substitute:             C4263
 
[82]         Schedule 1, entry for Sirolimus
substitute:
Sirolimus
Tablet 0.5 mg
Oral
Rapamune
PF
MP
 
 
100
3
100
 
 

 
 
 
 
 
MP
 
P1650 P3355
200
CN1650 CN3355
5
CN1650 CN3355
100
 
C(100)

 
Tablet 1 mg
Oral
Rapamune
PF
MP
 
 
100
3
100
 
 

 
 
 
 
 
MP
 
P1650 P3355
200
CN1650 CN3355
5
CN1650 CN3355
100
 
C(100)

 
Tablet 2 mg
Oral
Rapamune
PF
MP
 
 
100
3
100
 
 

 
 
 
 
 
MP
 
P1650 P3355
200
CN1650 CN3355
5
CN1650 CN3355
100
 
C(100)

 
Oral solution 1 mg per mL, 60 mL
Oral
Rapamune
PF
MP
 
 
1
3
1
 
 

 
 
 
 
 
MP
 
P1650 P3355
2
CN1650 CN3355
5
CN1650 CN3355
1
 
C(100)

[83]         Schedule 1, entry for Sulfasalazine in the form Tablet 500 mg [Maximum Quantity: 200; Number of Repeats: 11]
omit from the column headed “Purposes”:     P3035   substitute:             P4894
[84]         Schedule 1, entry for Sulfasalazine in the form Tablet 500 mg (enteric coated) [Maximum Quantity: 200; Number of Repeats: 11]
omit from the column headed “Purposes” (twice occurring):     P3035   substitute:             P4894
[85]         Schedule 1, entry for Tacrolimus
substitute:
Tacrolimus
Capsule 0.5 mg
Oral
Pharmacor Tacrolimus 0.5
CR
MP
 
 
100
3
100
 
 

 
 
 
Prograf
LL
MP
 
 
100
3
100
 
 

 
 
 
Tacrolimus Sandoz
SZ
MP
 
 
100
3
100
 
 

 
 
 
Pharmacor Tacrolimus 0.5
CR
MP
 
P1654 P3328
200
CN1654 CN3328
5
CN1654 CN3328
100
 
C(100)

 
 
 
Prograf
LL
MP
 
P1654 P3328
200
CN1654 CN3328
5
CN1654 CN3328
100
 
C(100)

 
 
 
Tacrolimus Sandoz
SZ
MP
 
P1654 P3328
200
CN1654 CN3328
5
CN1654 CN3328
100
 
C(100)

 
Capsule 1 mg
Oral
Pharmacor Tacrolimus 1
CR
MP
 
 
100
3
100
 
 

 
 
 
Prograf
LL
MP
 
 
100
3
100
 
 

 
 
 
Tacrolimus Sandoz
SZ
MP
 
 
100
3
100
 
 

 
 
 
Pharmacor Tacrolimus 1
CR
MP
 
P1654 P3328
200
CN1654 CN3328
5
CN1654 CN3328
100
 
C(100)

 
 
 
Prograf
LL
MP
 
P1654 P3328
200
CN1654 CN3328
5
CN1654 CN3328
100
 
C(100)

 
 
 
Tacrolimus Sandoz
SZ
MP
 
P1654 P3328
200
CN1654 CN3328
5
CN1654 CN3328
100
 
C(100)

 
Capsule 5 mg
Oral
Pharmacor Tacrolimus 5
CR
MP
 
 
50
3
50
 
 

 
 
 
Prograf
LL
MP
 
 
50
3
50
 
 

 
 
 
Tacrolimus Sandoz
SZ
MP
 
 
50
3
50
 
 

 
 
 
Pharmacor Tacrolimus 5
CR
MP
 
P1654 P3328
100
CN1654 CN3328
5
CN1654 CN3328
50
 
C(100)

 
 
 
Prograf
LL
MP
 
P1654 P3328
100
CN1654 CN3328
5
CN1654 CN3328
50
 
C(100)

 
 
 
Tacrolimus Sandoz
SZ
MP
 
P1654 P3328
100
CN1654 CN3328
5
CN1654 CN3328
50
 
C(100)

 
Capsule 0.5 mg (once daily prolonged release)
Oral
Prograf XL
LL
MP
 
 
30
3
30
 
 

 
 
 
 
 
MP
 
P1654 P3328
60
CN1654 CN3328
5
CN1654 CN3328
30
 
C(100)

 
Capsule 1 mg (once daily prolonged release)
Oral
Prograf XL
LL
MP
 
 
60
3
60
 
 

 
 
 
 
 
MP
 
P1654 P3328
120
CN1654 CN3328
5
CN1654 CN3328
60
 
C(100)

 
 
Capsule 5 mg (once daily prolonged release)
Oral
Prograf XL
LL
MP
 
 
30
3
30
 
 

 
 
 
 
 
MP
 
P1654 P3328
60
CN1654 CN3328
5
CN1654 CN3328
30
 
C(100)

