National Health (Listing of Pharmaceutical Benefits) Amendment Instrument 2015 (No. 12) (No. PB 117 of 2015)

PB 117 of 2015

National Health (Listing of Pharmaceutical Benefits) Amendment Instrument 2015
(No. 12)

National Health Act 1953

I, PENNY SHAKESPEARE, First Assistant Secretary, Pharmaceutical Benefits Division, Department of Health, delegate of the Minister for Health, make this Instrument under sections 84AF, 84AK, 85, 85A, 88 and 101 of the National Health Act 1953.

Dated 21 December 2015

PENNY SHAKESPEARE

First Assistant Secretary

Pharmaceutical Benefits Division

Department of Health

1 Name of Instrument

(1) This Instrument is the National Health (Listing of Pharmaceutical Benefits) Amendment Instrument 2015 (No. 12).

(2) This Instrument may also be cited as PB 117 of 2015.

2 Commencement

This Instrument commences on 1 January 2016.

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

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

Schedule 1 Amendments

[1] Schedule 1, entry for Alendronic Acid

omit:

				Ossmax 70mg	RA	MP NP	C4882 C4885 C4889		4	5	4

[2] Schedule 1, entry for Alendronic acid with colecalciferol in the form Tablet 70 mg (as alendronate sodium) with 70 micrograms colecalciferol

(a) omit:

				APO-Alendronate Plus D3 70 mg/70 mcg	TX	MP NP	C4070 C4087 C4110		4	5	4

(b) omit:

				Chem mart Alendronate Plus D3 70 mg/70 mcg	CH	MP NP	C4070 C4087 C4110		4	5	4

(c) omit:

				Terry White Chemists Alendronate Plus D3 70 mg/70 mcg	TW	MP NP	C4070 C4087 C4110		4	5	4

[3] Schedule 1, entry for Alendronic acid with colecalciferol in the form Tablet 70 mg (as alendronate sodium) with 140 micrograms colecalciferol

(a) omit:

				APO-Alendronate Plus D3 70 mg/140 mcg	TX	MP NP	C4122 C4123 C4133		4	5	4

(b) omit:

				Chem mart Alendronate Plus D3 70 mg/140 mcg	CH	MP NP	C4122 C4123 C4133		4	5	4

(c) omit:

				Terry White Chemists Alendronate Plus D3 70 mg/140 mcg	TW	MP NP	C4122 C4123 C4133		4	5	4

[4] Schedule 1, entry for Alginic acid with calcium carbonate and sodium bicarbonate

insert in the column headed “Circumstances”: C5837

[5] Schedule 1, entry for Aluminium Hydroxide with Magnesium Hydroxide

insert in the column headed “Circumstances”: C5837

[6] Schedule 1, omit entry for Aluminium Hydroxide with Magnesium Trisilicate and Magnesium Hydroxide

[7] Schedule 1, entry for Amoxycillin in the form Tablet 1 g (as trihydrate)

omit from the column headed “Circumstances” (twice occurring): C1582 substitute: C5843

[8] Schedule 1, entry for Amoxycillin in the form Powder for paediatric oral drops 100 mg (as trihydrate) per mL, 20 mL [Maximum Quantity: 1; Number of Repeats: 1]

(a) omit from the column headed “Brand”: Amoxil
(b) omit from the column headed “Responsible Person”: AS
(c) insert in the column headed “Circumstances”: C5863

[9] Schedule 1, entry for Amoxycillin in the form Powder for oral suspension 125 mg (as trihydrate) per 5 mL, 100 mL

(a) omit:

				GenRx Amoxycillin	GX	PDP			1	0	1

(b) omit:

				GenRx Amoxycillin	GX	MP NP			1	1	1

[10] Schedule 1, entry for Amoxycillin in the form Powder for oral suspension 250 mg (as trihydrate) per 5 mL, 100 mL

(a) omit:

				GenRx Amoxycillin	GX	PDP			1	0	1

(b) omit:

				GenRx Amoxycillin	GX	MP NP			1	1	1

[11] 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) [Maximum Quantity: 10; Number of Repeats: 0]

(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	AlphaClav Duo	AF	PDP	C5833 C5894		10	0	10

(c) omit from the column headed “Circumstances” (all instances): C1836 C1837 substitute: C5833 C5894

[12] 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) [Maximum Quantity: 10; Number of Repeats: 1]

(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	AlphaClav Duo	AF	MP NP MW	C5832 C5893		10	1	10

(c) omit from the column headed “Circumstances” (all instances): C1836 C1837 substitute: C5832 C5893

[13] 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) [Maximum Quantity: 10; Number of Repeats: 0]

(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	AlphaClav Duo Forte	AF	PDP	C5833 C5894		10	0	10

(c) omit from the column headed “Circumstances” (all instances): C1836 C1837 substitute: C5833 C5894

[14] 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) [Maximum Quantity: 10; Number of Repeats: 1]

(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	AlphaClav Duo Forte	AF	MP NP MW	C5832 C5893		10	1	10

(c) omit from the column headed “Circumstances” (all instances): C1836 C1837 substitute: C5832 C5893

[15] 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 [Maximum Quantity: 1; Number of Repeats: 0]

omit from the column headed “Circumstances” (all instances): C1836 C1837 substitute: C5833 C5894

[16] 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 [Maximum Quantity: 1; Number of Repeats: 1]

omit from the column headed “Circumstances” (all instances): C1836 C1837 substitute: C5832 C5893

[17] Schedule 1, entry for Amoxycillin with Clavulanic Acid in the forms: Powder for oral suspension containing 400 mg amoxycillin (as trihydrate) with 57 mg clavulanic acid (as potassium clavulanate) per 5 mL, 60 mL [Maximum Quantity: 1; Number of Repeats: 0]

omit from the column headed “Circumstances” (all instances): C1836 C1837 substitute: C5833 C5894

[18] Schedule 1, entry for Amoxycillin with Clavulanic Acid in the forms: Powder for oral suspension containing 400 mg amoxycillin (as trihydrate) with 57 mg clavulanic acid (as potassium clavulanate) per 5 mL, 60 mL [Maximum Quantity: 1; Number of Repeats: 1]

omit from the column headed “Circumstances” (all instances): C1836 C1837 substitute: C5832 C5893

[19] Schedule 1, entry for Aspirin in the form Tablet 100 mg

(a) omit:

				Astrix	YN	MP NP			112	1	112

(b) omit:

				Mayne Pharma Aspirin	YT	MP NP			112	1	112

(c) insert in the column headed “Circumstances” for the brand “Spren 100”: C5884

[20] Schedule 1, entry for Aspirin in the form Tablet, dispersible, 300 mg

(a) insert in the column headed “Circumstances” \[Authorised Prescriber PDP\]: C5870
(b) insert in the column headed “Circumstances” \[Authorised Prescriber MP NP\]: C5857

[21] Schedule 1, omit entry for Atorvastatin and ezetimibe

[22] Schedule 1, entry for Biperidin

omit from the column headed “Responsible Person”: LM substitute: ZC

[23] Schedule 1, entry for Bisacodyl

omit:

