National Health (Listing of Pharmaceutical Benefits) Amendment Instrument 2016 (No. 2) (PB 11 of 2016)

Schedule 1 Amendments

[1] Section 4

insert after the definition of “extemporaneously‑prepared pharmaceutical benefit”:

General Statement for drugs for the treatment of hepatitis C means the statement set out in Part 3 of Schedule 4;

[2] Schedule 1, entry for Aciclovir

substitute:

Eye ointment 30 mg per g, 4.5 g	Application to the eye		AciVision	DZ	MP NP	C5965		1	0	1
					AO	C5964		1	0	1
			Zovirax	GK	MP NP	C5965		1	0	1
					AO	C5964		1	0	1
Tablet 200 mg	Oral	a	Aciclovir Sandoz	HX	MP NP	C5936 C5942	P5936	50	0	25
		a	Acyclo‑V 200	AF	MP NP	C5936 C5942	P5936	50	0	25
		a	GenRx Aciclovir	GX	MP NP	C5936 C5942	P5936	50	0	50
		a	Lovir	GN	MP NP	C5936 C5942	P5936	50	0	25
		a	Zovirax 200 mg	GK	MP NP	C5936 C5942	P5936	50	0	25
		a	Aciclovir 200	CR	MP NP	C5942		90	5	90
		a	Aciclovir GH	GQ	MP NP	C5942		90	5	90
		a	Aciclovir Sandoz	HX	MP NP	C5936 C5942	P5942	90	5	90
		a	Acyclo‑V 200	AF	MP NP	C5936 C5942	P5942	90	5	90
		a	Chem mart Aciclovir	CH	MP NP	C5942		90	5	90
		a	GenRx Aciclovir	GX	MP NP	C5936 C5942	P5942	90	5	90
		a	Lovir	GN	MP NP	C5936 C5942	P5942	90	5	90
		a	Ozvir	RA	MP NP	C5942		90	5	90
		a	Terry White Chemists Aciclovir	TW	MP NP	C5942		90	5	90
		a	Zovirax 200 mg	GK	MP NP	C5936 C5942	P5942	90	5	90
Tablet 800 mg	Oral	a	Aciclovir 800	CR	MP NP	C5959 C5967		35	0	35
		a	Aciclovir Sandoz	HX	MP NP	C5959 C5967		35	0	35
		a	Acyclo‑V 800	AF	MP NP	C5946 C5959 C5967	P5959 P5967	35	0	35
		a	GenRx Aciclovir	GX	MP NP	C5959 C5967		35	0	35
		a	Zovirax 800 mg	GK	MP NP	C5959 C5967		35	0	35
			Acyclo‑V 800	AF	MP NP	C5946 C5959 C5967	P5946	120	5	120

[3] Schedule 1, after entry for Amino acid formula with fat, carbohydrate, vitamins, minerals, and trace elements, without methionine and supplemented with docosahexanoic acid

insert:

Amino acid formula with fat, carbohydrate, vitamins, minerals and trace elements without phenylalanine	Bottles containing oral powder 34 g, 30 (PKU Easy Shake & Go)	Oral		PKU Easy Shake & Go	OH	MP NP	C5970		4	5	1

[4] Schedule 1, entry for Amino acid formula with fat, carbohydrate, vitamins, minerals, trace elements and medium chain triglycerides

insert in numerical order in the column headed “Circumstances”: C5945 C5974

[5] Schedule 1, entry for Amino acid synthetic formula supplemented with long chain polyunsaturated fatty acids and medium chain triglycerides in the form Oral powder 400 g (Alfamino)

insert in numerical order in the column headed “Circumstances”: C4415 C5945 C5974

[6] Schedule 1, entry for Amiodarone in the form Tablet containing amiodarone hydrochloride 200 mg

omit from the column headed “Responsible Person” for the brand “Rithmik 200”: QA substitute: RW

[7] Schedule 1, entry for Amisulpride in the form Tablet 400 mg

omit from the column headed “Responsible Person” for the brand “Amipride 400”: QA substitute: RW

[8] Schedule 1, entry for Amlodipine in each of the forms: Tablet 5 mg (as besylate); and Tablet 10 mg (as besylate)

omit:

				Amlodipine‑DRLA	RZ	MP NP			30	5	30

[9] Schedule 1, entry for Amoxycillin with Clavulanic Acid in the form Tablet containing 500 mg amoxycillin (as trihydrate) with 125 mg clavulanic acid (as potassium clavulanate)

(a) omit:

			a	Clamoxyl Duo	AL	PDP	C5833 C5894		10	0	10

(b) omit:

			a	Clamoxyl Duo	AL	MP NP MW	C5832 C5893		10	1	10

[10] Schedule 1, entry for Amoxycillin with Clavulanic Acid in the form Tablet containing 875 mg amoxycillin (as trihydrate) with 125 mg clavulanic acid (as potassium clavulanate)

(a) omit:

			a	Clamoxyl Duo forte	AL	PDP	C5833 C5894		10	0	10

(b) omit:

			a	Clamoxyl Duo forte	AL	MP NP	C5832 C5893		10	1	10

[11] Schedule 1, entry for Amoxycillin with Clavulanic Acid in the form Powder for oral suspension containing 125 mg amoxycillin (as trihydrate) with 31.25 mg clavulanic acid (as potassium clavulanate) per 5 mL, 75 mL

(a) omit:

				Clamoxyl	AL	PDP	C5833 C5894		1	0	1

(b) omit:

				Clamoxyl	AL	MP NP	C5832 C5893		1	1	1

[12] Schedule 1, entry for Amoxycillin with Clavulanic Acid in the form Powder for oral suspension containing 400 mg amoxycillin (as trihydrate) with 57 mg clavulanic acid (as potassium clavulanate) per 5 mL, 60 mL

(a) omit:

				Clamoxyl Duo 400	AL	PDP	C5833 C5894		1	0	1

(b) omit:

				Clamoxyl Duo 400	AL	MP NP	C5832 C5893		1	1	1

[13] Schedule 1, entry for Anastrozole

(a) omit:

				Anastrozole‑DRLA	RZ	MP NP	C5464		30	5	30

(b) omit:

				Pharmacy Choice Anastrozole	RI	MP NP	C5464		30	5	30

[14] Schedule 1, entry for Atenolol in the form Tablet 50 mg

omit from the column headed “Responsible Person” for the brand “Tensig”: QA substitute: RW

[15] Schedule 1, entry for Atorvastatin in each of the forms: Tablet 10 mg (as calcium); Tablet 20 mg (as calcium); Tablet 40 mg (as calcium); and Tablet 80 mg (as calcium)

omit from the column headed “Responsible Person” for the brands “Torvastat 10”, “Torvastat 20”, “Torvastat 40” and “Torvastat 80” respectively (all instances): QA substitute: RW

[16] Schedule 1, entry for Azathioprine in the form Tablet 50 mg

omit from the column headed “Responsible Person” for the brand “Azapin”: QA substitute: RW

[17] Schedule 1, entry for Cabergoline in the form Tablet 500 micrograms [Maximum Quantity: 2; Number of Repeats: 0]

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

			a	APO-Cabergoline	TX	MP	C5136 C5137 C5357 C5172 C5398	P5172	2	0	2
						NP	C5172		2	0	2

(b) insert in the column headed “Schedule Equivalent” for the brands “Dostan” and “Dostinex”: a

[18] Schedule 1, entry for Cabergoline in the form Tablet 500 micrograms [Maximum Quantity: 8; Number of Repeats: 5]

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

			a	APO-Cabergoline	TX	MP	C5136 C5137 C5357 C5172 C5398	P5136 P5137 P5357 P5398	8	5	8

(b) insert in the column headed “Schedule Equivalent” for the brands “Dostan” and “Dostinex”: a

[19] Schedule 1, entry for Calcipotriol with betamethasone in the form Gel containing calcipotriol 50 micrograms with betamethasone 500 micrograms (as dipropionate) per g, 30 g

omit from the column headed “Circumstances”: C3827 substitute: C5955

[20] Schedule 1, entry for Calcipotriol with betamethasone in the form Gel containing calcipotriol 50 micrograms with betamethasone 500 micrograms (as dipropionate) per g, 60 g

omit from the column headed “Circumstances”: C5465 substitute: C5963

[21] Schedule 1, entry for Calcitriol

omit from the column headed “Responsible Person” for the brand “Kosteo”: QA substitute: RW

[22] Schedule 1, entry for Candesartan in each of the forms: Tablet containing candesartan cilexetil 4 mg; Tablet containing candesartan cilexetil 8 mg; Tablet containing candesartan cilexetil 16 mg; and Tablet containing candesartan cilexetil 32 mg

omit from the column headed “Responsible Person” for the brands “Candesartan Aspen 4”, “Candesartan Aspen 8”, “Candesartan Aspen 16” and “Candesartan Aspen 32” respectively:
QA substitute: RW

[23] Schedule 1, entry for Candesartan with Hydrochlorothiazide in each of the forms: Tablet containing candesartan cilexetil 16 mg with hydrochlorothiazide 12.5 mg; Tablet containing candesartan cilexetil 32 mg with hydrochlorothiazide 12.5 mg; and Tablet containing candesartan cilexetil 32 mg with hydrochlorothiazide 25 mg

omit from the column headed “Responsible Person” for the brands “Candesartan Combi Aspen 16/12.5”, “Candesartan Combi Aspen 32/12.5” and
“Candesartan Combi Aspen 32/25” respectively: QA substitute: RW

[24] Schedule 1, entry for Carmustine

omit from the column headed “Responsible Person”: OA substitute: EI

[25] Schedule 1, entry for Carvedilol in each of the forms: Tablet 3.125 mg; Tablet 6.25 mg; Tablet 12.5 mg; and Tablet 25 mg

omit from the column headed “Responsible Person” for the brands “Vedilol 3.125”, “Vedilol 6.25”, “Vedilol 12.5” and “Vedilol 25” respectively:
QA substitute: RW

[26] Schedule 1, entry for Celecoxib in each of the forms: Capsule 100 mg; and Capsule 200 mg

omit from the column headed “Responsible Person” for the brand “Celexi”: QA substitute: RW

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

omit:

				Ciprofloxacin‑DRLA	RZ	MP NP	C5614 C5615 C5666 C5687 C5688 C5689 C5722 C5780		14	0	14

[28] Schedule 1, entry for Ciprofloxacin in each of the forms: Tablet 500 mg (as hydrochloride); and Tablet 750 mg (as hydrochloride)

omit:

				Ciprofloxacin‑DRLA	RZ	MP NP	C5614 C5615 C5687 C5688 C5689 C5722 C5780		14	0	14

[29] Schedule 1, entry for Citalopram in each of the forms: Tablet 10 mg (as hydrobromide); and Tablet 40 mg (as hydrobromide)

omit from the column headed “Responsible Person” for the brand “Talam”: QA substitute: RW

[30] Schedule 1, entry for Clindamycin

omit from the column headed “Responsible Person” for the brand “Calindamin”: QA substitute: RW

