National Health (Listing of Pharmaceutical Benefits) Amendment Instrument 2018 (No. 9) (PB 74 of 2018) (Cth)

PB 74 of 2018

National Health (Listing of Pharmaceutical Benefits) Amendment Instrument 2018 (No. 9)

National Health Act 1953

___________________________________________________________________________

I, SEAN LANE, Assistant Secretary (Acting), Pricing and PBS Policy Branch, Technology Assessment and Access Division, Department of Health, delegate of the Minister for Health, make this Instrument under sections 84AF, 84AK, 85, 85A, 88 and 101 of the National Health Act 1953.

Dated 28 August 2018

SEAN LANE

Assistant Secretary (Acting)

Pricing and PBS Policy Branch

Technology Assessment and Access Division

Department of Health

___________________________________________________________________________

1. Name of Instrument

(1)This Instrument is the National Health (Listing of Pharmaceutical Benefits) Amendment Instrument 2018 (No. 9).

(2)This Instrument may also be cited as PB 74 of 2018.

1. Commencement

This Instrument commences on 1 September 2018.

1. 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 Aciclovir in the form Tablet 200 mg

omit:

a Ozvir RA MP NP C5942 90 5 90

1. Schedule 1, entry for Adalimumab

substitute:

Adalimumab	Injection 20 mg in 0.4 mL pre-filled syringe	Injection	Humira	VE	MP	See Note 3	See Note 3	See Note 3	See Note 3	2	C(100)
					MP	C5076 C5091 C5105 C5117 C7652 C7654 C7655 C7663 C7664	P5105	2	0	2
					MP	C5076 C5091 C5105 C5117 C7652 C7654 C7655 C7663 C7664	P5076 P5117 P7652 P7655 P7664	2	3	2
					MP	C5076 C5091 C5105 C5117 C7652 C7654 C7655 C7663 C7664	P5091 P7654 P7663	2	5	2
	Injection 40 mg in 0.8 mL pre-filled syringe	Injection	Humira	VE	MP	See Note 3	See Note 3	See Note 3	See Note 3	2	C(100)
					MP	C3695 C3697 C3747 C3748 C4492 C4501 C4517 C4518 C4531 C4610 C4643 C4700 C4724 C4845 C4851 C5075 C5076 C5090 C5091 C5105 C5117 C6423 C6430 C6437 C6439 C6445 C6458 C6695 C6696 C6726 C6727 C6728 C6753 C6755 C6756 C6902 C6922 C6923 C7151 C7443 C7652 C7654 C7655 C7663 C7664	P5105	2	0	2
					MP	C3695 C3697 C3747 C3748 C4492 C4501 C4517 C4518 C4531 C4610 C4643 C4700 C4724 C4845 C4851 C5075 C5076 C5090 C5091 C5105 C5117 C6423 C6430 C6437 C6439 C6445 C6458 C6695 C6696 C6726 C6727 C6728 C6753 C6755 C6756 C6902 C6922 C6923 C7151 C7443 C7652 C7654 C7655 C7663 C7664	P3695 P3747 P5076 P5090 P5117 P7151 P7443 P7652 P7655 P7664	2	2	2
					MP	C3695 C3697 C3747 C3748 C4492 C4501 C4517 C4518 C4531 C4610 C4643 C4700 C4724 C4845 C4851 C5075 C5076 C5090 C5091 C5105 C5117 C6423 C6430 C6437 C6439 C6445 C6458 C6695 C6696 C6726 C6727 C6728 C6753 C6755 C6756 C6902 C6922 C6923 C7151 C7443 C7652 C7654 C7655 C7663 C7664	P4492 P4501 P4518 P4610 P4700 P4851 P6430 P6437 P6445 P6458 P6902 P6923	2	3	2
					MP	C3695 C3697 C3747 C3748 C4492 C4501 C4517 C4518 C4531 C4610 C4643 C4700 C4724 C4845 C4851 C5075 C5076 C5090 C5091 C5105 C5117 C6423 C6430 C6437 C6439 C6445 C6458 C6695 C6696 C6726 C6727 C6728 C6753 C6755 C6756 C6902 C6922 C6923 C7151 C7443 C7652 C7654 C7655 C7663 C7664	P6695 P6726 P6727 P6728 P6753	2	4	2
					MP	C3695 C3697 C3747 C3748 C4492 C4501 C4517 C4518 C4531 C4610 C4643 C4700 C4724 C4845 C4851 C5075 C5076 C5090 C5091 C5105 C5117 C6423 C6430 C6437 C6439 C6445 C6458 C6695 C6696 C6726 C6727 C6728 C6753 C6755 C6756 C6902 C6922 C6923 C7151 C7443 C7652 C7654 C7655 C7663 C7664	P3697 P3748 P4517 P4531 P4643 P4724 P4845 P5075 P5091 P6423 P6439 P6696 P6755 P6756 P6922 P7654 P7663	2	5	2
