National Health (Listing of Pharmaceutical Benefits) Amendment Instrument 2019 (No. 8) (PB 66 of 2019) (Cth)

PB 66 of 2019

National Health (Listing of Pharmaceutical Benefits) Amendment Instrument 2019 (No. 8)

National Health Act 1953

________________________________________________________________________

I, THEA DANIEL, Assistant Secretary, Pricing and PBS Policy Branch, Technology Assessment and Access 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 29 August 2019

THEA DANIEL

Assistant Secretary

Pricing and PBS Policy Branch

Technology Assessment and Access Division

Department of Health

Name of Instrument

(1)This Instrument is the National Health (Listing of Pharmaceutical Benefits) Amendment Instrument 2019 (No. 8).

(2)This Instrument may also be cited as PB 66 of 2019.

Commencement

This Instrument commences on 1 September 2019.

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

Schedule 1, entry for Alendronic acid with colecalciferol and calcium

omit:

Fosamax Plus D-Cal

MP NP

C6306 C6319 C6325

Schedule 1, entry for Amino acid formula with vitamins and minerals without methionine, threonine and valine and low in isoleucine

omit:

Oral liquid 130 mL, 30 (MMA/PA cooler 15)

Oral

MMA/PA cooler 15

MP NP

C5542 C5560

Schedule 1, entry for Azacitidine

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

Azacitidine Juno

See Note 3

D(100)

Schedule 1, entry for Botulinum toxin type A purified neurotoxin complex

insert in numerical order in the column headed “Circumstances”: C9271 C9334

Schedule 1, entry for Buprenorphine

insert as first entry:

Injection (modified release) 8 mg in 0.16 mL pre-filled syringe	Injection	Buvidal Weekly	UR	MP NP	C9212	See Note 3	See Note 3	1	PB(100)
Injection (modified release) 16 mg in 0.32 mL pre-filled syringe	Injection	Buvidal Weekly	UR	MP NP	C9212	See Note 3	See Note 3	1	PB(100)
Injection (modified release) 24 mg in 0.48 mL pre-filled syringe	Injection	Buvidal Weekly	UR	MP NP	C9212	See Note 3	See Note 3	1	PB(100)
Injection (modified release) 32 mg in 0.64 mL pre-filled syringe	Injection	Buvidal Weekly	UR	MP NP	C9212	See Note 3	See Note 3	1	PB(100)
Injection (modified release) 64 mg in 0.18 mL pre-filled syringe	Injection	Buvidal Monthly	UR	MP NP	C9212	See Note 3	See Note 3	1	PB(100)
Injection (modified release) 96 mg in 0.27 mL pre-filled syringe	Injection	Buvidal Monthly	UR	MP NP	C9212	See Note 3	See Note 3	1	PB(100)
Injection (modified release) 128 mg in 0.36 mL pre-filled syringe	Injection	Buvidal Monthly	UR	MP NP	C9212	See Note 3	See Note 3	1	PB(100)

Schedule 1, entry for Dasatinib in the form Tablet 20 mg [Maximum Quantity: 60; Number of Repeats: 2]

(a)omit from the column headed “Circumstances”: C6959 C6968

(b)insert in numerical order in the column headed “Circumstances”: C9197 C9293

Schedule 1, entry for Dasatinib in the form Tablet 20 mg [Maximum Quantity: 60; Number of Repeats: 5]

(a)omit from the column headed “Circumstances”: C6959 C6968

(b)insert in numerical order in the column headed “Circumstances”: C9197 C9293

(c)omit from the column headed “Purposes”: P6959 P6968

(d)insert in numerical order in the column headed “Purposes”: P9197 P9293

Schedule 1, entry for Dasatinib in the form Tablet 50 mg [Maximum Quantity: 60; Number of Repeats: 2]

(a)omit from the column headed “Circumstances”: C6959 C6968

(b)insert in numerical order in the column headed “Circumstances”: C9197 C9293

Schedule 1, entry for Dasatinib in the form Tablet 50 mg [Maximum Quantity: 60; Number of Repeats: 5]

(a)omit from the column headed “Circumstances”: C6959 C6968

(b)insert in numerical order in the column headed “Circumstances”: C9197 C9293

(c)omit from the column headed “Purposes”: P6959 P6968

(d)insert in numerical order in the column headed “Purposes”: P9197 P9293

Schedule 1, entry for Dasatinib in the form Tablet 70 mg [Maximum Quantity: 60; Number of Repeats: 2]

(a)omit from the column headed “Circumstances”: C6959 C6968

(b)insert in numerical order in the column headed “Circumstances”: C9197 C9293

Schedule 1, entry for Dasatinib in the form Tablet 70 mg [Maximum Quantity: 60; Number of Repeats: 5]

(a)omit from the column headed “Circumstances”: C6959 C6968

(b)insert in numerical order in the column headed “Circumstances”: C9197 C9293

(c)omit from the column headed “Purposes”: P6959 P6968

(d)insert in numerical order in the column headed “Purposes”: P9197 P9293

Schedule 1, entry for Dasatinib in the form Tablet 100 mg [Maximum Quantity: 30; Number of Repeats: 2]

(a)omit from the column headed “Circumstances”: C6959 C6968

(b)insert in numerical order in the column headed “Circumstances”: C9197 C9293

Schedule 1, entry for Dasatinib in the form Tablet 100 mg [Maximum Quantity: 30; Number of Repeats: 5]

(a)omit from the column headed “Circumstances”: C6959 C6968

(b)insert in numerical order in the column headed “Circumstances”: C9197 C9293

(c)omit from the column headed “Purposes”: P6959 P6968

(d)insert in numerical order in the column headed “Purposes”: P9197 P9293

Schedule 1, entry for Deferasirox in the form Tablet 90 mg [Maximum Quantity: 180; Number of Repeats: 2]

(a)omit from the column headed “Circumstances”: C8444 C8445 C8446

(b)insert in numerical order in the column headed “Circumstances”: C9222 C9258 C9302

(c)omit from the column headed “Purposes”: P8444 P8445 P8446

(d)insert in numerical order in the column headed “Purposes”: P9222 P9258 P9302

Schedule 1, entry for Deferasirox in the form Tablet 90 mg [Maximum Quantity: 180; Number of Repeats: 5]

(a)omit from the column headed “Circumstances”: C8444 C8445 C8446

(b)insert in numerical order in the column headed “Circumstances”: C9222 C9258 C9302

Schedule 1, entry for Deferasirox in the form Tablet 180 mg [Maximum Quantity: 180; Number of Repeats: 2]

(a)omit from the column headed “Circumstances”: C8444 C8445 C8446

(b)insert in numerical order in the column headed “Circumstances”: C9222 C9258 C9302

(c)omit from the column headed “Purposes”: P8444 P8445 P8446

(d)insert in numerical order in the column headed “Purposes”: P9222 P9258 P9302

Schedule 1, entry for Deferasirox in the form Tablet 180 mg [Maximum Quantity: 180; Number of Repeats: 5]

(a)omit from the column headed “Circumstances”: C8444 C8445 C8446

(b)insert in numerical order in the column headed “Circumstances”: C9222 C9258 C9302

Schedule 1, entry for Deferasirox in the form Tablet 360 mg [Maximum Quantity: 180; Number of Repeats: 2]

(a)omit from the column headed “Circumstances”: C8444 C8445 C8446

(b)insert in numerical order in the column headed “Circumstances”: C9222 C9258 C9302

(c)omit from the column headed “Purposes”: P8444 P8445 P8446

(d)insert in numerical order in the column headed “Purposes”: P9222 P9258 P9302

Schedule 1, entry for Deferasirox in the form Tablet 360 mg [Maximum Quantity: 180; Number of Repeats: 5]

(a)omit from the column headed “Circumstances”: C8444 C8445 C8446

(b)insert in numerical order in the column headed “Circumstances”: C9222 C9258 C9302

Schedule 1, entry for Deferiprone in the form Oral solution 100 mg per mL, 250 mL

(a)omit from the column headed “Circumstances”: C6380

(b)omit from the column headed “Circumstances”: C6442

(c)insert in numerical order in the column headed “Circumstances”: C9228 C9286

Schedule 1, entry for Deferiprone in the form Tablet 500 mg

(a)omit from the column headed “Circumstances”: C6380

(b)omit from the column headed “Circumstances”: C6442

(c)insert in numerical order in the column headed “Circumstances”: C9228 C9286

Schedule 1, entry for Doxorubicin - pegylated liposomal in the form Suspension for I.V. infusion containing pegylated liposomal doxorubicin hydrochloride 20 mg in 10 mL

substitute:

Suspension for I.V. infusion containing pegylated liposomal doxorubicin hydrochloride 20 mg in 10 mL	Injection	a	Caelyx	JC	MP	C6234 C6274 C9223 C9287	4	5	1	D(100)
a	Liposomal Doxorubicin SUN	RA	MP	C6234 C6274 C9223 C9287	4	5	1	D(100)
Caelyx	JC	MP	C4786 C4787 C4791	See Note 3	See Note 3	1	D(100)
Liposomal Doxorubicin SUN	RA	MP	C4786 C4787 C4791	See Note 3	See Note 3	1	D(100)

Schedule 1, entry for Exemestane

omit:

a	Exaccord	RA	MP	C4796 C5522	30	5	30
NP	C5522	30	5	30

Schedule 1, entry for Famciclovir in the form Tablet 250 mg

omit:

Famciclovir FBM

MP NP

C5971

Schedule 1, entry for Flecainide in each of the forms: Tablet containing flecainide acetate 50 mg; and Tablet containing flecainide acetate
100 mg

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

APO-Flecainide

MP NP

C5550 C5584

Schedule 1, omit entry for Hydrochlorothiazide with triamterene

Schedule 1, entry for Ibandronic acid in the form Concentrated injection for I.V. infusion 6 mg (as ibandronate sodium monohydrate) in 6 mL

(a)omit from the column headed “Circumstances”: C5257

(b)insert in numerical order in the column headed “Circumstances”: C9333

Schedule 1, entry for Imatinib in the form Capsule 100 mg (as mesilate) [Maximum Quantity: 60; Number of Repeats: 2]

(a)omit from the column headed “Circumstances” (all instances): C6496 C6499

(b)omit from the column headed “Circumstances” (all instances): C6527

(c)omit from the column headed “Circumstances” (all instances): C6539 C6540 C6550

(d)omit from the column headed “Circumstances” (all instances): C6948 C6949 C6973 C8697 C8698 C9086 C9124

(e)insert in numerical order in the column headed “Circumstances” (all instances): C9200 C9203 C9204 C9206 C9207 C9209 C9240 C9242 C9243 C9274 C9276 C9295 C9296

(f)omit from the column headed “Purposes” (all instances): P9086 P9124

(g)insert in numerical order in the column headed “Purposes” (all instances): P9203 P9207

Schedule 1, entry for Imatinib in the form Capsule 100 mg (as mesilate) [Maximum Quantity: 60; Number of Repeats: 5]

(a)omit from the column headed “Circumstances” (all instances): C6496 C6499

(b)omit from the column headed “Circumstances” (all instances): C6527

(c)omit from the column headed “Circumstances” (all instances): C6539 C6540 C6550

(d)omit from the column headed “Circumstances” (all instances): C6948 C6949 C6973 C8697 C8698 C9086 C9124

(e)insert in numerical order in the column headed “Circumstances” (all instances): C9200 C9203 C9204 C9206 C9207 C9209 C9240 C9242 C9243 C9274 C9276 C9295 C9296

(f)omit from the column headed “Purposes” (all instances): P6496 P6499 P6527 P6539 P6540 P6550 P6948 P6949 P6973 P8697 P8698 substitute: P9200 P9204 P9206 P9209 P9240 P9242 P9243 P9274 P9276 P9295 P9296

Schedule 1, entry for Imatinib in the form Capsule 400 mg (as mesilate) [Maximum Quantity: 30; Number of Repeats: 2]

(a)omit from the column headed “Circumstances” (all instances): C6496 C6499

(b)omit from the column headed “Circumstances” (all instances): C6527

(c)omit from the column headed “Circumstances” (all instances): C6539 C6540 C6550

(d)omit from the column headed “Circumstances” (all instances): C6948 C6949 C6973 C8697 C8698 C9086 C9124

(e)insert in numerical order in the column headed “Circumstances” (all instances): C9200 C9203 C9204 C9206 C9207 C9209 C9240 C9242 C9243 C9274 C9276 C9295 C9296

(f)omit from the column headed “Purposes” (all instances): P9086 P9124

(g)insert in numerical order in the column headed “Purposes” (all instances): P9203 P9207

Schedule 1, entry for Imatinib in the form Capsule 400 mg (as mesilate) [Maximum Quantity: 30; Number of Repeats: 5]

(a)omit from the column headed “Circumstances” (all instances): C6496 C6499

(b)omit from the column headed “Circumstances” (all instances): C6527

(c)omit from the column headed “Circumstances” (all instances): C6539 C6540 C6550

(d)omit from the column headed “Circumstances” (all instances): C6948 C6949 C6973 C8697 C8698 C9086 C9124

(e)insert in numerical order in the column headed “Circumstances” (all instances): C9200 C9203 C9204 C9206 C9207 C9209 C9240 C9242 C9243 C9274 C9276 C9295 C9296

(f)omit from the column headed “Purposes” (all instances): P6496 P6499 P6527 P6539 P6540 P6550 P6948 P6949 P6973 P8697 P8698 substitute: P9200 P9204 P9206 P9209 P9240 P9242 P9243 P9274 P9276 P9295 P9296

