National Health (Listing of Pharmaceutical Benefits) Amendment Instrument 2014 (No. 6) (No. PB 45 of 2014) (Cth)

Case

PB 45 of 2014

National Health (Listing of Pharmaceutical Benefits) Amendment Instrument 2014
(No. 6)


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      11 June   2014

FELICITY McNEILL

First Assistant Secretary

Pharmaceutical Benefits Division

Department of Health

1          Name of Instrument

(1)        This Instrument is the National Health (Listing of Pharmaceutical    Benefits) Amendment Instrument 2014 (No. 6).

(2)        This Instrument may also be cited as PB 45 of 2014.

2          Commencement

This Instrument commences on 1 July 2014.

3          Amendment of National Health (Listing of Pharmaceutical Benefits) Instrument 2012 (PB 71 of 2012)

Schedule 1 amends the National Health (Listing of Pharmaceutical Benefits) Instrument 2012 (PB 71 of 2012).

Schedule 1     Amendments

  1. Schedule 1, entry for Acitretin in the form Capsule 10 mg

omit from the column headed “Responsible Person” for the brand “Neotigason”:             TA        substitute:          UA

  1. Schedule 1, entry for Acitretin in the form Capsule 25 mg

omit from the column headed “Responsible Person” for the brand “Neotigason”:             TA        substitute:          UA

  1. Schedule 1, entry for Atorvastatin and ezetimibe in the form Pack containing 30 tablets atorvastatin 10 mg (as calcium) and
    30 tablets ezetemibe 10 mg

(a)         omit from the column headed “Form”:           ezetemibe        substitute:             ezetimibe

(b)           omit from the column headed “Brand”:         10mg + 10mg

  1. Schedule 1, entry for Atorvastatin and ezetimibe in the form Pack containing 30 tablets atorvastatin 20 mg (as calcium) and
    30 tablets ezetemibe 10 mg

(a)         omit from the column headed “Form”:           ezetemibe        substitute:             ezetimibe

(b)           omit from the column headed “Brand”:         10mg + 20mg

  1. Schedule 1, entry for Atorvastatin and ezetimibe in the form Pack containing 30 tablets atorvastatin 40 mg (as calcium) and
    30 tablets ezetemibe 10 mg

(a)         omit from the column headed “Form”:       ezetemibe        substitute:         ezetimibe

(b)        omit from the column headed “Brand”:      10mg + 40mg

  1. Schedule 1, entry for Atorvastatin and ezetimibe in the form Pack containing 30 tablets atorvastatin 80 mg (as calcium) and
    30 tablets ezetemibe 10 mg

(a)         omit from the column headed “Form”:       ezetemibe        substitute:         ezetimibe

(b)        omit from the column headed “Brand”:      10mg + 80mg

  1. Schedule 1, after entry for Bimatoprost with timolol in the form Eye drops 300 micrograms bimatoprost with timolol 5 mg (as maleate)
    per mL, 3 mL

insert in the columns in the order indicated:

Eye drops 300 micrograms bimatoprost with timolol 5 mg (as maleate) per mL, single dose units 0.4 mL, 30 Application to the eye GANfort PF 0.3/5 AG MP C4572 1 5 1
AO C4326 1 5 1

  1. Schedule 1, entry for Candesartan with Hydrochlorothiazide in the form Tablet containing candesartan cilexetil 32 mg with hydrochlorothiazide 12.5 mg

insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:

Adesan HCT 32/12.5 AF MP NP C4374 30 5 30

  1. Schedule 1, entry for Candesartan with Hydrochlorothiazide in the form Tablet containing candesartan cilexetil 32 mg with hydrochlorothiazide 25 mg

insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:

Adesan HCT 32/25 AF MP NP C4374 30 5 30

  1. Schedule 1, entry for Cefepime in each of the forms: Powder for injection 1 g (as hydrochloride); and Powder for injection 2 g (as hydrochloride)

insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:

Cefepime Alphapharm AF MP NP C1427 10 0 1

  1. Schedule 1, entry for Cephalexin in the form Capsule 250 mg (anhydrous) [Maximum Quantity: 40; Number of Repeats: 2]

(a)omit from the column headed “Circumstances” (all instances):    C4243  

(b)insert in the column headed “Purposes” (all instances):            P4243

  1. Schedule 1, entry for Cinacalcet in the form Tablet 30 mg (as hydrochloride) [Maximum Quantity: 28; Number of Repeats: 5]

(a)omit from the column headed “Authorised Prescriber”:             MP       substitute:             MP  NP

(b)omit from the column headed “Purposes”:      P3672 P3673

(c)omit:

NP C3672 C3673 28 5 28

  1. Schedule 1, entry for Cinacalcet in the form Tablet 60 mg (as hydrochloride) [Maximum Quantity: 28; Number of Repeats: 5]

(a)omit from the column headed “Authorised Prescriber”:             MP       substitute:             MP  NP

(b)omit from the column headed “Purposes”:      P3672 P3673

(c)omit:

NP C3672 C3673 28 5 28

  1. Schedule 1, entry for Cinacalcet in the form Tablet 90 mg (as hydrochloride) [Maximum Quantity: 28; Number of Repeats: 5]

(a)omit from the column headed “Authorised Prescriber”:             MP       substitute:             MP  NP

(b)omit from the column headed “Purposes”:      P3672 P3673

(c)omit:

NP C3672 C3673 28 5 28

  1. Schedule 1, entry for Ciprofloxacin in the form Tablet 250 mg (as hydrochloride)

omit:

Cifran RA MP NP C1143 C1431 C1432 C1572 C1573 14 0 14

  1. Schedule 1, entry for Clarithromycin in the form Tablet 250 mg [Maximum Quantity: 14; Number of Repeats: 1]

insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:

Clarihexal HX MP NP 14 1 14

  1. Schedule 1, entry for Clarithromycin in the form Tablet 250 mg [Maximum Quantity: 100; Number of Repeats: 2]

substitute:

Klacid AB MP
See Note 1 		P1434 P3325 100 CN1434 CN3325 2 CN1434 CN3325 100 C(100)

  1. Schedule 1, entry for Clopidogrel in the form Tablet 75 mg (as besilate)

omit from the column headed “Responsible Person” for the brand “Clopidogrel Actavis”:              TA        substitute:          UA

  1. Schedule 1, entry for Diazepam in the form Oral liquid 1 mg in 1 mL, 100 mL

omit from the column headed “Circumstances”:          4244     substitute:          C4244

  1. Schedule 1, entry for Diltiazem in the form Tablet containing diltiazem hydrochloride 60 mg

omit:

Coras AF MP NP 90 5 90

  1. Schedule 1, entry for Diphenoxylate with Atropine

(a)omit from the column headed “Responsible Person” for the brand “Lofenoxal”:     HC       substitute:         IA

(b)omit from the column headed “Responsible Person” for the brand “Lomotil”:          BI        substitute:         IV

  1. Schedule 1, entry for Docetaxel in the form Solution concentrate for I.V. infusion 140 mg in 7 mL

omit from the column headed “Responsible Person”:                 TA        substitute:          GN

  1. Schedule 1, entry for Docetaxel in the form Solution concentrate for I.V. infusion 20 mg in 1 mL

(a)omit:

Oncotaxel 20 TA MP C3888 C3892 C3916 C3956 C4078 C4140 C4160 C4239 See Note 3 See Note 3 See
Note 3 		1 D(100)

(b)omit from the column headed “Purposes” for the brand “Taxotere”:           See Note 3

  1. Schedule 1, entry for Docetaxel in the form Solution concentrate for I.V. infusion 20 mg in 2 mL

omit from the column headed “Purposes” (twice occurring):    See Note 3

  1. Schedule 1, entry for Docetaxel in the form Solution concentrate for I.V. infusion 80 mg in 4 mL

omit from the column headed “Responsible Person” for the brand “Oncotaxel 80”:          TA        substitute:          GN

  1. Schedule 1, entry for Doxycycline in the form Tablet 100 mg (as monohydrate)

(a)omit:

Doxyhexal SZ PDP 7 0 7

(b)omit:

Doxyhexal SZ MP NP 7 1 7

(c)omit:

Doxyhexal SZ MP NP P4485 21 0 7

(d)omit:

Doxyhexal SZ MP NP P4514 28 0 7

  1. Schedule 1, entry for Doxycycline in the form Tablet 50 mg (as monohydrate)

omit:

Doxyhexal SZ MP NP C4475 C4529 C4539 25 5 25

  1. Schedule 1, entry for Eletriptan in each of the forms: Tablet 40 mg (as hydrobromide); and Tablet 80 mg (as hydrobromide)

omit from the column headed “Circumstances”:          C3233   substitute:          C4573

  1. Schedule 1, entry for Epirubicin in the form Solution for injection containing epirubicin hydrochloride 10 mg in 5 mL

omit from the column headed “Responsible Person” for the brand “Epirubicin Actavis 10”:           TA        substitute:          UA

  1. Schedule 1, entry for Epirubicin in the form Solution for injection containing epirubicin hydrochloride 20 mg in 10 mL

omit from the column headed “Responsible Person” for the brand “Epirubicin Actavis 20”:           TA        substitute:          UA

  1. Schedule 1, entry for Epirubicin in the form Solution for injection containing epirubicin hydrochloride 50 mg in 25 mL

omit from the column headed “Responsible Person” for the brand “Epirubicin Actavis 50”:           TA        substitute:          UA

  1. Schedule 1, entry for Epirubicin in the form Solution for injection containing epirubicin hydrochloride 200 mg in 100 mL

omit from the column headed “Responsible Person” for the brand “Epirubicin Actavis 200”:        TA        substitute:          UA

  1. Schedule 1, entry for Fludarabine in the form Powder for I.V. injection containing fludarabine phosphate 50 mg

omit from the column headed “Responsible Person” for the brand “Fludarabine Actavis”:             TA        substitute:          UA

  1. Schedule 1, entry for Fosinopril with Hydrochlorothiazide in each of the forms: Tablet containing fosinopril sodium 10 mg
    with hydrochlorothiazide 12.5 mg; and Tablet containing fosinopril sodium 20 mg with hydrochlorothiazide 12.5 mg

omit:

Hyforil RA MP NP C4389 30 5 30

  1. Schedule 1, entry for Glucose in the form I.V. infusion 278 mmol (anhydrous) per L, 1 L

(a)omit:

Fresenius Kabi Australia Pty Limited PK PDP 5 0 1

(b)omit:

Fresenius Kabi Australia Pty Limited PK MP NP 5 1 1

  1. Schedule 1, entry for Hydrocortisone in the form Injection 100 mg (as sodium succinate) with 2 mL solvent [Maximum Quantity: 6; Number of Repeats: 0]

(a)omit:

PDP C1128 6 0 1

(b)omit from the column headed “Authorised Prescriber”:             MP  NP             substitute:             MP  NP  PDP

  1. Schedule 1, entry for Hydrocortisone in the form Injection 250 mg (as sodium succinate) with 2 mL solvent [Maximum Quantity: 6; Number of Repeats: 0]

(a)omit from the column headed “Authorised Prescriber”:             MP  NP             substitute:             MP  NP  PDP

(b)omit:

PDP C1128 6 0 1

  1. Schedule 1, entry for Irinotecan in the form I.V. injection containing irinotecan hydrochloride trihydrate 40 mg in 2 mL

omit:

Irinotecan Actavis TA 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

omit from the column headed “Responsible Person” for the brand “Irinotecan Actavis”:                 TA        substitute:          UA

  1. Schedule 1, entry for Irinotecan in the form I.V. injection containing irinotecan hydrochloride trihydrate 500 mg in 25 mL

omit from the column headed “Responsible Person” for the brand “Irinotecan Actavis 500”:         TA        substitute:          UA

  1. Schedule 1, entry for Ivermectin in the form Tablet 3 mg [Maximum Quantity: 4; Number of Repeats: 0]

insert in numerical order in  the column headed “Circumstances”:        C4565  C4566

  1. Schedule 1, entry for Ivermectin in the form Tablet 3 mg [Maximum Quantity: 8; Number of Repeats: 2]

(a)insert in numerical order in  the column headed “Circumstances”:           C4565  C4566

(b)insert in numerical order in  the column headed “Purposes”:       P4565 P4566

  1. Schedule 1, entry for Lamotrigine in the form Tablet 5 mg

insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:

Lamotrigine Aspen 5 FM MP NP C1426 56 5 56

  1. Schedule 1, entry for Lamotrigine in the form Tablet 25 mg

omit from the column headed “Responsible Person” for the brand “Torlemo DT 25”:       TA        substitute:          UA

  1. Schedule 1, entry for Lamotrigine in the form Tablet 50 mg

omit from the column headed “Responsible Person” for the brand “Torlemo DT 50”:       TA        substitute:          UA

  1. Schedule 1, entry for Lamotrigine in the form Tablet 100 mg

omit from the column headed “Responsible Person” for the brand “Torlemo DT 100”:     TA        substitute:          UA

  1. Schedule 1, entry for Lamotrigine in the form Tablet 200 mg

omit from the column headed “Responsible Person” for the brand “Torlemo DT 200”:     TA        substitute:          UA

  1. Schedule 1, entry for Lanreotide in the form Powder for suspension for injection 30 mg (as acetate) with diluent

omit from the column headed “Circumstances”:          C2619  C3387    substitute:          C4559 C4567

  1. Schedule 1, entry for Lanreotide in the form Injection 60 mg (as acetate) in single dose pre‑filled syringe

(a)omit from the column headed “Circumstances”:           C2620  C2621  C3388  C3389     substitute:          C4569  C4570  C4574  C4575

(b)omit from the column headed “Number of Repeats”:     11         substitute:          5

  1. Schedule 1, entry for Lanreotide in the form Injection 90 mg (as acetate) in single dose pre‑filled syringe

(a)omit from the column headed “Circumstances”:           C2620  C2621  C3388  C3389     substitute:          C4569  C4570  C4574  C4575

(b)omit from the column headed “Number of Repeats”:     11         substitute:          5

  1. Schedule 1, entry for Lanreotide in the form Injection 120 mg (as acetate) in single dose pre‑filled syringe

(a)omit from the column headed “Circumstances”:           C2620  C2621  C3388  C3389     substitute:          C4569  C4570  C4574  C4575

(b)omit from the column headed “Number of Repeats”:     11         substitute:          5

  1. Schedule 1, entry for Lanthanum in the form Tablet, chewable, 500 mg (as carbonate hydrate) [Maximum Quantity: 90; Number of Repeats: 5]

(a)omit from the column headed “Authorised Prescriber”:             MP       substitute:             MP  NP

(b)omit from the column headed “Purposes”:      P3546 P3547

(c)omit:

NP C3546 C3547 90 5 90

  1. Schedule 1, entry for Lanthanum in the form Tablet, chewable, 750 mg (as carbonate hydrate) [Maximum Quantity: 90; Number of Repeats: 5]

(a)omit from the column headed “Authorised Prescriber”:             MP       substitute:             MP  NP

(b)omit from the column headed “Purposes”:      P3546 P3547

(c)omit:

NP C3546 C3547 90 5 90

  1. Schedule 1, entry for Lanthanum in the form Tablet, chewable, 1000 mg (as carbonate hydrate) [Maximum Quantity: 90; Number of Repeats: 5]

(a)omit from the column headed “Authorised Prescriber”:             MP       substitute:             MP  NP

(b)omit from the column headed “Purposes”:      P3546 P3547

(c)omit:

NP C3546 C3547 90 5 90

  1. Schedule 1, entry for Latanoprost

insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:

Latanoprost GH GQ MP AO 1 5 1

  1. Schedule 1, entry for Latanoprost with timolol

insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:

APO-Latanoprost/ Timolol 0.05/5 TX MP C4343 1 5 1
AO C4326 1 5 1

  1. Schedule 1, entry for Letrozole

omit from the column headed “Responsible Person” for the brand “Letrozole Actavis”:   TA        substitute:          VN

  1. Schedule 1, entry for Memantine in the form Tablet containing memantine hydrochloride 20 mg

insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:

APO-Memantine TX MP NP C4214 C4218 C4221 28 5 28

  1. Schedule 1, entry for Mirtazapine in the form Tablet 15 mg (orally disintegrating)

insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:

Mirtazapine Sandoz ODT 15 SZ MP NP C1211 30 5 30

  1. Schedule 1, entry for Mirtazapine in the form Tablet 30 mg (orally disintegrating)

insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:

Mirtazapine Sandoz ODT 30 SZ MP NP C1211 30 5 30

  1. Schedule 1, entry for Mirtazapine in the form Tablet 45 mg (orally disintegrating)

insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:

Mirtazapine Sandoz ODT 45 SZ MP NP C1211 30 5 30

  1. Schedule 1, entry for Naratriptan

omit from the column headed “Circumstances”:          C3280  C3281  C3282  C3283  C3284  C3285

substitute:          C3281 C3282 C3283 C3284 C3285 C4562

  1. Schedule 1, entry for Nicotine

omit:

Transdermal patch 24.9 mg Transdermal Nicorette Patch JT MP NP C4307 C4344 C4348 28 2 28

  1. Schedule 1, entry for Octreotide in the form Injection (modified release) 10 mg (as acetate), vial and diluent syringe

(a)omit from the column headed “Circumstances”:         C2624  C2625  C3409  C3410        substitute:        C4560 C4561 C4563 C4564 C4568 C4571

(b)omit from the column headed “Maximum Quantity”:     1          substitute:          2

(c)omit from the column headed “Number of Repeats”:     11         substitute:          5

  1. Schedule 1, entry for Octreotide in the form Injection (modified release) 20 mg (as acetate), vial and diluent syringe

(a)omit from the column headed “Circumstances”:        C2624  C2625  C3409  C3410           substitute:        C4560 C4561 C4563 C4564 C4568 C4571

(b)omit from the column headed “Maximum Quantity”:     1          substitute:          2

(c)omit from the column headed “Number of Repeats”:     11         substitute:          5

  1. Schedule 1, entry for Octreotide in the form Injection (modified release) 30 mg (as acetate), vial and diluent syringe

(a)omit from the column headed “Circumstances”:       C2624  C2625  C3409  C3410         substitute:        C4560 C4561 C4563 C4564 C4568 C4571

(b)omit from the column headed “Maximum Quantity”:     1          substitute:          2

(c)omit from the column headed “Number of Repeats”:     11         substitute:          5

  1. Schedule 1, entry for Oxaliplatin in the form Powder for I.V. infusion 50 mg

omit from the column headed “Responsible Person” for the brand “Oxaliplatin Actavis”:   TA        substitute:            UA

  1. Schedule 1, entry for Oxaliplatin in the form Powder for I.V. infusion 100 mg

omit from the column headed “Responsible Person” for the brand “Oxaliplatin Actavis”:   TA        substitute:            UA

  1. Schedule 1, entry for Paclitaxel in the form Solution concentrate for I.V. infusion 30 mg in 5 mL

omit from the column headed “Responsible Person” for the brand “Paclitaxel Actavis”:                 TA        substitute:          UA

  1. Schedule 1, entry for Paclitaxel in the form Solution concentrate for I.V. infusion 100 mg in 16.7 mL

omit from the column headed “Responsible Person” for the brand “Paclitaxel Actavis”:                 TA        substitute:          UA

  1. Schedule 1, entry for Paclitaxel in the form Solution concentrate for I.V. infusion 150 mg in 25 mL

omit from the column headed “Responsible Person” for the brand “Paclitaxel Actavis”:                 TA        substitute:          UA

  1. Schedule 1, entry for Paclitaxel in the form Solution concentrate for I.V. infusion 300 mg in 50 mL

omit from the column headed “Responsible Person” for the brand “Paclitaxel Actavis”:                 TA        substitute:          UA

  1. Schedule 1, entry for Pantoprazole in the form Tablet (enteric coated) 40 mg (as sodium sesquihydrate) [Maximum Quantity: 30;
    Number of Repeats: 2]

(a)insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:

Pantoprazole Actavis GN MP NP C1177 C1337 C1476 C1533 P1177 30 2 30

(b)omit from the column headed “Responsible Person” for the brand “Torzole 40”:   TA        substitute:          VN

  1. Schedule 1, entry for Pantoprazole in the form Tablet (enteric coated) 40 mg (as sodium sesquihydrate) [Maximum Quantity: 30;
    Number of Repeats: 5]

(a)insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:

Pantoprazole Actavis GN MP NP C1177 C1337 C1476 C1533 P1337 P1476 P1533 30 5 30

(b)omit from the column headed “Responsible Person” for the brand “Torzole 40”:   TA        substitute:          VN

  1. Schedule 1, entry for Pantoprazole in the form Tablet (enteric coated) 20 mg (as sodium sesquihydrate)

omit from the column headed “Responsible Person” for the brand “Torzole 20”:               TA        substitute:          VN

  1. Schedule 1, entry for Pravastatin in the form Tablet containing pravastatin sodium 10 mg [Maximum Quantity: 30; Number of Repeats: 5]

omit from the column headed “Responsible Person” for the brand “Pravastatin Actavis 10”:         TA        substitute:          UA

  1. Schedule 1, entry for Pravastatin in the form Tablet containing pravastatin sodium 10 mg [Maximum Quantity: 30; Number of Repeats: 11]

omit from the column headed “Responsible Person” for the brand “Pravastatin Actavis 10”:         TA        substitute:          UA

  1. Schedule 1, entry for Pravastatin in the form Tablet containing pravastatin sodium 20 mg [Maximum Quantity: 30; Number of Repeats: 5]

omit from the column headed “Responsible Person” for the brand “Pravastatin Actavis 20”:         TA        substitute:          UA

  1. Schedule 1, entry for Pravastatin in the form Tablet containing pravastatin sodium 20 mg [Maximum Quantity: 30; Number of Repeats: 11]

omit from the column headed “Responsible Person” for the brand “Pravastatin Actavis 20”:         TA        substitute:          UA

  1. Schedule 1, entry for Pravastatin in the form Tablet containing pravastatin sodium 40 mg [Maximum Quantity: 30; Number of Repeats: 5]

omit from the column headed “Responsible Person” for the brand “Pravastatin Actavis 40”:         TA        substitute:          UA

  1. Schedule 1, entry for Pravastatin in the form Tablet containing pravastatin sodium 40 mg [Maximum Quantity: 30; Number of Repeats: 11]

omit from the column headed “Responsible Person” for the brand “Pravastatin Actavis 40”:         TA        substitute:          UA

  1. Schedule 1, entry for Quetiapine in the form Tablet 25 mg (as fumarate)

(a)omit from the column headed “Responsible Person” for the brand “Quetiapine Actavis 25”:            TA        substitute:    VN