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

(a) omit from the column headed “Responsible Person” for the brand “Clovix 75”: QA substitute: RW
(b) omit from the column headed “Responsible Person” for the brand “Plidogrel”: FM substitute: RF

[32] Schedule 1, after entry for Dabrafenib in the form Capsule 75 mg (as mesilate)

insert:

Tablet 30 mg	Oral	Daklinza	BQ	MP	C5969 C5972	P5969	28	2	28
				MP	C5969 C5972	P5972	28	5	28
				MP	See Note 2	See Note 2	See Note 2	See Note 2	28	C(100)
Tablet 60 mg	Oral	Daklinza	BQ	MP	C5969 C5972	P5969	28	2	28
				MP	C5969 C5972	P5972	28	5	28
				MP	See Note 2	See Note 2	See Note 2	See Note 2	28	C(100)

[33] Schedule 1, entry for Diclofenac in each of the forms: Tablet (enteric coated) containing diclofenac sodium 25 mg; and Tablet (enteric coated) containing diclofenac sodium 50 mg

omit from the column headed “Responsible Person” for the brands “Clonac 25” and “Clonac 50” respectively: QA substitute: RW

[34] Schedule 1, entry for Dipyridamole with Aspirin

omit from the column headed “Responsible Person” for the brand “Diasp SR”: QA substitute: RW

[35] Schedule 1, entry for Doxorubicin – Pegylated Liposomal in each of the forms: Suspension for I.V. infusion containing pegylated liposomal doxorubicin hydrochloride 20 mg in 10 mL; and Suspension for I.V. infusion containing pegylated liposomal doxorubicin hydrochloride
50 mg in 25 mL

omit from the column headed “Responsible Person” for the brand “Liposomal Doxorubicin SUN”: ZF substitute: RA

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

omit from the column headed “Responsible Person” for the brand “Frakas”: QA substitute: RW

[37] Schedule 1, entry for Duloxetine in the form Capsule 30 mg (as hydrochloride)

(a) insert in the column headed “Schedule Equivalent” for all brands: a
(b) omit:

			a	Duloxetine-DRLA	RZ	MP NP	C1211		28	0	28

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

			a	Duloxetine Sandoz	HX	MP NP	C1211		28	0	28

[38] Schedule 1, entry for Duloxetine in the form Capsule 60 mg (as hydrochloride)

(a) insert in the column headed “Schedule Equivalent” for all brands: a
(b) omit:

			a	Duloxetine-DRLA	RZ	MP NP	C1211		28	5	28

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

			a	Duloxetine Sandoz	HX	MP NP	C1211		28	5	28

[39] Schedule 1, entry for Empagliflozin in each of the forms: Tablet 10 mg; and Tablet 25 mg

omit from the column headed “Circumstances”: C4848 substitute: C4983 C4991 C5629

[40] Schedule 1, after entry for Empagliflozin in the form Tablet 25 mg

insert:

Tablet containing 5 mg empagliflozin with 1 g metformin hydrochloride	Oral	Jardiamet 5 mg/1000 mg	BY	MP	C5657 C5798 C5953 C5966	60	5	60
				NP	C5657 C5798 C5966	60	5	60
Tablet containing 5 mg empagliflozin with 500 mg metformin hydrochloride	Oral	Jardiamet 5 mg/500 mg	BY	MP	C5657 C5798 C5953 C5966	60	5	60
				NP	C5657 C5798 C5966	60	5	60
Tablet containing 12.5 mg empagliflozin with 1 g metformin hydrochloride	Oral	Jardiamet 12.5 mg/1000 mg	BY	MP	C5657 C5798 C5953 C5966	60	5	60
				NP	C5657 C5798 C5966	60	5	60
Tablet containing 12.5 mg empagliflozin with 500 mg metformin hydrochloride	Oral	Jardiamet 12.5 mg/500 mg	BY	MP	C5657 C5798 C5953 C5966	60	5	60
				NP	C5657 C5798 C5966	60	5	60

[41] Schedule 1, entry for Famciclovir

substitute:

Tablet 125 mg	Oral	a	APO‑Famciclovir	TX	MP NP	C5937		40	1	40
		a	Auro-Famciclovir 125	DO	MP NP	C5937		40	1	40
		a	Ezovir	AF	MP NP	C5937		40	1	40
		a	Famciclovir AN	EA	MP NP	C5937		40	1	40
		a	Famciclovir‑GA	ED	MP NP	C5937		40	1	40
		a	Famvir	NV	MP NP	C5937		40	1	40
		a	Favic 125	QA	MP NP	C5937		40	1	40
Tablet 250 mg	Oral	a	APO‑Famciclovir	TX	MP NP	C5937 C5951 C5971	P5937	20	1	20
		a	Ezovir	AF	MP NP	C5937 C5951 C5971	P5937	20	1	20
		a	Famciclovir AN	EA	MP NP	C5937 C5951 C5971	P5937	20	1	20
		a	Famciclovir‑GA	ED	MP NP	C5937 C5951 C5971	P5937	20	1	20
		a	Famciclovir Sandoz	SZ	MP NP	C5937 C5951 C5971	P5937	20	1	20
		a	Famvir	NV	MP NP	C5937 C5951 C5971	P5937	20	1	20
		a	Favic 250	QA	MP NP	C5937 C5951 C5971	P5937	20	1	20
		a	APO‑Famciclovir	TX	MP NP	C5937 C5951 C5971	P5951	21	0	21
		a	Auro-Famciclovir 250	DO	MP NP	C5951 C5971	P5951	21	0	21
		a	Ezovir	AF	MP NP	C5937 C5951 C5971	P5951	21	0	21
		a	Famciclovir AN	EA	MP NP	C5937 C5951 C5971	P5951	21	0	21
		a	Famciclovir‑GA	ED	MP NP	C5937 C5951 C5971	P5951	21	0	21
		a	Famciclovir generichealth 250	GQ	MP NP	C5951 C5971	P5951	21	0	21
		a	Famciclovir Sandoz	SZ	MP NP	C5937 C5951 C5971	P5951	21	0	21
		a	Famciclovir SCP 250	CR	MP NP	C5951 C5971	P5951	21	0	21
		a	Famlo	RA	MP NP	C5951 C5971	P5951	21	0	21
		a	Famvir	NV	MP NP	C5937 C5951 C5971	P5951	21	0	21
		a	Favic 250	QA	MP NP	C5937 C5951 C5971	P5951	21	0	21
		a	APO‑Famciclovir	TX	MP NP	C5937 C5951 C5971	P5971	56	5	56
		a	Auro-Famciclovir 250	DO	MP NP	C5951 C5971	P5971	56	5	56
		a	Ezovir	AF	MP NP	C5937 C5951 C5971	P5971	56	5	56
		a	Famciclovir AN	EA	MP NP	C5937 C5951 C5971	P5971	56	5	56
		a	Famciclovir‑GA	ED	MP NP	C5937 C5951 C5971	P5971	56	5	56
		a	Famciclovir generichealth 250	GQ	MP NP	C5951 C5971	P5971	56	5	56
		a	Famciclovir Sandoz	SZ	MP NP	C5937 C5951 C5971	P5971	56	5	56
		a	Famciclovir SCP 250	CR	MP NP	C5951 C5971	P5971	56	5	56
		a	Famlo	RA	MP NP	C5951 C5971	P5971	56	5	56
		a	Famvir	NV	MP NP	C5937 C5951 C5971	P5971	56	5	56
		a	Favic 250	QA	MP NP	C5937 C5951 C5971	P5971	56	5	56
Tablet 500 mg	Oral	a	APO‑Famciclovir	TX	MP NP	C5943 C5947 C5948 C5949 C5954	P5943	30	0	30
		a	Auro-Famciclovir 500	DO	MP NP	C5943 C5947 C5948 C5949 C5954	P5943	30	0	30
		a	Chem mart Famciclovir	CH	MP NP	C5943 C5947 C5948 C5949 C5954	P5943	30	0	30
		a	Famciclovir AN	EA	MP NP	C5943 C5947 C5948 C5949 C5954	P5943	30	0	30
		a	Famciclovir Sandoz	SZ	MP NP	C5943 C5947 C5948 C5949 C5954	P5943	30	0	30
		a	Famvir	NV	MP NP	C5943 C5947 C5948 C5949 C5954	P5943	30	0	30
		a	Favic 500	QA	MP NP	C5943 C5947 C5948 C5949 C5954	P5943	30	0	30
		a	Terry White Chemists Famciclovir	TW	MP NP	C5943 C5947 C5948 C5949 C5954	P5943	30	0	30
		a	APO‑Famciclovir	TX	MP NP	C5943 C5947 C5948 C5949 C5954	P5947 P5948 P5949 P5954	56	5	56
		a	Auro-Famciclovir 500	DO	MP NP	C5943 C5947 C5948 C5949 C5954	P5947 P5948 P5949 P5954	56	5	56
		a	Chem mart Famciclovir	CH	MP NP	C5943 C5947 C5948 C5949 C5954	P5947 P5948 P5949 P5954	56	5	56
		a	Ezovir	AF	MP NP	C5947 C5948 C5949 C5954		56	5	56
		a	Famciclovir AN	EA	MP NP	C5943 C5947 C5948 C5949 C5954	P5947 P5948 P5949 P5954	56	5	56
		a	Famciclovir‑GA	ED	MP NP	C5947 C5948 C5949 C5954		56	5	56
		a	Famciclovir generichealth 500	GQ	MP NP	C5947 C5948 C5949 C5954		56	5	56
		a	Famciclovir Sandoz	SZ	MP NP	C5943 C5947 C5948 C5949 C5954	P5947 P5948 P5949 P5954	56	5	56
		a	Famvir	NV	MP NP	C5943 C5947 C5948 C5949 C5954	P5947 P5948 P5949 P5954	56	5	56
		a	Favic 500	QA	MP NP	C5943 C5947 C5948 C5949 C5954	P5947 P5948 P5949 P5954	56	5	56
		a	Terry White Chemists Famciclovir	TW	MP NP	C5943 C5947 C5948 C5949 C5954	P5947 P5948 P5949 P5954	56	5	56

[42] Schedule 1, entry for Fluvoxamine in each of the forms: Tablet containing fluvoxamine maleate 50 mg; and Tablet containing fluvoxamine maleate 100 mg

omit from the column headed “Responsible Person” for the brands “Faverin 50” and “Faverin 100” respectively: QA substitute: RW

[43] Schedule 1, entry for Folinic acid in the form Tablet containing calcium folinate equivalent to 15 mg folinic acid

substitute:

	Tablet containing calcium folinate equivalent to 15 mg folinic acid	Oral		Leucovorin Calcium (Hospira Pty Limited)	HH	MP	C5938		10	0	10
						MP	C5973		10	0	10		C(100)

[44] Schedule 1, entry for Galantamine in each of the forms: Capsule (prolonged release) 8 mg (as hydrobromide); Capsule (prolonged release) 16 mg (as hydrobromide); and Capsule (prolonged release) 24 mg (as hydrobromide)

omit from the column headed “Responsible Person” for the brand “Gamine XR”: QA substitute: RW