	Injection 40 mg in 0.8 mL pre-filled syringe, 6	Injection	Humira	VE	MP	C3695 C3747 C5076 C5090 C5117 C7151 C7443 C7652 C7655 C7664	1	0	1
	Injection 40 mg in 0.8 mL pre-filled pen	Injection	Humira	VE	MP	See Note 3	See Note 3	See Note 3	See Note 3	2	C(100)
					MP	C3695 C3697 C3747 C3748 C4492 C4501 C4517 C4518 C4531 C4610 C4643 C4700 C4724 C4845 C4851 C5075 C5076 C5090 C5091 C5105 C5117 C6423 C6430 C6437 C6439 C6445 C6458 C6695 C6696 C6726 C6727 C6728 C6753 C6755 C6756 C6902 C6922 C6923 C7151 C7443 C7652 C7654 C7655 C7663 C7664	P5105	2	0	2
					MP	C3695 C3697 C3747 C3748 C4492 C4501 C4517 C4518 C4531 C4610 C4643 C4700 C4724 C4845 C4851 C5075 C5076 C5090 C5091 C5105 C5117 C6423 C6430 C6437 C6439 C6445 C6458 C6695 C6696 C6726 C6727 C6728 C6753 C6755 C6756 C6902 C6922 C6923 C7151 C7443 C7652 C7654 C7655 C7663 C7664	P3695 P3747 P5076 P5090 P5117 P7151 P7443 P7652 P7655 P7664	2	2	2
					MP	C3695 C3697 C3747 C3748 C4492 C4501 C4517 C4518 C4531 C4610 C4643 C4700 C4724 C4845 C4851 C5075 C5076 C5090 C5091 C5105 C5117 C6423 C6430 C6437 C6439 C6445 C6458 C6695 C6696 C6726 C6727 C6728 C6753 C6755 C6756 C6902 C6922 C6923 C7151 C7443 C7652 C7654 C7655 C7663 C7664	P4492 P4501 P4518 P4610 P4700 P4851 P6430 P6437 P6445 P6458 P6902 P6923	2	3	2
					MP	C3695 C3697 C3747 C3748 C4492 C4501 C4517 C4518 C4531 C4610 C4643 C4700 C4724 C4845 C4851 C5075 C5076 C5090 C5091 C5105 C5117 C6423 C6430 C6437 C6439 C6445 C6458 C6695 C6696 C6726 C6727 C6728 C6753 C6755 C6756 C6902 C6922 C6923 C7151 C7443 C7652 C7654 C7655 C7663 C7664	P6695 P6726 P6727 P6728 P6753	2	4	2
					MP	C3695 C3697 C3747 C3748 C4492 C4501 C4517 C4518 C4531 C4610 C4643 C4700 C4724 C4845 C4851 C5075 C5076 C5090 C5091 C5105 C5117 C6423 C6430 C6437 C6439 C6445 C6458 C6695 C6696 C6726 C6727 C6728 C6753 C6755 C6756 C6902 C6922 C6923 C7151 C7443 C7652 C7654 C7655 C7663 C7664	P3697 P3748 P4517 P4531 P4643 P4724 P4845 P5075 P5091 P6423 P6439 P6696 P6755 P6756 P6922 P7654 P7663	2	5	2
	Injection 40 mg in 0.8 mL pre-filled pen, 4	Injection	Humira	VE	MP	C6946 C6971 C6972	P6946	1	2	1
					MP	C6946 C6971 C6972	P6971 P6972	1	5	1
	Injection 40 mg in 0.8 mL pre-filled pen, 6	Injection	Humira	VE	MP	C3695 C3747 C5076 C5090 C5117 C6951 C6963 C7151 C7443 C7652 C7655 C7664	1	0	1

1. Schedule 1, entry for Adrenaline (epinephrine)

(a)omit:

I.M. injection 150 micrograms in 0.15 mL single dose auto-injector (Emerade) Injection Emerade LM MP NP C4909 C4946 C4947 1 0 1

(b)omit:

I.M. injection 300 micrograms in 0.3 mL single dose auto-injector (Emerade) Injection Emerade LM MP NP C4909 C4946 C4947 1 0 1

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

(a)omit:

a Chem mart Alendronate Plus D3 70 mg/70 mcg CH MP NP C6307 C6315 C6320 4 5 4

(b)omit:

a Terry White Chemists Alendronate Plus D3 70 mg/70 mcg TW MP NP C6307 C6315 C6320 4 5 4

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

(a)omit:

a Chem mart Alendronate Plus D3 70 mg/140 mcg CH MP NP C6306 C6319 C6325 4 5 4

(b)omit:

a Terry White Chemists Alendronate Plus D3 70 mg/140 mcg TW MP NP C6306 C6319 C6325 4 5 4

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

omit:

a	Chem mart Allopurinol	CH	MP NP	200	2	200
a	Terry White Chemists Allopurinol	TW	MP NP	200	2	200