(b)omit:

Quipine VN MP NP C4385 C4391 C4396 60 0 60

  1. Schedule 1, entry for Quetiapine in the form Tablet 100 mg (as fumarate)

(a)omit from the column headed “Responsible Person” for the brand “Quetiapine Actavis 100”:          TA        substitute:    VN

(b)omit:

Quipine VN MP NP C1589 C2044 C2765 90 5 90

  1. Schedule 1, entry for Quetiapine in the form Tablet 200 mg (as fumarate)

(a)omit from the column headed “Responsible Person” for the brand “Quetiapine Actavis 200”:          TA        substitute:    VN

(b)omit:

Quipine VN MP NP C1589 C2044 C2765 60 5 60

  1. Schedule 1, entry for Quetiapine in the form Tablet 300 mg (as fumarate)

(a)omit from the column headed “Responsible Person” for the brand “Quetiapine Actavis 300”:          TA        substitute:    VN

(b)omit:

Quipine VN MP NP C1589 C2044 C2765 60 5 60

  1. Schedule 1, entry for Reteplase

omit from the column headed “Responsible Person”:                 TA        substitute:          GN

  1. Schedule 1, entry for Rizatriptan

omit from the column headed “Circumstances”:          C3233   substitute:          C4573

  1. Schedule 1, entry for Rosuvastatin in the form Tablet 5 mg (as calcium) [Maximum Quantity: 30; Number of Repeats: 5]

insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:

Rosuvastatin-DRLA RI MP C4225 C4228 C4238 C4248 P4228 P4248 30 5 30
NP C4228 C4248 30 5 30

  1. Schedule 1, entry for Rosuvastatin in the form Tablet 5 mg (as calcium) [Maximum Quantity: 30; Number of Repeats: 11]

insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:

Rosuvastatin-DRLA RI MP C4225 C4228 C4238 C4248 P4225 P4238 30 11 30

  1. Schedule 1, entry for Rosuvastatin in the form Tablet 10 mg (as calcium) [Maximum Quantity: 30; Number of Repeats: 5]

insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:

Rosuvastatin-DRLA RI MP C4225 C4228 C4238 C4248 P4228 P4248 30 5 30
NP C4228 C4248 30 5 30

  1. Schedule 1, entry for Rosuvastatin in the form Tablet 10 mg (as calcium) [Maximum Quantity: 30; Number of Repeats: 11]

insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:

Rosuvastatin-DRLA RI MP C4225 C4228 C4238 C4248 P4225 P4238 30 11 30

  1. Schedule 1, entry for Rosuvastatin in the form Tablet 20 mg (as calcium) [Maximum Quantity: 30; Number of Repeats: 5]

insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:

Rosuvastatin-DRLA RI MP C4225 C4227 C4238 C4259 P4227 P4259 30 5 30
NP C4227 C4259 30 5 30

  1. Schedule 1, entry for Rosuvastatin in the form Tablet 20 mg (as calcium) [Maximum Quantity: 30; Number of Repeats: 11]

insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:

Rosuvastatin-DRLA RI MP C4225 C4227 C4238 C4259 P4225 P4238 30 11 30

  1. Schedule 1, entry for Rosuvastatin in the form Tablet 40 mg (as calcium) [Maximum Quantity: 30; Number of Repeats: 5]

insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:

Rosuvastatin-DRLA RI MP C4225 C4226 C4238 C4263 P4226 P4263 30 5 30
NP C4226 C4263 30 5 30

  1. Schedule 1, entry for Rosuvastatin in the form Tablet 40 mg (as calcium) [Maximum Quantity: 30; Number of Repeats: 11]

insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:

Rosuvastatin-DRLA RI MP C4225 C4226 C4238 C4263 P4225 P4238 30 11 30

  1. Schedule 1, entry for Simvastatin in the form Tablet 10 mg

(a)omit:

Simvastatin‑Spirit 10 ZP MP C1540 C3047 P1540 30 5 30
NP C1540 30 5 30

(b)omit:

Simvastatin‑Spirit 10 ZP MP C1540 C3047 P3047 30 11 30

  1. Schedule 1, entry for Simvastatin in the form Tablet 20 mg

(a)omit:

Simvastatin‑Spirit 20 ZP MP C1540 C3047 P1540 30 5 30
NP C1540 30 5 30

(b)omit:

Simvastatin‑Spirit 20 ZP MP C1540 C3047 P3047 30 11 30

  1. Schedule 1, entry for Simvastatin in the form Tablet 40 mg

(a)omit:

Simvastatin‑Spirit 40 ZP MP C1540 C3047 P1540 30 5 30
NP C1540 30 5 30

(b)omit:

Simvastatin‑Spirit 40 ZP MP C1540 C3047 P3047 30 11 30

  1. Schedule 1, entry for Simvastatin in the form Tablet 80 mg

(a)omit:

Simvastatin‑Spirit 80 ZP MP C1540 C3047 P1540 30 5 30
NP C1540 30 5 30

(b)omit:

Simvastatin‑Spirit 80 ZP MP C1540 C3047 P3047 30 11 30

  1. Schedule 1, entry for Sodium Chloride in the form I.V. infusion 154 mmol per L. 1 L

(a)omit:

Fresenius Kabi Australia Pty Limited PK PDP 5 0 1

(b)omit:

Fresenius Kabi Australia Pty Limited PK MP NP 5 1 1

  1. Schedule 1, entry for Sodium Lactate Compound in the form I.V. infusion containing approximately 131 mmol sodium (as lactate and chloride), 5 mmol potassium (as chloride), 2 mmol calcium (as chloride), 29 mmol bicarbonate (as lactate) and 111 mmol chloride
    per L, 1 L

omit:

Fresenius Kabi Australia Pty Limited PK MP NP 5 1 1

  1. Schedule 1, entry for Sumatriptan in the form Tablet 50 mg (as succinate)

omit from the column headed “Circumstances” (all instances):               C3233   substitute:          C4558

  1. Schedule 1, entry for Sumatriptan in the form Tablet 50 mg (as succinate) [Maximum Quantity: 4; Number of Repeats: 5; Pack Quantity: 2]

insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:

Sumatran QA MP NP C4558 4 5 2

  1. Schedule 1, entry for Sumatriptan in the form Tablet 50 mg (as succinate) [Maximum Quantity: 4; Number of Repeats: 5; Pack Quantity: 4]

insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:

Sumatran QA MP NP C4558 4 5 4

  1. Schedule 1, entry for Sumatriptan in each of the forms: Tablet (fast disintegrating) 50 mg (as succinate); and Nasal spray 20 mg in 0.1 mL single dose unit

omit from the column headed “Circumstances”:          C3233   substitute:          C4558

  1. Schedule 1, entry for Telmisartan with amlodipine in each of the forms: Tablet 40 mg‑5 mg (as besylate); Tablet 40 mg‑10 mg (as besylate); Tablet 80 mg‑5 mg (as besylate); and Tablet 80 mg‑10 mg (as besylate)

insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:

Pritor/Amlodipine FI MP NP C4373 28 5 28

  1. Schedule 1, entry for Tramadol in the form Capsule containing tramadol hydrochloride 50 mg

(a)omit:

Lodam 50 ZP MP NP C1497 C1615 P1497 20 0 20
PDP C1497 C1615 20 0 20

(b)omit:

Lodam 50 ZP MP NP C1497 C1615 P1615 20 2 20

  1. Schedule 1, entry for Zolmitriptan

omit from the column headed “Circumstances” (twice occurring):          C3280   substitute:          C4573

  1. Schedule 3

omit:

BI Biotech Pharmaceuticals Pty Ltd  91 009 701 517

  1. Schedule 3

omit:

HC Biotech Pharmaceuticals Pty Ltd  91 009 701 517

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

insert:

IV iNova Pharmaceuticals (Australia) Pty Limited  88 000 222 408

  1. Schedule 3

omit:

TA Actavis Australia Pty Ltd  43 122 896 468

  1. Schedule 4, Part 1, entry for Bimatoprost with timolol

insert in numerical order following existing text:

C4572

Elevated intra-ocular pressure

The condition must have been inadequately controlled with monotherapy; AND

Patient must have open-angle glaucoma; OR

Patient must have ocular hypertension

  1. Schedule 4, Part 1, entry for Cephalexin

(a)omit from the column headed “Circumstances Code”:     C4243

(b)insert in  the column headed “Purposes Code”:   P4243

  1. Schedule 4, Part 1, entry for Cinacalcet

omit from the column headed “Purposes Code”:         P3672 P3673

  1. Schedule 4, Part 1, entry for Eletriptan

substitute:

Eletriptan C4573

Migraine attack

The condition must have usually failed to respond to analgesics in the past

 Compliance with Authority Required procedures - Streamlined Authority Code 4573

  1. Schedule 4, Part 1, entry for Hydrocortisone

omit from the column headed “Circumstances Code”:               C1128

  1. Schedule 4, Part 1, entry for Ivermectin

insert in numerical order following existing text:

C4565 P4565

Crusted (Norwegian) scabies

The condition must be established by clinical and/or parasitological examination; AND
Patient must be undergoing topical therapy for this condition; OR
Patient must have a contraindication to topical treatment
Patient must weigh 15 kg or over; AND
Patient must be 5 years of age or older

 Compliance with Authority Required procedures - Streamlined Authority Code 4565
C4566 P4566

Human sarcoptic scabies

The condition must be established by clinical and/or parasitological examination; AND
Patient must have completed and failed sequential treatment with topical permethrin and benzyl benzoate and finished the most recent course of topical therapy at least 4 weeks prior to initiating oral therapy; OR
Patient must have a contraindication to topical treatment
Patient must weigh 15 kg or over; AND
Patient must be 5 years of age or older

 Compliance with Authority Required procedures - Streamlined Authority Code 4566

  1. Schedule 4, Part 1, entry for Lanreotide

substitute:

Lanreotide C4559

Where the patient is receiving treatment at/from a private hospital

Acromegaly
The condition must be active; AND
Patient must have persistent elevation of mean growth hormone levels of greater than 2.5 micrograms per litre; AND
The treatment must be after failure of other therapy including dopamine agonists; OR
The treatment must be as interim treatment while awaiting the effects of radiotherapy and where treatment with dopamine agonists has failed; OR
The treatment must be in a patient who is unfit for or unwilling to undergo surgery and where radiotherapy is contraindicated; AND
The treatment must cease in a patient treated with radiotherapy if there is biochemical evidence of remission (normal IGF1) after lanreotide has been withdrawn for at least 4 weeks (6 weeks after the last dose); AND
The treatment must cease if IGF1 is not lower after 3 months of treatment
In a patient treated with radiotherapy, lanreotide should be withdrawn every 2 years in the 10 years after radiotherapy for assessment of remission

 Compliance with Written or Telephone Authority Required procedures
C4567

Where the patient is receiving treatment at/from a public hospital

Acromegaly
The condition must be active; AND
Patient must have persistent elevation of mean growth hormone levels of greater than 2.5 micrograms per litre; AND
The treatment must be after failure of other therapy including dopamine agonists; OR
The treatment must be as interim treatment while awaiting the effects of radiotherapy and where treatment with dopamine agonists has failed; OR
The treatment must be in a patient who is unfit for or unwilling to undergo surgery and where radiotherapy is contraindicated; AND
The treatment must cease in a patient treated with radiotherapy if there is biochemical evidence of remission (normal IGF1) after lanreotide has been withdrawn for at least 4 weeks (6 weeks after the last dose); AND
The treatment must cease if IGF1 is not lower after 3 months of treatment
In a patient treated with radiotherapy, lanreotide should be withdrawn every 2 years in the 10 years after radiotherapy for assessment of remission