Schedule 1, entry for Imatinib in the form Tablet 100 mg (as mesilate) [Brand: Gilmat; Maximum Quantity: 60; Number of Repeats: 2]

(a)omit from the column headed “Circumstances”: C6496 C6499

(b)omit from the column headed “Circumstances”: C6527

(c)omit from the column headed “Circumstances”: C6539 C6550

(d)omit from the column headed “Circumstances”: C6948 C6949 C6973 C8697 C9086 C9124

(e)insert in numerical order in the column headed “Circumstances”: C9200 C9203 C9207 C9209 C9240 C9242 C9243 C9274 C9276 C9295 C9296

(f)omit from the column headed “Purposes”: P9086 P9124

(g)insert in numerical order in the column headed “Purposes”: P9203 P9207

Schedule 1, entry for Imatinib in the form Tablet 100 mg (as mesilate) [Brand: Glivec; Maximum Quantity: 60; Number of Repeats: 2]

(a)omit from the column headed “Circumstances”: C4342 C4355 C6496 C6498 C6499

(b)omit from the column headed “Circumstances”: C6527

(c)omit from the column headed “Circumstances”: C6539 C6540 C6550

(d)omit from the column headed “Circumstances”: C6559 C6948 C6949 C6973 C8697 C8698 C9086 C9124

(e)insert in numerical order in the column headed “Circumstances”: C9200 C9203 C9204 C9206 C9207 C9208 C9209 C9238 C9240 C9242 C9243 C9274 C9276 C9278 C9295 C9296 C9319

(f)omit from the column headed “Purposes”: P6498

(g)omit from the column headed “Purposes”: P6559 P9086 P9124

(h)insert in numerical order in the column headed “Purposes”: P9203 P9207 P9208 P9319

Schedule 1, entry for Imatinib in the form Tablet 100 mg (as mesilate) [Brand: IMATINIB RBX; Maximum Quantity: 60; Number of Repeats: 2]

(a)omit from the column headed “Circumstances”: C6496 C6499

(b)omit from the column headed “Circumstances”: C6527

(c)omit from the column headed “Circumstances”: C6539 C6540 C6550

(d)omit from the column headed “Circumstances”: C6948 C6949 C6973 C8697 C8698 C9086 C9124

(e)insert in numerical order in the column headed “Circumstances”: C9200 C9203 C9204 C9206 C9207 C9209 C9240 C9242 C9243 C9274 C9276 C9295 C9296

(f)omit from the column headed “Purposes”: P9086 P9124

(g)insert in numerical order in the column headed “Purposes”: P9203 P9207

Schedule 1, entry for Imatinib in the form Tablet 100 mg (as mesilate) [Brand: Imatinib-Teva; Maximum Quantity: 60; Number of Repeats: 2]

(a)omit from the column headed “Circumstances”: C6496 C6499

(b)omit from the column headed “Circumstances”: C6527

(c)omit from the column headed “Circumstances”: C6539 C6550

(d)omit from the column headed “Circumstances”: C6948 C6949 C6973 C8697 C9086 C9124

(e)insert in numerical order in the column headed “Circumstances”: C9200 C9203 C9207 C9209 C9240 C9242 C9243 C9274 C9276 C9295 C9296

(f)omit from the column headed “Purposes”: P9086 P9124

(g)insert in numerical order in the column headed “Purposes”: P9203 P9207

Schedule 1, entry for Imatinib in the form Tablet 100 mg (as mesilate) [Brand: Gilmat; Maximum Quantity: 60; Number of Repeats: 5]

(a)omit from the column headed “Circumstances”: C6496 C6499

(b)omit from the column headed “Circumstances”: C6527

(c)omit from the column headed “Circumstances”: C6539 C6550

(d)omit from the column headed “Circumstances”: C6948 C6949 C6973 C8697 C9086 C9124

(e)insert in numerical order in the column headed “Circumstances”: C9200 C9203 C9207 C9209 C9240 C9242 C9243 C9274 C9276 C9295 C9296

(f)omit from the column headed “Purposes”: P6496 P6499 P6527 P6539 P6550 P6948 P6949 P6973 P8697 substitute: P9200 P9209 P9240 P9242 P9243 P9274 P9276 P9295 P9296

Schedule 1, entry for Imatinib in the form Tablet 100 mg (as mesilate) [Brand: Glivec; Maximum Quantity: 60; Number of Repeats: 5]

(a)omit from the column headed “Circumstances”: C4342 C4355 C6496 C6498 C6499

(b)omit from the column headed “Circumstances”: C6527

(c)omit from the column headed “Circumstances”: C6539 C6540 C6550

(d)omit from the column headed “Circumstances”: C6559 C6948 C6949 C6973 C8697 C8698 C9086 C9124

(e)insert in numerical order in the column headed “Circumstances”: C9200 C9203 C9204 C9206 C9207 C9208 C9209 C9238 C9240 C9242 C9243 C9274 C9276 C9278 C9295 C9296 C9319

(f)omit from the column headed “Purposes”: P4342 P4355 P6496 P6499 P6527 P6539 P6540 P6550 P6948 P6949 P6973 P8697 P8698 substitute: P9200 P9204 P9206 P9209 P9238 P9240 P9242 P9243 P9274 P9276 P9278 P9295 P9296

Schedule 1, entry for Imatinib in the form Tablet 100 mg (as mesilate) [Brand: IMATINIB RBX; Maximum Quantity: 60; Number of Repeats: 5]

(a)omit from the column headed “Circumstances”: C6496 C6499

(b)omit from the column headed “Circumstances”: C6527

(c)omit from the column headed “Circumstances”: C6539 C6540 C6550

(d)omit from the column headed “Circumstances”: C6948 C6949 C6973 C8697 C8698 C9086 C9124

(e)insert in numerical order in the column headed “Circumstances”: C9200 C9203 C9204 C9206 C9207 C9209 C9240 C9242 C9243 C9274 C9276 C9295 C9296

(f)omit from the column headed “Purposes”: P6496 P6499 P6527 P6539 P6540 P6550 P6948 P6949 P6973 P8697 P8698 substitute: P9200 P9204 P9206 P9209 P9240 P9242 P9243 P9274 P9276 P9295 P9296

Schedule 1, entry for Imatinib in the form Tablet 100 mg (as mesilate) [Brand: Imatinib-Teva; Maximum Quantity: 60; Number of Repeats: 5]

(a)omit from the column headed “Circumstances”: C6496 C6499

(b)omit from the column headed “Circumstances”: C6527

(c)omit from the column headed “Circumstances”: C6539 C6550

(d)omit from the column headed “Circumstances”: C6948 C6949 C6973 C8697 C9086 C9124

(e)insert in numerical order in the column headed “Circumstances”: C9200 C9203 C9207 C9209 C9240 C9242 C9243 C9274 C9276 C9295 C9296

(f)omit from the column headed “Purposes”: P6496 P6499 P6527 P6539 P6550 P6948 P6949 P6973 P8697 substitute: P9200 P9209 P9240 P9242 P9243 P9274 P9276 P9295 P9296

Schedule 1, entry for Imatinib in the form Tablet 400 mg (as mesilate) [Brand: Gilmat; Maximum Quantity: 30; Number of Repeats: 2]

(a)omit from the column headed “Circumstances”: C6496 C6499

(b)omit from the column headed “Circumstances”: C6527

(c)omit from the column headed “Circumstances”: C6539 C6550

(d)omit from the column headed “Circumstances”: C6948 C6949 C6973 C8697 C9086 C9124

(e)insert in numerical order in the column headed “Circumstances”: C9200 C9203 C9207 C9209 C9240 C9242 C9243 C9274 C9276 C9295 C9296

(f)omit from the column headed “Purposes”: P9086 P9124

(g)insert in numerical order in the column headed “Purposes”: P9203 P9207

Schedule 1, entry for Imatinib in the form Tablet 400 mg (as mesilate) [Brand: Glivec; Maximum Quantity: 30; Number of Repeats: 2]

(a)omit from the column headed “Circumstances”: C4342 C4355 C6496 C6498 C6499

(b)omit from the column headed “Circumstances”: C6527

(c)omit from the column headed “Circumstances”: C6539 C6540 C6550

(d)omit from the column headed “Circumstances”: C6559 C6948 C6949 C6973 C8697 C8698 C9086 C9124

(e)insert in numerical order in the column headed “Circumstances”: C9200 C9203 C9204 C9206 C9207 C9208 C9209 C9238 C9240 C9242 C9243 C9274 C9276 C9278 C9295 C9296 C9319

(f)omit from the column headed “Purposes”: P6498

(g)omit from the column headed “Purposes”: P6559 P9086 P9124

(h)insert in numerical order in the column headed “Purposes”: P9203 P9207 P9208 P9319

Schedule 1, entry for Imatinib in the form Tablet 400 mg (as mesilate) [Brand: IMATINIB RBX; Maximum Quantity: 30; Number of Repeats: 2]

(a)omit from the column headed “Circumstances”: C6496 C6499

(b)omit from the column headed “Circumstances”: C6527

(c)omit from the column headed “Circumstances”: C6539 C6540 C6550

(d)omit from the column headed “Circumstances”: C6948 C6949 C6973 C8697 C8698 C9086 C9124

(e)insert in numerical order in the column headed “Circumstances”: C9200 C9203 C9204 C9206 C9207 C9209 C9240 C9242 C9243 C9274 C9276 C9295 C9296

(f)omit from the column headed “Purposes”: P9086 P9124

(g)insert in numerical order in the column headed “Purposes”: P9203 P9207

Schedule 1, entry for Imatinib in the form Tablet 400 mg (as mesilate) [Brand: Imatinib-Teva; Maximum Quantity: 30; Number of Repeats: 2]

(a)omit from the column headed “Circumstances”: C6496 C6499

(b)omit from the column headed “Circumstances”: C6527

(c)omit from the column headed “Circumstances”: C6539 C6550

(d)omit from the column headed “Circumstances”: C6948 C6949 C6973 C8697 C9086 C9124

(e)insert in numerical order in the column headed “Circumstances”: C9200 C9203 C9207 C9209 C9240 C9242 C9243 C9274 C9276 C9295 C9296

(f)omit from the column headed “Purposes”: P9086 P9124

(g)insert in numerical order in the column headed “Purposes”: P9203 P9207

Schedule 1, entry for Imatinib in the form Tablet 400 mg (as mesilate) [Brand: Gilmat; Maximum Quantity: 30; Number of Repeats: 5]

(a)omit from the column headed “Circumstances”: C6496 C6499

(b)omit from the column headed “Circumstances”: C6527

(c)omit from the column headed “Circumstances”: C6539 C6550

(d)omit from the column headed “Circumstances”: C6948 C6949 C6973 C8697 C9086 C9124

(e)insert in numerical order in the column headed “Circumstances”: C9200 C9203 C9207 C9209 C9240 C9242 C9243 C9274 C9276 C9295 C9296

(f)omit from the column headed “Purposes”: P6496 P6499 P6527 P6539 P6550 P6948 P6949 P6973 P8697 substitute: P9200 P9209 P9240 P9242 P9243 P9274 P9276 P9295 P9296

Schedule 1, entry for Imatinib in the form Tablet 400 mg (as mesilate) [Brand: Glivec; Maximum Quantity: 30; Number of Repeats: 5]

(a)omit from the column headed “Circumstances”: C4342 C4355 C6496 C6498 C6499

(b)omit from the column headed “Circumstances”: C6527

(c)omit from the column headed “Circumstances”: C6539 C6540 C6550

(d)omit from the column headed “Circumstances”: C6559 C6948 C6949 C6973 C8697 C8698 C9086 C9124

(e)insert in numerical order in the column headed “Circumstances”: C9200 C9203 C9204 C9206 C9207 C9208 C9209 C9238 C9240 C9242 C9243 C9274 C9276 C9278 C9295 C9296 C9319

(f)omit from the column headed “Purposes”: P4342 P4355 P6496 P6499 P6527 P6539 P6540 P6550 P6948 P6949 P6973 P8697 P8698 substitute: P9200 P9204 P9206 P9209 P9238 P9240 P9242 P9243 P9274 P9276 P9278 P9295 P9296

Schedule 1, entry for Imatinib in the form Tablet 400 mg (as mesilate) [Brand: IMATINIB RBX; Maximum Quantity: 30; Number of Repeats: 5]

(a)omit from the column headed “Circumstances”: C6496 C6499

(b)omit from the column headed “Circumstances”: C6527

(c)omit from the column headed “Circumstances”: C6539 C6540 C6550

(d)omit from the column headed “Circumstances”: C6948 C6949 C6973 C8697 C8698 C9086 C9124

(e)insert in numerical order in the column headed “Circumstances”: C9200 C9203 C9204 C9206 C9207 C9209 C9240 C9242 C9243 C9274 C9276 C9295 C9296

(f)omit from the column headed “Purposes”: P6496 P6499 P6527 P6539 P6540 P6550 P6948 P6949 P6973 P8697 P8698 substitute: P9200 P9204 P9206 P9209 P9240 P9242 P9243 P9274 P9276 P9295 P9296

Schedule 1, entry for Imatinib in the form Tablet 400 mg (as mesilate) [Brand: Imatinib-Teva; Maximum Quantity: 30; Number of Repeats: 5]

(a)omit from the column headed “Circumstances”: C6496 C6499

(b)omit from the column headed “Circumstances”: C6527

(c)omit from the column headed “Circumstances”: C6539 C6550

(d)omit from the column headed “Circumstances”: C6948 C6949 C6973 C8697 C9086 C9124