1. Schedule 1, entry for Allopurinol in the form Tablet 300 mg

(a)omit:

a Chem mart Allopurinol CH MP NP 60 2 60

(b)omit:

a Terry White Chemists Allopurinol TW MP NP 60 2 60

1. Schedule 1, entry for Alprazolam in the form Tablet 250 micrograms

(a)omit from the column headed “Schedule Equivalent”: a

(b)omit:

MP NP C6773 10 0 50

1. Schedule 1, entry for Alprazolam in the form Tablet 500 micrograms

omit for the brand "Kalma 0.5":

MP NP C6773 10 0 50

1. Schedule 1, entry for Alprazolam in the form Tablet 1 mg

omit for the brand "Kalma 1":

MP NP C6773 10 0 50

1. Schedule 1, entry for Amlodipine with atorvastatin in the form Tablet 5 mg amlodipine (as besilate) with 10 mg atorvastatin (as calcium)

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

a APO-Amlodipine/Atorvastatin 5/10 TX MP NP 30 5 30

(b)omit:

a Blooms the Chemist Amlodipine/Atorvastatin 5/10  IB  MP NP 30 5 30

1. Schedule 1, entry for Amlodipine with atorvastatin in the form Tablet 5 mg amlodipine (as besilate) with 20 mg atorvastatin (as calcium)

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

a APO-Amlodipine/Atorvastatin 5/20  TX MP NP 30 5 30

(b)omit:

a Blooms the Chemist Amlodipine/Atorvastatin 5/20 IB MP NP 30 5 30

1. Schedule 1, entry for Amlodipine with atorvastatin in the form Tablet 5 mg amlodipine (as besilate) with 40 mg atorvastatin (as calcium)

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

a APO-Amlodipine/Atorvastatin 5/40 TX MP NP 30 5 30

(b)omit:

a Blooms the Chemist Amlodipine/Atorvastatin 5/40 IB  MP NP 30 5 30

1. Schedule 1, entry for Amlodipine with atorvastatin in the form Tablet 5 mg amlodipine (as besilate) with 80 mg atorvastatin (as calcium)

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

a APO-Amlodipine/Atorvastatin 5/80 TX MP NP 30 5 30

(b)omit:

a Blooms the Chemist Amlodipine/Atorvastatin 5/80 IB MP NP 30 5 30

1. Schedule 1, entry for Amlodipine with atorvastatin in the form Tablet 10 mg amlodipine (as besilate) with 10 mg atorvastatin (as calcium)

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

a APO-Amlodipine/Atorvastatin 10/10 TX MP NP 30 5 30

(b)omit:

a Blooms the Chemist Amlodipine/Atorvastatin 10/10 IB MP NP 30 5 30

1. Schedule 1, entry for Amlodipine with atorvastatin in the form Tablet 10 mg amlodipine (as besilate) with 20 mg atorvastatin (as calcium)

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

a APO-Amlodipine/Atorvastatin 10/20 TX MP NP 30 5 30

(b)omit:

a Blooms the Chemist Amlodipine/Atorvastatin 10/20 IB MP NP 30 5 30

1. Schedule 1, entry for Amlodipine with atorvastatin in the form Tablet 10 mg amlodipine (as besilate) with 40 mg atorvastatin (as calcium)

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

a APO-Amlodipine/Atorvastatin 10/40 TX MP NP 30 5 30

(b)omit:

a Blooms the Chemist Amlodipine/Atorvastatin 10/40  IB MP NP 30 5 30

1. Schedule 1, entry for Amlodipine with atorvastatin in the form Tablet 10 mg amlodipine (as besilate) with 80 mg atorvastatin (as calcium)

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

a APO-Amlodipine/Atorvastatin 10/80 TX MP NP 30 5 30

(b)omit:

a Blooms the Chemist Amlodipine/Atorvastatin 10/80 IB MP NP 30 5 30

1. Schedule 1, entry for Atomoxetine in all forms

omit from the column headed "Circumstances" (all instances): C4578 C6279  substitute: C7876 C7890

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

omit:

a Atorvastatin SCP 10 RZ MP NP 30 5 30

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

omit:

a Atorvastatin SCP 10 RZ MP P7598 30 11 30

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

omit:

a Atorvastatin SCP 20 RZ MP NP 30 5 30

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

omit:

a Atorvastatin SCP 20 RZ MP P7598 30 11 30

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

omit:

a Atorvastatin SCP 40 RZ MP NP 30 5 30

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

omit:

a Atorvastatin SCP 40 RZ MP P7598 30 11 30

1. Schedule 1, entry for Atorvastatin in the form Tablet 80 mg (as calcium) [Maximum Quantity: 30; Number of Repeats: 5]

omit:

a Atorvastatin SCP 80 RZ MP NP 30 5 30

1. Schedule 1, entry for Atorvastatin in the form Tablet 80 mg (as calcium) [Maximum Quantity: 30; Number of Repeats: 11]

omit:

a Atorvastatin SCP 80 RZ MP P7598 30 11 30

1. Schedule 1, after entry for Balsalazide

insert:

Baricitinib	Tablet 2 mg	Oral	Olumiant	LY	MP	C7881 C7882 C7899 C7905 C7907 C7925	P7905 P7907 P7925	28	3	28
					MP	C7881 C7882 C7899 C7905 C7907 C7925	P7881 P7882 P7899	28	5	28
	Tablet 4 mg	Oral	Olumiant	LY	MP	C7881 C7882 C7899 C7905 C7907 C7925	P7905 P7907 P7925	28	3	28
					MP	C7881 C7882 C7899 C7905 C7907 C7925	P7881 P7882 P7899	28	5	28

1. Schedule 1, entry for Carfilzomib

insert as the first entry:

Powder for injection 10 mg Injection Kyprolis AN MP C7344 C7348 C7355 See Note 3 See Note 3 1 D(100)

1. Schedule 1, entry for Carvedilol in the form Tablet 3.125 mg

omit:

a	Chem mart Carvedilol 3.125 mg	CH	MP NP	C5324 C5394	30	0	30
a	Terry White Chemists Carvedilol 3.125 mg	TW	MP NP	C5324 C5394	30	0	30

1. Schedule 1, entry for Carvedilol in the form Tablet 6.25 mg

(a)omit:

a Chem mart Carvedilol 6.25 mg CH MP NP C5324 C5394 60 5 60

(b)omit:

a Terry White Chemists Carvedilol 6.25 mg TW MP NP C5324 C5394 60 5 60

1. Schedule 1, entry for Carvedilol in the form Tablet 12.5 mg

(a)omit:

a Chem mart Carvedilol 12.5 mg CH MP NP C5324 C5394 60 5 60

(b)omit:

a Terry White Chemists Carvedilol 12.5 mg TW MP NP C5324 C5394 60 5 60

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

(a)omit:

a Chem mart Carvedilol 25 mg CH MP NP C5324 C5394 60 5 60

(b)omit:

a Terry White Chemists Carvedilol 25 mg TW MP NP C5324 C5394 60 5 60

1. Schedule 1, entry for Codeine

omit from the column headed “Brand”: Fawns and McAllan Proprietary Limited       substitute: Aspen Pharma Pty Ltd

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

(a)omit:

Chem mart Doxycycline CH MP NP C4475 C4529 C4539 25 5 25

(b)omit:

Terry White Chemists Doxycycline TW MP NP C4475 C4529 C4539 25 5 25

1. Schedule 1, entry for Doxycycline in the form Tablet 100 mg (as monohydrate) [Maximum Quantity: 7; Number of Repeats: 0]

(a)omit:

Chem mart Doxycycline CH PDP 7 0 7

(b)omit:

Terry White Chemists Doxycycline TW PDP 7 0 7

1. Schedule 1, entry for Doxycycline in the form Tablet 100 mg (as monohydrate) [Maximum Quantity: 7; Number of Repeats: 1]

(a)omit:

Chem mart Doxycycline CH MP NP 7 1 7

(b)omit:

Terry White Chemists Doxycycline TW MP NP 7 1 7

1. Schedule 1, entry for Doxycycline in the form Tablet 100 mg (as monohydrate) [Maximum Quantity: 21; Number of Repeats: 0]

(a)omit:

Chem mart Doxycycline CH MP NP P4485 21 0 7

(b)omit:

Terry White Chemists Doxycycline TW MP NP P4485 21 0 7

1. Schedule 1, entry for Doxycycline in the form Tablet 100 mg (as monohydrate) [Maximum Quantity: 28; Number of Repeats: 0]

(a)omit:

Chem mart Doxycycline CH MP NP P4514 28 0 7

(b)omit:

Terry White Chemists Doxycycline TW MP NP P4514 28 0 7

1. Schedule 1, entry for Doxycycline in the form Tablet 100 mg (as monohydrate) [Maximum Quantity: 28; Number of Repeats: 5]

(a)omit:

Chem mart Doxycycline CH MP P6200 28 5 7

(b)omit:

Terry White Chemists Doxycycline TW MP P6200 28 5 7

1. Schedule 1, entry for Ezetimibe

omit from the column headed "Circumstances" for the brands "APO-Ezetimibe" and "Blooms The Chemist Ezetimibe": C5563

1. Schedule 1, entry for Fluconazole in each of the forms: Capsule 50 mg; Capsule 100 mg; and Capsule 200 mg

(a)omit from the column headed "Circumstances" (all brands): C5996

(b)insert in numerical order in the column headed “Circumstances” (all brands): C7898

1. Schedule 1, entry for Fluconazole in the form Powder for oral suspension 50 mg in 5 mL, 35 mL

(a)omit from the column headed "Circumstances": C5982

(b)insert in numerical order in the column headed “Circumstances”: C7934

1. Schedule 1, entry for Fluconazole in the form Solution for I.V. infusion 100 mg in 50 mL

(a)omit from the column headed "Circumstances": C5996

(b)insert in numerical order in the column headed “Circumstances”: C7898

1. Schedule 1, entry for Fluconazole in the form Solution for I.V. infusion 200 mg in 100 mL

(a)omit from the column headed "Circumstances" (all brands): C6960

(b)insert in numerical order in the column headed “Circumstances” (all brands): C7897