[86]         Schedule 1, entry for Temozolomide
substitute:
Temozolomide
Capsule 5 mg
Oral
Astromide
GN
MP
 
 
5
5
5
 
 

 
 
 
Orion Temozolomide
ON
MP
 
 
5
5
5
 
 

 
 
 
Temizole 5
QA
MP
 
 
5
5
5
 
 

 
 
 
Temodal
MK
MP
 
 
5
5
5
 
 

 
 
 
Temozolomide Alphapharm
AF
MP
 
 
5
5
5
 
 

 
f
 
Temozolomide AN
EA
MP
 
 
5
5
5
 
 

 
 
 
Astromide
GN
MP
 
P4897
15
CN4897
2
CN4897
5
 
 

 
 
 
Orion Temozolomide
ON
MP
 
P4897
15
CN4897
2
CN4897
5
 
 

 
 
 
Temizole 5
QA
MP
 
P4897
15
CN4897
2
CN4897
5
 
 

 
 
 
Temodal
MK
MP
 
P4897
15
CN4897
2
CN4897
5
 
 

 
 
 
Temozolomide Alphapharm
AF
MP
 
P4897
15
CN4897
2
CN4897
5
 
 

 
 
 
Temozolomide AN
EA
MP
 
P4897
15
CN4897
2
CN4897
5
 
 

 
Capsule 20 mg
Oral
Astromide
GN
MP
 
 
5
5
5
 
 

 
 
 
Orion Temozolomide
ON
MP
 
 
5
5
5
 
 

 
 
 
Temizole 20
QA
MP
 
 
5
5
5
 
 

 
 
 
Temodal
MK
MP
 
 
5
5
5
 
 

 
 
 
Temozolomide Alphapharm
AF
MP
 
 
5
5
5
 
 

 
 
 
Temozolomide AN
EA
MP
 
 
5
5
5
 
 

 
 
 
Astromide
GN
MP
 
P4897
15
CN4897
2
CN4897
5
 
 

 
 
 
Orion Temozolomide
ON
MP
 
P4897
15
CN4897
2
CN4897
5
 
 

 
 
 
 
Temizole 20
QA
MP
 
P4897
15
CN4897
2
CN4897
5
 
 

 
 
 
Temodal
MK
MP
 
P4897
15
CN4897
2
CN4897
5
 
 

 
 
 
Temozolomide Alphapharm
AF
MP
 
P4897
15
CN4897
2
CN4897
5
 
 

 
 
 
Temozolomide AN
EA
MP
 
P4897
15
CN4897
2
CN4897
5
 
 

 
Capsule 100 mg
Oral
Astromide
GN
MP
 
 
5
5
5
 
 

 
 
 
Orion Temozolomide
ON
MP
 
 
5
5
5
 
 

 
 
 
Temizole 100
QA
MP
 
 
5
5
5
 
 

 
 
 
Temodal
MK
MP
 
 
5
5
5
 
 

 
 
 
Temozolomide Alphapharm
AF
MP
 
 
5
5
5
 
 

 
 
 
Temozolomide AN
EA
MP
 
 
5
5
5
 
 

 
 
 
Astromide
GN
MP
 
P4897
15
CN4897
2
CN4897
5
 
 

 
 
 
Orion Temozolomide
ON
MP
 
P4897
15
CN4897
2
CN4897
5
 
 

 
 
 
Temizole 100
QA
MP
 
P4897
15
CN4897
2
CN4897
5
 
 

 
 
 
Temodal
MK
MP
 
P4897
15
CN4897
2
CN4897
5
 
 

 
 
 
Temozolomide Alphapharm
AF
MP
 
P4897
15
CN4897
2
CN4897
5
 
 

 
 
 
Temozolomide AN
EA
MP
 
P4897
15
CN4897
2
CN4897
5
 
 

 
Capsule 140 mg
Oral
Astromide
GN
MP
 
 
5
5
5
 
 

 
 
 
Orion Temozolomide
ON
MP
 
 
5
5
5
 
 

 
 
 
Temizole 140
QA
MP
 
 
5
5
5
 
 

 
 
 
Temodal
MK
MP
 
 
5
5
5
 
 

 
 
 
Temozolomide Alphapharm
AF
MP
 
 
5
5
5
 
 

 
 
 
Temozolomide AN
EA
MP
 
 
5
5
5
 
 

 
 
 
Astromide
GN
MP
 
P4897
15
CN4897
2
CN4897
5
 
 

 
 
 
Orion Temozolomide
ON
MP
 
P4897
15
CN4897
2
CN4897
5
 
 

 
 
 
 
Temizole 140
QA
MP
 
P4897
15
CN4897
2
CN4897
5
 
 

 
 
 
Temodal
MK
MP
 
P4897
15
CN4897
2
CN4897
5
 
 

 
 
 
Temozolomide Alphapharm
AF
MP
 
P4897
15
CN4897
2
CN4897
5
 
 

 
 
 
Temozolomide AN
EA
MP
 
P4897
15
CN4897
2
CN4897
5
 
 