(e)insert in numerical order in the column headed “Circumstances”: C9200 C9203 C9207 C9209 C9240 C9242 C9243 C9274 C9276 C9295 C9296

(f)omit from the column headed “Purposes”: P6496 P6499 P6527 P6539 P6550 P6948 P6949 P6973 P8697 substitute: P9200 P9209 P9240 P9242 P9243 P9274 P9276 P9295 P9296

Schedule 1, entry for Indapamide in the form Tablet containing indapamide hemihydrate 2.5 mg

omit:

Indapamide Sandoz

MP NP

Schedule 1, entry for Insulin isophane

omit:

Injection (bovine) 100 units per mL, 10 mL

Injection

Hypurin Isophane

MP NP

C4332

Schedule 1, entry for Insulin neutral

omit:

Injection (bovine) 100 units per mL, 10 mL

Injection

Hypurin Neutral

MP NP

C4332

Schedule 1, entry for Interferon alfa-2a in the form Injection 3,000,000 I.U. in 0.5 mL single dose pre-filled syringe [Maximum Quantity: 15; Number of Repeats: 4; Section 100/Prescriber Bag only: C(100)]

(a)omit from the column headed “Circumstances”: C5003

(b)insert in numerical order in the column headed “Circumstances”: C9259

Schedule 1, entry for Interferon alfa-2a in the form Injection 3,000,000 I.U. in 0.5 mL single dose pre-filled syringe [Maximum Quantity: 15; Number of Repeats: 5; Section 100/Prescriber Bag only: C(100)]

(a)omit from the column headed “Circumstances”: C5003

(b)insert in numerical order in the column headed “Circumstances”: C9259

Schedule 1, entry for Interferon alfa-2a in the form Injection 3,000,000 I.U. in 0.5 mL single dose pre-filled syringe [Maximum Quantity: 30; Number of Repeats: 5]

(a)omit from the column headed “Circumstances”: C5003

(b)insert in numerical order in the column headed “Circumstances”: C9259

(c)omit from the column headed “Purposes”: P5003

(d)insert in numerical order in the column headed “Purposes”: P9259

Schedule 1, entry for Interferon alfa-2a in the form Injection 9,000,000 I.U. in 0.5 mL single dose pre-filled syringe [Maximum Quantity: 5;
Number of Repeats: 4; Section 100/Prescriber Bag only: C(100)]

(a)omit from the column headed “Circumstances”: C5003

(b)insert in numerical order in the column headed “Circumstances”: C9259

Schedule 1, entry for Interferon alfa-2a in the form Injection 9,000,000 I.U. in 0.5 mL single dose pre-filled syringe [Maximum Quantity: 5;
Number of Repeats: 5; Section 100/Prescriber Bag only: C(100)]

(a)omit from the column headed “Circumstances”: C5003

(b)insert in numerical order in the column headed “Circumstances”: C9259

Schedule 1, entry for Interferon alfa-2a in the form Injection 9,000,000 I.U. in 0.5 mL single dose pre-filled syringe [Maximum Quantity: 30; Number of Repeats: 5]

(a)omit from the column headed “Circumstances”: C5003

(b)insert in numerical order in the column headed “Circumstances”: C9259

(c)omit from the column headed “Purposes”: P5003

(d)insert in numerical order in the column headed “Purposes”: P9259

Schedule 1, entry for Lanreotide in each of the forms: Injection 60 mg (as acetate) in single dose pre-filled syringe; and Injection 90 mg (as acetate) in single dose pre-filled syringe

(a)omit from the column headed “Circumstances”: C4569

(b)omit from the column headed “Circumstances”: C7041

(c)insert in numerical order in the column headed “Circumstances”: C9260 C9261

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”: C4569

(b)omit from the column headed “Circumstances”: C7041

(c)omit from the column headed “Circumstances”: C8261

(d)insert in numerical order in the column headed “Circumstances”: C9260 C9261 C9323

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

(a)omit from the column headed “Circumstances”: C7063

(b)insert in numerical order in the column headed “Circumstances”: C9225

Schedule 1, entry for Lenograstim in each of the forms: Powder for injection 13,400,000 I.U. (105 micrograms); and Powder for injection 33,600,000 I.U. (263 micrograms)

(a)omit from the column headed “Circumstances”: C6488 C6490 C6494

(b)omit from the column headed “Circumstances”: C6512

(c)omit from the column headed “Circumstances”: C6521

(d)omit from the column headed “Circumstances”: C6543 C6546 C6622 C6623 C6633

(e)omit from the column headed “Circumstances”: C6649

(f)omit from the column headed “Circumstances”: C6656

(g)omit from the column headed “Circumstances”: C6663

(h)omit from the column headed “Circumstances”: C6681

(i)insert in numerical order in the column headed “Circumstances”: C9226 C9227 C9229 C9230 C9231 C9263 C9264 C9265 C9266 C9314 C9324 C9325 C9326 C9327

Schedule 1, entry for Lipegfilgrastim

(a)omit from the column headed “Circumstances”: C7823

(b)omit from the column headed “Circumstances”: C7862

(c)insert in numerical order in the column headed “Circumstances”: C9224 C9322

Schedule 1, entry for Macrogol 3350

substitute:

Macrogol 3350	Oral liquid 13.125 g in 25 mL with electrolytes, 500 mL	Oral	Movicol Liquid	NE	MP NP	C4576 C4577 C4580 C4596 C4601 C6171	P6171	2	3	1
MP NP	C4576 C4577 C4580 C4596 C4601 C6171	P4576 P4577 P4580 P4596 P4601	2	5	1
Sachets containing powder for oral solution 13.125 g with electrolytes, 30	Oral	a	APO-MACROGOL plus ELECTROLYTES	TX	MP	See Note 2	See Note 2	See Note 2	See Note 2	1	C(100)
a	Chemists' Own Macrogol with Electrolytes	RW	MP	See Note 2	See Note 2	See Note 2	See Note 2	1	C(100)
a	lax-sachets	AE	MP	See Note 2	See Note 2	See Note 2	See Note 2	1	C(100)
a	LaxaCon	EA	MP	See Note 2	See Note 2	See Note 2	See Note 2	1	C(100)
a	Macrovic	RF	MP	See Note 2	See Note 2	See Note 2	See Note 2	1	C(100)
a	Molaxole	GO	MP	See Note 2	See Note 2	See Note 2	See Note 2	1	C(100)
a	Movicol	NE	MP	See Note 2	See Note 2	See Note 2	See Note 2	1	C(100)
a	APO-MACROGOL plus ELECTROLYTES	TX	MP NP	C4576 C4577 C4580 C4596 C4601 C6171	P4576 P4577 P4580 P4596 P4601	1	5	1
a	Chemists' Own Macrogol with Electrolytes	RW	MP NP	C4576 C4577 C4580 C4596 C4601 C6171	P4576 P4577 P4580 P4596 P4601	1	5	1
a	lax-sachets	AE	MP NP	C4576 C4577 C4580 C4596 C4601 C6171	P4576 P4577 P4580 P4596 P4601	1	5	1
a	LaxaCon	EA	MP NP	C4576 C4577 C4580 C4596 C4601 C6171	P4576 P4577 P4580 P4596 P4601	1	5	1
a	Macrovic	RF	MP NP	C4576 C4577 C4580 C4596 C4601 C6171	P4576 P4577 P4580 P4596 P4601	1	5	1
a	Molaxole	GO	MP NP	C4576 C4577 C4580 C4596 C4601 C6171	P4576 P4577 P4580 P4596 P4601	1	5	1
a	Movicol	NE	MP NP	C4576 C4577 C4580 C4596 C4601 C6171	P4576 P4577 P4580 P4596 P4601	1	5	1
a	APO-MACROGOL plus ELECTROLYTES	TX	MP NP	C4576 C4577 C4580 C4596 C4601 C6171	P6171	2	3	1
a	Chemists' Own Macrogol with Electrolytes	RW	MP NP	C4576 C4577 C4580 C4596 C4601 C6171	P6171	2	3	1
a	lax-sachets	AE	MP NP	C4576 C4577 C4580 C4596 C4601 C6171	P6171	2	3	1
a	LaxaCon	EA	MP NP	C4576 C4577 C4580 C4596 C4601 C6171	P6171	2	3	1
a	Macrovic	RF	MP NP	C4576 C4577 C4580 C4596 C4601 C6171	P6171	2	3	1
a	Molaxole	GO	MP NP	C4576 C4577 C4580 C4596 C4601 C6171	P6171	2	3	1
a	Movicol	NE	MP NP	C4576 C4577 C4580 C4596 C4601 C6171	P6171	2	3	1
Powder for oral solution 510 g	Oral	OsmoLax	KY	MP	See Note 2	See Note 2	See Note 2	See Note 2	1	C(100)
MP NP	C4171 C4173 C4177 C4179 C4180 C6170	P4171 P4173 P4177 P4179 P4180	1	5	1
MP NP	C4171 C4173 C4177 C4179 C4180 C6170	P6170	2	3	1

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

omit:

Avanza SolTab

MP NP

C5650

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

omit:

Avanza SolTab

MP NP

C5650

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

omit:

Avanza SolTab

MP NP

C5650

Schedule 1, entry for Morphine in each of the forms: Capsule containing morphine sulfate pentahydrate 10 mg (containing sustained release pellets); and Capsule containing morphine sulfate pentahydrate 20 mg (containing sustained release pellets)

insert in numerical order in the column headed “Circumstances”: C9248

Schedule 1, entry for Morphine in the form Injection containing morphine hydrochloride trihydrate 10 mg in 1 mL

omit from the column headed “Schedule Equivalent” for the brand “Morphine Juno”: a

Schedule 1, entry for Morphine in the form Injection containing morphine sulfate pentahydrate 10 mg in 1 mL

(a)omit from the column headed “Schedule Equivalent” for the brand “Hospira Pty Limited”: a

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

MORPHINE SULFATE 10 mg/1 mL MEDSURGE

MP NP MW PDP

Schedule 1, entry for Morphine in the form Injection containing morphine sulfate pentahydrate 15 mg in 1 mL

(a)insert in the column headed “Schedule Equivalent” for the brand “Hospira Pty Limited”: a

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

MORPHINE SULFATE 15 mg/1 mL MEDSURGE

MP NP MW PDP

Schedule 1, entry for Morphine in the form Injection containing morphine sulfate pentahydrate 30 mg in 1 mL

(a)insert in the column headed “Schedule Equivalent” for the brand “Hospira Pty Limited”: a

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

MORPHINE SULFATE 30 mg/1 mL MEDSURGE

MP NP PDP

Schedule 1, entry for Nivolumab in each of the forms: Injection concentrate for I.V. infusion 40 mg in 4 mL; and Injection concentrate for I.V. infusion 100 mg in 10 mL

(a)omit from the column headed “Circumstances”: C6070 C6095 C6111 C6997 C6999 C7567 C7787 C7802 C7864

(b)omit from the column headed “Circumstances”: C8143

(c)omit from the column headed “Circumstances”: C8552 C8568

(d)omit from the column headed “Circumstances”: C8581

(e)insert in numerical order in the column headed “Circumstances”: C9214 C9216 C9217 C9219 C9252 C9253 C9298 C9299 C9311 C9312 C9320 C9321 C9331

Schedule 1, entry for Octreotide in each of the forms: Injection 50 micrograms (as acetate) in 1 mL; Injection 100 micrograms (as acetate) in
1 mL; and Injection 500 micrograms (as acetate) in 1 mL

(a)omit from the column headed “Circumstances” (all instances): C6388

(b)omit from the column headed “Circumstances” (all instances): C6477 C8148

(c)insert in numerical order in the column headed “Circumstances” (all instances): C9232 C9233 C9289

Schedule 1, entry for Octreotide in each of the forms: Injection (modified release) 10 mg (as acetate), vial and diluent syringe; Injection (modified release) 20 mg (as acetate), vial and diluent syringe; and Injection (modified release) 30 mg (as acetate), vial and diluent syringe

(a)omit from the column headed “Circumstances”: C5899

(b)omit from the column headed “Circumstances”: C5910

(c)omit from the column headed “Circumstances”: C8196

(d)insert in numerical order in the column headed “Circumstances”: C9262 C9288 C9313

Schedule 1, omit entry for Ofatumumab

Schedule 1, entry for Olmesartan with amlodipine in each of the forms: Tablet containing olmesartan medoxomil 20 mg with amlodipine 5 mg (as besilate); Tablet containing olmesartan medoxomil 40 mg with amlodipine 5 mg (as besilate); and Tablet containing olmesartan medoxomil
40 mg with amlodipine 10 mg (as besilate)

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

OLMEKAR

MP NP

C4373

Schedule 1, entry for Pamidronic acid in the form Concentrated injection containing pamidronate disodium 15 mg in 5 mL [Maximum Quantity: 4; Number of Repeats: 2]

(a)omit from the column headed “Circumstances”: C4430

(b)insert in numerical order in the column headed “Circumstances”: C9234

Schedule 1, entry for Pamidronic acid in the form Concentrated injection containing pamidronate disodium 30 mg in 10 mL
[Maximum Quantity: 2; Number of Repeats: 2]

(a)omit from the column headed “Circumstances”: C4430

(b)insert in numerical order in the column headed “Circumstances”: C9234

Schedule 1, entry for Pamidronic acid in the form Concentrated injection containing pamidronate disodium 60 mg in 10 mL
[Maximum Quantity: 1; Number of Repeats: 2]

(a)omit from the column headed “Circumstances”: C4430

(b)insert in numerical order in the column headed “Circumstances”: C9234

Schedule 1, entry for Pamidronic acid in the form Concentrated injection containing pamidronate disodium 90 mg in 10 mL