Suppositories 10 mg, 10	Rectal	a	Dulcolax	BY	MP NP	C5613 C5640 C5641 C5685 C5720 C5774 C5775 C5776 C5804	P5641	3	0	1
		a	Petrus Bisacodyl Suppositories	PP	MP NP	C5613 C5640 C5641 C5685 C5720 C5774 C5775 C5776 C5804	P5641	3	0	1
		a	Dulcolax	BY	MP NP	C5613 C5640 C5641 C5685 C5720 C5774 C5775 C5776 C5804	P5774	3	3	1
		a	Petrus Bisacodyl Suppositories	PP	MP NP	C5613 C5640 C5641 C5685 C5720 C5774 C5775 C5776 C5804	P5774	3	3	1
		a	Dulcolax	BY	MP NP	C5613 C5640 C5641 C5685 C5720 C5774 C5775 C5776 C5804	P5613 P5640 P5685 P5720 P5775 P5776 P5804	3	5	1
		a	Petrus Bisacodyl Suppositories	PP	MP NP	C5613 C5640 C5641 C5685 C5720 C5774 C5775 C5776 C5804	P5613 P5640 P5685 P5720 P5775 P5776 P5804	3	5	1
			Dulcolax	BY	MP	See Note 2		See Note 2	See Note 2	1	C(100)
			Petrus Bisacodyl Suppositories	PP	MP	See Note 2	See Note 2	See Note 2	See Note 2	1	C(100)
Suppositories 10 mg, 12	Rectal		Petrus Bisacodyl Suppositories	PP	MP NP	C5613 C5640 C5641 C5685 C5720 C5774 C5775 C5776 C5804	P5641	3	0	1
					MP NP	C5613 C5640 C5641 C5685 C5720 C5774 C5775 C5776 C5804	P5774	3	3	1
					MP NP	C5613 C5640 C5641 C5685 C5720 C5774 C5775 C5776 C5804	P5613 P5640 P5685 P5720 P5775 P5776 P5804	3	4	1
					MP	See Note 2		See Note 2	See Note 2	1	C(100)

substitute:

Suppositories 10 mg, 10	Rectal	a	Dulcolax	BY	MP NP	C5640 C5641 C5774 C5775 C5819 C5823 C5851 C5866 C5879	P5641	3	0	1
		a	Petrus Bisacodyl Suppositories	PP	MP NP	C5640 C5641 C5774 C5775 C5819 C5823 C5851 C5866 C5879	P5641	3	0	1
		a	Dulcolax	BY	MP NP	C5640 C5641 C5774 C5775 C5819 C5823 C5851 C5866 C5879	P5774	3	3	1
		a	Petrus Bisacodyl Suppositories	PP	MP NP	C5640 C5641 C5774 C5775 C5819 C5823 C5851 C5866 C5879	P5774	3	3	1
		a	Dulcolax	BY	MP NP	C5640 C5641 C5774 C5775 C5819 C5823 C5851 C5866 C5879	P5640 P5775 P5819 P5823 P5851 P5866 P5879	3	5	1
		a	Petrus Bisacodyl Suppositories	PP	MP NP	C5640 C5641 C5774 C5775 C5819 C5823 C5851 C5866 C5879	P5640 P5775 P5819 P5823 P5851 P5866 P5879	3	5	1
			Dulcolax	BY	MP	See Note 2		See Note 2	See Note 2	1	C(100)
			Petrus Bisacodyl Suppositories	PP	MP	See Note 2		See Note 2	See Note 2	1	C(100)
Suppositories 10 mg, 12	Rectal		Petrus Bisacodyl Suppositories	PP	MP NP	C5640 C5641 C5774 C5775 C5819 C5823 C5851 C5866 C5879	P5641	3	0	1
					MP NP	C5640 C5641 C5774 C5775 C5819 C5823 C5851 C5866 C5879	P5774	3	3	1
					MP NP	C5640 C5641 C5774 C5775 C5819 C5823 C5851 C5866 C5879	P5640 P5775 P5819 P5823 P5851 P5866 P5879	3	4	1
					MP	See Note 2		See Note 2	See Note 2	1	C(100)

[24] Schedule 1, entry for Buprenorphine in each of the forms: Tablet (sublingual) 400 micrograms (as hydrochloride); Tablet (sublingual) 2 mg (as hydrochloride); and Tablet (sublingual) 8 mg (as hydrochloride)

omit from the column headed “Responsible Person”: RC substitute: IR

[25] Schedule 1, entry for Buprenorphine with naloxone in each of the forms: Film (soluble) 2 mg (as hydrochloride)-0.5 mg (as hydrochloride); and Film (soluble) 8 mg (as hydrochloride)-2 mg (as hydrochloride)

omit from the column headed “Responsible Person”: RC substitute: IR

[26] Schedule 1, entry for Calcitriol

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

			a	APO-Calcitriol	TX	MP NP	C5089 C5114 C5255 C5401 C5402		100	3	100

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

[27] Schedule 1, entry for Candesartan with Hydrochlorothiazide in the form Tablet containing candesartan cilexetil 16 mg with hydrochlorothiazide 12.5 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	Asartan HCT 16/12.5	DO	MP NP	C4374		30	5	30

[28] Schedule 1, entry for Candesartan with Hydrochlorothiazide in the form Tablet containing candesartan cilexetil 32 mg with hydrochlorothiazide 12.5 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	Asartan HCT 32/12.5	DO	MP NP	C4374		30	5	30

[29] Schedule 1, entry for Candesartan with Hydrochlorothiazide in the form Tablet containing candesartan cilexetil 32 mg with hydrochlorothiazide 25 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	Asartan HCT 32/25	DO	MP NP	C4374		30	5	30

[30] Schedule 1, entry for Capecitabine in the form Tablet 150 mg

omit:

				Xeloda	RO	MP			60	2	60

[31] Schedule 1, entry for Carbimazole

omit from the column headed “Responsible Person”: LM substitute: ZC

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

omit from the column headed “Circumstances” (all instances): C1427 substitute: C5842

[33] Schedule 1, entry for Cefotaxime in the form Powder for injection 1 g (as sodium)

(a) omit from the column headed “Circumstances” \[Authorised Prescriber MP NP\] (twice occurring): C1169 C1846 C1847  
substitute: C5827 C5828 C5829
(b) omit from the column headed “Circumstances” \[Authorised Prescriber PDP\] (twice occurring): C1169 substitute: C5892

[34] Schedule 1, entry for Cefotaxime in the form Powder for injection 2 g (as sodium)

(a) omit:

				Cefotaxime Sandoz	SZ	MP NP	C1169 C1846 C1847		10	0	1
						PDP	C1169		10	0	1

(b) omit from the column headed “Circumstances” for the brand “Hospira Pty Limited” \[Authorised Prescriber MP NP\]: C1169 C1846 C1847  
substitute: C5826 C5881 C5890
(c) omit from the column headed “Circumstances” for the brand “Hospira Pty Limited” \[Authorised Prescriber PDP\]: C1169 substitute: C5519