[45] Schedule 1, entry for Gemcitabine in each of the forms: Powder for I.V. infusion 200 mg (as hydrochloride); and Powder for I.V. infusion 1 g (as hydrochloride)

omit from the column headed “Responsible Person” for the brand “Gemcitabine Sun”: ZF substitute: RA

[46] Schedule 1, after entry for Glycomacropeptide and essential amino acids with vitamins and minerals in the form Sachets containing oral powder 49 g, 28 (Camino Pro Bettermilk)

insert in the columns in the order indicated:

	Sachets containing oral powder 49 g, 30 (Camino Pro Bettermilk)	Oral		Camino Pro Bettermilk	QH	MP NP	C4295		4	5	1

[47] Schedule 1, entry for Irbesartan in each of the forms: Tablet 75 mg; Tablet 150 mg; and Tablet 300 mg

omit:

				Irbesartan-DRLA	RZ	MP NP			30	5	30

[48] Schedule 1, entry for Irbesartan with Hydrochlorothiazide in each of the forms: Tablet 150 mg-12.5 mg; Tablet 300 mg-12.5 mg; and Tablet 300 mg-25 mg

omit from the column headed “Responsible Person” for the brands “KSART HCT 150/12.5”, “KSART HCT 300/12.5” and “KSART HCT 300/25” respectively: QA substitute: RW

[49] Schedule 1, entry for Lamotrigine in each of the forms: Tablet 5 mg; Tablet 25 mg; Tablet 50 mg; Tablet 100 mg; and Tablet 200 mg

omit:

				Lamogine	AF	MP NP	C5138		56	5	56

[50] Schedule 1, after entry for Latanoprost with timolol [Brand: Xamalol 50/5]

insert:

MP	C5944 C5969 C5972	P5944	28	1	28
MP	C5944 C5969 C5972	P5969	28	2	28
MP	C5944 C5969 C5972	P5972	28	5	28
MP	See Note 2	See Note 2	See Note 2	See Note 2	28	C(100)

[51] Schedule 1, entry for Leflunomide in each of the forms: Tablet 10 mg; and Tablet 20 mg

(a) insert in the column headed “Schedule Equivalent” for all brands: a
(b) insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:

			a	Leflunomide APOTEX	GX	MP	C5681 C5766		30	5	30

[52] Schedule 1, entry for Lercanidipine in each of the forms: Tablet containing lercanidipine hydrochloride 10 mg; and Tablet containing lercanidipine hydrochloride 20 mg

omit from the column headed “Responsible Person” for the brand “Lercan”: QA substitute: RW

[53] Schedule 1, entry for Letrozole

(a) omit:

				Letrozole‑DRLA	RZ	MP NP	C5464		30	5	30

(b) omit:

				Pharmacy Choice Letrozole	RI	MP NP	C5464		30	5	30

[54] Schedule 1, after entry for Leuprorelin in the form I.M. injection (modified release), powder for injection containing leuprorelin acetate
30 mg with diluent in pre-filled dual-chamber syringe

insert in the columns in the order indicated:

	I.M. injection (modified release), powder for injection containing leuprorelin acetate 45 mg with diluent in pre-filled dual-chamber syringe	Injection		Lucrin Depot 6-Month	VE	MP	C5646		1	0	1

[55] Schedule 1, entry for Levetiracetam in the form Tablet 250 mg

omit from the column headed “Responsible Person” for the brand “Levi 250”: FM substitute: RW

[56] Schedule 1, entry for Levetiracetam in the form Tablet 500 mg

(a) insert in the column headed “Schedule Equivalent” for all brands: a
(b) omit from the column headed “Brand”: Levetiracetam generichealth substitute: Levetiracetam GH
(c) omit from the column headed “Responsible Person” for the brand “Levi 500”: FM substitute: RW

[57] Schedule 1, entry for Levetiracetam in the form Tablet 1 g

omit from the column headed “Responsible Person” for the brand “Levi 1000”: FM substitute: RW

[58] Schedule 1, entry for Lisinopril in each of the forms: Tablet 5 mg; Tablet 10 mg; and Tablet 20 mg

omit:

				Lisinopril‑DRLA	RZ	MP NP			30	5	30

[59] Schedule 1, entry for Macrogol 3350 in the form Sachets containing powder for oral solution 13.125 g with electrolytes, 30

(a) omit from the column headed “Responsible Person” for the brand “Chemists’ Own Macrogol with Electrolytes” (all instances):  
FM substitute: RW
(b) omit from the column headed “Responsible Person” for the brand “Macrovic” (all instances): QA substitute: RF

[60] Schedule 1, entry for Memantine in the form Tablet containing memantine hydrochloride 10 mg

omit from the column headed “Responsible Person” for the brand “Memanxa”: QA substitute: RW

[61] Schedule 1, entry for Metformin in each of the forms: Tablet containing metformin hydrochloride 500 mg; and Tablet containing metformin hydrochloride 850 mg

omit from the column headed “Responsible Person” for the brands “Formet Aspen 500” and “Formet Aspen 850” respectively: AS substitute: RW

[62] Schedule 1, entry for Metoprolol in the form Tablet containing metoprolol tartrate 50 mg

(a) omit:

				Metatar	FM	MP NP			100	5	100

(b) omit from the column headed “Responsible Person” for the brand “Metrol 50”: QA substitute: RW
(c) omit:

				Metatar	FM	MP NP			60	5	60

[63] Schedule 1, entry for Metoprolol in the form Tablet containing metoprolol tartrate 100 mg

(a) omit:

				Metatar	FM	MP NP			60	5	60

(b) omit from the column headed “Responsible Person” for the brand “Metrol 100”: QA substitute: RW

[64] Schedule 1, entry for Metoprolol succinate in each of the forms: Tablet 23.75 mg (controlled release); Tablet 47.5 mg (controlled release); Tablet 95 mg (controlled release); and Tablet 190 mg (controlled release)

omit from the column headed “Responsible Person” for the brands “Metrol-XL 23.75”, “Metrol-XL 47.5”, “Metrol-XL 95” and “Metrol-XL 190” respectively:
QA substitute: RW

[65] Schedule 1, entry for Mirtazapine in each of the forms: Tablet 30 mg; and Tablet 45 mg

omit from the column headed “Responsible Person” for the brand “Mirtazon”: QA substitute: RW

[66] Schedule 1, entry for Montelukast in each of the forms: Tablet, chewable, 4 mg (as sodium); and Tablet, chewable, 5 mg (as sodium)

omit from the column headed “Responsible Person” for the brands “Respikast 4” and “Respikast 5” respectively:
QA substitute: RW

[67] Schedule 1, entry for Morphine in each of the forms: Tablet containing morphine sulfate 10 mg (controlled release); Tablet containing morphine sulfate 30 mg (controlled release); Tablet containing morphine sulfate 60 mg (controlled release); and Tablet containing morphine sulfate 100 mg (controlled release)

omit from the column headed “Responsible Person” for the brands “Momex SR 10”, “Momex SR 30”, “Momex SR 60” and “Momex SR 100” respectively:
QA substitute: RW

[68] Schedule 1, entry for Nifedipine in each of the forms: Tablet 30 mg (controlled release); and Tablet 60 mg (controlled release)

omit from the column headed “Responsible Person” for the brands “Addos XR 30” and “Addos XR 60” respectively: QA substitute: RW

[69] Schedule 1, entry for Nitrazepam

omit:

				Alodorm	AF	MP NP		P5661 P5684 P5770 P5771	50CN5661 CN5684 CN5770 CN5771	5CN5661 CN5684 CN5770 CN5771	25
				Mogadon	IA	MP NP		P5661 P5684 P5770 P5771	50CN5661 CN5684 CN5770 CN5771	5CN5661 CN5684 CN5770 CN5771	25

substitute:

			a	Alodorm	AF	MP NP		P5661 P5771 P5941 P5950	50CN5661 CN5771 CN5941 CN5950	5CN5661 CN5771 CN5941 CN5950	25
			a	Mogadon	IA	MP NP		P5661 P5771 P5941 P5950	50CN5661 CN5771 CN5941 CN5950	5CN5661 CN5771 CN5941 CN5950	25

[70] 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

omit from the column headed “Responsible Person” for the brand “Octreotide (SUN)”: ZF substitute: RA

[71] Schedule 1, entry for Olanzapine in the form Tablet 2.5 mg

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

				Olanzacor 2.5	CR	MP NP	C5856 C5869		28	5	28

(b) omit:

				Pharmacor Olanzapine 2.5	CR	MP NP	C5856 C5869		28	5	28

(c) omit:

				Pharmacy Choice Olanzapine	RI	MP NP	C5856 C5869		28	5	28

[72] Schedule 1, entry for Olanzapine in the form Tablet 5 mg

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

				Olanzacor 5	CR	MP NP	C5856 C5869		28	5	28

(b) omit:

				Pharmacor Olanzapine 5	CR	MP NP	C5856 C5869		28	5	28

(c) omit:

				Pharmacy Choice Olanzapine	RI	MP NP	C5856 C5869		28	5	28

[73] Schedule 1, entry for Olanzapine in the form Tablet 7.5 mg

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

				Olanzacor 7.5	CR	MP NP	C5856 C5869		28	5	28

(b) omit:

				Pharmacor Olanzapine 7.5	CR	MP NP	C5856 C5869		28	5	28

(c) omit:

				Pharmacy Choice Olanzapine	RI	MP NP	C5856 C5869		28	5	28

[74] Schedule 1, entry for Olanzapine in the form Tablet 10 mg

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

				Olanzacor 10	CR	MP NP	C5856 C5869		28	5	28

(b) omit:

				Pharmacor Olanzapine 10	CR	MP NP	C5856 C5869		28	5	28

(c) omit:

				Pharmacy Choice Olanzapine	RI	MP NP	C5856 C5869		28	5	28

[75] Schedule 1, entry for Olanzapine in each of the forms: Tablet 5 mg (orally disintegrating); and Tablet 10 mg (orally disintegrating)

omit:

				Pharmacy Choice Olanzapine ODT	RI	MP NP	C5856 C5869		28	5	28

[76] Schedule 1, entry for Omeprazole in the form Capsule 20 mg

omit from the column headed “Responsible Person” for the brand “Pemzo” (twice occurring): QA substitute: RW

[77] Schedule 1, entry for Oxaliplatin in the form Solution concentrate for I.V. infusion 50 mg in 10 mL

omit from the column headed “Responsible Person” for the brand “Oxaliplatin SUN”: ZF substitute: RA

[78] Schedule 1, entry for Oxaliplatin in the form Solution concentrate for I.V. infusion 100 mg in 20 mL

(a) omit:

				Oxaliplatin MYX	YN	MP			See Note 3	SeeNote 3	1		D(100)

(b) omit from the column headed “Responsible Person” for the brand “Oxaliplatin SUN”: ZF substitute: RA