(a)omit from the column headed “Circumstances”: C4430

(b)omit from the column headed “Circumstances”: C5256 C5257

(c)insert in numerical order in the column headed “Circumstances”: C9234 C9315 C9335

Schedule 1, entry for Pazopanib in the form Tablet 200 mg (as hydrochloride) [Maximum Quantity: 30; Number of Repeats: 5]

(a)omit from the column headed “Circumstances”: C4444

(b)omit from the column headed “Circumstances”: C7457

(c)omit from the column headed “Circumstances”: C8551

(d)insert in numerical order in the column headed “Circumstances”: C9247 C9281

Schedule 1, entry for Pazopanib in the form Tablet 200 mg (as hydrochloride) [Maximum Quantity: 90; Number of Repeats: 2]

(a)omit from the column headed “Circumstances”: C4444

(b)omit from the column headed “Circumstances”: C7457

(c)omit from the column headed “Circumstances”: C8551

(d)insert in numerical order in the column headed “Circumstances”: C9247 C9281

(e)omit from the column headed “Purposes”: P4444 P8551 substitute: P9247 P9281

Schedule 1, entry for Pazopanib in the form Tablet 200 mg (as hydrochloride) [Maximum Quantity: 90; Number of Repeats: 5]

(a)omit from the column headed “Circumstances”: C4444

(b)omit from the column headed “Circumstances”: C7457

(c)omit from the column headed “Circumstances”: C8551

(d)insert in numerical order in the column headed “Circumstances”: C9247 C9281

(e)omit from the column headed “Purposes”: P7457

Schedule 1, entry for Pazopanib in the form Tablet 400 mg (as hydrochloride) [Maximum Quantity: 30; Number of Repeats: 5]

(a)omit from the column headed “Circumstances”: C4444

(b)omit from the column headed “Circumstances”: C7457

(c)omit from the column headed “Circumstances”: C8551

(d)insert in numerical order in the column headed “Circumstances”: C9247 C9281

Schedule 1, entry for Pazopanib in the form Tablet 400 mg (as hydrochloride) [Maximum Quantity: 60; Number of Repeats: 2]

(a)omit from the column headed “Circumstances”: C4444

(b)omit from the column headed “Circumstances”: C7457

(c)omit from the column headed “Circumstances”: C8551

(d)insert in numerical order in the column headed “Circumstances”: C9247 C9281

(e)omit from the column headed “Purposes”: P4444 P8551 substitute: P9247 P9281

Schedule 1, entry for Pazopanib in the form Tablet 400 mg (as hydrochloride) [Maximum Quantity: 60; Number of Repeats: 5]

(a)omit from the column headed “Circumstances”: C4444

(b)omit from the column headed “Circumstances”: C7457

(c)omit from the column headed “Circumstances”: C8551

(d)insert in numerical order in the column headed “Circumstances”: C9247 C9281

(e)omit from the column headed “Purposes”: P7457

Schedule 1, entry for Pegfilgrastim

(a)omit from the column headed “Circumstances” (all instances): C7823

(b)omit from the column headed “Circumstances” (all instances): C7862

(c)insert in numerical order in the column headed “Circumstances” (all instances): C9235 C9303

Schedule 1, entry for Pembrolizumab

omit:

Powder for injection 50 mg

Injection

Keytruda

C7606 C7610 C7773 C9044 C9127 C9178

See Note 3

D(100)

Schedule 1, entry for Plerixafor

(a)omit from the column headed “Circumstances”: C4550

(b)insert in numerical order in the column headed “Circumstances”: C9329

Schedule 1, entry for Pravastatin in each of the forms: Tablet containing pravastatin sodium 20 mg; and Tablet containing pravastatin sodium
40 mg

(a)omit:

Cholvastin

MP NP

(b)omit:

Cholvastin

P7598

Schedule 1, entry for Ramipril in the form Tablet 10 mg

(a)omit:

Chem mart Ramipril

MP NP

(b)omit:

Terry White Chemists Ramipril

MP NP

Schedule 1, entry for Ribavirin

omit:

Tablet 200 mg	Oral	Ibavyr	IX	MP NP	C5957 C5958	P5957	28	2	28
MP NP	C5957 C5958	P5958	28	5	28

Schedule 1, entry for Risedronic acid in the form Tablet containing risedronate sodium 150 mg

omit:

ATELVIA ONCE-A-MONTH

MP NP

C6310 C6323 C6327

Schedule 1, entry for Salbutamol

omit:

Capsule containing powder for oral inhalation 200 micrograms (as sulfate) (for use in Ventolin Rotahaler)

Inhalation by mouth

Ventolin Rotacaps

MP NP

256

128

Schedule 1, entry for Somatropin in the form Injection 0.4 mg (1.2 i.u.) with diluent in single use syringe (without preservative)

(a)omit from the column headed “Circumstances”: C8381

(b)insert in numerical order in the column headed “Circumstances”: C9221

Schedule 1, entry for Somatropin in the form Injection 0.6 mg (1.8 i.u.) with diluent in single use syringe (without preservative)

(a)omit from the column headed “Circumstances”: C8381

(b)insert in numerical order in the column headed “Circumstances”: C9221

Schedule 1, entry for Somatropin in the form Injection 0.8 mg (2.4 i.u.) with diluent in single use syringe (without preservative)

(a)omit from the column headed “Circumstances”: C8381

(b)insert in numerical order in the column headed “Circumstances”: C9221

Schedule 1, entry for Somatropin in the form Injection 1 mg (3 i.u.) with diluent in single use syringe (without preservative)

(a)omit from the column headed “Circumstances”: C8381

(b)insert in numerical order in the column headed “Circumstances”: C9221

Schedule 1, entry for Somatropin in the form Injection 1.2 mg (3.6 i.u.) with diluent in single use syringe (without preservative)

(a)omit from the column headed “Circumstances”: C8381

(b)insert in numerical order in the column headed “Circumstances”: C9221

Schedule 1, entry for Somatropin in the form Injection 1.4 mg (4.2 i.u.) with diluent in single use syringe (without preservative)

(a)omit from the column headed “Circumstances”: C8381

(b)insert in numerical order in the column headed “Circumstances”: C9221

Schedule 1, entry for Somatropin in the form Injection 1.6 mg (4.8 i.u.) with diluent in single use syringe (without preservative)

(a)omit from the column headed “Circumstances”: C8381

(b)insert in numerical order in the column headed “Circumstances”: C9221

Schedule 1, entry for Somatropin in the form Injection 1.8 mg (5.4 i.u.) with diluent in single use syringe (without preservative)

(a)omit from the column headed “Circumstances”: C8381

(b)insert in numerical order in the column headed “Circumstances”: C9221

Schedule 1, entry for Somatropin in the form Injection 2 mg (6 i.u.) with diluent in single use syringe (without preservative)

(a)omit from the column headed “Circumstances”: C8381

(b)insert in numerical order in the column headed “Circumstances”: C9221

Schedule 1, entry for Somatropin in the form Injection 4 mg (12 i.u.) vial with diluent (with preservative)

(a)omit from the column headed “Circumstances”: C8381

(b)insert in numerical order in the column headed “Circumstances”: C9221

Schedule 1, entry for Somatropin in the form Injection 10 mg (30 i.u.) vial with diluent (with preservative)

(a)omit from the column headed “Circumstances”: C8381

(b)insert in numerical order in the column headed “Circumstances”: C9221

Schedule 1, entry for Somatropin in the form Injection 18 i.u. (6 mg) cartridge with 3.15 mL diluent (with preservative)

(a)omit from the column headed “Circumstances”: C8381

(b)insert in numerical order in the column headed “Circumstances”: C9221

Schedule 1, entry for Somatropin in the form Injection 72 i.u. (24 mg) cartridge with 3.15 mL diluent (with preservative)

(a)omit from the column headed “Circumstances”: C8381

(b)insert in numerical order in the column headed “Circumstances”: C9221

Schedule 1, entry for Somatropin in the form Powder for injection 5 mg (15 i.u.) with diluent in pre-filled pen (with preservative)

(a)omit from the column headed “Circumstances”: C8121 C8242

(b)omit from the column headed “Circumstances”: C8381

(c)insert in numerical order in the column headed “Circumstances”: C9221 C9300 C9301

Schedule 1, entry for Somatropin in the form Powder for injection 12 mg (36 i.u.) with diluent in pre-filled pen (with preservative)

(a)omit from the column headed “Circumstances”: C8121 C8242

(b)omit from the column headed “Circumstances”: C8381

(c)insert in numerical order in the column headed “Circumstances”: C9221 C9300 C9301

Schedule 1, entry for Somatropin in the form Injection 36 i.u. (12 mg) cartridge with 3.15 mL diluent (with preservative)

(a)omit from the column headed “Circumstances”: C8381

(b)insert in numerical order in the column headed “Circumstances”: C9221

Schedule 1, entry for Somatropin in the form Solution for injection 5 mg (15 i.u.) in 1.5 mL cartridge (with preservative) in pre-filled pen

(a)omit from the column headed “Circumstances”: C8381

(b)insert in numerical order in the column headed “Circumstances”: C9221

Schedule 1, entry for Somatropin in the form Solution for injection 5 mg (15 i.u.) in 1.5 mL cartridge (with preservative)

(a)omit from the column headed “Circumstances” for the brand “Norditropin SimpleXx”: C8381

(b)insert in numerical order in the column headed “Circumstances” for the brand “Norditropin SimpleXx”: C9221

(c)omit from the column headed “Circumstances” for the brand “Omnitrope Surepal 10”: C8382

(d)insert in numerical order in the column headed “Circumstances” for the brand “Omnitrope Surepal 10”: C9257

(e)omit from the column headed “Circumstances” for the brand “SciTropin A”: C8382

(f)insert in numerical order in the column headed “Circumstances” for the brand “SciTropin A”: C9257

Schedule 1, entry for Somatropin in the form Solution for injection 6 mg (18 i.u.) in 1.03 mL cartridge (with preservative)

(a)omit from the column headed “Circumstances”: C8381

(b)insert in numerical order in the column headed “Circumstances”: C9221

Schedule 1, entry for Somatropin in the form Solution for injection 10 mg (30 i.u.) in 1.5 mL cartridge (with preservative)

(a)omit from the column headed “Circumstances” for the brand “Norditropin SimpleXx”: C8381

(b)insert in numerical order in the column headed “Circumstances” for the brand “Norditropin SimpleXx”: C9221

(c)omit from the column headed “Circumstances” for the brand “Omnitrope Surepal 10”: C8382

(d)insert in numerical order in the column headed “Circumstances” for the brand “Omnitrope Surepal 10”: C9257

(e)omit from the column headed “Circumstances” for the brand “SciTropin A”: C8382

(f)insert in numerical order in the column headed “Circumstances” for the brand “SciTropin A”: C9257

Schedule 1, entry for Somatropin in the form Solution for injection 10 mg (30 i.u.) in 1.5 mL cartridge (with preservative) in pre-filled pen

(a)omit from the column headed “Circumstances”: C8381

(b)insert in numerical order in the column headed “Circumstances”: C9221

Schedule 1, entry for Somatropin in the form Solution for injection 10 mg (30 i.u.) in 2 mL cartridge (with preservative)

(a)omit from the column headed “Circumstances”: C8121 C8242

(b)omit from the column headed “Circumstances”: C8381

(c)insert in numerical order in the column headed “Circumstances”: C9221 C9300 C9301

Schedule 1, entry for Somatropin in the form Solution for injection 12 mg (36 i.u.) in 1.5 mL cartridge (with preservative)

(a)omit from the column headed “Circumstances”: C8381

(b)insert in numerical order in the column headed “Circumstances”: C9221

Schedule 1, entry for Somatropin in the form Solution for injection 15 mg (45 i.u.) in 1.5 mL cartridge (with preservative)

(a)omit from the column headed “Circumstances” for the brand “Norditropin SimpleXx”: C8381

(b)insert in numerical order in the column headed “Circumstances” for the brand “Norditropin SimpleXx”: C9221

(c)omit from the column headed “Circumstances” for the brand “Omnitrope Surepal 15”: C8382

(d)insert in numerical order in the column headed “Circumstances” for the brand “Omnitrope Surepal 15”: C9257

Schedule 1, entry for Somatropin in the form Solution for injection 15 mg (45 i.u.) in 1.5 mL cartridge (with preservative) in pre-filled pen

(a)omit from the column headed “Circumstances”: C8381

(b)insert in numerical order in the column headed “Circumstances”: C9221

Schedule 1, entry for Somatropin in the form Solution for injection 20 mg (60 i.u.) in 2.5 mL cartridge (with preservative)

(a)omit from the column headed “Circumstances”: C8381

(b)insert in numerical order in the column headed “Circumstances”: C9221

Schedule 1, entry for Sunitinib in the form Capsule 12.5 mg (as malate) [Maximum Quantity: 28; Number of Repeats: 1]

(a)omit from the column headed “Circumstances”: C8549

(b)insert in numerical order in the column headed “Circumstances”: C9210

(c)omit from the column headed “Purposes”: P8549

(d)insert in numerical order in the column headed “Purposes”: P9210

Schedule 1, entry for Sunitinib in the form Capsule 12.5 mg (as malate) [Maximum Quantity: 28; Number of Repeats: 2]

(a)omit from the column headed “Circumstances”: C8549

(b)insert in numerical order in the column headed “Circumstances”: C9210

Schedule 1, entry for Sunitinib in the form Capsule 12.5 mg (as malate) [Maximum Quantity: 28; Number of Repeats: 3]