 Compliance with Written or Telephone Authority Required procedures - Streamlined Authority Code 4567
C4569

Where the patient is receiving treatment at/from a private hospital

Functional carcinoid tumour
The condition must be causing intractable symptoms; AND
Patient must have experienced on average over 1 week, 3 or more episodes per day of diarrhoea and/or flushing, which persisted despite the use of anti-histamines, anti-serotonin agents and anti-diarrhoea agents; AND
Patient must be one in whom surgery or antineoplastic therapy has failed or is inappropriate; AND
The treatment must cease if there is failure to produce a clinically significant reduction in the frequency and severity of symptoms after 3 months' therapy at a dose of 120 mg every 28 days
Dosage and tolerance to the drug should be assessed regularly and the dosage should be titrated slowly downwards to determine the minimum effective dose

 Compliance with Written or Telephone Authority Required procedures
C4570

Where the patient is receiving treatment at/from a public hospital

Acromegaly
The condition must be active; AND
Patient must have persistent elevation of mean growth hormone levels of greater than 2.5 micrograms per litre; AND
The treatment must be after failure of other therapy including dopamine agonists; OR
The treatment must be as interim treatment while awaiting the effects of radiotherapy and where treatment with dopamine agonists has failed; OR
The treatment must be in a patient who is unfit for or unwilling to undergo surgery and where radiotherapy is contraindicated; AND
The treatment must cease in a patient treated with radiotherapy if there is biochemical evidence of remission (normal IGF1) after lanreotide has been withdrawn for at least 4 weeks (8 weeks after the last dose); AND
The treatment must cease if IGF1 is not lower after 3 months of treatment
In a patient treated with radiotherapy, lanreotide should be withdrawn every 2 years in the 10 years after radiotherapy for assessment of remission

 Compliance with Written or Telephone Authority Required procedures - Streamlined Authority Code 4570
C4574

Where the patient is receiving treatment at/from a private hospital

Acromegaly
The condition must be active; AND
Patient must have persistent elevation of mean growth hormone levels of greater than 2.5 micrograms per litre; AND
The treatment must be after failure of other therapy including dopamine agonists; OR
The treatment must be as interim treatment while awaiting the effects of radiotherapy and where treatment with dopamine agonists has failed; OR
The treatment must be in a patient who is unfit for or unwilling to undergo surgery and where radiotherapy is contraindicated; AND
The treatment must cease in a patient treated with radiotherapy if there is biochemical evidence of remission (normal IGF1) after lanreotide has been withdrawn for at least 4 weeks (8 weeks after the last dose); AND
The treatment must cease if IGF1 is not lower after 3 months of treatment
In a patient treated with radiotherapy, lanreotide should be withdrawn every 2 years in the 10 years after radiotherapy for assessment of remission

 Compliance with Written or Telephone Authority Required procedures
C4575

Where the patient is receiving treatment at/from a public hospital

Functional carcinoid tumour
The condition must be causing intractable symptoms; AND
Patient must have experienced on average over 1 week, 3 or more episodes per day of diarrhoea and/or flushing, which persisted despite the use of anti-histamines, anti-serotonin agents and anti-diarrhoea agents; AND
Patient must be one in whom surgery or antineoplastic therapy has failed or is inappropriate; AND
The treatment must cease if there is failure to produce a clinically significant reduction in the frequency and severity of symptoms after 3 months' therapy at a dose of 120 mg every 28 days
Dosage and tolerance to the drug should be assessed regularly and the dosage should be titrated slowly downwards to determine the minimum effective dose

 Compliance with Written or Telephone Authority Required procedures - Streamlined Authority Code 4575

  1. Schedule 4, Part 1, entry for Lanthanum

(a)omit from the column headed “Purposes Code”:               P3546 P3547

  1. Schedule 4, Part 1, entry for Naratriptan

(a)omit:

C3280 Migraine attack in a patient where attacks in the past have usually failed to respond to analgesics Compliance with Authority Required procedures

(b)insert in numerical order following existing text:

C4562

Migraine attack

The condition must have usually failed to respond to analgesics in the past

 Compliance with Authority Required procedures

  1. Schedule 4, Part 1, entry for Octreotide

(a)omit

C2624

Where the patient is receiving treatment at/from a private hospital

Acromegaly
Acromegaly in a patient controlled on Sandostatin subcutaneous injections
In a patient treated with radiotherapy, treatment must cease if there is biochemical evidence of remission (normal IGF1) after octreotide has been withdrawn for at least 4 weeks (8 weeks after the last dose). Octreotide should be withdrawn every 2 years in the 10 years after radiotherapy for assessment of remission
Treatment must cease if IGF1 is not lower after 3 months of treatment

 Compliance with Written or Telephone Authority Required procedures
C2625

Where the patient is receiving treatment at/from a private hospital

Functional carcinoid tumour or VIPoma
Functional carcinoid tumour or vasoactive intestinal peptide secreting tumour (VIPoma) with symptom control on Sandostatin subcutaneous injections
Treatment must cease if there is failure to produce a clinically significant reduction in the frequency and severity of symptoms after 3 months' therapy at a dose of 30 mg every 28 days and having allowed adequate rescue therapy with Sandostatin subcutaneous injections. Dosage and tolerance to the drug should be assessed regularly and the dosage should be titrated slowly downwards to determine the minimum effective dose