[79] Schedule 1, entry for Oxaliplatin in the form Solution concentrate for I.V. infusion 200 mg in 40 mL

omit from the column headed “Responsible Person” for the brand “Oxaliplatin SUN”: ZF substitute: RA:

[80] Schedule 1, entry for Perindopril in the form Tablet containing perindopril erbumine 2 mg

omit:

				Indopril 2	QA	MP NP			30	5	30

[81] Schedule 1, entry for Perindopril in the form Tablet containing perindopril erbumine 4 mg

omit:

				Indopril 4	QA	MP NP			30	5	30

[82] Schedule 1, entry for Perindopril in the form Tablet containing perindopril erbumine 8 mg

omit:

				Indopril 8	QA	MP NP			30	5	30

[83] Schedule 1, entry for Phenoxybenzamine in the form Capsules containing phenoxybenzamine hydrochloride 10 mg, 30

omit from the column headed “Brand”: Dibenyline substitute: Amdipharm Mercury (Australia) Pty Limited

[84] Schedule 1, entry for Pramipexole in each of the forms: Tablet (extended release) containing pramipexole hydrochloride 375 micrograms; Tablet (extended release) containing pramipexole hydrochloride 750 micrograms; Tablet (extended release) containing pramipexole hydrochloride 1.5 mg; Tablet (extended release) containing pramipexole hydrochloride 2.25 mg; Tablet (extended release) containing pramipexole hydrochloride 3 mg; Tablet (extended release) containing pramipexole hydrochloride 3.75 mg; and Tablet (extended release) containing pramipexole hydrochloride 4.5 mg

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

			a	APO-Pramipexole ER	TX	MP NP	C5131		30	5	30

(b) insert in the column headed “Schedule Equivalent” for the brand “Sifrol ER” (all instances): a

[85] Schedule 1, after entry for Propylthiouracil

insert:

Protein formula with amino acids, carbohydrates, vitamins and minerals without phenylalanine, and supplemented with docosahexaenoic acid	Oral liquid 130 mL, 30 (PKU Easy)	Oral		PKU Easy	OH	MP NP	C5970		4	5	1

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

(a) omit:

				Pharmacy Choice Quetiapine	RI	MP NP	C4385 C4391 C4396		60	0	60

(b) omit from the column headed “Responsible Person” for the brand “Quetia 25”: FM substitute: RW
(c) omit from the column headed “Responsible Person” for the brand “Seronia 25”: QA substitute: RF

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

(a) omit:

				Pharmacy Choice Quetiapine	RI	MP NP	C4246 C5611 C5639		90	5	90

(b) omit from the column headed “Responsible Person” for the brand “Quetia 100”: FM substitute: RW

[88] Schedule 1, entry for Quetiapine in each of the forms: Tablet 200 mg (as fumarate); and Tablet 300 mg (as fumarate)

(a) omit:

				Pharmacy Choice Quetiapine	RI	MP NP	C4246 C5611 C5639		60	5	60

(b) omit from the column headed “Responsible Person” for the brands “Quetia 200” and “Quetia 300” respectively: FM substitute: RW

[89] Schedule 1, entry for Rabeprazole in each of the forms: Tablet containing rabeprazole sodium 10 mg (enteric coated); and Tablet containing rabeprazole sodium 20 mg (enteric coated)

omit from the column headed “Responsible Person” for the brand “Parbezol”: QA substitute: RW

[90] Schedule 1, entry for Ramipril in each of the forms: Tablet 2.5 mg; Tablet 5 mg; and Capsule 10 mg

omit from the column headed “Responsible Person” for the brands “Prilace 2.5”, “Prilace 5” and “Prilace 10” respectively: QA substitute: RW

[91] Schedule 1, after entry for Reteplase

insert:

Tablet 400 mg	Oral	Ibavyr	IX	MP	C5957 C5958	P5957	28	2	28
				MP	C5957 C5958	P5958	28	5	28
				MP	See Note 2	See Note 2	See Note 2	See Note 2	28	C(100)
Tablet 600 mg	Oral	Ibavyr	IX	MP	C5957 C5958	P5957	28	2	28
				MP	C5957 C5958	P5958	28	5	28
				MP	See Note 2	See Note 2	See Note 2	See Note 2	28	C(100)

[92] Schedule 1, entry for Ribavirin and Peginterferon Alfa-2a

substitute:

Pack containing 168 tablets ribavirin 200 mg and 4 pre‑filled syringes peginterferon alfa‑2a injection 135 micrograms	Injection/oral	Pegasys RBV	RO	MP	C4184 C4185 C4187 C4188 C4193 C4197 C4206 C4207		2	5	1	PB(100)
Pack containing 112 tablets ribavirin 200 mg and 4 pre‑filled syringes peginterferon alfa‑2a injection 180 micrograms	Injection/oral	Pegasys RBV	RO	MP	C4184 C4185 C4187 C4188 C4193 C4197 C4206 C4207		2	5	1	PB(100)
Pack containing 140 tablets ribavirin 200 mg and 4 pre-filled syringes peginterferon alfa-2a injection 180 micrograms	Injection/oral	Pegasys RBV	RO	MP	C4184 C4185 C4187 C4188 C4193 C4197 C4206 C4207 C5956	P5956	1	2	1
				MP	See Note 2	See Note 2	See Note 2	See Note 2	1	C(100)
				MP	C4184 C4185 C4187 C4188 C4193 C4197 C4206 C4207 C5956	P4184 P4185 P4187 P4188 P4193 P4197 P4206 P4207	2	5	1	C(100)
Pack containing 168 tablets ribavirin 200 mg and 4 pre-filled syringes peginterferon alfa-2a injection 180 micrograms	Injection/oral	Pegasys RBV	RO	MP	C4184 C4185 C4187 C4188 C4193 C4197 C4206 C4207 C5956	P5956	1	2	1
				MP	See Note 2	See Note 2	See Note 2	See Note 2	1	C(100)
				MP	C4184 C4185 C4187 C4188 C4193 C4197 C4206 C4207 C5956	P4184 P4185 P4187 P4188 P4193 P4197 P4206 P4207	2	5	1	C(100)

[93] Schedule 1, entry for Risperidone in the form Tablet 0.5 mg

(a) omit:

				Risperidone‑DRLA	RZ	MP NP	C5902 C5903 C5908 C5911	P5902 P5908 P5911	60	2	60

(b) omit:

				Risperidone‑DRLA	RZ	MP NP	C5902 C5903 C5908 C5911	P5903	60	5	60

[94] Schedule 1, entry for Risperidone in the form Tablet 1 mg

(a) omit:

				Risperidone‑DRLA	RZ	MP NP	C4246 C5897 C5898 C5907 C5916	P5897 P5898 P5916	60	2	60

(b) omit:

				Risperidone‑DRLA	RZ	MP NP	C4246 C5897 C5898 C5907 C5916	P4246 P5907	60	5	60

[95] Schedule 1, entry for Risperidone in the form Tablet 2 mg

(a) omit:

				Risperidone‑DRLA	RZ	MP NP	C4246 C5898 C5907 C5916	P5898 P5916	60	2	60

(b) omit:

				Risperidone‑DRLA	RZ	MP NP	C4246 C5898 C5907 C5916	P4246 P5907	60	5	60

[96] Schedule 1, entry for Risperidone in the form Tablet 3 mg

omit:

				Risperidone‑DRLA	RZ	MP NP	C4246 C5907		60	5	60

[97] Schedule 1, entry for Risperidone in the form Tablet 4 mg

omit:

				Risperidone‑DRLA	RZ	MP NP	C4246 C5907		60	5	60

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

(a) insert in the column headed “Schedule Equivalent” for all brands: a
(b) insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:

			a	Rosuvastatin AMNEAL	EF	MP	C4225 C4226 C4238 C4263	P4226 P4263	30	5	30
						NP	C4226 C4263		30	5	30

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

(a) insert in the column headed “Schedule Equivalent” for all brands: a
(b) insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:

			a	Rosuvastatin AMNEAL	EF	MP	C4225 C4226 C4238 C4263	P4225 P4238	30	11	30

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

(a) insert in the column headed “Schedule Equivalent” for all brands: a
(b) insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:

			a	Rosuvastatin AMNEAL	EF	MP	C4225 C4226 C4238 C4263	P4226 P4263	30	5	30
						NP	C4226 C4263		30	5	30

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

(a) insert in the column headed “Schedule Equivalent” for all brands: a
(b) insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:

			a	Rosuvastatin AMNEAL	EF	MP	C4225 C4226 C4238 C4263	P4225 P4238	30	11	30

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

(a) insert in the column headed “Schedule Equivalent” for all brands: a
(b) insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:

			a	Rosuvastatin AMNEAL	EF	MP	C4225 C4226 C4238 C4263	P4226 P4263	30	5	30
						NP	C4226 C4263		30	5	30

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

(a) insert in the column headed “Schedule Equivalent” for all brands: a
(b) insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:

			a	Rosuvastatin AMNEAL	EF	MP	C4225 C4226 C4238 C4263	P4225 P4238	30	11	30

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

(a) insert in the column headed “Schedule Equivalent” for all brands: a
(b) insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:

			a	Rosuvastatin AMNEAL	EF	MP	C4225 C4226 C4238 C4263	P4226 P4263	30	5	30
						NP	C4226 C4263		30	5	30

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

(a) insert in the column headed “Schedule Equivalent” for all brands: a
(b) insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:

			a	Rosuvastatin AMNEAL	EF	MP	C4225 C4226 C4238 C4263	P4225 P4238	30	11	30

[106] Schedule 1, entry for Sertraline in each of the forms: Tablet 50 mg (as hydrochloride); and Tablet 100 mg (as hydrochloride)

omit:

				Sertraline‑DRLA	RZ	MP NP	C1211		30	5	30

[107] Schedule 1, entry for Simeprevir

omit from the column headed “Circumstances”: C4758 C4759

[108] Schedule 1, entry for Simvastatin in the form Tablet 10 mg

(a) omit:

				Simvastatin‑DRLA	RZ	MP	C1540 C3047	P1540	30	5	30
						NP	C1540		30	5	30

(b) omit:

				Simvastatin‑DRLA	RZ	MP	C1540 C3047	P3047	30	11	30

[109] Schedule 1, entry for Simvastatin in the form Tablet 20 mg

(a) omit:

				Simvastatin‑DRLA	RZ	MP	C1540 C3047	P1540	30	5	30
						NP	C1540		30	5	30

(b) omit:

				Simvastatin‑DRLA	RZ	MP	C1540 C3047	P3047	30	11	30

[110] Schedule 1, entry for Simvastatin in the form Tablet 40 mg

(a) omit:

				Simvastatin‑DRLA	RZ	MP	C1540 C3047	P1540	30	5	30
						NP	C1540		30	5	30

(b) omit:

				Simvastatin‑DRLA	RZ	MP	C1540 C3047	P3407	30	11	30

[111] Schedule 1, entry for Simvastatin in the form Tablet 80 mg

(a) omit:

				Simvastatin‑DRLA	RZ	MP	C1540 C3047	P1540	30	5	30
						NP	C1540		30	5	30

(b) omit:

				Simvastatin‑DRLA	RZ	MP	C1540 C3047	P3047	30	11	30

[112] Schedule 1, after entry for Sodium Lactate Compound

insert:

Sofosbuvir	Tablet 400 mg	Oral		Sovaldi	GI	MP	C5969 C5972	P5969	28	2	28
						MP	C5969 C5972	P5972	28	5	28
						MP	See Note 2	See Note 2	See Note 2	See Note 2	28		C(100)

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

(a) omit:

				Sumatab	AF	MP NP	C5259		4	5	2

(b) omit from the column headed “Responsible Person” for the brand “Sumatran” (twice occurring): QA substitute: OW

[114] Schedule 1, entry for Temazepam

omit:

APO‑Temazepam	TX	MP NP	P5661 P5684 P5770	50CN5661 CN5684 CN5770	5CN5661 CN5684 CN5770	25
Normison	QA	MP NP	P5661 P5684 P5770	50CN5661 CN5684 CN5770	5CN5661 CN5684 CN5770	25
Temaze	AF	MP NP	P5661 P5684 P5770	50CN5661 CN5684 CN5770	5CN5661 CN5684 CN5770	25
Temtabs	FM	MP NP	P5661 P5684 P5770	50CN5661 CN5684 CN5770	5CN5661 CN5684 CN5770	25

substitute:

APO‑Temazepam	TX	MP NP	P5661 P5941 P5950	50CN5661 CN5941 CN5950	5CN5661 CN5941 CN5950	25
Normison	QA	MP NP	P5661 P5941 P5950	50CN5661 CN5941 CN5950	5CN5661 CN5941 CN5950	25
Temaze	AF	MP NP	P5661 P5941 P5950	50CN5661 CN5941 CN5950	5CN5661 CN5941 CN5950	25
Temtabs	FM	MP NP	P5661 P5941 P5950	50CN5661 CN5941 CN5950	5CN5661 CN5941 CN5950	25

[115] Schedule 1, entry for Terbinafine in the form Tablet 250 mg (as hydrochloride)

(a) omit:

				Pharmacy Choice Terbinafine	RI	MP NP	C2191 C2865 C3244	P2865 P3244	42	0	42

(b) omit:

				Pharmacy Choice Terbinafine	RI	MP NP	C2191 C2865 C3244	P2191	42	1	42

[116] Schedule 1, entry for Ursodeoxycholic Acid

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

			a	Ursodox GH	GQ	MP NP	C5757		200	2	100

(b) insert in the column headed “Schedule Equivalent” for the brands “Ursofalk” and “Ursosan”: a

[117] Schedule 1, entry for Valaciclovir

substitute:

a	APO‑Valaciclovir	TX	MP NP	C5940 C5960 C5961 C5962 C5968	P5960	20	0	10
a	Vaclovir	AF	MP NP	C5940 C5960 C5961 C5962 C5968	P5960	20	0	10
a	Valaciclovir Actavis	ED	MP NP	C5940 C5960 C5961 C5962 C5968	P5960	20	0	10
a	Valaciclovir AN	EA	MP NP	C5940 C5960 C5961 C5962 C5968	P5960	20	0	10
a	Valaciclovir GA	GN	MP NP	C5940 C5960 C5961 C5962 C5968	P5960	20	0	10
a	Valaciclovir Sandoz	SZ	MP NP	C5960 C5961 C5962 C5968	P5960	20	0	10
a	Valnir	QA	MP NP	C5940 C5960 C5961 C5962 C5968	P5960	20	0	10
a	Valtrex	AS	MP NP	C5940 C5960 C5961 C5962 C5968	P5960	20	0	10
a	Zelitrex	FM	MP NP	C5940 C5960 C5961 C5962 C5968	P5960	20	0	10
a	APO‑Valaciclovir	TX	MP NP	C5940 C5960 C5961 C5962 C5968	P5940 P5961	30	5	30
a	Chem mart Valaciclovir	CH	MP NP	C5940 C5961 C5962 C5968	P5940 P5961	30	5	30
a	Shilova 500	DO	MP NP	C5940 C5961		30	5	30
a	Terry White Chemists Valaciclovir	TW	MP NP	C5940 C5961 C5962 C5968	P5940 P5961	30	5	30
a	Vaclovir	AF	MP NP	C5940 C5960 C5961 C5962 C5968	P5940 P5961	30	5	30
a	Valaciclovir Actavis	ED	MP NP	C5940 C5960 C5961 C5962 C5968	P5940 P5961	30	5	30
a	Valaciclovir AN	EA	MP NP	C5940 C5960 C5961 C5962 C5968	P5940 P5961	30	5	30
a	Valaciclovir GA	GN	MP NP	C5940 C5960 C5961 C5962 C5968	P5940 P5961	30	5	30
a	Valaciclovir generichealth	GQ	MP NP	C5940 C5961 C5962 C5968	P5940 P5961	30	5	30
a	Valaciclovir RBX	RA	MP NP	C5940 C5961 C5962 C5968	P5940 P5961	30	5	30
a	Valaciclovir Sandoz	SZ	MP NP	C5960 C5961 C5962 C5968	P5961	30	5	30
a	Valaciclovir SZ	HX	MP NP	C5940 C5961		30	5	30
a	Valacor 500	CR	MP NP	C5940 C5961 C5962 C5968	P5940 P5961	30	5	30
a	Valnir	QA	MP NP	C5940 C5960 C5961 C5962 C5968	P5940 P5961	30	5	30
a	Valtrex	AS	MP NP	C5940 C5960 C5961 C5962 C5968	P5940 P5961	30	5	30
a	Zelitrex	FM	MP NP	C5940 C5960 C5961 C5962 C5968	P5940 P5961	30	5	30
a	APO‑Valaciclovir	TX	MP NP	C5940 C5960 C5961 C5962 C5968	P5962 P5968	42	0	42
a	Chem mart Valaciclovir	CH	MP NP	C5940 C5961 C5962 C5968	P5962 P5968	42	0	42
a	Terry White Chemists Valaciclovir	TW	MP NP	C5940 C5961 C5962 C5968	P5962 P5968	42	0	42
a	Vaclovir	AF	MP NP	C5940 C5960 C5961 C5962 C5968	P5962 P5968	42	0	42
a	Valaciclovir Actavis	ED	MP NP	C5940 C5960 C5961 C5962 C5968	P5962 P5968	42	0	42
a	Valaciclovir AN	EA	MP NP	C5940 C5960 C5961 C5962 C5968	P5962 P5968	42	0	42
a	Valaciclovir GA	GN	MP NP	C5940 C5960 C5961 C5962 C5968	P5962 P5968	42	0	42
a	Valaciclovir generichealth	GQ	MP NP	C5940 C5961 C5962 C5968	P5962 P5968	42	0	42
a	Valaciclovir RBX	RA	MP NP	C5940 C5961 C5962 C5968	P5962 P5968	42	0	42
a	Valaciclovir Sandoz	SZ	MP NP	C5960 C5961 C5962 C5968	P5962 P5968	42	0	42
a	Valacor 500	CR	MP NP	C5940 C5961 C5962 C5968	P5962 P5968	42	0	42
a	Valnir	QA	MP NP	C5940 C5960 C5961 C5962 C5968	P5962 P5968	42	0	42
a	Valtrex	AS	MP NP	C5940 C5960 C5961 C5962 C5968	P5962 P5968	42	0	42
a	Zelitrex	FM	MP NP	C5940 C5960 C5961 C5962 C5968	P5962 P5968	42	0	42
a	APO‑Valaciclovir	TX	MP	C5939 C5975		500	2	100	C(100)
a	Valaciclovir RBX	RA	MP	C5939 C5975		500	2	100	C(100)
a	Valtrex	AS	MP	C5939 C5975		500	2	100	C(100)
a	Zelitrex	FM	MP	C5939 C5975		500	2	100	C(100)

[118] Schedule 1, entry for Voriconazole in the form Tablet 50 mg [Maximum Quantity: 56; Number of Repeats: 0]

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

			a	Vttack	AF	MP NP	C4683 C4685 C5692 C5725 C5748	P4685	56	0	56

[119] Schedule 1, entry for Voriconazole in the form Tablet 50 mg [Maximum Quantity: 56; Number of Repeats: 2]

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

			a	Vttack	AF	MP NP	C4683 C4685 C5692 C5725 C5748	P4683 P5692 P5725 P5748	56	2	56

[120] Schedule 1, entry for Voriconazole in the form Tablet 200 mg [Maximum Quantity: 56; Number of Repeats: 0]

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

			a	Vttack	AF	MP NP	C4683 C4685 C5692 C5725 C5748	P4685	56	0	56

[121] Schedule 1, entry for Voriconazole in the form Tablet 200 mg [Maximum Quantity: 56; Number of Repeats: 2]

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

			a	Vttack	AF	MP NP	C4683 C4685 C5692 C5725 C5748	P4683 P5692 P5725 P5748	56	2	56

[122] Schedule 1, entry for Zolmitriptan

omit from the column headed “Responsible Person” for the brand “Zoltrip”: QA substitute: RW

[123] Schedule 3, after details relevant to Responsible Person code OE

insert:

OH	Orpharma Pty Ltd	19 157 901 267

[124] Schedule 3

omit:

ZF	Sun Pharmaceutical Industries (Australia) Pty Ltd	64 130119603

[125] Schedule 4, Part 1, entry for Aciclovir

substitute:

C5936	P5936	Initial moderate to severe genital herpesMicrobiological confirmation of diagnosis [viral culture, antigen detection or nucleic acid amplification by polymerase chain reaction (PCR)] is desirable but need not delay treatment.	Compliance with Authority Required procedures - Streamlined Authority Code 5936
C5942	P5942	Recurrent moderate to severe genital herpesEpisodic treatment or suppressive therapyMicrobiological confirmation of diagnosis [viral culture, antigen detection or nucleic acid amplification by polymerase chain reaction (PCR)] is desirable but need not delay treatment.	Compliance with Authority Required procedures - Streamlined Authority Code 5942
C5946	P5946	Advanced human immunodeficiency virus (HIV) diseasePatient must have CD4 cell counts of less than 150 million per litre.	Compliance with Authority Required procedures - Streamlined Authority Code 5946
C5959	P5959	Herpes zoster ophthalmicus	Compliance with Authority Required procedures - Streamlined Authority Code 5959
C5964		Herpes simplex keratitis
C5965		Herpes simplex keratitis
C5967	P5967	Herpes zosterThe treatment must be administered within 72 hours of the onset of the rash.	Compliance with Authority Required procedures - Streamlined Authority Code 5967

[126] Schedule 4, Part 1, after entry for Amino acid formula with fat, carbohydrate, vitamins, minerals, and trace elements, without methionine and supplemented with docosahexanoic acid

insert:

Amino acid formula with fat, carbohydrate, vitamins, minerals and trace elements without phenylalanine	C5970			Phenylketonuria

[127] Schedule 4, Part 1, entry for Amino acid formula with fat, carbohydrate, vitamins, minerals, trace elements and medium chain triglycerides

insert in numerical order:

	C5945			Eosinophilic oesophagitisInitial treatment for up to 3 monthsPatient must require an amino acid based formula as a component of a dietary elimination program.Patient must be 18 years of age or less.Must be treated by a clinical immunologist, suitably qualified allergist or gastroenterologist.Treatment with oral steroids should not be commenced during the period of initial treatment.Eosinophilic oesophagitis is demonstrated by the following criteria:(i) Chronic symptoms of reflux that persisted despite a 2-month trial of a proton pump inhibitor or chronic dysphagia; and(ii) A lack of demonstrable anatomic abnormality with the exception of stricture, which can be attributable to eosinophilic oesophagitis; and(iii) Eosinophilic infiltration of the oesophagus, demonstrated by oesophageal biopsy specimens obtained by endoscopy and where the most densely involved oesophageal biopsy had 20 or more eosinophils in any single 400 x high powered field, along with normal antral and duodenal biopsies.The date of birth of the patient must be included in the authority application.	Compliance with Authority Required procedures
	C5974			Eosinophilic oesophagitisContinuing treatmentPatient must have responded to an initial course of PBS-subsidised treatment.Patient must be 18 years of age or less.Must be treated by a clinical immunologist, suitably qualified allergist or gastroenterologist.Response to initial treatment is demonstrated by oesophageal biopsy specimens obtained by endoscopy, where the most densely involved oesophageal biopsy had 5 or less eosinophils in any single 400 x high powered field, along with normal antral and duodenal biopsies. The response criteria will not be deemed to have been met if oral steroids were commenced during initial treatment.	Compliance with Authority Required procedures

[128] Schedule 4, Part 1, entry for Amino acid synthetic formula supplemented with long chain polyunsaturated fatty acids and medium chain triglycerides

insert in numerical order:

	C4415			Severe intestinal malabsorption including short bowel syndromePatient must have failed to respond to protein hydrolysate formulae; ORPatient must have been receiving parenteral nutrition.	Compliance with Authority Required procedures
	C5945			Eosinophilic oesophagitisInitial treatment for up to 3 monthsPatient must require an amino acid based formula as a component of a dietary elimination program.Patient must be 18 years of age or less.Must be treated by a clinical immunologist, suitably qualified allergist or gastroenterologist.Treatment with oral steroids should not be commenced during the period of initial treatment.Eosinophilic oesophagitis is demonstrated by the following criteria:(i) Chronic symptoms of reflux that persisted despite a 2-month trial of a proton pump inhibitor or chronic dysphagia; and(ii) A lack of demonstrable anatomic abnormality with the exception of stricture, which can be attributable to eosinophilic oesophagitis; and(iii) Eosinophilic infiltration of the oesophagus, demonstrated by oesophageal biopsy specimens obtained by endoscopy and where the most densely involved oesophageal biopsy had 20 or more eosinophils in any single 400 x high powered field, along with normal antral and duodenal biopsies.The date of birth of the patient must be included in the authority application.	Compliance with Authority Required procedures
	C5974			Eosinophilic oesophagitisContinuing treatmentPatient must have responded to an initial course of PBS-subsidised treatment.Patient must be 18 years of age or less.Must be treated by a clinical immunologist, suitably qualified allergist or gastroenterologist.Response to initial treatment is demonstrated by oesophageal biopsy specimens obtained by endoscopy, where the most densely involved oesophageal biopsy had 5 or less eosinophils in any single 400 x high powered field, along with normal antral and duodenal biopsies. The response criteria will not be deemed to have been met if oral steroids were commenced during initial treatment.	Compliance with Authority Required procedures

[129] Schedule 4, Part 1, entry for Calcipotriol with betamethasone

(a) omit:

	C3827			Chronic stable plaque type psoriasis vulgaris of the scalp in a patient who is not adequately controlled with either calcipotriol or potent topical corticosteroid monotherapy
	C5465	P5465	CN5465	Chronic stable plaque type psoriasis vulgarisThe condition must be on the patient's scalp; ANDThe condition must be inadequately controlled with either a vitamin D analogue or potent topical corticosteroid as monotherapy; ANDPatient must require more than 30 grams of the product per month.	Compliance with Authority Required procedures - Streamlined Authority Code 5465

(b) insert in numerical order after existing text:

	C5955			Chronic stable plaque type psoriasis vulgarisThe condition must be inadequately controlled with either a vitamin D analogue or potent topical corticosteroid as monotherapy.
	C5963			Chronic stable plaque type psoriasis vulgarisThe condition must be inadequately controlled with either a vitamin D analogue or potent topical corticosteroid as monotherapy; ANDPatient must require more than 30 grams of product per month.	Compliance with Authority Required procedures - Streamlined Authority Code 5963

[130] Schedule 4, Part 1, after entry for Dabrafenib

insert:

Daclatasvir	C5969	P5969		Chronic hepatitis C infectionPatient must meet the criteria set out in the General Statement for Drugs for the Treatment of Hepatitis C; ANDPatient must be taking this drug as part of a regimen set out in the matrix in the General Statement for Drugs for the Treatment of Hepatitis C, based on the hepatitis C virus genotype, patient treatment history and cirrhotic status; ANDThe treatment must be limited to a maximum duration of 12 weeks.	Compliance with Written or Telephone Authority Required procedures
	C5972	P5972		Chronic hepatitis C infectionPatient must meet the criteria set out in the General Statement for Drugs for the Treatment of Hepatitis C; ANDPatient must be taking this drug as part of a regimen set out in the matrix in the General Statement for Drugs for the Treatment of Hepatitis C, based on the hepatitis C virus genotype, patient treatment history and cirrhotic status; ANDThe treatment must be limited to a maximum duration of 24 weeks.	Compliance with Written or Telephone Authority Required procedures

[131] Schedule 4, Part 1, entry for Empagliflozin

substitute:

Empagliflozin	C4983			Diabetes mellitus type 2The treatment must be in combination with metformin; ORThe treatment must be in combination with a sulfonylurea; ANDPatient must have, or have had, a HbA1c measurement greater than 7% despite treatment with either metformin or a sulfonylurea; ORPatient must have, or have had, where HbA1c measurement is clinically inappropriate, blood glucose levels greater than 10 mmol per L in more than 20% of tests over a 2 week period despite treatment with either metformin or a sulfonylurea.The date and level of the qualifying HbA1c measurement must be, or must have been, documented in the patient's medical records at the time treatment with a dipeptidyl peptidase 4 inhibitor (gliptin), a thiazolidinedione (glitazone), a glucagon-like peptide-1 or a sodium-glucose co-transporter 2 (SGLT2) inhibitor is initiated.The HbA1c must be no more than 4 months old at the time treatment with a gliptin, a glitazone, a glucagon-like peptide-1 or an SGLT2 inhibitor was initiated.Blood glucose monitoring may be used as an alternative assessment to HbA1c levels in the following circumstances:(a) A clinical condition with reduced red blood cell survival, including haemolytic anaemias and haemoglobinopathies; and/or(b) Had red cell transfusion within the previous 3 months.The results of the blood glucose monitoring, which must be no more than 4 months old at the time of initiation of treatment with a gliptin, a glitazone, a glucagon-like peptide-1 or an SGLT2 inhibitor, must be documented in the patient's medical records.A patient whose diabetes was previously demonstrated unable to be controlled with metformin or a sulfonylurea does not need to requalify on this criterion before being eligible for PBS-subsidised treatment with this drug.	Compliance with Authority Required procedures - Streamlined Authority Code 4983
	C4991			Diabetes mellitus type 2The treatment must be in combination with insulin; ANDPatient must have, or have had, a HbA1c measurement greater than 7% prior to the initiation of a dipeptidyl peptidase 4 inhibitor (gliptin), a thiazolidinedione (glitazone), a glucagon-like peptide-1 or a sodium-glucose co-transporter 2 (SGLT2) inhibitor despite treatment with insulin and oral antidiabetic agents, or insulin alone where metformin is contraindicated; ORPatient must have, or have had, where HbA1c measurement is clinically inappropriate, blood glucose levels greater than 10 mmol per L in more than 20% of tests over a 2 week period prior to initiation with a gliptin, a glitazone, a glucagon-like peptide-1 or an SGLT2 inhibitor despite treatment with insulin and oral antidiabetic agents, or insulin alone where metformin is contraindicated.The date and level of the qualifying HbA1c measurement must be, or must have been, documented in the patient's medical records at the time treatment with a gliptin, a glitazone, a glucagon-like peptide-1 or an SGLT2 inhibitor is initiated.The HbA1c must be no more than 4 months old at the time treatment with a gliptin, a glitazone, a glucagon-like peptide-1 or an SGLT2 inhibitor was initiated.Blood glucose monitoring may be used as an alternative assessment to HbA1c levels in the following circumstances:(a) A clinical condition with reduced red blood cell survival, including haemolytic anaemias and haemoglobinopathies; and/or(b) Had red cell transfusion within the previous 3 months.The results of the blood glucose monitoring, which must be no more than 4 months old at the time of initiation of treatment with a gliptin, a glitazone, a glucagon-like peptide-1 or an SGLT2 inhibitor, must be documented in the patient's medical records.	Compliance with Authority Required procedures - Streamlined Authority Code 4991
	C5629			Diabetes mellitus type 2The treatment must be in combination with metformin; ANDThe treatment must be in combination with a sulfonylurea; ANDPatient must have, or have had, a HbA1c measurement greater than 7% prior to the initiation of a dipeptidyl peptidase 4 inhibitor (gliptin), a thiazolidinedione (glitazone), a glucagon-like peptide-1 or a sodium-glucose co-transporter 2 (SGLT2) inhibitor despite treatment with optimal doses of dual oral therapy; ORPatient must have, or have had, where HbA1c measurement is clinically inappropriate, blood glucose levels greater than 10 mmol per L in more than 20% of tests over a 2 week period prior to initiation with a gliptin, a glitazone, a glucagon-like peptide-1 or an SGLT2 despite treatment with optimal doses of dual oral therapy.The date and level of the qualifying HbA1c measurement must be, or must have been, documented in the patient's medical records at the time treatment with a gliptin, a glitazone, a glucagon-like peptide-1 or an SGLT2 inhibitor is initiated.The HbA1c must be no more than 4 months old at the time treatment with a gliptin, a glitazone, a glucagon-like peptide-1 or an SGLT2 inhibitor was initiated.Blood glucose monitoring may be used as an alternative assessment to HbA1c levels in the following circumstances:(a) A clinical condition with reduced red blood cell survival, including haemolytic anaemias and haemoglobinopathies; and/or(b) Had red cell transfusion within the previous 3 months.The results of the blood glucose monitoring, which must be no more than 4 months old at the time of initiation of treatment with a gliptin, a glitazone, a glucagon-like peptide-1 or an SGLT2 inhibitor, must be documented in the patient's medical records.A patient whose diabetes was previously demonstrated unable to be controlled with metformin or a sulfonylurea does not need to requalify on this criterion before being eligible for PBS-subsidised treatment with this drug.	Compliance with Authority Required procedures - Streamlined Authority Code 5629