(a)omit from the column headed “Circumstances”: C8549

(b)insert in numerical order in the column headed “Circumstances”: C9210

Schedule 1, entry for Sunitinib in the form Capsule 12.5 mg (as malate) [Maximum Quantity: 28; Number of Repeats: 5]

(a)omit from the column headed “Circumstances”: C8549

(b)insert in numerical order in the column headed “Circumstances”: C9210

Schedule 1, entry for Sunitinib in the form Capsule 25 mg (as malate) [Maximum Quantity: 28; Number of Repeats: 1]

(a)omit from the column headed “Circumstances”: C8549

(b)insert in numerical order in the column headed “Circumstances”: C9210

(c)omit from the column headed “Purposes”: P8549

(d)insert in numerical order in the column headed “Purposes”: P9210

Schedule 1, entry for Sunitinib in the form Capsule 25 mg (as malate) [Maximum Quantity: 28; Number of Repeats: 2]

(a)omit from the column headed “Circumstances”: C8549

(b)insert in numerical order in the column headed “Circumstances”: C9210

Schedule 1, entry for Sunitinib in the form Capsule 25 mg (as malate) [Maximum Quantity: 28; Number of Repeats: 3]

(a)omit from the column headed “Circumstances”: C8549

(b)insert in numerical order in the column headed “Circumstances”: C9210

Schedule 1, entry for Sunitinib in the form Capsule 25 mg (as malate) [Maximum Quantity: 28; Number of Repeats: 5]

(a)omit from the column headed “Circumstances”: C8549

(b)insert in numerical order in the column headed “Circumstances”: C9210

Schedule 1, entry for Sunitinib in the form Capsule 37.5 mg (as malate) [Maximum Quantity: 28; Number of Repeats: 1]

(a)omit from the column headed “Circumstances”: C8549

(b)insert in numerical order in the column headed “Circumstances”: C9210

(c)omit from the column headed “Purposes”: P8549

(d)insert in numerical order in the column headed “Purposes”: P9210

Schedule 1, entry for Sunitinib in the form Capsule 37.5 mg (as malate) [Maximum Quantity: 28; Number of Repeats: 2]

(a)omit from the column headed “Circumstances”: C8549

(b)insert in numerical order in the column headed “Circumstances”: C9210

Schedule 1, entry for Sunitinib in the form Capsule 37.5 mg (as malate) [Maximum Quantity: 28; Number of Repeats: 3]

(a)omit from the column headed “Circumstances”: C8549

(b)insert in numerical order in the column headed “Circumstances”: C9210

Schedule 1, entry for Sunitinib in the form Capsule 37.5 mg (as malate) [Maximum Quantity: 28; Number of Repeats: 5]

(a)omit from the column headed “Circumstances”: C8549

(b)insert in numerical order in the column headed “Circumstances”: C9210

Schedule 1, entry for Sunitinib in the form Capsule 50 mg (as malate) [Maximum Quantity: 28; Number of Repeats: 1]

(a)omit from the column headed “Circumstances”: C8549

(b)insert in numerical order in the column headed “Circumstances”: C9210

(c)omit from the column headed “Purposes”: P8549

(d)insert in numerical order in the column headed “Purposes”: P9210

Schedule 1, entry for Sunitinib in the form Capsule 50 mg (as malate) [Maximum Quantity: 28; Number of Repeats: 2]

(a)omit from the column headed “Circumstances”: C8549

(b)insert in numerical order in the column headed “Circumstances”: C9210

Schedule 1, entry for Sunitinib in the form Capsule 50 mg (as malate) [Maximum Quantity: 28; Number of Repeats: 3]

(a)omit from the column headed “Circumstances”: C8549

(b)insert in numerical order in the column headed “Circumstances”: C9210

Schedule 1, entry for Sunitinib in the form Capsule 50 mg (as malate) [Maximum Quantity: 28; Number of Repeats: 5]

(a)omit from the column headed “Circumstances”: C8549

(b)insert in numerical order in the column headed “Circumstances”: C9210

Schedule 1, entry for Teriflunomide

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

TERIFLAGIO

C6854 C7741

Schedule 1, entry for Thalidomide in each of the forms: Capsule 50 mg; and Capsule 100 mg

(a)omit from the column headed “Circumstances”: C5909

(b)insert in numerical order in the column headed “Circumstances”: C9290

Schedule 1, entry for Valaciclovir in the form Tablet 500 mg (as hydrochloride) [Maximum Quantity: 500; Number of Repeats: 2]

(a)omit from the column headed “Circumstances” (all instances): C5939

(b)insert in numerical order in the column headed “Circumstances” (all instances): C9267

Schedule 1, entry for Valganciclovir in the form Powder for oral solution 50 mg (as hydrochloride) per mL, 100 mL

(a)omit from the column headed “Circumstances”: C5031

(b)insert in numerical order in the column headed “Circumstances”: C9316

Schedule 1, entry for Valganciclovir in the form Tablet 450 mg (as hydrochloride)

(a)omit from the column headed “Circumstances” (all instances): C5031

(b)insert in numerical order in the column headed “Circumstances” (all instances): C9316

Schedule 1, entry for Zoledronic acid in the form Injection concentrate for I.V. infusion 4 mg (as monohydrate) in 5 mL

(a)omit from the column headed “Circumstances” (all instances): C5606 C5676 C5677

(b)omit from the column headed “Circumstances” (all instances): C5736

(c)insert in numerical order in the column headed “Circumstances” (all instances): C9268 C9304 C9317 C9328

Schedule 1, entry for Zoledronic acid in the form Injection concentrate for I.V. infusion 4 mg (as monohydrate) in 5 mL vial

(a)omit from the column headed “Circumstances”: C5606 C5676 C5677

(b)omit from the column headed “Circumstances”: C5736

(c)insert in numerical order in the column headed “Circumstances”: C9236 C9269 C9270 C9291

Schedule 1, entry for Zoledronic acid in the form Solution for I.V. infusion 4 mg (as monohydrate) in 100 mL

(a)omit from the column headed “Circumstances” for the brand “DBL Zoledronic Acid”: C5606 C5676 C5677

(b)omit from the column headed “Circumstances” for the brand “DBL Zoledronic Acid”: C5736

(c)insert in numerical order in the column headed “Circumstances” for the brand “DBL Zoledronic Acid”: C9268 C9304 C9317 C9328

(d)omit:

Zoledronic Acid 4 mg/100 mL APOTEX

C5605 C5606 C5676 C5677 C5703 C5704 C5735 C5736

PB(100)

Schedule 3

omit:

TU Theramex Australia Pty Ltd 37 623 186 845

Schedule 3, after details relevant to Responsible Person code UO

insert:

UR Camurus Pty Ltd 79 627 784 605

Schedule 4, Part 1, entry for Botulinum toxin type A purified neurotoxin complex

insert in numerical order after existing text:

C9271	Moderate to severe spasticity of the lower limb following an acute event Grandfathered treatment Must be treated by a neurologist; OR Must be treated by an orthopaedic surgeon; OR Must be treated by a rehabilitation specialist; OR Must be treated by a plastic surgeon; OR Must be treated by a geriatrician. Patient must have previously received non-PBS subsidised treatment with this drug for this condition prior to 1 September 2019; AND The condition must have been moderate to severe spasticity of the lower limb/s following an acute event, defined as a Modified Ashworth Scale rating of 3 or more prior to commencing non-PBS subsidised treatment; AND The treatment must only be used as second line therapy when standard management has failed; OR The treatment must only be used as an adjunct to physical therapy; AND The treatment must not continue if the patient does not respond (defined as not having had a decrease in spasticity rating of at least 1, using the Modified Ashworth Scale, in at least one joint) after two treatment periods (with any botulinum toxin type A); AND Patient must not have established severe contracture in the limb to be treated; AND The treatment must not exceed a maximum of 4 treatment periods (with any botulinum toxin type A) per lower limb in the the first year of treatment, and 2 treatment periods (with any botulinum toxin type A) per lower limb each year thereafter. Patient must be aged 18 years or older. Standard management includes physiotherapy and/or oral spasticity agents.	Compliance with Authority Required procedures - Streamlined Authority Code 9271
C9334	Moderate to severe spasticity of the lower limb following an acute event Must be treated by a neurologist; OR Must be treated by an orthopaedic surgeon; OR Must be treated by a rehabilitation specialist; OR Must be treated by a plastic surgeon; OR Must be treated by a geriatrician. The condition must be moderate to severe spasticity of the lower limb/s following stroke or other acute neurological event, defined as a Modified Ashworth Scale rating of 3 or more; AND The treatment must only be used as second line therapy when standard management has failed; OR The treatment must only be used as an adjunct to physical therapy; AND The treatment must not continue if the patient does not respond (defined as not having had a decrease in spasticity rating of at least 1, using the Modified Ashworth Scale, in at least one joint) after two treatment periods (with any botulinum toxin type A); AND Patient must not have established severe contracture in the limb to be treated; AND The treatment must not exceed a maximum of 4 treatment periods (with any botulinum toxin type A) per lower limb in the the first year of treatment, and 2 treatment periods (with any botulinum toxin type A) per lower limb each year thereafter. Patient must be aged 18 years or older. Standard management includes physiotherapy and/or oral spasticity agents.	Compliance with Authority Required procedures - Streamlined Authority Code 9334

Schedule 4, Part 1, entry for Buprenorphine

insert in numerical order after existing text:

C9212

Opiate dependence
Must be treated by a health care professional.
The treatment must be within a framework of medical, social and psychological treatment; AND
Patient must be stabilised on sublingual buprenorphine or buprenorphine/naloxone prior to commencing treatment with this drug for this condition.

Schedule 4, Part 1, entry for Dasatinib

(a)omit entry for circumstances code “C6947” and substitute:

C6947

P6947

Chronic Myeloid Leukaemia (CML)
First continuing treatment
The condition must be in the chronic phase; AND
Patient must have received initial PBS-subsidised first line treatment with this drug for this condition; OR
Patient must have experienced intolerance, not a failure to respond, to first continuing PBS-subsidised treatment with imatinib as a first line therapy for this condition; OR
Patient must have experienced intolerance, not a failure to respond, to first continuing PBS-subsidised treatment with nilotinib as a first line therapy for this condition; AND
Patient must have demonstrated a major cytogenic response; OR
Patient must have demonstrated a peripheral blood level of BCR-ABL of less than 1%; AND
The treatment must not exceed a total maximum of 24 weeks of therapy with a PBS-subsidised treatment with a tyrosine kinase inhibitor for this condition under this restriction; AND
The treatment must be the sole PBS-subsidised therapy for this condition.
First continuing applications for authorisation must be in writing and must include:
(1) a completed authority prescription form; and
(2) demonstration of continued response to treatment as evidenced by either:
(a) a major cytogenetic response [see Note explaining requirements]; or
(b) a peripheral blood level of BCR-ABL of less than 1% on the international scale [see Note explaining requirements].Where this has been supplied within the previous 12 months, only the date of the relevant pathology report need be provided.

Compliance with Authority Required procedures

(b)omit:

C6959	P6959	Chronic Myeloid Leukaemia (CML) Initial treatment The condition must be a primary diagnosis; AND The condition must be in the chronic phase; AND The condition must be expressing the Philadelphia chromosome; OR The condition must have the transcript BCR-ABL tyrosine kinase; AND The treatment must be for first line therapy for this condition; AND Patient must not have previously experienced a failure to respond to the PBS-subsidised first line treatment with this drug for this condition; OR Patient must have experienced intolerance, not a failure to respond, to initial PBS-subsidised treatment with imatinib as a first line therapy for this condition; OR Patient must have experienced intolerance, not a failure to respond, to initial PBS-subsidised treatment with nilotinib as a first line therapy for this condition; AND The treatment must not exceed a total maximum of 18 months of therapy with a PBS-subsidised treatment with a tyrosine kinase inhibitor for this condition; AND The treatment must be the sole PBS-subsidised therapy for this condition. Applications under this restriction will be limited to provide patients with a maximum of 18 months of therapy with dasatinib, imatinib or nilotinib from the date the first application for initial treatment was approved. Patients should be commenced on a dose of dasatinib of 100 mg (base) daily. Continuing therapy is dependent on patients demonstrating a response to dasatinib therapy following the initial 18 months of treatment and at 12 monthly intervals thereafter. Applications for authorisation must be in writing and must include: (1) a completed authority prescription form; and (2) a completed Chronic Myeloid Leukaemia - Chronic Phase, First Line - Supporting Information form; and (3) a pathology cytogenetic report conducted on peripheral blood or bone marrow supporting the diagnosis of chronic myeloid leukaemia to confirm eligibility for treatment, or a qualitative PCR report documenting the presence of the BCR-ABL transcript in either peripheral blood or bone marrow; and (4) a signed patient acknowledgement form	Compliance with Authority Required procedures
C6968	P6968	Chronic Myeloid Leukaemia (CML) Subsequent continuing treatment The condition must be in the chronic phase; AND Patient must have received the First continuing PBS-subsidised treatment with this drug as a first line therapy for this condition; OR Patient must have experienced intolerance, not a failure to respond, to subsequent continuing PBS-subsidised treatment with imatinib as a first line therapy for this condition; OR Patient must have experienced intolerance, not a failure to respond, to subsequent continuing PBS-subsidised treatment with nilotinib as a first line therapy for this condition; AND Patient must have maintained a major cytogenic response; OR Patient must have maintained a peripheral blood level of BCR-ABL of less than 1%; AND The treatment must not exceed a total maximum of 24 weeks of therapy with a PBS-subsidised treatment with a tyrosine kinase inhibitor for this condition under this restriction; AND The treatment must be the sole PBS-subsidised therapy for this condition. Subsequent authority applications for continuing therapy with this drug may be made by telephoning the Department of Human Services on 1800 700 270 (hours of operation 8 a.m. to 5 p.m. EST Monday to Friday).	Compliance with Authority Required procedures