[35] Schedule 1, entry for Ceftriaxone in the form Powder for injection 500 mg (as sodium) [Maximum Quantity: 1; Number of Repeats: 0]

(a) omit from the column headed “Circumstances”: C1143 C1169 C1846 C1847 substitute: C5826 C5855 C5881 C5890
(b) omit from the column headed “Purposes”: P1143 substitute: P5855

[36] Schedule 1, entry for Ceftriaxone in the form Powder for injection 500 mg (as sodium) [Maximum Quantity: 5; Number of Repeats: 0]

(a) omit from the column headed “Circumstances”: C1143 C1169 C1846 C1847 substitute: C5826 C5855 C5881 C5890
(b) omit from the column headed “Purposes”: P1169 P1846 P1847 substitute: P5826 P5881 P5890

[37] Schedule 1, entry for Ceftriaxone in the form Powder for injection 1 g (as sodium)

omit from the column headed “Circumstances” (all instances): C1169 C1846 C1847 substitute: C5830 C5862 C5868

[38] Schedule 1, entry for Ceftriaxone in the form Powder for injection 2 g (as sodium)

omit from the column headed “Circumstances” (all instances): C1169 C1846 C1847 substitute: C5826 C5881 C5890

[39] Schedule 1, entry for Cephazolin in the form Powder for injection 500 mg (as sodium)

omit from the column headed “Circumstances”: C1169 C1846 C1847 C3132 substitute: C5826 C5867 C5881 C5890

[40] Schedule 1, entry for Cephazolin in the form Powder for injection 1 g (as sodium)

omit from the column headed “Circumstances” (all instances): C1169 C1846 C1847 C3132 substitute: C5861 C5882 C5883 C5891

[41] Schedule 1, entry for Cephazolin in the form Powder for injection 2 g (as sodium)

(a) omit:

				Cefazolin Sandoz	SZ	MP NP	C1169 C1846 C1847 C3132		10	0	1

(b) omit from the column headed “Circumstances” for the brand “Cephazolin Alphapharm”: C1169 C1846 C1847 C3132  
substitute: C5826 C5867 C5881 C5890

[42] Schedule 1, omit entry for Chloramphenicol

[43] Schedule 1, entry for Chlorthalidone

omit from the column headed “Responsible Person”: LM substitute: ZC

[44] Schedule 1, entry for Clarithromycin in the form Tablet 250 mg

omit:

				Klacid	GO	MP		P1434 P3325	100 CN1434 CN3325	2CN1434 CN3325	100		C(100)

[45] Schedule 1, entry for Clarithromycin in the form Tablet 500 mg

(a) omit from the column headed “Brand”: Klacid substitute: APO-Clarithromycin
(b) omit from the column headed “Responsible Person”: GO substitute: TX
(c) omit from the column headed “Circumstances”: C1434 C3325 substitute: C5873 C5874

[46] Schedule 1, entry for Cyproheptadine

omit from the column headed “Circumstances”: C1288 substitute: C5858

[47] Schedule 1, entry for Electrolyte Replacement, Oral

(a) omit:

				O.R.S.	AS	MP NP			1	0	1

(b) insert in the column headed “Circumstances” for the brands “Repalyte New Formulation” and “restore O.R.S.”: C5889

[48] Schedule 1, entry for Erythromycin in the form Tablet 400 mg (as ethyl succinate)

omit from the column headed “Responsible Person” for the brand “E.E.S. 400 Filmtab” (twice occurring): LM substitute: ZC

[49] Schedule 1, entry for Erythromycin in the form Powder for oral liquid 200 mg (as ethyl succinate) per 5 mL, 100 mL

omit from the column headed “Responsible Person” for the brand “E.E.S. 200” (twice occurring): LM substitute: ZC

[50] Schedule 1, entry for Erythromycin in the form Powder for oral liquid 400 mg (as ethyl succinate) per 5 mL, 100 mL

omit from the column headed “Responsible Person” for the brand “E.E.S. Granules” (twice occurring): LM substitute: ZC

[51] Schedule 1, entry for Erythromycin in the form Powder for I.V. infusion 1 g (as lactobionate)

omit from the column headed “Responsible Person”: LM substitute: ZC

[52] Schedule 1, entry for Famciclovir in the form Tablet 125 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	Auro-Famciclovir 125	DO	MP NP	C3624		40	1	40

[53] Schedule 1, entry for Famciclovir in the form Tablet 500 mg [Maximum Quantity: 30; Number of Repeats: 0]

(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	Auro-Famciclovir 500	DO	MP NP	C3625 C3626 C3627 C3628 C3629	P3625	30	0	30

[54] Schedule 1, entry for Famciclovir in the form Tablet 500 mg [Maximum Quantity: 56; Number of Repeats: 5]

(a) insert in the column headed “Schedule Equivalent” for all brands: a
(b) insert in numerical order in the column headed “Circumstances” for the brand “Auro-Famciclovir 500”: C3625
(c) insert in the column headed “Purposes” for the brand “Auro-Famciclovir 500”: P3626 P3627 P3628 P3629

[55] Schedule 1, omit entry for Ferrous fumarate

[56] Schedule 1, omit entry for Ferrous Fumarate with Folic Acid

[57] Schedule 1, entry for Folic Acid in the form Tablet 500 micrograms

insert in the column headed “Circumstances” for the brands “Foltabs 500” and “Megafol 0.5”: C5824

[58] Schedule 1, entry for Folic Acid Tablet 5 mg

insert in the column headed “Circumstances”: C5820

[59] Schedule 1, entry for Glucose and Ketone Indicator—Urine

substitute:

Glucose and Ketone Indicator—Urine	Test strips, 50 (Keto‑Diabur‑Test 5000)	For external use		Keto‑Diabur‑Test 5000	RD	MP NP	C5852		2	2	1
	Test strips, 50 (Keto‑Diastix)	For external use		Keto‑Diastix	BN	MP NP	C5852		2	2	1

[60] Schedule 1, entry for Glucose Indicator—Blood

(a) omit:

	Test strips, 51 (Accu‑Chek Integra)	For external use		Accu‑Chek Integra	RD	MP NP			2	5	1
						MP		P4241	2	11	1

(b) omit:

	Test strips, 100 (GoodLife)	For external use		GoodLife	JN	MP NP			1	5	1
						MP		P4241	1	11	1

[61] Schedule 1, entry for Glucose Indicator—Urine

substitute:

Glucose Indicator—Urine	Test strips, 50 (Diastix)	For external use		Diastix	BN	MP NP	C5852		2	2	1

[62] Schedule 1, entry for Glycerol

substitute:

Suppositories 700 mg, 12	Rectal	Petrus Pharmaceuticals Pty Ltd	PP	MP NP	C5640 C5641 C5774 C5775 C5819 C5823 C5851 C5866 C5879	P5641	3	0	1
				MP NP	C5640 C5641 C5774 C5775 C5819 C5823 C5851 C5866 C5879	P5774	3	3	1
				MP NP	C5640 C5641 C5774 C5775 C5819 C5823 C5851 C5866 C5879	P5640 P5775 P5819 P5823 P5851 P5866 P5879	3	5	1
				MP	See Note 2		See Note 2	See Note 2	1	C(100)
Suppositories 1.4 g, 12	Rectal	Petrus Pharmaceuticals Pty Ltd	PP	MP NP	C5640 C5641 C5774 C5775 C5819 C5823 C5851 C5866 C5879	P5641	3	0	1
				MP NP	C5640 C5641 C5774 C5775 C5819 C5823 C5851 C5866 C5879	P5774	3	3	1
				MP NP	C5640 C5641 C5774 C5775 C5819 C5823 C5851 C5866 C5879	P5640 P5775 P5819 P5823 P5851 P5866 P5879	3	5	1
				MP	See Note 2		See Note 2	See Note 2	1	C(100)
Suppositories 2.8 g, 12	Rectal	Petrus Pharmaceuticals Pty Ltd	PP	MP NP	C5640 C5641 C5774 C5775 C5819 C5823 C5851 C5866 C5879	P5641	3	0	1
				MP NP	C5640 C5641 C5774 C5775 C5819 C5823 C5851 C5866 C5879	P5774	3	3	1
				MP NP	C5640 C5641 C5774 C5775 C5819 C5823 C5851 C5866 C5879	P5640 P5775 P5819 P5823 P5851 P5866 P5879	3	5	1
				MP	See Note 2		See Note 2	See Note 2	1	C(100)

[63] Schedule 1, entry for Hydrocortisone

(a) omit:

Cortic‑DS 1%	FM	PDP	C4899 C4934	P4934	1	0	1
Sigmacort	QA	PDP	C4899 C4934	P4934	1	0	1
Cortic‑DS 1%	FM	MP NP	C4899 C4934	P4899	1	1	1
Sigmacort	QA	MP NP	C4899 C4934	P4899	1	1	1

(b) omit:

Cortic‑DS 1%	FM	PDP	C4899 C4934	P4934	1	0	1
Sigmacort	QA	PDP	C4899 C4934	P4934	1	0	1
Cortic‑DS 1%	FM	MP NP	C4899 C4934	P4899	1	1	1
Sigmacort	QA	MP NP	C4899 C4934	P4899	1	1	1

[64] Schedule 1, entry for Hydroxocobalamin in the form Injection 1 mg (as acetate) in 1 mL

omit from the column headed “Circumstances”: C4111 C4134 C4135 substitute: C5840 C5841 C5854

[65] Schedule 1, entry for Hydroxocobalamin in the form Injection 1 mg (as chloride) in 1 mL

(a) omit:

				Hydroxo‑B12	AS	MP NP	C4111 C4134 C4135		3	0	3

(b) omit from the column headed “Circumstances” for the brand “Neo‑B12”: C4111 C4134 C4135 substitute: C5840 C5841 C5854

[66] Schedule 1, entry for Imipramine in the form Tablet containing imipramine hydrochloride 10 mg

omit from the column headed “Responsible Person” for the brand “Tofranil 10”: LM substitute: ZC

[67] Schedule 1, entry for Imipramine in the form Tablet containing imipramine hydrochloride 25 mg

omit from the column headed “Responsible Person” for the brand “Tofranil 25”: LM substitute: ZC

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

omit:

				Hospira Pty Limited	HH	MP			See Note 3	SeeNote 3	1		D(100)

[69] Schedule 1, entry for Metoclopramide in the form Tablet containing metoclopramide hydrochloride 10 mg

insert in the column headed “Schedule Equivalent” for all brands: a

[70] Schedule 1, entry for Naratriptan

(a) omit from the column headed “Circumstances”: C3281 C3282 C3283 C3284 C3285
(b) insert in numerical order after existing “Circumstances” code: C5849 C5850 C5859 C5860 C5887

[71] Schedule 1, entry for Nystatin

omit:

Mycostatin	FM	PDP	1	0	1
Nilstat	QA	PDP	1	0	1
Mycostatin	FM	MP NP	1	1	1
Nilstat	QA	MP NP	1	1	1

[72] Schedule 1, entry for Olanzapine in each of the forms: Tablet 2.5 mg; Tablet 5 mg; Tablet 7.5 mg; Tablet 10 mg; Tablet 2.5 mg (as benzoate); Tablet 5 mg (as benzoate); Tablet 7.5 mg (as benzoate); Tablet 10 mg (as benzoate); Tablet 5 mg (orally disintegrating); Tablet 10 mg (orally disintegrating); Tablet 15 mg (orally disintegrating); Tablet 20 mg (orally disintegrating); Wafer 5 mg; Wafer 10 mg; Wafer 15 mg; and Wafer 20 mg

omit from the column headed “Circumstances” (all instances): C1589 C2044 substitute: C5856 C5869

[73] Schedule 1, entry for Paracetamol

substitute:

Suppositories 500 mg, 24	Rectal		Panadol	GC	MP NP	C4940 C4950	P4950	4	0	1
					MP NP	C4940 C4950	P4940	4	3	1
Oral liquid 120 mg per 5 mL, 100 mL	Oral		Panamax	SW	PDP	C5846		1	0	1
					MP NP	C5835		1	2	1
Oral liquid 240 mg per 5 mL, 200 mL	Oral		Panamax 240 Elixir	SW	PDP	C5846		1	0	1
					MP NP	C5835		1	2	1
Tablet 500 mg	Oral	a	APO-Paracetamol	TX	PDP	C5846 C5885	P5846	100	0	100
		a	Febridol	EA	PDP	C5846 C5885	P5846	100	0	100
		a	Generic Health Pty Ltd	GQ	PDP	C5846 C5885	P5846	100	0	100
		a	Panamax	SW	PDP	C5846 C5885	P5846	100	0	100
		a	Paracetamol (Sandoz)	SZ	PDP	C5846 C5885	P5846	100	0	100
		a	Paralgin	FM	PDP	C5846 C5885	P5846	100	0	100
		a	Parapane	AF	PDP	C5846 C5885	P5846	100	0	100
		a	APO-Paracetamol	TX	MP NP	C5835 C5865	P5835	100	1	100
		a	Febridol	EA	MP NP	C5835 C5865	P5835	100	1	100
		a	Generic Health Pty Ltd	GQ	MP NP	C5835 C5865	P5835	100	1	100
		a	Panamax	SW	MP NP	C5835 C5865	P5835	100	1	100
		a	Paracetamol (Sandoz)	SZ	MP NP	C5835 C5865	P5835	100	1	100
		a	Paralgin	FM	MP NP	C5835 C5865	P5835	100	1	100
		a	Parapane	AF	MP NP	C5835 C5865	P5835	100	1	100
		a	APO-Paracetamol	TX	PDP	C5846 C5885	P5885	300	0	100
		a	Febridol	EA	PDP	C5846 C5885	P5885	300	0	100
		a	Generic Health Pty Ltd	GQ	PDP	C5846 C5885	P5885	300	0	100
		a	Panamax	SW	PDP	C5846 C5885	P5885	300	0	100
		a	Paracetamol (Sandoz)	SZ	PDP	C5846 C5885	P5885	300	0	100
		a	Paralgin	FM	PDP	C5846 C5885	P5885	300	0	100
		a	Parapane	AF	PDP	C5846 C5885	P5885	300	0	100
		a	APO-Paracetamol	TX	MP NP	C5835 C5865	P5865	300	4	100
		a	Febridol	EA	MP NP	C5835 C5865	P5865	300	4	100
		a	Generic Health Pty Ltd	GQ	MP NP	C5835 C5865	P5865	300	4	100
		a	Panamax	SW	MP NP	C5835 C5865	P5865	300	4	100
		a	Paracetamol (Sandoz)	SZ	MP NP	C5835 C5865	P5865	300	4	100
		a	Paralgin	FM	MP NP	C5835 C5865	P5865	300	4	100
		a	Parapane	AF	MP NP	C5835 C5865	P5865	300	4	100
Tablet 665 mg (modified release)	Oral		Osteomol 665 Paracetamol	CR	MP NP	C4940 C4950 C5847	P4950	192	0	96
					MP NP	C4940 C4950 C5847	P4940	192	3	96
					MP NP	C4940 C4950 C5847	P5847	192	5	96