 
Capsule 180 mg
Oral
Astromide
GN
MP
 
 
5
5
5
 
 

 
 
 
Orion Temozolomide
ON
MP
 
 
5
5
5
 
 

 
 
 
Temodal
MK
MP
 
 
5
5
5
 
 

 
 
 
Astromide
GN
MP
 
P4897
15
CN4897
2
CN4897
5
 
 

 
 
 
Orion Temozolomide
ON
MP
 
P4897
15
CN4897
2
CN4897
5
 
 

 
 
 
Temodal
MK
MP
 
P4897
15
CN4897
2
CN4897
5
 
 

 
Capsule 250 mg
Oral
Astromide
GN
MP
 
 
5
5
5
 
 

 
 
 
Orion Temozolomide
ON
MP
 
 
5
5
5
 
 

 
 
 
Temizole 250
QA
MP
 
 
5
5
5
 
 

 
 
 
Temodal
MK
MP
 
 
5
5
5
 
 

 
 
 
Temozolomide Alphapharm
AF
MP
 
 
5
5
5
 
 

 
 
 
Temozolomide AN
EA
MP
 
 
5
5
5
 
 

[87]         Schedule 1, entry for Tiludronic Acid
omit from the column headed “Circumstances”:          C3256   substitute:          C4877
[88]         Schedule 1, entry for Tramadol in the form Tablet (sustained release) containing tramadol hydrochloride 200 mg
omit:
 
 
 
Lodam SR 200
ZP
MP NP
C1537
 
20
0
20
 
 
[89]         Schedule 1, entry for Valsartan in the form Tablet 40 mg
insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
 
 
 
Dilart
AF
MP NP
 
 
28
0
28
 
 
 
 
[90]         Schedule 1, entry for Valsartan in each of the forms: Tablet 80 mg; Tablet 160 mg; and Tablet 320 mg
insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
 
 
 
Dilart
AF
MP NP
 
 
28
5
28
 
 
[91]         Schedule 1, entry for Valsartan 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”:
 
 
 
Dilart HCT 80/12.5
AF
MP NP
C4374
 
28
5
28
 
 
[92]         Schedule 1, entry for Valsartan with hydrochlorothiazide in the form Tablet 160 mg-12.5 mg
insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
 
 
 
Dilart HCT 160/12.5
AF
MP NP
C4374
 
28
5
28
 
 
[93]         Schedule 1, entry for Valsartan with hydrochlorothiazide in the form Tablet 160 mg-25 mg
insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
 
 
 
Dilart HCT 160/25
AF
MP NP
C4374
 
28
5
28
 
 
[94]         Schedule 1, entry for Valsartan with hydrochlorothiazide in the form Tablet 320 mg-1.25 mg
insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
 
 
 
Dilart HCT 320/12.5
AF
MP NP
C4361
 
28
5
28
 
 
[95]         Schedule 1, entry for Valsartan with hydrochlorothiazide in the form Tablet 320 mg-25 mg
insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
 
 
 
Dilart HCT 320/25
AF
MP NP
C4361
 
28
5
28
 
 
[96]         Schedule 1, entry for Zoledronic acid in the form Solution for I.V. infusion 5 mg (as monohydrate) in 100 mL
(a)      omit from the column headed “Circumstances”:            C3290
(b)      insert in numerical order:     C4876
[97]         After Schedule 1
omit:
Note 1:       The pharmaceutical benefit may be covered by a special arrangement under section 100 of the Act. The persons who may prescribe the pharmaceutical benefit may be modified in the special arrangement instrument or the special arrangement instrument may provide for the supply of the pharmaceutical benefit otherwise than on a prescription. When the pharmaceutical benefit is supplied under the special arrangement, the modified matters will apply.
[subsequent Notes are not renumbered]
 
[98]         Schedule 3
omit:
BU
Bausch & Lomb (Australia) Pty Ltd
 34 000 650 251
[99]         Schedule 3, after details relevant to Responsible Person code FZ
insert:
GA
Galderma  Australia Pty Ltd
 12 003 976 930
[100]       Schedule 3, after details relevant to Responsible Person code SZ
insert:
TB
Teva Pharma Australia Pty Limited
 41 169 715 664
[101]       Schedule 4, Part 1, entry for Alendronic Acid
substitute:

Alendronic Acid
C4882
 
 
Established osteoporosis
Patient must have fracture due to minimal trauma; AND
Patient must not receive concomitant treatment with any other PBS-subsidised anti-resorptive agent for this condition
The fracture must have been demonstrated radiologically and the year of plain x-ray or computed tomography (CT) scan or magnetic resonance imaging (MRI) scan must be documented in the patient's medical records when treatment is initiated
A vertebral fracture is defined as a 20% or greater reduction in height of the anterior or mid portion of a vertebral body relative to the posterior height of that body, or, a 20% or greater reduction in any of these heights compared to the vertebral body above or below the affected vertebral body
 