1. Schedule 1, entry for Fluconazole in the form Solution for I.V. infusion 400 mg in 200 mL

(a)omit from the column headed "Circumstances": C5996

(b)insert in numerical order in the column headed “Circumstances”: C7898

1. Schedule 1, entry for Fluorouracil in each of the forms: Injection 1000 mg in 20 mL; Injection 2500 mg in 50 mL; and Injection 5000 mg in 100 mL

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

Fluorouracil Accord OC MP C6266 C6297 See Note 3 See Note 3 1 D(100)

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

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

a APO-Gliclazide TX MP NP 100 5 100

(b)omit:

a Chem mart Gliclazide CH MP NP 100 5 100

(c)omit:

a Terry White Chemists Gliclazide TW MP NP 100 5 100

1. Schedule 1, entry for Glimepiride in each of the forms: Tablet 1 mg; Tablet 2 mg; Tablet 3 mg; and Tablet 4 mg

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

a Glimepiride APOTEX GX MP NP 30 5 30

1. Schedule 1, entry for Glucose and ketone indicator-urine

omit from the column headed "Responsible Person": BN           substitute: DX

1. Schedule 1, entry for Glucose indicator-urine

omit from the column headed "Responsible Person": BN           substitute: DX

1. Schedule 1, after entry for Griseofulvin in the form Tablet 500 mg

insert:

Guanfacine	Tablet 1 mg (as hydrochloride)	Oral	Intuniv	ZI	MP	C7874 C7889	28	5	28
	Tablet 2 mg (as hydrochloride)	Oral	Intuniv	ZI	MP	C7874 C7889	28	5	28
	Tablet 3 mg (as hydrochloride)	Oral	Intuniv	ZI	MP	C7874 C7889	28	5	28
	Tablet 4 mg (as hydrochloride)	Oral	Intuniv	ZI	MP	C7874 C7889	28	5	28

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

(a)omit from the column headed "Circumstances" (all brands): C6907

(b)insert in numerical order in the column headed “Circumstances" (all brands): C7884

(c)omit from the column headed "Purposes" (all brands): P6907

(d)insert in numerical order in the column headed “Purposes" (all brands): P7884

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

(a)omit from the column headed "Circumstances" (all brands): C6907

(b)insert in numerical order in the column headed “Circumstances" (all brands): C7884

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

(a)omit from the column headed "Circumstances" (all brands): C6907

(b)insert in numerical order in the column headed “Circumstances" (all brands): C7884

(c)omit from the column headed "Purposes" (all brands): P6907

(d)insert in numerical order in the column headed “Purposes" (all brands): P7884

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

(a)omit from the column headed "Circumstances" (all brands): C6907

(b)insert in numerical order in the column headed “Circumstances" (all brands): C7884

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

(a)omit from the column headed "Circumstances" (all brands): C6907

(b)insert in numerical order in the column headed “Circumstances" (all brands): C7884

(c)omit from the column headed "Purposes" (all brands): P6907

(d)insert in numerical order in the column headed “Purposes" (all brands): P7884

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

(a)omit from the column headed "Circumstances" (all brands): C6907

(b)insert in numerical order in the column headed “Circumstances" (all brands): C7884

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

(a)omit from the column headed "Circumstances" (all brands): C6907

(b)insert in numerical order in the column headed “Circumstances" (all brands): C7884

(c)omit from the column headed "Purposes" (all brands): P6907

(d)insert in numerical order in the column headed “Purposes" (all brands): P7884

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

(a)omit from the column headed "Circumstances" (all brands): C6907

(b)insert in numerical order in the column headed “Circumstances" (all brands): C7884

1. Schedule 1, entry for Iron sucrose

omit from the column headed "Responsible Person": AS      substitute: VL

1. Schedule 1, entry for Latanoprost

(a)omit:

a Chem mart Latanoprost CH AO MP 1 5 1

(b)omit:

a Terry White Chemists Latanoprost TW AO MP 1 5 1

1. Schedule 1, entry for Lercanidipine in the form Tablet containing lercanidipine hydrochloride 10 mg

omit:

a Lercanidipine GH GQ MP NP 28 5 28

1. Schedule 1, entry for Letrozole

omit:

a Letrozole RBX RA MP NP C5464 30 5 30

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

(a)omit:

a Chem mart Lisinopril CH MP NP 30 5 30

(b)omit:

a Terry White Chemists Lisinopril TW MP NP 30 5 30

1. Schedule 1, entry for Montelukast in the form Tablet, chewable, 4 mg (as sodium)

(a)omit:

a Chem mart Montelukast CH MP NP C6666 28 5 28

(b)omit:

a Terry White Chemists Montelukast TW MP NP C6666 28 5 28

1. Schedule 1, entry for Montelukast in the form Tablet, chewable, 5 mg (as sodium)

(a)omit:

a Chem mart Montelukast CH MP NP C6674 C7781 28 5 28

(b)omit:

a Terry White Chemists Montelukast TW MP NP C6674 C7781 28 5 28

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

(a)omit from the column headed "Circumstances": C6996

(b)insert in numerical order in the column headed "Circumstances": C7567

1. Schedule 1, entry for Olanzapine in each of the forms: Tablet 15 mg (orally disintegrating); and Tablet 20 mg (orally disintegrating)