[74] Schedule 1, entry for Pemetrexed in the form Powder for I.V. infusion 100 mg (as disodium heptahydrate)

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

			a	Pemetrexed MYX	YN	MP	C4789 C4792		See Note 3	SeeNote 3	1		D(100)

[75] Schedule 1, entry for Pemetrexed in the form Powder for I.V. infusion 500 mg (as disodium heptahydrate)

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

			a	Pemetrexed MYX	YN	MP	C4789 C4792		See Note 3	SeeNote 3	1		D(100)

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

			a	Pemetrexed Sandoz	SZ	MP	C4789 C4792		See Note 3	SeeNote 3	1		D(100)

[76] Schedule 1, entry for Propranolol in each of the forms: Tablet containing propranolol hydrochloride 10 mg; and Tablet containing propranolol hydrochloride 40 mg

insert in the column headed “Schedule Equivalent” for all brands: a

[77] Schedule 1, entry for Rituximab

omit:

	Solution for I.V. infusion 100 mg in 10 mL	Injection		Mabthera	RO	MP	C4674 C4677 C4678 C4686 C4701 C4706 C4726	See Note 3	See Note 3	SeeNote 3	2		D(100)

substitute:

	Solution for I.V. infusion 100 mg in 10 mL	Injection		Mabthera	RO	MP	See Note 3	See Note 3	See Note 3	SeeNote 3	1		D(100)
						MP	C4674 C4677 C4678 C4686 C4701 C4706 C4726	See Note 3	See Note 3	SeeNote 3	2		D(100)

[78] Schedule 1, entry for Sapropterin

omit from the column headed “Responsible Person”: SG substitute: IO

[79] Schedule 1, entry for Tacrolimus in the form Capsule 0.5 mg

(a) omit:

				TACROLIMUS APOTEX	TX	MP			100	3	100

(b) omit:

				TACROLIMUS APOTEX	TX	MP		P5569 P5602	200CN5569 CN5602	5CN5569 CN5602	100		C(100)

[80] Schedule 1, entry for Tacrolimus in the form Capsule 1 mg

(a) omit:

				TACROLIMUS APOTEX	TX	MP			100	3	100

(b) omit:

				TACROLIMUS APOTEX	TX	MP		P5569 P5602	200CN5569 CN5602	5CN5569 CN5602	100		C(100)

[81] Schedule 1, entry for Tacrolimus in the form Capsule 5 mg

(a) omit:

				TACROLIMUS APOTEX	TX	MP			50	3	50

(b) omit:

				TACROLIMUS APOTEX	TX	MP		P5569 P5602	100CN5569 CN5602	5CN5569 CN5602	50		C(100)

[82] Schedule 1, entry for Ticarcillin with Clavulanic Acid

(a) omit from the column headed “Circumstances” \[Authorised Prescriber MP NP\]: C1169 C1846 C1847 substitute: C5826 C5881 C5890
(b) omit from the column headed “Circumstances” \[Authorised Prescriber PDP\]: C1169 substitute: C5831

[83] Schedule 1, entry for Tramadol in the form Capsule containing tramadol hydrochloride 50 mg [Maximum Quantity: 20;
Number of Repeats: 0]

(a) omit from the column headed “Circumstances” \[Authorised Prescriber MP NP\] (all instances): C1497 C1615 substitute: C5848 C5877
(b) omit from the column headed “Purposes” (all instances): P1497 substitute: P5877
(c) omit from the column headed “Circumstances” \[Authorised Prescriber PDP\] (all instances): C1497 C1615 substitute: C5875 C5876

[84] Schedule 1, entry for Tramadol in the form Capsule containing tramadol hydrochloride 50 mg [Maximum Quantity: 20;
Number of Repeats: 2]

(a) omit from the column headed “Circumstances” (all instances): C1497 C1615 substitute: C5848 C5877
(b) omit from the column headed “Purposes” (all instances): P1615 substitute: P5848

[85] Schedule 1, entry for Tramadol in each of the forms: Tablet (sustained release) containing tramadol hydrochloride 50 mg; Tablet (sustained release) containing tramadol hydrochloride 100 mg; Tablet (sustained release) containing tramadol hydrochloride 150 mg; and Tablet (sustained release) containing tramadol hydrochloride 200 mg

omit from the column headed “Circumstances” (all instances): C1537 substitute: C5822

[86] Schedule 1, entry for Tramadol

omit:

Oral drops containing tramadol hydrochloride 100 mg per mL, 10 mL	Oral	Tramal	CS	MP NP PDP	C1537	1	1
Injection containing tramadol hydrochloride 100 mg in 2 mL	Injection	Tramadol ACT	EA	MP NP PDP	C1378	5	5
		Tramadol Sandoz	SZ	MP NP PDP	C1378	5	5
		Tramal 100	CS	MP NP PDP	C1378	5	5

substitute:

Oral drops containing tramadol hydrochloride 100 mg per mL, 10 mL	Oral	Tramal	CS	MP NP	C5822	1	1
				PDP	C5878	1	1
Injection containing tramadol hydrochloride 100 mg in 2 mL	Injection	Tramadol ACT	EA	MP NP	C5886	5	5
				PDP	C5818	5	5
		Tramadol Sandoz	SZ	MP NP	C5886	5	5
				PDP	C5818	5	5
		Tramal 100	CS	MP NP	C5886	5	5
				PDP	C5818	5	5

[87] Schedule 1, entry for Trandolapril in each of the forms: Capsule 500 micrograms; Capsule 1 mg; Capsule 2 mg; and Capsule 4 mg

omit:

				APO‑Trandolapril	TX	MP NP			28	5	28

[88] Schedule 1, entry for Trastuzumab in each of the forms: Powder for I.V. infusion 60 mg; and Powder for I.V. infusion 150 mg

insert in numerical order in the column headed “Circumstances”: C5825 C5834 C5844

[89] Schedule 1, entry for Triglycerides, medium chain in each of the forms: Oil 500 mL (MCT Oil); and Oral emulsion 250 mL (Liquigen)

(a) omit from the column headed “Circumstances”: C5616
(b) insert in numerical order: C5853 C5888

[90] Schedule 3, Responsible Person code GH

omit from the column headed “Responsible Person”: Mercury Pharma (Australia) Pty Limited
substitute: Amdipharm Mercury (Australia) Pty Limited

[91] Schedule 3, after details relevant to Responsible Person code IK

insert:

IO	BioMarin Pharmaceutical Australia Pty Ltd	69 159 743 496

[92] Schedule 3, after details relevant to Responsible Person code IQ

insert:

IR	Indivior Pty Ltd	22 169 280 102

[93] Schedule 3

omit:

JN	JNS Biomedical Pty Ltd	79 163 593 833

[94] Schedule 3, after details relevant to Responsible Person code YT

insert:

ZC	Anspec Pty Limited	13 056 263 239

[95] Schedule 4, Part 1, after entry for Alendronic acid with colecalciferol and calcium

insert:

Alginic acid with calcium carbonate and sodium bicarbonate	C5837			For treatment of a patient identifying as Aboriginal or Torres Strait Islander

[96] Schedule 4, Part 1, after entry for Alprazolam

insert:

Aluminium hydroxide with magnesium hydroxide	C5837			For treatment of a patient identifying as Aboriginal or Torres Strait Islander

[97] Schedule 4, Part 1, entry for Amoxycillin

substitute:

Amoxycillin	C5843			Chronic bronchitisPatient must have acute exacerbations of the condition.
	C5863			Infection suspected or proven to be due to a susceptible organismThe treatment must be for patients who require a liquid formulation and in whom the syrup formulations are unsuitable.	Compliance with Authority Required procedures

[98] Schedule 4, Part 1, entry for Amoxycillin with Clavulanic Acid

substitute:

Amoxycillin with clavulanic acid	C5832			Infections where resistance to amoxycillin is proven
	C5833			Infection where resistance to amoxycillin is suspected
	C5893			Infection where resistance to amoxycillin is suspected
	C5894			Infections where resistance to amoxycillin is proven

[99] Schedule 4, Part 1, after entry for Asenapine

insert:

Aspirin	C5857			For treatment of a patient identifying as Aboriginal or Torres Strait Islander

	C5870			For treatment of a patient identifying as Aboriginal or Torres Strait Islander
	C5884			For treatment of a patient identifying as Aboriginal or Torres Strait Islander

[100] Schedule 4, Part 1, omit entry for Atorvastatin and ezetimibe

[101] Schedule 4, Part 1, entry for Bisacodyl

insert in numerical order:

C5819	P5819	ConstipationPatient must be receiving long-term nursing care and in respect of whom a Carer Allowance is payable as a disabled adult.Patient must identify as Aboriginal or Torres Strait Islander.
C5823	P5823	Anorectal congenital abnormalitiesPatient must identify as Aboriginal or Torres Strait Islander.
C5851	P5851	Terminal malignant neoplasiaPatient must identify as Aboriginal or Torres Strait Islander.
C5866	P5866	MegacolonPatient must identify as Aboriginal or Torres Strait Islander.
C5879	P5879	ConstipationPatient must be receiving long-term nursing care on account of age, infirmity or other condition in a hospital, nursing home or residential facility.Patient must identify as Aboriginal or Torres Strait Islander.

[102] Schedule 4, Part 1, entry for Buprenorphine [Circumstances Code C4951]

omit from the column headed “Circumstances and Purposes”: non-narcotic analgesics substitute: non-opioid analgesics

[103] Schedule 4, Part 1, entry for Cefepime

substitute:

Cefepime	C5842			Febrile neutropenia	Compliance with Authority Required procedures

[104] Schedule 4, Part 1, entry for Cefotaxime

substitute:

Cefotaxime	C5519			Infection where positive bacteriological evidence confirms that this antibiotic is an appropriate therapeutic agent
	C5826			Septicaemia, suspected
	C5827			Infection where positive bacteriological evidence confirms that this antibiotic is an appropriate therapeutic agent
	C5828			Septicaemia, suspected
	C5829			Septicaemia, proven
	C5881			Infection where positive bacteriological evidence confirms that this antibiotic is an appropriate therapeutic agent
	C5890			Septicaemia, proven
	C5892			Infection where positive bacteriological evidence confirms that this antibiotic is an appropriate therapeutic agent

[105] Schedule 4, Part 1, entry for Ceftriaxone

substitute:

C5826	P5826	Septicaemia, suspected
C5830		Infection where positive bacteriological evidence confirms that this antibiotic is an appropriate therapeutic agent
C5855	P5855	Gonorrhoea
C5862		Septicaemia, proven
C5868		Septicaemia, suspected
C5881	P5881	Infection where positive bacteriological evidence confirms that this antibiotic is an appropriate therapeutic agent
C5890	P5890	Septicaemia, proven

[106] Schedule 4, Part 1, entry for Cephazolin

substitute:

Cephazolin	C5826			Septicaemia, suspected
	C5861			Septicaemia, suspected
	C5867			Cellulitis
	C5881			Infection where positive bacteriological evidence confirms that this antibiotic is an appropriate therapeutic agent
	C5882			Septicaemia, proven
	C5883			Cellulitis
	C5890			Septicaemia, proven
	C5891			Infection where positive bacteriological evidence confirms that this antibiotic is an appropriate therapeutic agent

[107] Schedule 4, Part 1, entry for Clarithromycin

(a) omit:

	C1434			Where the patient is receiving treatment at/from a private hospitalTreatment of Mycobacterium avium complex infections	Compliance with Written or Telephone Authority Required procedures

(b) omit:

	C3325			Where the patient is receiving treatment at/from a public hospitalTreatment of Mycobacterium avium complex infections	Compliance with Written or Telephone Authority Required procedures – Streamlined Authority Code 3325

(c) insert in numerical order after existing text

	C5873			Where the patient is receiving treatment at/from a private hospitalMycobacterium avium complex infection	Compliance with Written or Telephone Authority Required procedures
	C5874			Where the patient is receiving treatment at/from a public hospitalMycobacterium avium complex infection	Compliance with Written or Telephone Authority Required procedures - Streamlined Authority Code 5874

[108] Schedule 4, Part 1, entry for Codeine with paracetamol [Purposes Code P4903]

omit from the column headed “Circumstances and Purposes”: non-narcotic analgesics substitute: non-opioid analgesics