 
C4885
 
 
Corticosteroid-induced osteoporosis
Patient must currently be on long-term (at least 3 months), high-dose (at least 7.5 mg per day prednisolone or equivalent) corticosteroid therapy; AND
Patient must have a Bone Mineral Density (BMD) T-score of -1.5 or less; AND
Patient must not receive concomitant treatment with any other PBS-subsidised anti-resorptive agent for this condition
The duration and dose of corticosteroid therapy together with 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
 

 
C4889
 
 
Osteoporosis
Patient must have a Bone Mineral Density (BMD) T-score of -2.5 or less; AND
Patient must not receive concomitant treatment with any other PBS-subsidised anti-resorptive agent for this condition
Patient must be aged 70 years or older
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
 

[102]       Schedule 4, Part 1, entry for Balsalazide
substitute:
Balsalazide
C4824
 
 
Ulcerative colitis
Patient must have had a documented hypersensitivity reaction to a sulphonamide; OR
Patient must be intolerant to sulfasalazine
Compliance with Authority Required procedures - Streamlined Authority Code 4824
[103]       Schedule 4, Part 1, omit entry for Carbomer with Triglyceride Lipids
[104]       Schedule 4, Part 1, entry for Cyclosporin [Circumstances Code C1654]
(a)      omit from the column headed “Circumstances Code”:     C1654
(b)      insert in the column headed “Purposes Code”:                 P1654
(c)      insert in the column headed “Conditions Code”:             CN1654
[105]       Schedule 4, Part 1, entry for Cyclosporin [Circumstances Code C1655]
(a)      omit from the column headed “Circumstances Code”:     C1655
(b)      insert in the column headed “Purposes Code”:                 P1655
(c)      insert in the column headed “Conditions Code”:             CN1655
[106]       Schedule 4, Part 1, entry for Cyclosporin [Circumstances Code C1656]
(a)      omit from the column headed “Circumstances Code”:     C1656
(b)      insert in the column headed “Purposes Code”:                 P1656
(c)      insert in the column headed “Conditions Code”:             CN1656
[107]       Schedule 4, Part 1, entry for Cyclosporin [Circumstances Code C1657]
(a)      omit from the column headed “Circumstances Code”:     C1657
(b)      insert in the column headed “Purposes Code”:                 P1657
(c)      insert in the column headed “Conditions Code”:             CN1657
[108]       Schedule 4, Part 1, entry for Cyclosporin [Circumstances Code C1658]
(a)      omit from the column headed “Circumstances Code”:     C1658
(b)      insert in the column headed “Purposes Code”:                 P1658
(c)      insert in the column headed “Conditions Code”:             CN1658
[109]       Schedule 4, Part 1, entry for Cyclosporin
omit:

 
C2049
 
 
Maintenance therapy, following initiation and stabilisation of treatment with cyclosporin, of patients with organ or tissue transplants, where therapy remains under the supervision and direction of the transplant unit reviewing the patient and where the name of the specialised transplant unit reviewing treatment and the date of the latest review at the specialised transplant unit are included in the authority application
Compliance with Authority Required procedures

 
C2050
 
 
Maintenance therapy, following initiation and stabilisation of treatment with cyclosporin, of patients with severe atopic dermatitis for whom other systemic therapies are ineffective or inappropriate, where therapy remains under the supervision and direction of a dermatologist, clinical immunologist or specialised unit reviewing the patient and where the name of the dermatologist, clinical immunologist or specialised unit reviewing treatment and the date of the latest review are included in the authority application
Compliance with Authority Required procedures

 
C2051
 
 
Maintenance therapy, following initiation and stabilisation of treatment with cyclosporin, of patients with severe psoriasis for whom other systemic therapies are ineffective or inappropriate and in whom the disease has caused significant interference with quality of life, where therapy remains under the supervision and direction of a dermatologist or specialised unit reviewing the patient and where the name of the dermatologist or specialised unit reviewing treatment and the date of the latest review are included in the authority application
Compliance with Authority Required procedures

 
C2052
 
 
Maintenance therapy, following initiation and stabilisation of treatment with cyclosporin, of patients with nephrotic syndrome in whom steroids and cytostatic drugs have failed or are not tolerated or are considered inappropriate and in whom renal function is unimpaired, where therapy remains under the supervision and direction of a nephrologist or specialised unit reviewing the patient and where the name of the nephrologist or specialised unit reviewing treatment and the date of the latest review are included in the authority application
Compliance with Authority Required procedures

 
C2053
 
 
Maintenance therapy, following initiation and stabilisation of treatment with cyclosporin, of patients with severe active rheumatoid arthritis for whom classical slow‑acting anti‑rheumatic agents (including methotrexate) are ineffective or inappropriate, where therapy remains under the supervision and direction of a rheumatologist, clinical immunologist or specialised unit reviewing the patient and where the name of the rheumatologist, clinical immunologist or specialised unit reviewing treatment and the date of the latest review are included in the authority application
Compliance with Authority Required procedures