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

PRYZEX ODT RW MP NP C5856 C5869 28 5 28

1. Schedule 1, after entry for Perampanel in the form Tablet 12 mg (as hemisesquihydrate)

insert:

Perfluorohexyloctane Eye drops, 3 mL Application to the eye Novatears AE AO MP NP C6172 1 5 1

1. Schedule 1, entry for Perindopril with indapamide in the form Tablet containing perindopril erbumine 4 mg with indapamide hemihydrate 1.25 mg

(a)omit:

Chem mart Perindopril/ Indapamide 4/1.25 CH MP NP C4375 30 5 30

(b)omit:

Terry White Chemists Perindopril/ Indapamide 4/1.25 TW MP NP C4375 30 5 30

1. Schedule 1, entry for Ponatinib in the form Tablet 15 mg (as hydrochloride) [Maximum Quantity: 60; Number of Repeats: 2]

(a)insert in numerical order in the column headed "Circumstances": C7901 C7914 C7926

(b)insert in numerical order in the column headed "Purposes": P7901 P7914 P7926

1. Schedule 1, entry for Ponatinib in the form Tablet 15 mg (as hydrochloride) [Maximum Quantity: 60; Number of Repeats: 5]

insert in numerical order in the column headed "Circumstances": C7901 C7914 C7926

1. Schedule 1, entry for Ponatinib in the form Tablet 45 mg (as hydrochloride) [Maximum Quantity: 30; Number of Repeats: 2]

(a)insert in numerical order in the column headed "Circumstances": C7901 C7914 C7926

(b)insert in numerical order in the column headed "Purposes": P7901 P7914 P7926

1. Schedule 1, entry for Ponatinib in the form Tablet 45 mg (as hydrochloride) [Maximum Quantity: 30; Number of Repeats: 5]

insert in numerical order in the column headed "Circumstances": C7901 C7914 C7926

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

(a)omit:

a Chem mart Pravastatin CH MP NP 30 5 30

(b)omit:

a Terry White Chemists Pravastatin TW MP NP 30 5 30

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

(a)omit:

a Chem mart Pravastatin CH MP P7598 30 11 30

(b)omit:

a Terry White Chemists Pravastatin TW MP P7598 30 11 30

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

(a)omit:

a Chem mart Pravastatin CH MP NP 30 5 30

(b)omit:

a Terry White Chemists Pravastatin TW MP NP 30 5 30

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

(a)omit:

a Chem mart Pravastatin CH MP P7598 30 11 30

(b)omit:

a Terry White Chemists Pravastatin TW MP P7598 30 11 30

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

(a)omit:

a Chem mart Pravastatin CH MP NP 30 5 30

(b)omit:

a Terry White Chemists Pravastatin TW MP NP 30 5 30

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

(a)omit:

a Chem mart Pravastatin CH MP P7598 30 11 30

(b)omit:

a Terry White Chemists Pravastatin TW MP P7598 30 11 30

1. Schedule 1, entry for Pravastatin in the form Tablet containing pravastatin sodium 80 mg [Maximum Quantity: 30; Number of Repeats: 5]

(a)omit:

a Chem mart Pravastatin CH MP NP 30 5 30

(b)omit:

a Terry White Chemists Pravastatin TW MP NP 30 5 30

1. Schedule 1, entry for Pravastatin in the form Tablet containing pravastatin sodium 80 mg [Maximum Quantity: 30; Number of Repeats: 11]

(a)omit:

a Chem mart Pravastatin CH MP P7598 30 11 30

(b)omit:

a Terry White Chemists Pravastatin TW MP P7598 30 11 30

1. Schedule 1, entry for Prazosin in each of the forms: Tablet 1 mg (as hydrochloride); Tablet 2 mg (as hydrochloride); and Tablet 5 mg (as hydrochloride)

(a)omit:

a Chem mart Prazosin CH MP NP 100 5 100

(b)omit:

a Terry White Chemists Prazosin TW MP NP 100 5 100

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

omit from the column headed "Circumstances" (all brands): C4385 C4391 C4396            substitute (all brands): C7893 C7916 C7927