[132] Schedule 4, Part 1, after entry for Empagliflozin

insert:

C5657	Diabetes mellitus type 2The treatment must be in combination with insulin; ANDPatient must have, or have had, a HbA1c measurement greater than 7% prior to the initiation of a dipeptidyl peptidase 4 inhibitor (gliptin), a thiazolidinedione (glitazone), a glucagon-like peptide-1 or a sodium-glucose co-transporter 2 (SGLT2) inhibitor despite treatment with insulin and oral antidiabetic agents, or insulin alone where metformin is contraindicated; ORPatient must have, or have had, where HbA1c measurement is clinically inappropriate, blood glucose levels greater than 10 mmol per L in more than 20% of tests over a 2 week period prior to initiation with a gliptin, a glitazone, a glucagon-like peptide-1 or an SGLT2 inhibitor despite treatment with insulin and oral antidiabetic agents, or insulin alone where metformin is contraindicated.The date and level of the qualifying HbA1c measurement must be, or must have been, documented in the patient's medical records at the time treatment with a gliptin, a glitazone, a glucagon-like peptide-1 or an SGLT2 inhibitor is initiated.The HbA1c must be no more than 4 months old at the time treatment with a gliptin, a glitazone, a glucagon-like peptide-1 or an SGLT2 inhibitor was initiated.Blood glucose monitoring may be used as an alternative assessment to HbA1c levels in the following circumstances:(a) A clinical condition with reduced red blood cell survival, including haemolytic anaemias and haemoglobinopathies; and/or(b) Had red cell transfusion within the previous 3 months.The results of the blood glucose monitoring, which must be no more than 4 months old at the time of initiation of treatment with a gliptin, a glitazone, a glucagon-like peptide-1 or an SGLT2 inhibitor, must be documented in the patient's medical records.	Compliance with Authority Required procedures - Streamlined Authority Code 5657
C5798	Diabetes mellitus type 2The treatment must be in combination with a sulfonylurea; ANDPatient must have, or have had, a HbA1c measurement greater than 7% prior to the initiation of a dipeptidyl peptidase 4 inhibitor (gliptin), a thiazolidinedione (glitazone), a glucagon-like peptide-1 or a sodium-glucose co-transporter 2 (SGLT2) inhibitor despite treatment with optimal doses of dual oral therapy; ORPatient must have, or have had, where HbA1c measurement is clinically inappropriate, blood glucose levels greater than 10 mmol per L in more than 20% of tests over a 2 week period prior to initiation with a gliptin, a glitazone, a glucagon-like peptide-1 or an SGLT2 despite treatment with optimal doses of dual oral therapy.The date and level of the qualifying HbA1c measurement must be, or must have been, documented in the patient's medical records at the time treatment with a gliptin, a glitazone, a glucagon-like peptide-1 or an SGLT2 inhibitor is initiated.The HbA1c must be no more than 4 months old at the time treatment with a gliptin, a glitazone, a glucagon-like peptide-1 or an SGLT2 inhibitor was initiated.Blood glucose monitoring may be used as an alternative assessment to HbA1c levels in the following circumstances:(a) A clinical condition with reduced red blood cell survival, including haemolytic anaemias and haemoglobinopathies; and/or(b) Had red cell transfusion within the previous 3 months.The results of the blood glucose monitoring, which must be no more than 4 months old at the time of initiation of treatment with a gliptin, a glitazone, a glucagon-like peptide-1 or an SGLT2 inhibitor, must be documented in the patient's medical records.A patient whose diabetes was previously demonstrated unable to be controlled with metformin or a sulfonylurea does not need to requalify on this criterion before being eligible for PBS-subsidised treatment with this fixed dose combination.	Compliance with Authority Required procedures - Streamlined Authority Code 5798
C5953	Diabetes mellitus type 2Patient must have, or have had, a HbA1c measurement greater than 7% despite treatment with metformin; ORPatient must have, or have had, where HbA1c measurement is clinically inappropriate, blood glucose levels greater than 10 mmol per L in more than 20% of tests over a 2 week period despite treatment with metformin.The date and level of the qualifying HbA1c measurement must be, or must have been, documented in the patient's medical records at the time treatment with a dipeptidyl peptidase 4 inhibitor (gliptin), a thiazolidinedione (glitazone), a glucagon-like peptide-1 or a sodium-glucose co-transporter 2 (SGLT2) inhibitor is initiated.The HbA1c must be no more than 4 months old at the time treatment with a gliptin, a glitazone, a glucagon-like peptide-1 or an SGLT2 inhibitor was initiated.Blood glucose monitoring may be used as an alternative assessment to HbA1c levels in the following circumstances:(a) A clinical condition with reduced red blood cell survival, including haemolytic anaemias and haemoglobinopathies; and/or(b) Had red cell transfusion within the previous 3 months.The results of the blood glucose monitoring, which must be no more than 4 months old at the time of initiation of treatment with a gliptin, a glitazone, a glucagon-like peptide-1 or an SGLT2 inhibitor, must be documented in the patient's medical records.	Compliance with Authority Required procedures - Streamlined Authority Code 5953
C5966	Diabetes mellitus type 2Continuing treatmentPatient must have previously received and been stabilised on a PBS-subsidised regimen of oral diabetic medicines which includes metformin and empagliflozin.	Compliance with Authority Required procedures - Streamlined Authority Code 5966

[133] Schedule 4, Part 1, entry for Famciclovir

substitute:

C5937	P5937	Recurrent moderate to severe genital herpesEpisodic treatmentMicrobiological confirmation of diagnosis [viral culture, antigen detection or nucleic acid amplification by polymerase chain reaction (PCR)] is desirable but need not delay treatment.	Compliance with Authority Required procedures - Streamlined Authority Code 5937
C5943	P5943	Herpes zosterPatient must be immunocompromised; ANDThe treatment must be administered within 72 hours of the onset of the rash.	Compliance with Authority Required procedures - Streamlined Authority Code 5943
C5947	P5947	Recurrent moderate to severe oral or labial herpesEpisodic treatmentPatient must have HIV infection; ANDPatient must have a CD4 cell count of less than 500 million per litre.Microbiological confirmation of diagnosis [viral culture, antigen detection or nucleic acid amplification by polymerase chain reaction (PCR)] is desirable but need not delay treatment.	Compliance with Authority Required procedures - Streamlined Authority Code 5947
C5948	P5948	Recurrent moderate to severe oral or labial herpesSuppressive therapyPatient must have HIV infection; ANDPatient must have CD4 cell counts of less than 150 million per litre.Microbiological confirmation of diagnosis [viral culture, antigen detection or nucleic acid amplification by polymerase chain reaction (PCR)] is desirable but need not delay treatment.	Compliance with Authority Required procedures - Streamlined Authority Code 5948
C5949	P5949	Recurrent moderate to severe oral or labial herpesSuppressive therapyPatient must have HIV infection; ANDPatient must present with other opportunistic infections or AIDS defining tumours.Microbiological confirmation of diagnosis [viral culture, antigen detection or nucleic acid amplification by polymerase chain reaction (PCR)] is desirable but need not delay treatment.	Compliance with Authority Required procedures - Streamlined Authority Code 5949
C5951	P5951	Herpes zosterThe treatment must be administered within 72 hours of the onset of the rash.	Compliance with Authority Required procedures - Streamlined Authority Code 5951
C5954	P5954	Recurrent moderate to severe genital herpesEpisodic treatment or suppressive therapyPatient must be immunocompromised.Microbiological confirmation of diagnosis [viral culture, antigen detection or nucleic acid amplification by polymerase chain reaction (PCR)] is desirable but need not delay treatment.	Compliance with Authority Required procedures - Streamlined Authority Code 5954
C5971	P5971	Recurrent moderate to severe genital herpesSuppressive therapyMicrobiological confirmation of diagnosis [viral culture, antigen detection or nucleic acid amplification by polymerase chain reaction (PCR)] is desirable but need not delay treatment.	Compliance with Authority Required procedures - Streamlined Authority Code 5971

[134] Schedule 4, Part 1, entry for Folinic acid

substitute:

Folinic acid	C5938			Megaloblastic anaemiasThe condition must be a result of folic acid deficiency from the use of folic acid antagonists.
	C5973			Megaloblastic anaemiasThe condition must be a result of folic acid deficiency from the use of folic acid antagonists.

[135] Schedule 4, Part 1, after entry for Latanoprost with timolol

insert:

Ledipasvir with sofosbuvir	C5944	P5944		Chronic hepatitis C infectionPatient must meet the criteria set out in the General Statement for Drugs for the Treatment of Hepatitis C; ANDPatient must be taking this drug as part of a regimen set out in the matrix in the General Statement for Drugs for the Treatment of Hepatitis C, based on the hepatitis C virus genotype, patient treatment history and cirrhotic status; ANDThe treatment must be limited to a maximum duration of 8 weeks.	Compliance with Written or Telephone Authority Required procedures
	C5969	P5969		Chronic hepatitis C infectionPatient must meet the criteria set out in the General Statement for Drugs for the Treatment of Hepatitis C; ANDPatient must be taking this drug as part of a regimen set out in the matrix in the General Statement for Drugs for the Treatment of Hepatitis C, based on the hepatitis C virus genotype, patient treatment history and cirrhotic status; ANDThe treatment must be limited to a maximum duration of 12 weeks.	Compliance with Written or Telephone Authority Required procedures
	C5972	P5972		Chronic hepatitis C infectionPatient must meet the criteria set out in the General Statement for Drugs for the Treatment of Hepatitis C; ANDPatient must be taking this drug as part of a regimen set out in the matrix in the General Statement for Drugs for the Treatment of Hepatitis C, based on the hepatitis C virus genotype, patient treatment history and cirrhotic status; ANDThe treatment must be limited to a maximum duration of 24 weeks.	Compliance with Written or Telephone Authority Required procedures

[136] Schedule 4, Part 1, entry for Nitrazepam

(a) omit:

		P5684	CN5684	Benzodiazepine dependencePatient must be receiving long-term nursing care and in respect of whom a Carer Allowance is payable as a disabled adult; ANDPatient must have demonstrated, within the past 6 months, benzodiazepine dependence by an unsuccessful attempt at gradual withdrawal.	Compliance with Authority Required procedures
		P5770	CN5770	Benzodiazepine dependencePatient must be receiving long-term nursing care on account of age, infirmity or other condition in hospitals, nursing homes or residential facilities; ANDPatient must have demonstrated, within the past 6 months, benzodiazepine dependence by an unsuccessful attempt at gradual withdrawal.	Compliance with Authority Required procedures

(b) insert in numerical order after existing text:

		P5941	CN5941	InsomniaPatient must be receiving this drug for the management of insomnia; ANDPatient must be receiving long-term nursing care; ANDPatient must be one in respect of whom a Carer Allowance is payable as a disabled adult; ANDPatient must have demonstrated, within the past 6 months, benzodiazepine dependence by an unsuccessful attempt at gradual withdrawal.	Compliance with Authority Required procedures
		P5950	CN5950	InsomniaPatient must be receiving this drug for the management of insomnia; ANDPatient must be receiving long-term nursing care on account of age, infirmity or other condition in a hospital, nursing home or residential facility; ANDPatient must have demonstrated, within the past 6 months, benzodiazepine dependence by an unsuccessful attempt at gradual withdrawal.	Compliance with Authority Required procedures

[137] Schedule 4, Part 1, after entry for Propantheline

insert:

Protein formula with amino acids, carbohydrates, vitamins and minerals without phenylalanine, and supplemented with docosahexaenoic acid	C5970			Phenylketonuria

[138] Schedule 4, Part 1, after entry for Reteplase

insert:

Ribavirin	C5957	P5957		Chronic hepatitis C infectionPatient must meet the criteria set out in the General Statement for Drugs for the Treatment of Hepatitis C; ANDPatient must be taking this drug as part of a regimen set out in the matrix in the General Statement for Drugs for the Treatment of Hepatitis C, based on the hepatitis C virus genotype, patient treatment history and cirrhotic status; ANDThe treatment must be limited to a maximum duration of 12 weeks.Patient must not be pregnant or breastfeeding. Female partners of male patients must not be pregnant. Patients and their partners must each be using an effective form of contraception if of child-bearing age.	Compliance with Written or Telephone Authority Required procedures
	C5958	P5958		Chronic hepatitis C infectionPatient must meet the criteria set out in the General Statement for Drugs for the Treatment of Hepatitis C; ANDPatient must be taking this drug as part of a regimen set out in the matrix in the General Statement for Drugs for the Treatment of Hepatitis C, based on the hepatitis C virus genotype, patient treatment history and cirrhotic status; ANDThe treatment must be limited to a maximum duration of 24 weeks.Patient must not be pregnant or breastfeeding. Female partners of male patients must not be pregnant. Patients and their partners must each be using an effective form of contraception if of child-bearing age.	Compliance with Written or Telephone Authority Required procedures

[139] Schedule 4, Part 1, entry for Ribavirin and Peginterferon Alfa-2a

(a) insert in the column headed “Purposes Code” for Circumstances Codes C4184, C4185, C4187, C4188, C4193, C4197, C4206 and C4207 respectively:  
P4184  
P4185  
P4187  
P4188  
P4193  
P4197  
P4206  
P4207
(b) insert in numerical order:

	C5956	P5956		Chronic hepatitis C infectionPatient must meet the criteria set out in the General Statement for Drugs for the Treatment of Hepatitis C; ANDPatient must be taking this drug as part of a regimen set out in the matrix in the General Statement for Drugs for the Treatment of Hepatitis C, based on the hepatitis C virus genotype, patient treatment history and cirrhotic status; ANDThe treatment must be limited to a maximum duration of 12 weeks.Patient must not be pregnant or breastfeeding. Female partners of male patients must not be pregnant. Patients and their partners must each be using an effective form of contraception if of child-bearing age.	Compliance with Written or Telephone Authority Required procedures

[140] Schedule 4, Part 1, entry for Simeprevir

(a) omit from the column headed “Circumstances and Purposes” for Circumstances Codes C4669 and C4684:  
Where the patient is receiving treatment at/from a private hospital
(b) omit:

	C4758			Where the patient is receiving treatment at/from a public hospitalChronic genotype 1 hepatitis C infectionPatient must have compensated liver disease; ANDPatient must not have received prior interferon alfa or peginterferon alfa treatment for hepatitis C; ANDThe treatment must be in combination with peginterferon alfa and ribavirin; ANDThe treatment must be limited to a maximum duration of 12 weeks; ANDThe treatment must cease if the results of an HCV RNA quantitative assay at week 4 show that the plasma HCV RNA is 25 IU/mL or greaterPatient must be aged 18 years or older; ANDPatient must not be pregnant or breastfeeding. Female partners of male patients must not be pregnant. Patients and their partners must each be using an effective form of contraception if of child-bearing ageMust be treated in an accredited treatment centreEvidence of chronic genotype 1 hepatitis C infection (repeatedly anti-HCV positive and HCV RNA positive) must be documented in the patient's medical recordsPatients who have received prior treatment with an NS3/4A protease inhibitor are not eligible to receive PBS-subsidised simeprevir, except where the patient has developed an intolerance to the other NS3/4A protease inhibitor of a severity necessitating permanent treatment withdrawal. Details of the intolerance must be documented in the patient's medical records	Compliance with Written and Telephone Authority Required procedures - Streamlined Authority Code 4758
	C4759			Where the patient is receiving treatment at/from a public hospitalChronic genotype 1 hepatitis C infectionPatient must have compensated liver disease; ANDPatient must have received prior treatment with interferon alfa or peginterferon alfa for hepatitis C; ANDThe treatment must be in combination with peginterferon alfa and ribavirin; ANDThe treatment must be limited to a maximum duration of 12 weeks; ANDThe treatment must cease if the results of an HCV RNA quantitative assay at week 4 show that the plasma HCV RNA is 25 IU/mL or greaterPatient must be 18 years or older; ANDPatient must not be pregnant or breastfeeding. Female partners of male patients must not be pregnant. Patients and their partners must each be using an effective form of contraception if of child-bearing ageMust be treated in an accredited treatment centreEvidence of chronic genotype 1 hepatitis C infection (repeatedly anti-HCV positive and HCV RNA positive) must be documented in the patient's medical recordsPatients who have received prior treatment with an NS3/4A protease inhibitor are not eligible to receive PBS-subsidised simeprevir, except where the patient has developed an intolerance to the other NS3/4A protease inhibitor of a severity necessitating permanent treatment withdrawal. Details of the intolerance must be documented in the patient's medical records	Compliance with Written and Telephone Authority Required procedures - Streamlined Authority Code 4759

[141] Schedule 4, Part 1, after entry for Sodium Acid Phosphate

insert:

Sofosbuvir	C5969	P5969		Chronic hepatitis C infectionPatient must meet the criteria set out in the General Statement for Drugs for the Treatment of Hepatitis C; ANDPatient must be taking this drug as part of a regimen set out in the matrix in the General Statement for Drugs for the Treatment of Hepatitis C, based on the hepatitis C virus genotype, patient treatment history and cirrhotic status; ANDThe treatment must be limited to a maximum duration of 12 weeks.	Compliance with Written or Telephone Authority Required procedures
	C5972	P5972		Chronic hepatitis C infectionPatient must meet the criteria set out in the General Statement for Drugs for the Treatment of Hepatitis C; ANDPatient must be taking this drug as part of a regimen set out in the matrix in the General Statement for Drugs for the Treatment of Hepatitis C, based on the hepatitis C virus genotype, patient treatment history and cirrhotic status; ANDThe treatment must be limited to a maximum duration of 24 weeks.	Compliance with Written or Telephone Authority Required procedures

[142] Schedule 4, Part 1, entry for Temazepam

(a) omit:

		P5684	CN5684	Benzodiazepine dependencePatient must be receiving long-term nursing care and in respect of whom a Carer Allowance is payable as a disabled adult; ANDPatient must have demonstrated, within the past 6 months, benzodiazepine dependence by an unsuccessful attempt at gradual withdrawal.	Compliance with Authority Required procedures
		P5770	CN5770	Benzodiazepine dependencePatient must be receiving long-term nursing care on account of age, infirmity or other condition in hospitals, nursing homes or residential facilities; ANDPatient must have demonstrated, within the past 6 months, benzodiazepine dependence by an unsuccessful attempt at gradual withdrawal.	Compliance with Authority Required procedures

(b) insert in numerical order after existing text:

		P5941	CN5941	InsomniaPatient must be receiving this drug for the management of insomnia; ANDPatient must be receiving long-term nursing care; ANDPatient must be one in respect of whom a Carer Allowance is payable as a disabled adult; ANDPatient must have demonstrated, within the past 6 months, benzodiazepine dependence by an unsuccessful attempt at gradual withdrawal.	Compliance with Authority Required procedures
		P5950	CN5950	InsomniaPatient must be receiving this drug for the management of insomnia; ANDPatient must be receiving long-term nursing care on account of age, infirmity or other condition in a hospital, nursing home or residential facility; ANDPatient must have demonstrated, within the past 6 months, benzodiazepine dependence by an unsuccessful attempt at gradual withdrawal.	Compliance with Authority Required procedures

[143] Schedule 4, Part 1, entry for Valaciclovir

substitute:

C5939		Where the patient is receiving treatment at/from a private hospitalCytomegalovirus infection and diseaseProphylaxisPatient must have undergone a renal transplant; ANDPatient must be at risk of cytomegalovirus disease.	Compliance with Written or Telephone Authority Required procedures
C5940	P5940	Recurrent moderate to severe genital herpesSuppressive therapyMicrobiological confirmation of diagnosis [viral culture, antigen detection or nucleic acid amplification by polymerase chain reaction (PCR)] is desirable but need not delay treatment.	Compliance with Authority Required procedures - Streamlined Authority Code 5940
C5960	P5960	Initial moderate to severe genital herpesMicrobiological confirmation of diagnosis [viral culture, antigen detection or nucleic acid amplification by polymerase chain reaction (PCR)] is desirable but need not delay treatment.	Compliance with Authority Required procedures - Streamlined Authority Code 5960
C5961	P5961	Recurrent moderate to severe genital herpesEpisodic treatmentMicrobiological confirmation of diagnosis [viral culture, antigen detection or nucleic acid amplification by polymerase chain reaction (PCR)] is desirable but need not delay treatment.	Compliance with Authority Required procedures - Streamlined Authority Code 5961
C5962	P5962	Herpes zosterThe treatment must be administered within 72 hours of the onset of the rash.	Compliance with Authority Required procedures - Streamlined Authority Code 5962
C5968	P5968	Herpes zoster ophthalmicus	Compliance with Authority Required procedures - Streamlined Authority Code 5968
C5975		Where the patient is receiving treatment at/from a public hospitalCytomegalovirus infection and diseaseProphylaxisPatient must have undergone a renal transplant; ANDPatient must be at risk of cytomegalovirus disease.	Compliance with Written or Telephone Authority Required procedures - Streamlined Authority Code 5975

[144] After Schedule 4, Part 2

insert:

National Health (Listing of Pharmaceutical Benefits) Amendment Instrument 2016 (No. 2) (PB 11 of 2016)

Plain English Summary

Deep dive

Current sections

Amendments

General statement for drugs for the treatment of hepatitis C

Criteria for eligibility for drugs for the treatment of chronic hepatitis C

Assessment of patient

Source text: opening excerpt

1 National Health (Listing of Pharmaceutical Benefits) Amendment Instrument 2016 (No. 2) (PB 11 of 2016)