 Compliance with Written or Telephone Authority Required procedures

(b)omit

C3409

Where the patient is receiving treatment at/from a public hospital

Acromegaly
Acromegaly in a patient controlled on Sandostatin subcutaneous injections
In a patient treated with radiotherapy, treatment must cease if there is biochemical evidence of remission (normal IGF1) after octreotide has been withdrawn for at least 4 weeks (8 weeks after the last dose). Octreotide should be withdrawn every 2 years in the 10 years after radiotherapy for assessment of remission
Treatment must cease if IGF1 is not lower after 3 months of treatment

 Compliance with Written or Telephone Authority Required procedures - Streamlined Authority Code 3409
C3410

Where the patient is receiving treatment at/from a public hospital

Functional carcinoid tumour or VIPoma
Functional carcinoid tumour or vasoactive intestinal peptide secreting tumour (VIPoma) with symptom control on Sandostatin subcutaneous injections
Treatment must cease if there is failure to produce a clinically significant reduction in the frequency and severity of symptoms after 3 months' therapy at a dose of 30 mg every 28 days and having allowed adequate rescue therapy with Sandostatin subcutaneous injections. Dosage and tolerance to the drug should be assessed regularly and the dosage should be titrated slowly downwards to determine the minimum effective dose

 Compliance with Written or Telephone Authority Required procedures - Streamlined Authority Code 3410

(c)insert in numerical order following existing text:

C4560

Where the patient is receiving treatment at/from a private hospital

Vasoactive intestinal peptide secreting tumour (VIPoma)

Patient must have achieved symptom control on octreotide immediate release injections; AND

The treatment must cease if there is failure to produce a clinically significant reduction in the frequency and severity of symptoms after 3 months' therapy at a dose of 30 mg every 28 days and having allowed adequate rescue therapy with octreotide immediate release injections

Dosage and tolerance to the drug should be assessed regularly and the dosage should be titrated slowly downwards to determine the minimum effective dose

 Compliance with Written or Telephone Authority Required procedures
C4561

Where the patient is receiving treatment at/from a public hospital

Functional carcinoid tumour

Patient must have achieved symptom control on octreotide immediate release injections; AND

The treatment must cease if there is failure to produce a clinically significant reduction in the frequency and severity of symptoms after 3 months' therapy at a dose of 30 mg every 28 days and having allowed adequate rescue therapy with octreotide immediate release injections

Dosage and tolerance to the drug should be assessed regularly and the dosage should be titrated slowly downwards to determine the minimum effective dose

 Compliance with Written or Telephone Authority Required procedures - Streamlined Authority Code 4561
C4563

Where the patient is receiving treatment at/from a public hospital

Acromegaly

The condition must be controlled with octreotide immediate release injections; AND

The treatment must cease in a patient treated with radiotherapy if there is biochemical evidence of remission (normal IGF1) after octreotide has been withdrawn for at least 4 weeks (8 weeks after the last dose); AND

The treatment must cease if IGF1 is not lower after 3 months of treatment;

In a patient treated with radiotherapy, octreotide should be withdrawn every 2 years in the 10 years after radiotherapy for assessment of remission

 Compliance with Written or Telephone Authority Required procedures - Streamlined Authority Code 4563
C4564

Where the patient is receiving treatment at/from a public hospital

Vasoactive intestinal peptide secreting tumour (VIPoma)

Patient must have achieved symptom control on octreotide immediate release injections; AND

The treatment must cease if there is failure to produce a clinically significant reduction in the frequency and severity of symptoms after 3 months' therapy at a dose of 30 mg every 28 days and having allowed adequate rescue therapy with octreotide immediate release injections

Dosage and tolerance to the drug should be assessed regularly and the dosage should be titrated slowly downwards to determine the minimum effective dose

 Compliance with Written or Telephone Authority Required procedures - Streamlined Authority Code 4564
C4568

Where the patient is receiving treatment at/from a private hospital

Functional carcinoid tumour

Patient must have achieved symptom control on octreotide immediate release injections; AND

The treatment must cease if there is failure to produce a clinically significant reduction in the frequency and severity of symptoms after 3 months' therapy at a dose of 30 mg every 28 days and having allowed adequate rescue therapy with octreotide immediate release injections

Dosage and tolerance to the drug should be assessed regularly and the dosage should be titrated slowly downwards to determine the minimum effective dose

 Compliance with Written or Telephone Authority Required procedures
C4571

Where the patient is receiving treatment at/from a private hospital

Acromegaly

The condition must be controlled with octreotide immediate release injections; AND

The treatment must cease in a patient treated with radiotherapy if there is biochemical evidence of remission (normal IGF1) after octreotide has been withdrawn for at least 4 weeks (8 weeks after the last dose); AND

The treatment must cease if IGF1 is not lower after 3 months of treatment;

In a patient treated with radiotherapy, octreotide should be withdrawn every 2 years in the 10 years after radiotherapy for assessment of remission

 Compliance with Written or Telephone Authority Required procedures

  1. Schedule 4, Part 1, entry for Rizatriptan

substitute:

Rizatriptan C4573

Migraine attack

The condition must have usually failed to respond to analgesics in the past

 Compliance with Authority Required procedures - Streamlined Authority Code 4573

  1. Schedule 4, Part 1, entry for Sumatriptan

substitute:

Sumatriptan C4558

Migraine attack

The condition must have usually failed to respond to analgesics in the past

 Compliance with Authority Required procedures - Streamlined Authority Code 4558

  1. Schedule 4, Part 1, entry for Zolmitriptan

substitute:

Zolmitriptan C4573

Migraine attack

The condition must have usually failed to respond to analgesics in the past

 Compliance with Authority Required procedures - Streamlined Authority Code 4573
Actions
Download as PDF Download as Word Document
Cases Citing This Decision

0

Cases Cited

0

Statutory Material Cited

0