1. Schedule 1, entry for Tacrolimus in the form Capsule 0.5 mg [Maximum Quantity: 100; Number of Repeats: 3]

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

a Tacrograf RW MP 100 3 100

1. Schedule 1, entry for Tacrolimus in the form Capsule 0.5 mg [Maximum Quantity: 200; Number of Repeats: 5]

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

a Tacrograf RW MP P5569 P5602 200
CN5569 CN5602 5
CN5569 CN5602 100 C(100)

1. Schedule 1, entry for Tacrolimus in the form Capsule 1 mg [Maximum Quantity: 100; Number of Repeats: 3]

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

a Tacrograf RW MP 100 3 100

1. Schedule 1, entry for Tacrolimus in the form Capsule 1 mg [Maximum Quantity: 200; Number of Repeats: 5]

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

a Tacrograf RW MP P5569 P5602 200
CN5569 CN5602 5
CN5569 CN5602 100 C(100)

1. Schedule 1, entry for Tacrolimus in the form Capsule 5 mg [Maximum Quantity: 50; Number of Repeats: 3]

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

a Tacrograf RW MP 50 3 50

1. Schedule 1, entry for Tacrolimus in the form Capsule 5 mg [Maximum Quantity: 100; Number of Repeats: 5]

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

a Tacrograf RW MP P5569 P5602 100
CN5569 CN5602 5
CN5569 CN5602 50 C(100)

1. Schedule 1, entry for Tobramycin in the form Solution for inhalation 300 mg in 5 mL

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

a TOBRAMYCIN WOCKHARDT WC MP C5520 56 2 56

1. Schedule 1, entry for Triglycerides, long chain

substitute:

Triglycerides, long chain Oral liquid 225 mL, 15 (carbzero) Oral Carbzero VF MP NP C4437 2 5 1

1. Schedule 1, entry for Triglycerides, medium chain

(a)insert in the columns in the order indicated, and in alphabetical order for the column headed "Form":

Oral liquid 225 mL, 15 (betaquik) Oral Betaquik VF MP NP C6147 C6191 2 5 1

(b)omit:

Oral liquid 250 mL, 18 (betaquik) Oral betaquik VF MP NP C6147 C6191 2 5 1

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

insert:

DX Ascensia Diabetes Care Australia Pty Ltd 62 607 554 325

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

insert:

WC Wockhardt Bio Pty Ltd 91 607 752 090 

1. Schedule 4, entry for Adalimumab

omit:

C5116 P5116 Severe Crohn disease
Initial PBS-subsidised treatment of Crohn disease in a paediatric patient who has previously received non-PBS-subsidised therapy with this drug (Initial 3 - Grandfather)
Must be treated by a gastroenterologist (code 87) or a consultant physician [internal medicine specialising in gastroenterology (code 81)] or a consultant physician [general medicine specialising in gastroenterology (code 82)]; OR
Must be treated by a paediatrician or a specialist paediatric gastroenterologist.
Patient must have been receiving treatment with this drug prior to 1 August 2015; AND
Patient must have confirmed Crohn disease, defined by standard clinical, endoscopic and/or imaging features, including histological evidence, with the diagnosis confirmed by a gastroenterologist, consultant physician, paediatrician or specialist paediatric gastroenterologist; AND
Patient must have failed to achieve an adequate response to 2 of the following 3 conventional prior therapies including: (i) a tapered course of steroids, starting at a dose of at least 1 mg per kg or 40 mg (whichever is the lesser) prednisolone (or equivalent), over a 6 week period; (ii) an 8 week course of enteral nutrition; or (iii) immunosuppressive therapy including azathioprine at a dose of at least 2 mg per kg daily for 3 or more months, or, 6-mercaptopurine at a dose of at least 1 mg per kg daily for 3 or more months, or, methotrexate at a dose of at least 10 mg per square metre weekly for 3 or more months; OR
Patient must have a documented intolerance of a severity necessitating permanent treatment withdrawal or a contra-indication to each of prednisolone (or equivalent), azathioprine, 6-mercaptopurine and methotrexate; AND
Patient must have had disease severity considered to be severe as demonstrated by a Paediatric Crohn Disease Activity Index (PCDAI) Score greater than or equal to 40 preferably whilst still on prior conventional treatment, but no longer than 1 month following cessation of the most recent prior conventional treatment; AND
Patient must have demonstrated an adequate response to treatment with this drug as defined as a reduction in PCDAI Score by at least 15 points as compared to baseline and a total of PCDAI score of 40 points or less with the PCDAI assessment being no more than 1 month old at the time of application.
Patient must be aged 6 to 17 years inclusive.
Applications for authorisation of initial treatment must be in writing and must include:
(a) a completed authority prescription form; and
(b) a completed paediatric Crohn Disease PBS Authority Application -Supporting Information Form [may be downloaded from the Department of Human Services website ( which includes the following:
(i) the completed current and baseline Paediatric Crohn Disease Activity Index (PCDAI) Score calculation sheet;
(ii) the date of commencement of this drug; and
(iii) the signed patient or guardian acknowledgement indicating they understand and acknowledge that the PBS-subsidised treatment will cease if they do not meet the predetermined response criterion for ongoing PBS-subsidised treatment, as outlined in the restriction for continuing treatment.
The patient's current PCDAI assessment must be no more than 1 month old at the time of application. The baseline PCDAI assessment must be from immediately prior to commencing treatment with this drug.
The assessment of the patient's response to a continuing course of therapy must be made within the 4 weeks prior to completion of that course and posted to the Department of Human Services no less than 2 weeks prior to the date the next dose is scheduled, in order to ensure continuity of treatment for those patients who meet the continuation criterion.
Where an assessment is not submitted to the Department of Human Services within these timeframes, patients will be deemed to have failed to respond, or to have failed to sustain a response, to treatment with this drug.
A maximum of 24 weeks treatment will be approved under this criterion.
Where fewer than 5 repeats are requested at the time of the application, authority approvals for sufficient repeats to complete a maximum of 24 weeks of treatment with this drug may be requested by telephone by contacting the Department of Human Services on 1800 700 270 (hours of operation 8 a.m. to 5 p.m. EST Monday to Friday) and authorised through the Balance of Supply treatment phase PBS restriction.
Patients may qualify for PBS-subsidised treatment under this restriction once only. For continuing PBS-subsidised treatment, a Grandfathered patient must qualify under the Continuing treatment criteria. Compliance with Written Authority Required procedures