[110]       Schedule 4, Part 1, entry for Cyclosporin [Circumstances Code C3328]
(a)      omit from the column headed “Circumstances Code”:     C3328
(b)      insert in the column headed “Purposes Code”:                 P3328
(c)      insert in the column headed “Conditions Code”:             CN3328
[111]       Schedule 4, Part 1, entry for Cyclosporin [Circumstances Code C3329]
(a)      omit from the column headed “Circumstances Code”:     C3329
(b)      insert in the column headed “Purposes Code”:                 P3329
(c)      insert in the column headed “Conditions Code”:             CN3329
[112]       Schedule 4, Part 1, entry for Cyclosporin [Circumstances Code C3330]
(a)      omit from the column headed “Circumstances Code”:     C3330
(b)      insert in the column headed “Purposes Code”:                 P3330
(c)      insert in the column headed “Conditions Code”:             CN3330
[113]       Schedule 4, Part 1, entry for Cyclosporin [Circumstances Code C3331]
(a)      omit from the column headed “Circumstances Code”:     C3331
(b)      insert in the column headed “Purposes Code”:                 P3331
(c)      insert in the column headed “Conditions Code”:             CN3331
[114]       Schedule 4, Part 1, entry for Cyclosporin [Circumstances Code C3332]
(a)      omit from the column headed “Circumstances Code”:     C3332
(b)      insert in the column headed “Purposes Code”:                 P3332
(c)      insert in the column headed “Conditions Code”:             CN3332
[115]       Schedule 4, Part 1, entry for Fludarabine
omit:
 
C3015
 
 
B‑cell chronic lymphocytic leukaemia in combination with cyclophosphamide where the patient has advanced disease (Binet Stage B or C) or evidence of progressive Stage A disease, and where:
(1) Stage A progressive disease is defined by at least 1 of the following:
— persistent rise in lymphocyte count with doubling time less than 12 months;
— a downward trend in haemoglobin or platelets, or both;
— more than 50% increase in the size of liver, spleen, or lymph nodes, or appearance of these signs if not previously present;
— constitutional symptoms attributable to disease; and
(2) the diagnosis of chronic lymphocytic leukaemia has been established based on:
(a) a lymphocytosis, with more than 5,000 million lymphocytes per L in the peripheral blood; and
(b) a clonal population of B‑cells (CD5/CD19) documented by flow cytometry
Compliance with Authority Required procedures
 
[116]       Schedule 4, Part 1, entry for Glatiramer
substitute:

Glatiramer
C4881
 
 
Multiple sclerosis
Initial treatment
The condition must be diagnosed as clinically definite relapsing-remitting multiple sclerosis by magnetic resonance imaging of the brain and/or spinal cord; OR
The condition must be diagnosed as clinically definite relapsing-remitting multiple sclerosis, with written certification provided by a radiologist that a magnetic resonance imaging scan is contraindicated because of the risk of physical (not psychological) injury to the patient; AND
Patient must have experienced at least 2 documented attacks of neurological dysfunction, believed to be due to the multiple sclerosis, in the preceding 2 years; AND
Patient must be ambulatory (without assistance or support)
Where applicable, the date of the magnetic resonance imaging scan must be recorded in the patient's medical records
Compliance with Authority Required procedures - Streamlined Authority Code 4881


 
C4887
 
 
Multiple sclerosis
Continuing treatment
The condition must be diagnosed as clinically definite relapsing-remitting multiple sclerosis; AND
Patient must have previously been issued with an authority prescription for this drug; AND
Patient must not show continuing progression of disability while on treatment with this drug; AND
Patient must have demonstrated compliance with, and an ability to tolerate this therapy
Compliance with Authority Required procedures - Streamlined Authority Code 4887


[117]       Schedule 4, Part 1, entry for Goserelin
substitute:

Goserelin
C4874
 
 
Breast cancer
The condition must be hormone receptor positive; AND
The treatment must be an alternative to adjuvant chemotherapy
 

 
C4890
 
 
Carcinoma of the prostate
The condition must be locally advanced (stage C); OR
The condition must be metastatic (stage D)
 

 
C4891
 
 
Breast cancer
The condition must be locally advanced (stage III); OR
The condition must be metastatic (stage IV); AND
The condition must be hormone receptor positive
 

 
C4892
 
 
Endometriosis
The condition must be visually proven; AND
The treatment must be for the short-term (up to 6 months)
 

[118]       Schedule 4, Part 1, entry for Goserelin and Bicalutamide
substitute:
Goserelin and Bicalutamide
C4895
 
 
Carcinoma of the prostate
The condition must be metastatic (stage D); AND
Patient must require a combination of an antiandrogen and a GnRH (LH-RH) agonist
 
[119]       Schedule 4, Part 1, entry for Hydrocortisone
(a)      omit:
 
C1294
 
 
Proctitis
 
(b)      omit:
 
C1454
 
 
Ulcerative colitis
 
(c)      insert in numerical order after existing text:

 
C4872
 
 
Ulcerative colitis
 

 
C4893
 
 
Proctitis
 

[120]       Schedule 4, Part 1, entry for Interferon Beta-1a
substitute:

Interferon Beta-1a
C4881
 
 
Multiple sclerosis
Initial treatment
The condition must be diagnosed as clinically definite relapsing-remitting multiple sclerosis by magnetic resonance imaging of the brain and/or spinal cord; OR
The condition must be diagnosed as clinically definite relapsing-remitting multiple sclerosis, with written certification provided by a radiologist that a magnetic resonance imaging scan is contraindicated because of the risk of physical (not psychological) injury to the patient; AND
Patient must have experienced at least 2 documented attacks of neurological dysfunction, believed to be due to the multiple sclerosis, in the preceding 2 years; AND
Patient must be ambulatory (without assistance or support)
Where applicable, the date of the magnetic resonance imaging scan must be recorded in the patient's medical records
Compliance with Authority Required procedures - Streamlined Authority Code 4881


 
C4887
 
 
Multiple sclerosis
Continuing treatment
The condition must be diagnosed as clinically definite relapsing-remitting multiple sclerosis; AND
Patient must have previously been issued with an authority prescription for this drug; AND
Patient must not show continuing progression of disability while on treatment with this drug; AND
Patient must have demonstrated compliance with, and an ability to tolerate this therapy
Compliance with Authority Required procedures - Streamlined Authority Code 4887


[121]       Schedule 4, Part 1, entry for Interferon Beta-1b
substitute:

Interferon Beta-1b
C4881
 
 
Multiple sclerosis
Initial treatment
The condition must be diagnosed as clinically definite relapsing-remitting multiple sclerosis by magnetic resonance imaging of the brain and/or spinal cord; OR
The condition must be diagnosed as clinically definite relapsing-remitting multiple sclerosis, with written certification provided by a radiologist that a magnetic resonance imaging scan is contraindicated because of the risk of physical (not psychological) injury to the patient; AND
Patient must have experienced at least 2 documented attacks of neurological dysfunction, believed to be due to the multiple sclerosis, in the preceding 2 years; AND
Patient must be ambulatory (without assistance or support)
Where applicable, the date of the magnetic resonance imaging scan must be recorded in the patient's medical records
Compliance with Authority Required procedures - Streamlined Authority Code 4881


 
C4887
 
 
Multiple sclerosis
Continuing treatment
The condition must be diagnosed as clinically definite relapsing-remitting multiple sclerosis; AND
Patient must have previously been issued with an authority prescription for this drug; AND
Patient must not show continuing progression of disability while on treatment with this drug; AND
Patient must have demonstrated compliance with, and an ability to tolerate this therapy
Compliance with Authority Required procedures - Streamlined Authority Code 4887


[122]       Schedule 4, Part 1, entry for Leuprorelin
insert in numerical order after existing text:

 
C4871
 
 
Central precocious puberty
Continuing treatment
Patient must have previously been issued with an authority prescription for this drug for this condition
Must be treated by a medical practitioner in consultation with a paediatric endocrinologist; OR
Must be treated by a medical practitioner in consultation with an endocrinologist specialising in paediatrics
Compliance with Authority Required procedures - Streamlined Authority Code 4871


 
C4884
 
 
Central precocious puberty
Initial treatment
Patient must be under 8 years of age (girls) or 9 years of age (boys); OR
Patient must have received treatment with a gonadotropin releasing hormone analogue (GnRHa) for this condition prior to 1 May 2015
Must be treated by a paediatric endocrinologist; OR
Must be treated by an endocrinologist specialising in paediatrics
Compliance with Authority Required procedures


[123]       Schedule 4, Part 1, entry for Mesalazine
(a)      omit:

 
C1707
 
 
Acute episode of mild to moderate ulcerative colitis
Compliance with Authority Required procedures – Streamlined Authority Code 1707

 
C1708
 
 
Ulcerative colitis where hypersensitivity to sulfonamides exists
Compliance with Authority Required procedures – Streamlined Authority Code 1708

 
C1709
 
 
Ulcerative colitis where intolerance to sulfasalazine exists
Compliance with Authority Required procedures – Streamlined Authority Code 1709

 
C1978
 
 
Acute episode of mild to moderate ulcerative proctitis
 

 

 
C2268
 
 
Crohn disease where hypersensitivity to sulfonamides exists
Compliance with Authority Required procedures – Streamlined Authority Code 2268

 
C2269
 
 
Crohn disease where intolerance to sulfasalazine exists
Compliance with Authority Required procedures – Streamlined Authority Code 2269

(b)      insert in numerical order following existing text:

 
C4873
 
 
Ulcerative colitis
Patient must have had a documented hypersensitivity reaction to a sulphonamide; OR
Patient must be intolerant to sulfasalazine
Compliance with Authority Required procedures - Streamlined Authority Code 4873

 
C4878
 
 
Acute episode of mild to moderate ulcerative proctitis

 

