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

Case

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

  1. Schedule 1, entry for Alendronic Acid

    omit from the column headed “Circumstances” (all instances):           C4122  C4123  C4133    substitute:             C4882  C4885  C4889

  2. 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

  1. 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

  1. 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

  1. 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

  1. 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

  1. 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

  1. 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

  1. Schedule 1, entry for Balsalazide

    omit from the column headed “Circumstances”:       C1708  C1709    substitute:             C4824

  2. 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

  1. Schedule 1, omit entry for Carbomer with Triglyceride Lipids

  2. 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

  1. 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

  1. 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

  1. 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

  1. 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)

  1. 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)

  1. 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

  1. Schedule 1, entry for Fludarabine in the form Tablet containing fludarabine phosphate 10 mg  

    omit from the column headed “Circumstances”:       C3015

  2. 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)

  1. 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

  1. 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

  2. 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

  3. 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

  4. 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

  5. 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

  6. 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

  7. Schedule 1, entry for Interferon Beta-1b

    omit from the column headed “Circumstances”:       C1175  C1751    substitute:             C4881  C4887

  8. 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)

  1. 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)

  1. 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

  1. 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

  1. 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

  2. Schedule 1, entry for Mesalazine in the form Tablet 1.2 g (prolonged release)

    omit from the column headed “Circumstances”:       C1708  C1709    substitute:             C4824  

  3. 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

  4. 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

  5. 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

  1. 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

  2. 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

  3. Schedule 1, entry for Mianserin in the form Tablet containing mianserin hydrochloride 10 mg

    omit:

Tolvon MK MP NP C1355 50 5 50

  1. 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)

  1. Schedule 1, entry for Oestradiol

    omit:

Vaginal tablets 25 micrograms, 15 Vaginal Vagifem NO MP NP 1 2 1

  1. 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

  2. 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

  1. 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

  1. 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)

  1. 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)

  1. 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)

  1. 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

  2. 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

  3. 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

  1. 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

  2. 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

  1. Schedule 1, entry for Poly-l-lactic acid

    omit from the column headed “Responsible Person”:               SW       substitute:          GA

  2. 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

  1. 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

  1. 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

  1. 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

  1. 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

  1. 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

  1. 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

  1. 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

  1. 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

  1. 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

  1. 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

  1. 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

  2. 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

  1. 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

  1. 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

  1. 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

  1. 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

  2. Schedule 1, entry for Risedronic Acid in the form Tablet containing risedronate sodium 30 mg

    omit from the column headed “Circumstances”:         C3256   substitute:          C4877

  3. 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”]:              
    P4228P4248           substitute:             P4226P4263

    (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”]:               
    C4228C4248           substitute:             C4226C4263

    (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”]:       
    P4228P4248           substitute:             P4226P4263

    (k)omit from the column headed “Circumstances” for the brand “Rosuvastatin Actavis 5” [Authorised Prescriber “NP”]:     
    C4228C4248           substitute:             C4226C4263

    (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”]:  
    P4228P4248           substitute:             P4226P4263

    (r)omit from the column headed “Circumstances” for the brands: “Rosuvastatin-DRLA”; and “Rosuvastatin GH” [Authorised Prescriber “NP”]:   
    C4228C4248           substitute:             C4226C4263

    (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”]:      
    P4228P4248           substitute:             P4226P4263

    (y)omit from the column headed “Circumstances” for the brand “Terry White Chemists Rosuvastatin” [Authorised Prescriber “NP”]:       
    C4228C4248           substitute:             C4226C4263

  4. 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

  5. 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”]:            
    P4228P4248           substitute:             P4226P4263

    (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”]:             
    C4228C4248           substitute:             C4226C4263

    (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”]:     
    C4228C4248           substitute:             C4226C4263

    (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”]:  
    P4228P4248           substitute:             P4226P4263

    (r)omit from the column headed “Circumstances” for the brands: “Rosuvastatin-DRLA”; and “Rosuvastatin GH” [Authorised Prescriber “NP”]:   
    C4228C4248           substitute:             C4226C4263

    (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”]:      
    P4228P4248           substitute:             P4226P4263

    (y)omit from the column headed “Circumstances” for the brand “Terry White Chemists Rosuvastatin” [Authorised Prescriber “NP”]:       
    C4228C4248           substitute:             C4226C4263

  6. 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

  1. 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”]:            
    P4227P4259           substitute:             P4226P4263

    (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”]:             
    C4227C4259           substitute:             C4226C4263

    (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”]:     
    P4227P4259           substitute:             P4226P4263

    (k)omit from the column headed “Circumstances” for the brand “Rosuvastatin Actavis 20” [Authorised Prescriber “NP”]:     
    C4227C4259           substitute:             C4226C4263

    (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”]:  
    P4227P4259           substitute:             P4226P4263

    (r)omit from the column headed “Circumstances” for the brands: “Rosuvastatin-DRLA”; and “Rosuvastatin GH” [Authorised Prescriber “NP”]:   
    C4227C4259           substitute:             C4226C4263

    (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”]:      
    P4227P4258           substitute:             P4226P4263

    (y)omit from the column headed “Circumstances” for the brand “Terry White Chemists Rosuvastatin” [Authorised Prescriber “NP”]:       
    C4227C4259           substitute:             C4226C4263

  1. 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

  1. 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)

  1. 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

  2. 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

  3. 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)

  1. 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

  1. Schedule 1, entry for Tiludronic Acid

    omit from the column headed “Circumstances”:         C3256   substitute:          C4877

  2. 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

  1. 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

  1. 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

  1. 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

  1. 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

  1. 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

  1. 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

  1. 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

  1. 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

  2. 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]

  1. Schedule 3

    omit:

BU Bausch & Lomb (Australia) Pty Ltd  34 000 650 251

  1. Schedule 3, after details relevant to Responsible Person code FZ

    insert:

GA Galderma  Australia Pty Ltd  12 003 976 930

  1. Schedule 3, after details relevant to Responsible Person code SZ

    insert:

TB Teva Pharma Australia Pty Limited  41 169 715 664

  1. 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

  1. 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

  1. Schedule 4, Part 1, omit entry for Carbomer with Triglyceride Lipids

  2. 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

  3. 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

  4. 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

  5. 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

  6. 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

  7. 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

  1. 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

  2. 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

  3. 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

  4. 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

  5. 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

  1. 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

  1. 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

  1. 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)

  1. 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

  1. 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

  1. 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

  1. 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

  1. 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

  1. 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

  1. 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

  2. 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

  1. 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

  1. 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

  2. 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

  3. 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

  4. 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

  5. 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

  6. 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

  1. 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

  2. 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

  1. 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

  1. Schedule 4, Part 1, entry for Prednisolone

    substitute:

Prednisolone C4872 Ulcerative colitis
C4893 Proctitis

  1. 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

  1. 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

  1. 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

  2. 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

  1. 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

  2. Schedule 4, Part 1, entry for Sulfasalazine

    omit from in the column headed “Purposes Code”:     P3035   substitute:             P4894

  3. 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

  4. 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

  1. 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

  1. Schedule 4, Part 1, entry for Temozolomide

    substitute:

Temozolomide P4897 CN4897

Glioblastoma multiforme

Patient must be undergoing concomitant radiotherapy

  1. Schedule 4, Part 1, entry for Tiludronic Acid

    substitute:

Tiludronic Acid C4877 Symptomatic Paget disease of bone

  1. 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
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