[109] Schedule 4, Part 1, entry for Cyproheptadine

substitute:

Cyproheptadine	C5858			Prevention of migraine

[110] Schedule 4, Part 1, after entry for Eformoterol

insert:

Electrolyte replacement, oral	C5889			For treatment of a patient identifying as Aboriginal or Torres Strait Islander

[111] Schedule 4, Part 1, entry for Fentanyl [Circumstances Code C4952]

omit from the column headed “Circumstances and Purposes”: non-narcotic analgesics substitute: non-opioid analgesics

[112] Schedule 4, Part 1, after entry for Fluvoxamine

insert:

Folic acid	C5820			For treatment of a patient identifying as Aboriginal or Torres Strait Islander
	C5824			For treatment of a patient identifying as Aboriginal or Torres Strait Islander

[113] Schedule 4, Part 1, entry for Glucose and Ketone Indicator—Urine

substitute:

Glucose and ketone indicator—urine	C5852			For treatment of a patient identifying as Aboriginal or Torres Strait Islander

[114] Schedule 4, Part 1, entry for Glucose Indicator—Urine

substitute:

Glucose indicator—urine	C5852			For treatment of a patient identifying as Aboriginal or Torres Strait Islander

[115] Schedule 4, Part 1, entry for Glycerol

(a) omit:

	C5613	P5613		ConstipationPatient must be receiving long-term nursing care and in respect of whom a Carer Allowance is payable as a disabled adult.

(b) omit:

	C5685	P5685		Anorectal congenital abnormalities
	C5720	P5720		ConstipationPatient must be receiving long-term nursing care on account of age, infirmity or other condition in a hospital, nursing home or residential facility.

(c) omit:

	C5776	P5776		Terminal malignant neoplasia
	C5804	P5804		Megacolon

(d) insert in numerical order after existing text:

C5819	P5819	ConstipationPatient must be receiving long-term nursing care and in respect of whom a Carer Allowance is payable as a disabled adult.Patient must identify as Aboriginal or Torres Strait Islander.
C5823	P5823	Anorectal congenital abnormalitiesPatient must identify as Aboriginal or Torres Strait Islander.
C5851	P5851	Terminal malignant neoplasiaPatient must identify as Aboriginal or Torres Strait Islander.
C5866	P5866	MegacolonPatient must identify as Aboriginal or Torres Strait Islander.
C5879	P5879	ConstipationPatient must be receiving long-term nursing care on account of age, infirmity or other condition in a hospital, nursing home or residential facility.Patient must identify as Aboriginal or Torres Strait Islander.

[116] Schedule 4, Part 1, entry for Hydromorphone [Circumstances Codes: C4556; C4926; and C4959]

omit from the column headed “Circumstances and Purposes”: non-narcotic analgesics substitute: non-opioid analgesics

[117] Schedule 4, Part 1, entry for Hydroxocobalamin

substitute:

Hydroxocobalamin	C5840			Pernicious anaemiaPatient must identify as Aboriginal or Torres Strait Islander.
	C5841			Anaemias associated with vitamin B12 deficiencyPatient must have had a gastrectomy; ANDThe treatment must be for prophylaxis.Patient must identify as Aboriginal or Torres Strait Islander.
	C5854			Proven vitamin B12 deficiencies other than pernicious anaemiaPatient must identify as Aboriginal or Torres Strait Islander.

[118] Schedule 4, Part 1, entry for Methadone [Circumstances Codes: C4902; C4941; and C4953]

omit from the column headed “Circumstances and Purposes”: non-narcotic analgesics substitute: non-opioid analgesics

[119] Schedule 4, Part 1, entry for Morphine [Circumstances Codes: C4556; C4900; C4911; C4926; C4927; C4935; C4948; C4959; and C4960]

omit from the column headed “Circumstances and Purposes”: non-narcotic analgesics substitute: non-opioid analgesics

[120] Schedule 4, Part 1, entry for Naratriptan

(a) omit:

C3281	Migraine attack in a patient where attacks in the past have usually failed to respond to analgesics, and where adverse events have occurred with other suitable PBS‑listed drugs	Compliance with Authority Required procedures
C3282	Migraine attack in a patient where attacks in the past have usually failed to respond to analgesics, and where drug interactions have occurred with other suitable PBS‑listed drugs	Compliance with Authority Required procedures
C3283	Migraine attack in a patient where attacks in the past have usually failed to respond to analgesics, and where drug interactions are expected to occur with other suitable PBS‑listed drugs	Compliance with Authority Required procedures
C3284	Migraine attack in a patient where attacks in the past have usually failed to respond to analgesics, and where transfer to another suitable PBS‑listed drug would cause patient confusion resulting in problems with compliance	Compliance with Authority Required procedures
C3285	Migraine attack in a patient where attacks in the past have usually failed to respond to analgesics, and where transfer to another suitable PBS‑listed drug is likely to result in adverse clinical consequences	Compliance with Authority Required procedures

(b) insert in numerical order after existing text:

C5849	Migraine attackThe condition must have usually failed to respond to analgesics in the past; ANDPatient must be one in whom transfer to another suitable PBS-listed drug would cause patient confusion resulting in problems with compliance.	Compliance with Authority Required procedures
C5850	Migraine attackThe condition must have usually failed to respond to analgesics in the past; ANDPatient must be one in whom transfer to another suitable PBS-listed drug is likely to result in adverse clinical consequences.	Compliance with Authority Required procedures
C5859	Migraine attackThe condition must have usually failed to respond to analgesics in the past; ANDPatient must be one in whom adverse events have occurred with other suitable PBS-listed drugs.	Compliance with Authority Required procedures
C5860	Migraine attackThe condition must have usually failed to respond to analgesics in the past; ANDPatient must be one in whom drug interactions are expected to occur with other suitable PBS-listed drugs.	Compliance with Authority Required procedures
C5887	Migraine attackThe condition must have usually failed to respond to analgesics in the past; ANDPatient must be one in whom drug interactions have occurred with other suitable PBS-listed drugs.	Compliance with Authority Required procedures

[121] Schedule 4, Part 1, entry for Olanzapine

(a) omit:

	C1589			Schizophrenia	Compliance with Authority Required procedures – Streamlined Authority Code 1589
	C2044			Maintenance treatment of bipolar I disorder	Compliance with Authority Required procedures – Streamlined Authority Code 2044

(b) insert in numerical order after existing text:

	C5856			Schizophrenia	Compliance with Authority Required procedures - Streamlined Authority Code 5856
	C5869			Bipolar I disorderThe treatment must be maintenance therapy.	Compliance with Authority Required procedures - Streamlined Authority Code 5869

[122] Schedule 4, Part 1, entry for Oxycodone [Circumstances Codes: C4583; C4926; and C4959]

omit from the column headed “Circumstances and Purposes”: non-narcotic analgesics substitute: non-opioid analgesics

[123] Schedule 4, Part 1, entry for Oxycodone with naloxone [Circumstances Code C4951]

omit from the column headed “Circumstances and Purposes”: non-narcotic analgesics substitute: non-opioid analgesics

[124] Schedule 4, Part 1, entry for Paracetamol

(a) omit:

		P4913		Chronic arthropathies

(b) omit:

	C4969	P4969		Persistent painThe condition must be associated with osteoarthritis

(c) insert in numerical order after existing text:

C5835	P5835	For treatment of a patient identifying as Aboriginal or Torres Strait Islander
C5846	P5846	For treatment of a patient identifying as Aboriginal or Torres Strait Islander
C5847	P5847	Persistent painThe condition must be associated with osteoarthritis.Patient must identify as Aboriginal or Torres Strait Islander.
C5865	P5865	Chronic arthropathiesPatient must identify as Aboriginal or Torres Strait Islander.
C5885	P5885	Chronic arthropathiesPatient must identify as Aboriginal or Torres Strait Islander.