 
C4888
 
 
Acute episode of mild to moderate ulcerative colitis

Compliance with Authority Required procedures - Streamlined Authority Code 4888

 
C4896
 
 
Crohn disease
Patient must have had a documented hypersensitivity reaction to a sulphonamide; OR
Patient must be intolerant to sulfasalazine
Compliance with Authority Required procedures - Streamlined Authority Code 4896

[124]       Schedule 4, Part 1, entry for Mycophenolic Acid [Circumstances Code C1650]
(a)      omit from the column headed “Circumstances Code”:     C1650
(b)      insert in the column headed “Purposes Code”:                 P1650
(c)      insert in the column headed “Conditions Code”:             CN1650
[125]       Schedule 4, Part 1, entry for Mycophenolic Acid [Circumstances Code C1651]
(a)      omit from the column headed “Circumstances Code”:     C1651
(b)      insert in the column headed “Purposes Code”:                 P1651
(c)      insert in the column headed “Conditions Code”:             CN1651
 
[126]       Schedule 4, Part 1, entry for Mycophenolic Acid
omit:

 
C1763
 
 
Maintenance therapy of patients with renal transplants following initiation and stabilisation of treatment with mycophenolate sodium, where therapy remains under the supervision and direction of the transplant unit reviewing that patient and where the name of the specialised transplant unit reviewing treatment and the date of the latest review at the specialised transplant unit are included in the authority application
Compliance with Authority Required procedures

 
C1765
 
 
Maintenance therapy of patients with renal transplants following initiation and stabilisation of treatment with mycophenolate mofetil, where therapy remains under the supervision and direction of the transplant unit reviewing that patient and where the name of the specialised transplant unit reviewing treatment and the date of the latest review at the specialised transplant unit are included in the authority application
Compliance with Authority Required procedures

 
C1766
 
 
Maintenance therapy of patients with cardiac transplants following initiation and stabilisation of treatment with mycophenolate mofetil, where therapy remains under the supervision and direction of the transplant unit reviewing that patient and where the name of the specialised transplant unit reviewing treatment and the date of the latest review at the specialised transplant unit are included in the authority application
Compliance with Authority Required procedures

[127]       Schedule 4, Part 1, entry for Mycophenolic Acid [Circumstances Code C3355]
(a)      omit from the column headed “Circumstances Code”:     C3355
(b)      insert in the column headed “Purposes Code”:                 P3355
(c)      insert in the column headed “Conditions Code”:             CN3355
[128]       Schedule 4, Part 1, entry for Mycophenolic Acid [Circumstances Code C3356]
(a)      omit from the column headed “Circumstances Code”:     C3356
(b)      insert in the column headed “Purposes Code”:                 P3356
(c)      insert in the column headed “Conditions Code”:             CN3356
[129]       Schedule 4, Part 1, entry for Mycophenolic Acid [Circumstances Code C4084]
(a)      omit from the column headed “Circumstances Code”:     C4084
(b)      insert in the column headed “Purposes Code”:                 P4084
(c)      insert in the column headed “Conditions Code”:             CN4084
[130]       Schedule 4, Part 1, entry for Mycophenolic Acid [Circumstances Code C4095]
(a)      omit from the column headed “Circumstances Code”:     C4095
(b)      insert in the column headed “Purposes Code”:                 P4095
(c)      insert in the column headed “Conditions Code”:             CN4095
[131]       Schedule 4, Part 1, entry for Mycophenolic Acid [Circumstances Code C4108]
(a)      omit from the column headed “Circumstances Code”:     C4108
(b)      insert in the column headed “Purposes Code”:                 P4108
(c)      insert in the column headed “Conditions Code”:             CN4108
[132]       Schedule 4, Part 1, entry for Mycophenolic Acid
omit:
 
C4131
P4131
 
WHO Class III, IV or V lupus nephritis
Maintenance
The condition must be proven by biopsy;
Patient must have received initiation treatment;
The treatment must be under the supervision and direction of a nephrologist reviewing the patient
The name of the nephrologist reviewing treatment and the date of the latest review, which must be within the last 12 months, must be included in the authority application
Compliance with Written or Telephone Authority Required procedures
[133]       Schedule 4, Part 1, entry for Mycophenolic Acid [Circumstances Code C4146]
(a)      omit from the column headed “Circumstances Code”:     C4146
(b)      insert in the column headed “Purposes Code”:                 P4146
(c)      insert in the column headed “Conditions Code”:             CN4146
[134]       Schedule 4, Part 1, entry for Olsalazine
substitute:
Olsalazine
C4824
 
 
Ulcerative colitis
Patient must have had a documented hypersensitivity reaction to a sulphonamide; OR
Patient must be intolerant to sulfasalazine
Compliance with Authority Required procedures - Streamlined Authority Code 4824
[135]       Schedule 4, Part 1, entry for Pamidronic Acid
(a)      omit:
 
C4420
 
 
Symptomatic Paget disease of bone
Compliance with Authority Required procedures – Streamlined Authority Code 4420
(b)      omit:
 
C4422
 
 
Symptomatic Paget disease of bone
Compliance with Authority Required procedures – Streamlined Authority Code 4422
(c)      insert in numerical order after existing text:

 
C4877
 
 
Symptomatic Paget disease of bone
 

 
C4883
 
 
Symptomatic Paget disease of bone
 

[136]       Schedule 4, Part 1, entry for Prednisolone
substitute:

Prednisolone
C4872
 
 
Ulcerative colitis
 

 
C4893
 
 
Proctitis
 

[137]       Schedule 4, Part 1, entry for Risedronic Acid
substitute:

Risedronic Acid
C4877
 
 
Symptomatic Paget disease of bone
 

 
C4882
 
 
Established osteoporosis
Patient must have fracture due to minimal trauma; AND
Patient must not receive concomitant treatment with any other PBS-subsidised anti-resorptive agent for this condition
The fracture must have been demonstrated radiologically and the year of plain x-ray or computed tomography (CT) scan or magnetic resonance imaging (MRI) scan must be documented in the patient's medical records when treatment is initiated
A vertebral fracture is defined as a 20% or greater reduction in height of the anterior or mid portion of a vertebral body relative to the posterior height of that body, or, a 20% or greater reduction in any of these heights compared to the vertebral body above or below the affected vertebral body
 

 
C4885
 
 
Corticosteroid-induced osteoporosis
Patient must currently be on long-term (at least 3 months), high-dose (at least 7.5 mg per day prednisolone or equivalent) corticosteroid therapy; AND
Patient must have a Bone Mineral Density (BMD) T-score of -1.5 or less; AND
Patient must not receive concomitant treatment with any other PBS-subsidised anti-resorptive agent for this condition
The duration and dose of corticosteroid therapy together with 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
 

 
C4889
 
 
Osteoporosis
Patient must have a Bone Mineral Density (BMD) T-score of -2.5 or less; AND
Patient must not receive concomitant treatment with any other PBS-subsidised anti-resorptive agent for this condition
Patient must be aged 70 years or older
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
 

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

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

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

(b)      omit:

 
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
 

[139]       Schedule 4, Part 1, entry for Sirolimus [Circumstances Code C1650]
(a)      omit from the column headed “Circumstances Code”:     C1650
(b)      insert in the column headed “Purposes Code”:                 P1650
(c)      insert in the column headed “Conditions Code”:             CN1650
[140]       Schedule 4, Part 1, entry for Sirolimus
omit:
 
C1952
 
 
Maintenance therapy of patients with renal transplants following initiation and stabilisation of treatment with sirolimus, where therapy remains under the supervision and direction of the transplant unit reviewing that patient and where the name of the specialised transplant unit reviewing treatment and the date of the latest review at the specialised transplant unit are included in the authority application
Compliance with Authority Required procedures
[141]       Schedule 4, Part 1, entry for Sirolimus [Circumstances Code C3355]
(a)      omit from the column headed “Circumstances Code”:     C3355
(b)      insert in the column headed “Purposes Code”:                 P3355
(c)      insert in the column headed “Conditions Code”:             CN3355
[142]       Schedule 4, Part 1, entry for Sulfasalazine
omit from in the column headed “Purposes Code”:     P3035   substitute:             P4894
[143]       Schedule 4, Part 1, entry for Tacrolimus [Circumstances Code C1654]
(a)      omit from the column headed “Circumstances Code”:     C1654
(b)      insert in the column headed “Purposes Code”:                 P1654
(c)      insert in the column headed “Conditions Code”:             CN1654
[144]       Schedule 4, Part 1, entry for Tacrolimus
omit:
 
C3080
 
 
Maintenance therapy, following initiation and stabilisation of treatment with tacrolimus, of patients with organ or tissue transplants, where therapy remains under the supervision and direction of the transplant unit reviewing the patient and where the name of the specialised transplant unit reviewing treatment and the date of the latest review at the specialised transplant unit are included in the authority application
Compliance with Authority Required procedures
[145]       Schedule 4, Part 1, entry for Tacrolimus [Circumstances Code C3328]
(a)      omit from the column headed “Circumstances Code”:     C3328
(b)      insert in the column headed “Purposes Code”:                 P3328
(c)      insert in the column headed “Conditions Code”:             CN3328
[146]       Schedule 4, Part 1, entry for Temozolomide
substitute:
Temozolomide
 
P4897
CN4897
Glioblastoma multiforme
Patient must be undergoing concomitant radiotherapy
 
[147]       Schedule 4, Part 1, entry for Tiludronic Acid
substitute:
Tiludronic Acid
C4877
 
 
Symptomatic Paget disease of bone
 
[148]       Schedule 4, Part 1, entry for Zoledronic acid
(a)      omit:
 
C3290
 
 
Symptomatic Paget disease of bone, and where PBS‑subsidised treatment is limited to 1 dose each year
Compliance with Authority Required procedures
(b)      insert in numerical order after existing text:
 
C4876
 
 
Symptomatic Paget disease of bone
Only 1 treatment each year per patient will be PBS-subsidised
Compliance with Authority Required procedures - Streamlined Authority Code 4876