(c)insert in numerical order after existing text:

C9197	P9197	Chronic Myeloid Leukaemia (CML) Subsequent continuing treatment The condition must be in the chronic phase; AND Patient must have received the First continuing PBS-subsidised treatment with this drug as a first line therapy for this condition; OR Patient must have experienced intolerance, not a failure to respond, to subsequent continuing PBS-subsidised treatment with imatinib as a first line therapy for this condition; OR Patient must have experienced intolerance, not a failure to respond, to subsequent continuing PBS-subsidised treatment with nilotinib as a first line therapy for this condition; AND Patient must have maintained a major cytogenic response; OR Patient must have maintained a peripheral blood level of BCR-ABL of less than 1%; AND The treatment must not exceed a total maximum of 24 weeks of therapy with a PBS-subsidised treatment with a tyrosine kinase inhibitor for this condition under this restriction; AND The treatment must be the sole PBS-subsidised therapy for this condition.	Compliance with Authority Required procedures
C9293	P9293	Chronic Myeloid Leukaemia (CML) Initial treatment The condition must be a primary diagnosis; AND The condition must be in the chronic phase; AND The condition must be expressing the Philadelphia chromosome; OR The condition must have the transcript BCR-ABL tyrosine kinase; AND The treatment must be for first line therapy for this condition; AND Patient must not have previously experienced a failure to respond to the PBS-subsidised first line treatment with this drug for this condition; OR Patient must have experienced intolerance, not a failure to respond, to initial PBS-subsidised treatment with imatinib as a first line therapy for this condition; OR Patient must have experienced intolerance, not a failure to respond, to initial PBS-subsidised treatment with nilotinib as a first line therapy for this condition; AND The treatment must not exceed a total maximum of 18 months of therapy with a PBS-subsidised treatment with a tyrosine kinase inhibitor for this condition; AND The treatment must be the sole PBS-subsidised therapy for this condition. Applications under this restriction will be limited to provide patients with a maximum of 18 months of therapy with dasatinib, imatinib or nilotinib from the date the first application for initial treatment was approved. Patients should be commenced on a dose of dasatinib of 100 mg (base) daily. Continuing therapy is dependent on patients demonstrating a response to dasatinib therapy following the initial 18 months of treatment and at 12 monthly intervals thereafter. Applications for authorisation must be in writing and must include: (1) a completed authority prescription form; and (2) a completed Chronic Myeloid Leukaemia - Chronic Phase, First Line - Supporting Information form; and (3) a pathology cytogenetic report conducted on peripheral blood or bone marrow supporting the diagnosis of chronic myeloid leukaemia to confirm eligibility for treatment, or a qualitative PCR report documenting the presence of the BCR-ABL transcript in either peripheral blood or bone marrow.	Compliance with Written Authority Required procedures

Schedule 4, Part 1, entry for Deferasirox

(a)omit:

C8444	P8444	Chronic iron overload Continuing treatment Patient must be transfusion dependent; AND Patient must not have a malignant disorder of erythropoiesis; AND Patient must have previously received PBS-subsidised therapy with deferasirox for this condition.	Compliance with Authority Required procedures
C8445	P8445	Chronic iron overload Continuing treatment Patient must not be transfusion dependent; AND The condition must be thalassaemia; AND Patient must have previously received PBS-subsidised therapy with deferasirox for this condition.	Compliance with Authority Required procedures
C8446	P8446	Chronic iron overload Continuing treatment Patient must be red blood cell transfusion dependent; AND Patient must have a malignant disorder of haemopoieisis; AND Patient must have previously received PBS-subsidised therapy with deferasirox for this condition.	Compliance with Authority Required procedures

(b)insert in numerical order after existing text:

C9222	P9222	Chronic iron overload Continuing treatment Patient must not be transfusion dependent; AND The condition must be thalassaemia; AND Patient must have previously received PBS-subsidised therapy with deferasirox for this condition.	Compliance with Authority Required procedures - Streamlined Authority Code 9222
C9258	P9258	Chronic iron overload Continuing treatment Patient must be red blood cell transfusion dependent; AND Patient must have a malignant disorder of haemopoieisis; AND Patient must have previously received PBS-subsidised therapy with deferasirox for this condition.	Compliance with Authority Required procedures - Streamlined Authority Code 9258
C9302	P9302	Chronic iron overload Continuing treatment Patient must be transfusion dependent; AND Patient must not have a malignant disorder of erythropoiesis; AND Patient must have previously received PBS-subsidised therapy with deferasirox for this condition.	Compliance with Authority Required procedures - Streamlined Authority Code 9302

Schedule 4, Part 1, entry for Deferiprone

insert in numerical order after existing text:

C9228	Iron overload Patient must have thalassaemia major; AND Patient must be one in whom desferrioxamine therapy has proven ineffective.	Compliance with Authority Required procedures - Streamlined Authority Code 9228
C9286	Iron overload Patient must have thalassaemia major; AND Patient must be unable to take desferrioxamine therapy.	Compliance with Authority Required procedures - Streamlined Authority Code 9286

Schedule 4, Part 1, entry for Doxorubicin - pegylated liposomal

(a)omit:

C6233

P6233

Kaposi sarcoma
The condition must be AIDS-related; AND
Patient must have a CD4 cell count of less than 200 per cubic millimetre; AND
The condition must include extensive visceral involvement.

Compliance with Authority Required procedures

(b)omit:

C6264

P6264

Kaposi sarcoma
The condition must be AIDS-related; AND
Patient must have a CD4 cell count of less than 200 per cubic millimetre; AND
The condition must include extensive mucocutaneous involvement.

Compliance with Authority Required procedures

(c)insert in numerical order after existing text:

C9223	P9223	Kaposi sarcoma The condition must be AIDS-related; AND Patient must have a CD4 cell count of less than 200 per cubic millimetre; AND The condition must include extensive visceral involvement.	Compliance with Authority Required procedures - Streamlined Authority Code 9223
C9287	P9287	Kaposi sarcoma The condition must be AIDS-related; AND Patient must have a CD4 cell count of less than 200 per cubic millimetre; AND The condition must include extensive mucocutaneous involvement.	Compliance with Authority Required procedures - Streamlined Authority Code 9287

Schedule 4, Part 1, entry for Ibandronic acid

(a)omit:

C5257

Bone metastases
The condition must be due to breast cancer.

Compliance with Authority Required procedures

(b)insert in numerical order after existing text:

C9333

Bone metastases
The condition must be due to breast cancer.

Compliance with Authority Required procedures - Streamlined Authority Code 9333

Schedule 4, Part 1, entry for Imatinib

(a)omit:

C4342	P4342	Gastrointestinal stromal tumour Continuing treatment The treatment must be adjuvant to complete surgical resection of primary gastrointestinal stromal tumour (GIST); AND Patient must be at high risk of recurrence following complete surgical resection of primary GIST; AND The treatment must not exceed a dose of 400 mg per day for a period of 36 months in total (initial plus continuing therapy); AND Patient must have previously been issued with an authority prescription for imatinib for adjuvant treatment following complete resection of primary GIST. Applications for continuing therapy may be made by telephone.	Compliance with Written Authority Required procedures
C4355	P4355	Gastrointestinal stromal tumour Initial treatment The treatment must be adjuvant to complete surgical resection of primary gastrointestinal stromal tumour (GIST); AND Patient must be at high risk of recurrence following complete surgical resection of primary GIST; AND The condition must be histologically confirmed by the detection of CD117 on immunohistochemical staining; AND The treatment must not exceed a dose of 400 mg per day for a period of 36 months in total (initial plus continuing therapy). Applications for authorisation of initial treatment must be in writing and must include: (1) a completed authority prescription form; and (2) a completed Imatinib Mesilate (Glivec) PBS Authority Application for Use in Adjuvant Treatment of Gastrointestinal Stromal Tumour - Supporting Information Form which includes the following: (i) a copy of a pathology report from an Approved Pathology Authority supporting the diagnosis of a gastrointestinal stromal tumour and confirming the presence of CD117 on immunohistochemical staining; and (ii) a copy of the pathology report must include the size and mitotic rate of the tumour, and the date of tumour resection must be documented, which must not be more than 3 months prior to the date of this application. High risk of recurrence is defined as: Primary GIST greater than 5 cm with a mitotic count of greater than 5/50 high power fields (HPF); or Primary GIST greater than 10 cm with any mitotic rate; or Primary GIST with a mitotic count of greater than 10/50 HPF.	Compliance with Written Authority Required procedures
C6496	P6496	Dermatofibrosarcoma protuberans Initial treatment The condition must be unresectable; OR The condition must be locally recurrent; OR The condition must be metastatic; AND The treatment must not exceed a maximum dose of 800 mg per day. (1) Where the application for authority to prescribe is being sought on the basis of unresectable tumour, written evidence in support of that claim must be provided; and (2) Where the application for authority to prescribe is being sought on the basis of locally recurrent disease, the site of the local recurrence must be specified; and (3) Where the application for authority to prescribe is being sought on the basis of metastatic disease, the site(s) of metastatic disease must be provided. Applications for authorisation for initial treatment must be made in writing and must include: (a) a completed authority prescription form; and (b) a completed Rare Diseases Imatinib PBS Authority Application - Supporting Information Form; and (c) a signed patient acknowledgement	Compliance with Written Authority Required procedures
C6498	P6498	Malignant gastrointestinal stromal tumour Continuing treatment The condition must be metastatic; OR The condition must be unresectable; AND Patient must have previously received PBS-subsidised treatment with this drug for this condition; AND The treatment must be given at a dose not exceeding 600 mg per day. Patients who have failed to respond or are intolerant to imatinib are no longer eligible to receive PBS-subsidised imatinib Patients with metastatic/unresectable disease who achieve a response to treatment at an imatinib dose of 400 mg per day should be continued at this dose and assessed for response at regular intervals. Patients who fail to achieve a response to 400 mg per day may have their dose increased to 600 mg per day. Authority applications for doses higher than 600 mg per day will not be approved. A response to treatment is defined as a decrease from baseline in the sum of the products of the perpendicular diameters of all measurable lesions of 50% or greater. (Response definition based on the Southwest Oncology Group standard criteria, see Demetri et al. N Engl J Med 2002; 347: 472-80.) Applications for continuing treatment may be made by telephone	Compliance with Authority Required procedures
C6499	P6499	Chronic eosinophilic leukaemia or Hypereosinophilic syndrome Initial treatment Patient must have confirmed evidence of carrying the FIP1L1-PDGFRA fusion gene; AND The treatment must not exceed a maximum dose of 400 mg per day. Applications for authorisation must be made in writing and must include: (a) a completed authority prescription form; and (b) a completed Rare Diseases Imatinib PBS Authority Application - Supporting Information Form; and (c) a copy of the pathology report confirming the presence of the FIP1L1-PDGFRA fusion gene; and (d) a copy of the full blood examination report confirming the presence of hypereosinophilic syndrome or chronic eosinophilic leukaemia; and (e) details of organ involvement requiring treatment, including a copy of the radiology, nuclear medicine, respiratory function or anatomical pathology reports as appropriate; and (f) a signed patient acknowledgement	Compliance with Written Authority Required procedures

(b)omit:

C8381	Short stature due to short stature homeobox (SHOX) gene disorders Continuing treatment as a reclassified patient Patient must have previously received treatment under the PBS S100 Growth Hormone Program (treatment) under a category other than short stature due to short stature homeobox (SHOX) gene disorders; AND The treatment must not have lapsed due to failure to respond to growth hormone at a dose of 9.5mg/m²/week or greater for the most recent treatment period (32 weeks for an initial or recommencement treatment period and 26 weeks for a continuing treatment period, whichever applies); OR The treatment must not have lapsed due to failure to respond to growth hormone at a dose of 9.5mg/m²/week or greater for the most recent treatment period (32 weeks for an initial or recommencement treatment period and 26 weeks for a continuing treatment period, whichever applies), unless response was affected by a significant medical illness; OR The treatment must not have lapsed due to failure to respond to growth hormone at a dose of 9.5mg/m²/week or greater for the most recent treatment period (32 weeks for an initial or recommencement treatment period and 26 weeks for a continuing treatment period, whichever applies), unless response was affected by major surgery (e.g. renal transplant); OR The treatment must not have lapsed due to failure to respond to growth hormone at a dose of 9.5mg/m²/week or greater for the most recent treatment period (32 weeks for an initial or recommencement treatment period and 26 weeks for a continuing treatment period, whichever applies), unless response was affected by an adverse reaction to growth hormone; OR The treatment must not have lapsed due to failure to respond to growth hormone at a dose of 9.5mg/m²/week or greater for the most recent treatment period (32 weeks for an initial or recommencement treatment period and 26 weeks for a continuing treatment period, whichever applies), unless response was affected by non-compliance due to social/family problems; AND Patient must have diagnostic results consistent with a SHOX mutation/deletion, defined as a karyotype confirming the presence of a SHOX mutation/deletion without the presence of mixed gonadal dysgenesis; OR Patient must have diagnostic results consistent with a SHOX mutation/deletion, defined as mixed gonadal dysgenesis (45X mosaic karyotype with the presence of any Y chromosome material and/or SRY gene positive by FISH study) and have an appropriate plan of management in place for the patient's increased risk of gonadoblastoma; AND Patient must have had a height at or below the 1^stpercentile for age and sex immediately prior to commencing treatment; OR Patient must have had a growth velocity below the 25^thpercentile for bone age and sex measured over the 12 month interval immediately prior to commencement of treatment (or the 6 month interval immediately prior to commencement of treatment if the patient was an older child at commencement of treatment); OR Patient must have had an annual growth velocity of 14 cm per year or less in the 12 month period immediately prior to commencement of treatment, if the patient had a chronological age of 2 years or less at commencement of treatment; OR Patient must have had an annual growth velocity of 8 cm per year or less in the 12 month period immediately prior to commencement of treatment, if the patient had a bone or chronological age of 2.5 years or less at commencement of treatment; AND Patient must not have diabetes mellitus; AND Patient must not have a condition with a known risk of malignancy including chromosomal abnormalities such as Down and Bloom syndromes (excluding gonadoblastoma secondary to mixed gonadal dysgenesis); AND Patient must not have an active tumour or evidence of tumour growth or activity; AND Patient must be male and must not have a height greater than or equal to 167.7cm; OR Patient must be female and must not have a height greater than or equal to 155.0cm; AND Patient must be male and must not have a bone age of 15.5 years or more; OR Patient must be female and must not have a bone age of 13.5 years or more. Must be treated by a medical practitioner in consultation with a nominated specialist or consultant physician in paediatric endocrinology; OR Must be treated by a medical practitioner in consultation with a nominated specialist or consultant physician in general paediatrics. An older child is defined as a male with a chronological age of at least 12 years or a bone age of at least 10 years, or a female with a chronological age of at least 10 years or a bone age of at least 8 years. The maximum duration of each continuing treatment phase is 26 weeks. Prescribers must determine an appropriate weekly dose in accordance with the dosing arrangements detailed in the National Health (Growth Hormone Program) Special Arrangement 2015 and request the appropriate number of vials/cartridges required to provide sufficient drug for 13 weeks' worth of treatment (with up to 1 repeat allowed). The authority application must be in writing and must include: 1. A completed authority prescription form; AND 2. A completed Growth Hormone Authority Application Supporting Information Form for continuing treatment as a reclassified patient; AND 3. A minimum of 12 months of growth data (height and weight measurements) from immediately prior to commencement of treatment, or a minimum of 6 months of growth data from immediately prior to commencement of treatment if the patient was an older child at commencement of treatment; and the result of a bone age assessment performed within the 12 months immediately prior to commencement of treatment (except for a patient whose chronological age was 2.5 years or less at commencement of treatment); AND 4. Confirmation that the patient has diagnostic results consistent with a short stature homeobox (SHOX) gene disorder; AND 5. If the patient's condition is secondary to mixed gonadal dysgenesis, confirmation that an appropriate plan of management for the patient's increased risk of gonadoblastoma is in place; AND 6. Growth data (height and weight) for the most recent 6 month treatment period, including data at both the start and end of the treatment period. The most recent data must not be older than three months; AND 7. A bone age result performed within the last 12 months (except for a patient whose chronological age is 2.5 years or less); AND 8. The proprietary name (brand), form and strength of somatropin requested, and the number of vials/cartridges required to provide sufficient drug for 13 weeks' worth of treatment (with up to 1 repeat allowed). Prescribers must keep a copy of any clinical records relating to the prescription, including such records required to demonstrate that the prescription was written in compliance with any relevant circumstances and/or purposes. These records must be kept for 2 years after the date the prescription to which the records relate is written.	Compliance with Written Authority Required procedures
C8382	Short stature due to short stature homeobox (SHOX) gene disorders Continuing treatment as a reclassified patient Patient must have previously received treatment under the PBS S100 Growth Hormone Program (treatment) under a category other than short stature due to short stature homeobox (SHOX) gene disorders; AND The treatment must not have lapsed due to failure to respond to growth hormone at a dose of 9.5mg/m²/week or greater for the most recent treatment period (32 weeks for an initial or recommencement treatment period and 26 weeks for a continuing treatment period, whichever applies); OR The treatment must not have lapsed due to failure to respond to growth hormone at a dose of 9.5mg/m²/week or greater for the most recent treatment period (32 weeks for an initial or recommencement treatment period and 26 weeks for a continuing treatment period, whichever applies), unless response was affected by a significant medical illness; OR The treatment must not have lapsed due to failure to respond to growth hormone at a dose of 9.5mg/m²/week or greater for the most recent treatment period (32 weeks for an initial or recommencement treatment period and 26 weeks for a continuing treatment period, whichever applies), unless response was affected by major surgery (e.g. renal transplant); OR The treatment must not have lapsed due to failure to respond to growth hormone at a dose of 9.5mg/m²/week or greater for the most recent treatment period (32 weeks for an initial or recommencement treatment period and 26 weeks for a continuing treatment period, whichever applies), unless response was affected by an adverse reaction to growth hormone; OR The treatment must not have lapsed due to failure to respond to growth hormone at a dose of 9.5mg/m²/week or greater for the most recent treatment period (32 weeks for an initial or recommencement treatment period and 26 weeks for a continuing treatment period, whichever applies), unless response was affected by non-compliance due to social/family problems; AND Patient must have diagnostic results consistent with a SHOX mutation/deletion, defined as a karyotype confirming the presence of a SHOX mutation/deletion without the presence of mixed gonadal dysgenesis; OR Patient must have diagnostic results consistent with a SHOX mutation/deletion, defined as mixed gonadal dysgenesis (45X mosaic karyotype with the presence of any Y chromosome material and/or SRY gene positive by FISH study) and have an appropriate plan of management in place for the patient's increased risk of gonadoblastoma; AND Patient must have had a height at or below the 1^stpercentile for age and sex immediately prior to commencing treatment; OR Patient must have had a growth velocity below the 25^thpercentile for bone age and sex measured over the 12 month interval immediately prior to commencement of treatment (or the 6 month interval immediately prior to commencement of treatment if the patient was an older child at commencement of treatment); OR Patient must have had an annual growth velocity of 14 cm per year or less in the 12 month period immediately prior to commencement of treatment, if the patient had a chronological age of 2 years or less at commencement of treatment; OR Patient must have had an annual growth velocity of 8 cm per year or less in the 12 month period immediately prior to commencement of treatment, if the patient had a bone or chronological age of 2.5 years or less at commencement of treatment; AND Patient must not have diabetes mellitus; AND Patient must not have a condition with a known risk of malignancy including chromosomal abnormalities such as Down and Bloom syndromes (excluding gonadoblastoma secondary to mixed gonadal dysgenesis); AND Patient must not have an active tumour or evidence of tumour growth or activity; AND Patient must be male and must not have a height greater than or equal to 167.7cm; OR Patient must be female and must not have a height greater than or equal to 155.0cm; AND Patient must be male and must not have a bone age of 15.5 years or more; OR Patient must be female and must not have a bone age of 13.5 years or more. Patient must be aged 3 years or older. Must be treated by a medical practitioner in consultation with a nominated specialist or consultant physician in paediatric endocrinology; OR Must be treated by a medical practitioner in consultation with a nominated specialist or consultant physician in general paediatrics. An older child is defined as a male with a chronological age of at least 12 years or a bone age of at least 10 years, or a female with a chronological age of at least 10 years or a bone age of at least 8 years. The maximum duration of each continuing treatment phase is 26 weeks. Prescribers must determine an appropriate weekly dose in accordance with the dosing arrangements detailed in the National Health (Growth Hormone Program) Special Arrangement 2015 and request the appropriate number of vials/cartridges required to provide sufficient drug for 13 weeks' worth of treatment (with up to 1 repeat allowed). The authority application must be in writing and must include: 1. A completed authority prescription form; AND 2. A completed Growth Hormone Authority Application Supporting Information Form for continuing treatment as a reclassified patient; AND 3. A minimum of 12 months of growth data (height and weight measurements) from immediately prior to commencement of treatment, or a minimum of 6 months of growth data from immediately prior to commencement of treatment if the patient was an older child at commencement of treatment; and the result of a bone age assessment performed within the 12 months immediately prior to commencement of treatment (except for a patient whose chronological age was 2.5 years or less at commencement of treatment); AND 4. Confirmation that the patient has diagnostic results consistent with a short stature homeobox (SHOX) gene disorder; AND 5. If the patient's condition is secondary to mixed gonadal dysgenesis, confirmation that an appropriate plan of management for the patient's increased risk of gonadoblastoma is in place; AND 6. Growth data (height and weight) for the most recent 6 month treatment period, including data at both the start and end of the treatment period. The most recent data must not be older than three months; AND 7. A bone age result performed within the last 12 months; AND 8. The proprietary name (brand), form and strength of somatropin requested, and the number of vials/cartridges required to provide sufficient drug for 13 weeks' worth of treatment (with up to 1 repeat allowed). Prescribers must keep a copy of any clinical records relating to the prescription, including such records required to demonstrate that the prescription was written in compliance with any relevant circumstances and/or purposes. These records must be kept for 2 years after the date the prescription to which the records relate is written.	Compliance with Written Authority Required procedures

(c)insert in numerical order after existing text:

C9221	Short stature due to short stature homeobox (SHOX) gene disorders Continuing treatment as a reclassified patient Patient must have previously received treatment under the PBS S100 Growth Hormone Program (treatment) under a category other than short stature due to short stature homeobox (SHOX) gene disorders; AND The treatment must not have lapsed due to failure to respond to growth hormone at a dose of 9.5mg/m²/week or greater for the most recent treatment period (32 weeks for an initial or recommencement treatment period and 26 weeks for a continuing treatment period, whichever applies); OR The treatment must not have lapsed due to failure to respond to growth hormone at a dose of 9.5mg/m²/week or greater for the most recent treatment period (32 weeks for an initial or recommencement treatment period and 26 weeks for a continuing treatment period, whichever applies), unless response was affected by a significant medical illness; OR The treatment must not have lapsed due to failure to respond to growth hormone at a dose of 9.5mg/m²/week or greater for the most recent treatment period (32 weeks for an initial or recommencement treatment period and 26 weeks for a continuing treatment period, whichever applies), unless response was affected by major surgery (e.g. renal transplant); OR The treatment must not have lapsed due to failure to respond to growth hormone at a dose of 9.5mg/m²/week or greater for the most recent treatment period (32 weeks for an initial or recommencement treatment period and 26 weeks for a continuing treatment period, whichever applies), unless response was affected by an adverse reaction to growth hormone; OR The treatment must not have lapsed due to failure to respond to growth hormone at a dose of 9.5mg/m²/week or greater for the most recent treatment period (32 weeks for an initial or recommencement treatment period and 26 weeks for a continuing treatment period, whichever applies), unless response was affected by non-compliance due to social/family problems; AND Patient must have diagnostic results consistent with a SHOX mutation/deletion, defined as a karyotype confirming the presence of a SHOX mutation/deletion without the presence of mixed gonadal dysgenesis; OR Patient must have diagnostic results consistent with a SHOX mutation/deletion, defined as mixed gonadal dysgenesis (45X mosaic karyotype with the presence of any Y chromosome material and/or SRY gene positive by FISH study) and have an appropriate plan of management in place for the patient's increased risk of gonadoblastoma; AND Patient must have had a height at or below the 1^stpercentile for age and sex immediately prior to commencing treatment; AND Patient must have had a growth velocity below the 25^thpercentile for bone age and sex measured over the 12 month interval immediately prior to commencement of treatment (or the 6 month interval immediately prior to commencement of treatment if the patient was an older child at commencement of treatment); OR Patient must have had an annual growth velocity of 14 cm per year or less in the 12 month period immediately prior to commencement of treatment, if the patient had a chronological age of 2 years or less at commencement of treatment; OR Patient must have had an annual growth velocity of 8 cm per year or less in the 12 month period immediately prior to commencement of treatment, if the patient had a bone or chronological age of 2.5 years or less at commencement of treatment; AND Patient must not have diabetes mellitus; AND Patient must not have a condition with a known risk of malignancy including chromosomal abnormalities such as Down and Bloom syndromes (excluding gonadoblastoma secondary to mixed gonadal dysgenesis); AND Patient must not have an active tumour or evidence of tumour growth or activity; AND Patient must be male and must not have a height greater than or equal to 167.7cm; OR Patient must be female and must not have a height greater than or equal to 155.0cm; AND Patient must be male and must not have a bone age of 15.5 years or more; OR Patient must be female and must not have a bone age of 13.5 years or more. Must be treated by a medical practitioner in consultation with a nominated specialist or consultant physician in paediatric endocrinology; OR Must be treated by a medical practitioner in consultation with a nominated specialist or consultant physician in general paediatrics. An older child is defined as a male with a chronological age of at least 12 years or a bone age of at least 10 years, or a female with a chronological age of at least 10 years or a bone age of at least 8 years. The maximum duration of each continuing treatment phase is 26 weeks. Prescribers must determine an appropriate weekly dose in accordance with the dosing arrangements detailed in the National Health (Growth Hormone Program) Special Arrangement 2015 and request the appropriate number of vials/cartridges required to provide sufficient drug for 13 weeks' worth of treatment (with up to 1 repeat allowed). The authority application must be in writing and must include: 1. A completed authority prescription form; AND 2. A completed Growth Hormone Authority Application Supporting Information Form for continuing treatment as a reclassified patient; AND 3. A minimum of 12 months of growth data (height and weight measurements) from immediately prior to commencement of treatment, or a minimum of 6 months of growth data from immediately prior to commencement of treatment if the patient was an older child at commencement of treatment; and the result of a bone age assessment performed within the 12 months immediately prior to commencement of treatment (except for a patient whose chronological age was 2.5 years or less at commencement of treatment); AND 4. Confirmation that the patient has diagnostic results consistent with a short stature homeobox (SHOX) gene disorder; AND 5. If the patient's condition is secondary to mixed gonadal dysgenesis, confirmation that an appropriate plan of management for the patient's increased risk of gonadoblastoma is in place; AND 6. Growth data (height and weight) for the most recent 6 month treatment period, including data at both the start and end of the treatment period. The most recent data must not be older than three months; AND 7. A bone age result performed within the last 12 months (except for a patient whose chronological age is 2.5 years or less); AND 8. The proprietary name (brand), form and strength of somatropin requested, and the number of vials/cartridges required to provide sufficient drug for 13 weeks' worth of treatment (with up to 1 repeat allowed). Prescribers must keep a copy of any clinical records relating to the prescription, including such records required to demonstrate that the prescription was written in compliance with any relevant circumstances and/or purposes. These records must be kept for 2 years after the date the prescription to which the records relate is written.	Compliance with Written Authority Required procedures
C9257	Short stature due to short stature homeobox (SHOX) gene disorders Continuing treatment as a reclassified patient Patient must have previously received treatment under the PBS S100 Growth Hormone Program (treatment) under a category other than short stature due to short stature homeobox (SHOX) gene disorders; AND The treatment must not have lapsed due to failure to respond to growth hormone at a dose of 9.5mg/m²/week or greater for the most recent treatment period (32 weeks for an initial or recommencement treatment period and 26 weeks for a continuing treatment period, whichever applies); OR The treatment must not have lapsed due to failure to respond to growth hormone at a dose of 9.5mg/m²/week or greater for the most recent treatment period (32 weeks for an initial or recommencement treatment period and 26 weeks for a continuing treatment period, whichever applies), unless response was affected by a significant medical illness; OR The treatment must not have lapsed due to failure to respond to growth hormone at a dose of 9.5mg/m²/week or greater for the most recent treatment period (32 weeks for an initial or recommencement treatment period and 26 weeks for a continuing treatment period, whichever applies), unless response was affected by major surgery (e.g. renal transplant); OR The treatment must not have lapsed due to failure to respond to growth hormone at a dose of 9.5mg/m²/week or greater for the most recent treatment period (32 weeks for an initial or recommencement treatment period and 26 weeks for a continuing treatment period, whichever applies), unless response was affected by an adverse reaction to growth hormone; OR The treatment must not have lapsed due to failure to respond to growth hormone at a dose of 9.5mg/m²/week or greater for the most recent treatment period (32 weeks for an initial or recommencement treatment period and 26 weeks for a continuing treatment period, whichever applies), unless response was affected by non-compliance due to social/family problems; AND Patient must have diagnostic results consistent with a SHOX mutation/deletion, defined as a karyotype confirming the presence of a SHOX mutation/deletion without the presence of mixed gonadal dysgenesis; OR Patient must have diagnostic results consistent with a SHOX mutation/deletion, defined as mixed gonadal dysgenesis (45X mosaic karyotype with the presence of any Y chromosome material and/or SRY gene positive by FISH study) and have an appropriate plan of management in place for the patient's increased risk of gonadoblastoma; AND Patient must have had a height at or below the 1^stpercentile for age and sex immediately prior to commencing treatment; AND Patient must have had a growth velocity below the 25^thpercentile for bone age and sex measured over the 12 month interval immediately prior to commencement of treatment (or the 6 month interval immediately prior to commencement of treatment if the patient was an older child at commencement of treatment); OR Patient must have had an annual growth velocity of 14 cm per year or less in the 12 month period immediately prior to commencement of treatment, if the patient had a chronological age of 2 years or less at commencement of treatment; OR Patient must have had an annual growth velocity of 8 cm per year or less in the 12 month period immediately prior to commencement of treatment, if the patient had a bone or chronological age of 2.5 years or less at commencement of treatment; AND Patient must not have diabetes mellitus; AND Patient must not have a condition with a known risk of malignancy including chromosomal abnormalities such as Down and Bloom syndromes (excluding gonadoblastoma secondary to mixed gonadal dysgenesis); AND Patient must not have an active tumour or evidence of tumour growth or activity; AND Patient must be male and must not have a height greater than or equal to 167.7cm; OR Patient must be female and must not have a height greater than or equal to 155.0cm; AND Patient must be male and must not have a bone age of 15.5 years or more; OR Patient must be female and must not have a bone age of 13.5 years or more. Patient must be aged 3 years or older. Must be treated by a medical practitioner in consultation with a nominated specialist or consultant physician in paediatric endocrinology; OR Must be treated by a medical practitioner in consultation with a nominated specialist or consultant physician in general paediatrics. An older child is defined as a male with a chronological age of at least 12 years or a bone age of at least 10 years, or a female with a chronological age of at least 10 years or a bone age of at least 8 years. The maximum duration of each continuing treatment phase is 26 weeks. Prescribers must determine an appropriate weekly dose in accordance with the dosing arrangements detailed in the National Health (Growth Hormone Program) Special Arrangement 2015 and request the appropriate number of vials/cartridges required to provide sufficient drug for 13 weeks' worth of treatment (with up to 1 repeat allowed). The authority application must be in writing and must include: 1. A completed authority prescription form; AND 2. A completed Growth Hormone Authority Application Supporting Information Form for continuing treatment as a reclassified patient; AND 3. A minimum of 12 months of growth data (height and weight measurements) from immediately prior to commencement of treatment, or a minimum of 6 months of growth data from immediately prior to commencement of treatment if the patient was an older child at commencement of treatment; and the result of a bone age assessment performed within the 12 months immediately prior to commencement of treatment (except for a patient whose chronological age was 2.5 years or less at commencement of treatment); AND 4. Confirmation that the patient has diagnostic results consistent with a short stature homeobox (SHOX) gene disorder; AND 5. If the patient's condition is secondary to mixed gonadal dysgenesis, confirmation that an appropriate plan of management for the patient's increased risk of gonadoblastoma is in place; AND 6. Growth data (height and weight) for the most recent 6 month treatment period, including data at both the start and end of the treatment period. The most recent data must not be older than three months; AND 7. A bone age result performed within the last 12 months; AND 8. The proprietary name (brand), form and strength of somatropin requested, and the number of vials/cartridges required to provide sufficient drug for 13 weeks' worth of treatment (with up to 1 repeat allowed). Prescribers must keep a copy of any clinical records relating to the prescription, including such records required to demonstrate that the prescription was written in compliance with any relevant circumstances and/or purposes. These records must be kept for 2 years after the date the prescription to which the records relate is written.	Compliance with Written Authority Required procedures
C9300	Severe growth hormone deficiency Initial treatment Must be treated by an endocrinologist. Patient must have a documented childhood onset growth hormone deficiency due to a congenital, genetic or structural cause; OR Patient must have adult onset growth hormone deficiency secondary to organic hypothalamic or pituitary disease; AND Patient must have an insulin tolerance test with maximum serum growth hormone (GH) less than 2.5 micrograms per litre; OR Patient must have an arginine infusion test with maximum serum GH less than 0.4 micrograms per litre; OR Patient must have a glucagon provocation test with maximum serum GH less than 3 micrograms per litre. Patient must be aged 18 years or older. Grandfathered patient who has previously received non-PBS subsidised treatment with this drug for this condition prior to 1 December 2018 must have met all the initial restriction criteria prior to initiating non-PBS subsidised treatment. Additional information of a baseline serum IGF-1 measurement, including the date of testing and laboratory reference range for age and sex, of less than 12 weeks prior to initiating non-PBS subsidised treatment with this drug for this condition must be provided at the time of application. A Grandfathered patient may qualify for PBS-subsidised treatment under this restriction once only. For continuing PBS-subsidised treatment, a Grandfathered patient must qualify under the Continuing treatment criteria. The authority application must be in writing and must include: A completed authority prescription form; AND A completed Severe Growth Hormone Deficiency supporting information form; AND Confirmation of childhood onset growth hormone deficiency due to a congenital, genetic or structural cause; OR Confirmation of adult onset growth hormone deficiency due to organic hypothalamic or pituitary disease; AND Results of the growth hormone stimulation testing, including the date of testing, the type of test performed, the peak growth hormone concentration, and laboratory reference range for age/gender; AND A baseline serum IGF-1 measurement, including the date of testing and laboratory reference range for age and sex, of less than 12 weeks old at the time of application.	Compliance with Written Authority Required procedures
C9301	Severe growth hormone deficiency Continuing treatment Must be treated by an endocrinologist or in consultation with an endocrinologist. Patient must have previously received PBS-subsidised therapy with this drug for this condition at the age of 18 years or older; AND Patient must maintain IGF-1 levels within the normal range for age and sex. Patient must be aged 18 years or older. The authority application must be in writing and must include: A completed authority prescription form; AND A completed Severe Growth Hormone Deficiency supporting information form; AND A serum IGF-1 measurement, including the date of testing and laboratory reference range for age and sex, of less than 12 weeks old at the time of application.	Compliance with Written Authority Required procedures

Schedule 4, Part 1, entry for Sunitinib

(a)omit:

C8549

P8549

Stage IV clear cell variant renal cell carcinoma (RCC)
Initial treatment
The condition must be classified as favourable to intermediate risk according to the International Metastatic Renal Cell Carcinoma Database Consortium (IMDC); AND
Patient must have a WHO performance status of 2 or less; AND
The treatment must be the sole PBS-subsidised tyrosine kinase inhibitor therapy for this condition.
Patients who have developed progressive disease on pazopanib are not eligible to receive PBS-subsidised sunitinib.

Compliance with Authority Required procedures

(b)insert in numerical order after existing text:

C9210

P9210

Compliance with Authority Required procedures - Streamlined Authority Code 9210

Schedule 4, Part 1, entry for Thalidomide

(a)omit:

C5909

Multiple myeloma

Compliance with Authority Required procedures

(b)insert in numerical order after existing text:

C9290

Multiple myeloma

Compliance with Authority Required procedures - Streamlined Authority Code 9290

Schedule 4, Part 1, entry for Valaciclovir

(a)omit:

C5939

Cytomegalovirus infection and disease
Prophylaxis
Patient must have undergone a renal transplant; AND
Patient must be at risk of cytomegalovirus disease.

Compliance with Authority Required procedures

(b)insert in numerical order after existing text:

C9267

Cytomegalovirus infection and disease
Prophylaxis
Patient must have undergone a renal transplant; AND
Patient must be at risk of cytomegalovirus disease.

Compliance with Authority Required procedures - Streamlined Authority Code 9267

Schedule 4, Part 1, entry for Valganciclovir

(a)omit:

C5031

Cytomegalovirus infection and disease
Prophylaxis
Patient must be a solid organ transplant recipient at risk of cytomegalovirus disease.

Compliance with Authority Required procedures

(b)insert in numerical order after existing text:

C9316

Cytomegalovirus infection and disease
Prophylaxis
Patient must be a solid organ transplant recipient at risk of cytomegalovirus disease.

Compliance with Authority Required procedures - Streamlined Authority Code 9316

Schedule 4, Part 1, entry for Zoledronic acid

(a)omit:

C5606	Bone metastases The condition must be due to castration-resistant prostate cancer.	Compliance with Authority Required procedures
C5676	Multiple myeloma	Compliance with Authority Required procedures
C5677	Hypercalcaemia of malignancy Patient must have a malignancy refractory to anti-neoplastic therapy.	Compliance with Authority Required procedures

(b)omit:

C5736

Bone metastases
The condition must be due to breast cancer.

Compliance with Authority Required procedures

(c)insert in numerical order after existing text:

C9236	Hypercalcaemia of malignancy Patient must have a malignancy refractory to anti-neoplastic therapy.	Compliance with Authority Required procedures - Streamlined Authority Code 9236
C9268	Multiple myeloma	Compliance with Authority Required procedures - Streamlined Authority Code 9268
C9269	Multiple myeloma	Compliance with Authority Required procedures - Streamlined Authority Code 9269
C9270	Bone metastases The condition must be due to breast cancer.	Compliance with Authority Required procedures - Streamlined Authority Code 9270
C9291	Bone metastases The condition must be due to castration-resistant prostate cancer.	Compliance with Authority Required procedures - Streamlined Authority Code 9291
C9304	Bone metastases The condition must be due to castration-resistant prostate cancer.	Compliance with Authority Required procedures - Streamlined Authority Code 9304
C9317	Hypercalcaemia of malignancy Patient must have a malignancy refractory to anti-neoplastic therapy.	Compliance with Authority Required procedures - Streamlined Authority Code 9317
C9328	Bone metastases The condition must be due to breast cancer.	Compliance with Authority Required procedures - Streamlined Authority Code 9328

Schedule 5, omit entry for Macrogol 3350

Schedule 5, entry for Morphine in the form Injection containing morphine sulfate pentahydrate 10 mg in 1 mL [GRP-20890]

insert in alphabetical order in the column headed “Brand”: MORPHINE SULFATE 10 mg/1 mL MEDSURGE

Schedule 5, entry for Ramipril in the form Tablet 10 mg [GRP-15431]

(a)omit from the column headed “Brand”: Chem mart Ramipril

(b)omit from the column headed “Brand”: Terry White Chemists Ramipril

Schedule 5, entry for Zoledronic acid in the form Solution for I.V. infusion 4 mg (as monohydrate) in 100 mL [GRP-17614]

omit from the column headed “Brand”: Zoledronic Acid 4 mg/100 mL APOTEX