[125] Schedule 4, Part 1, entry for Tapentadol [Circumstances Code C4556]

omit from the column headed “Circumstances and Purposes”: non-narcotic analgesics substitute: non-opioid analgesics

[126] Schedule 4, Part 1, entry for Ticarcillin with Clavulanic Acid

substitute:

Ticarcillin with clavulanic acid	C5826			Septicaemia, suspected
	C5831			Infection where positive bacteriological evidence confirms that this antibiotic is an appropriate therapeutic agent
	C5881			Infection where positive bacteriological evidence confirms that this antibiotic is an appropriate therapeutic agent
	C5890			Septicaemia, proven

[127] Schedule 4, Part 1, entry for Tramadol

substitute:

C5818		Acute painThe treatment must be for the short-term.
C5822		PainThe condition must be one in which aspirin and/or paracetamol alone are inappropriate or have failed.
C5848	P5848	Chronic painDose titrationThe condition must be one in which aspirin and/or paracetamol alone are inappropriate or have failed.
C5875		Acute painThe condition must be one in which aspirin and/or paracetamol alone are inappropriate or have failed.
C5876		Chronic painDose titrationThe condition must be one in which aspirin and/or paracetamol alone are inappropriate or have failed.
C5877	P5877	Acute painThe condition must be one in which aspirin and/or paracetamol alone are inappropriate or have failed.
C5878		PainThe condition must be one in which aspirin and/or paracetamol alone are inappropriate or have failed.
C5886		Acute painThe treatment must be for the short-term.

[128] Schedule 4, Part 1, entry for Trastuzumab

insert in numerical order:

	C5825			Metastatic (Stage IV) HER2 positive adenocarcinoma of the stomach or gastro-oesophageal junctionInitial PBS-subsidised treatment (Grandfather patient)Patient must have evidence of human epidermal growth factor receptor 2 (HER2) positivity; ANDPatient must have been treated with this drug for this condition prior to 1 January 2016; ANDThe treatment must not be used in a patient with a left ventricular ejection fraction (LVEF) of less than 45% and/or with symptomatic heart failure.Cardiac function must be tested by echocardiography (ECHO) or multigated acquisition (MUGA), at 3 monthly intervals during treatment.Authority applications for initial treatment must be made in writing and must include:(a) a completed authority prescription form; and(b) a completed Metastatic (Stage IV) HER2 positive adenocarcinoma of stomach or gastro-oesophageal junction authority application form which includes confirmation that the patient has Stage IV disease and a copy of the pathology report from an Approved Pathology Authority confirming evidence of human epidermal growth factor receptor 2 (HER2) positivity.	Compliance with Written Authority Required procedures
	C5834			Metastatic (Stage IV) HER2 positive adenocarcinoma of the stomach or gastro-oesophageal junctionContinuing treatmentPatient must have previously been issued with an authority prescription for this drug for this condition; ANDPatient must not have progressive disease; ANDThe treatment must not be used in a patient with a left ventricular ejection fraction (LVEF) of less than 45% and/or with symptomatic heart failure.Cardiac function must be tested by echocardiography (ECHO) or multigated acquisition (MUGA), at 3 monthly intervals during treatment.	Compliance with Written or Telephone Authority Required procedures
	C5844			Metastatic (Stage IV) HER2 positive adenocarcinoma of the stomach or gastro-oesophageal junctionInitial treatmentPatient must have evidence of human epidermal growth factor receptor 2 (HER2) positivity as demonstrated by immunohistochemistry 2+ or more in tumour material; ANDPatient must have evidence of HER2 gene amplification as demonstrated by in situ hybridisation results based on more than 6 copies of HER2 in the same tumour tissue sample; ANDPatient must have evidence of HER2 gene amplification as demonstrated by in situ hybridisation results based on the ratio of HER2 to chromosome 17 being more than 2 in the same tumour tissue sample; ANDPatient must commence treatment in combination with cisplatin and capecitabine; ORPatient must commence treatment in combination with cisplatin and 5 fluorouracil; ANDPatient must not have previously received this drug for this condition; ANDPatient must not have received prior chemotherapy for this condition; ANDPatient must have a WHO performance status of 2 or less; ANDThe treatment must not be used in a patient with a left ventricular ejection fraction (LVEF) of less than 45% and/or with symptomatic heart failure.Authority applications for initial treatment must be made in writing and must include:(a) a completed authority prescription form; and(b) a completed Metastatic (Stage IV) HER2 positive adenocarcinoma of stomach or gastro-oesophageal junction authority application form which includes confirmation that the patient has Stage IV disease and a copy of the pathology report from an Approved Pathology Authority confirming evidence of human epidermal growth factor receptor 2 (HER2) gene amplification as demonstrated in tumour material by both (i) immunohistochemistry (IHC) 2+ or IHC 3+ AND (ii) in situ hybridisation (ISH) results based on both more than 6 copies of HER2 AND the ratio of HER2: chromosome 17 being more than 2 in the same tumour tissue sampleCardiac function must be tested by echocardiography (ECHO) or multigated acquisition (MUGA), prior to seeking the initial authority approval and then at 3 monthly intervals during treatment.	Compliance with Written Authority Required procedures

[129] Schedule 4, Part 1, entry for Triglycerides, medium chain

(a) omit:

	C5616			Intractable childhood epilepsyPatient must require a ketogenic diet.Cerebrospinal fluid glucose transporter defectPatient must require a ketogenic diet.	Compliance with Authority Required procedures

(b) insert in numerical order after existing text:

	C5853			Intractable childhood epilepsyPatient must require a ketogenic diet.	Compliance with Authority Required procedures
	C5888			Cerebrospinal fluid glucose transporter defectPatient must require a ketogenic diet.	Compliance with Authority Required procedures

National Health (Listing of Pharmaceutical Benefits) Amendment Instrument 2015 (No. 12) (No. PB 117 of 2015)

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National Health (Listing of Pharmaceutical Benefits) Amendment Instrument 2015 (No. 12) (No. PB 117 of 2015)

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1 National Health (Listing of Pharmaceutical Benefits) Amendment Instrument 2015 (No. 12) (No. PB 117 of 2015)