1. Schedule 4, entry for Atomoxetine

substitute:

Atomoxetine	C7876	Attention deficit hyperactivity disorder Initial treatment Must be treated by a paediatrician or psychiatrist. The condition must be or have been diagnosed according to the DSM-5 criteria; AND Patient must have a contraindication to dexamfetamine, methylphenidate or lisdexamfetamine as specified in TGA-approved Product Information; OR Patient must have a comorbid mood disorder that has developed or worsened as a result of dexamfetamine, methylphenidate or lisdexamfetamine treatment and is of a severity necessitating treatment withdrawal; OR Patient must be at an unacceptable medical risk of a severity necessitating permanent stimulant treatment withdrawal if given a stimulant treatment with another agent; OR Patient must have experienced adverse reactions of a severity necessitating permanent treatment withdrawal following treatment with dexamfetamine, methylphenidate and lisdexamfetamine (not simultaneously). Patient must be or have been diagnosed between the ages of 6 and 18 years inclusive.	Compliance with Authority Required procedures - Streamlined Authority Code 7876
	C7890	Attention deficit hyperactivity disorder Continuing treatment Patient must have previously received PBS-subsidised treatment with this drug for this condition.	Compliance with Authority Required procedures - Streamlined Authority Code 7890

1. Schedule 4, after entry for Balsalazide

insert:

Baricitinib	C7881	P7881	Severe active rheumatoid arthritis Continuing and Initial 3 (Grandfathered patients) treatment - balance of supply Must be treated by a rheumatologist; OR Must be treated by a clinical immunologist with expertise in the management of rheumatoid arthritis. Patient must have received insufficient therapy with this drug under the Continuing treatment restriction to complete 24 weeks of treatment; OR Patient must have received insufficient treatment with this drug to complete 24 weeks of treatment under the Initial 3 (Grandfathered patients); AND The treatment must provide no more than the balance of up to 24 weeks treatment available under the above restrictions. Patient must be aged 18 years or older.	Compliance with Authority Required procedures
	C7882	P7882	Severe active rheumatoid arthritis Initial treatment – Initial 3 (Grandfathered patients) Must be treated by a rheumatologist; OR Must be treated by a clinical immunologist with expertise in the management of rheumatoid arthritis. Patient must be aged 18 years or older. Patient must have a documented history of severe active rheumatoid arthritis; AND Patient must have previously received non-PBS-subsidised therapy with this drug for this condition prior to 1 September 2018; AND Patient must be receiving treatment with this drug for this condition at the time of application; AND Patient must have failed to achieve an adequate response to a trial of at least 6 months of intensive treatment with disease modifying anti-rheumatic drugs (DMARDs) which must include at least 3 months continuous treatment with each of at least 2 DMARDs, one of which must be methotrexate at a dose of at least 20 mg weekly and one of which must be: (i) hydroxychloroquine at a dose of at least 200 mg daily; or (ii) leflunomide at a dose of at least 10 mg daily; or (iii) sulfasalazine at a dose of at least 2 g daily; OR Patient must have failed to achieve an adequate response to a trial of at least 6 months of intensive treatment with DMARDs which, if methotrexate is contraindicated according to the Therapeutic Goods Administration (TGA)-approved Product Information or cannot be tolerated at a 20 mg weekly dose, must include at least 3 months continuous treatment with each of at least 2 of the following DMARDs: (i) hydroxychloroquine at a dose of at least 200 mg daily; and/or (ii) leflunomide at a dose of at least 10 mg daily; and/or (iii) sulfasalazine at a dose of at least 2 g daily; OR Patient must have failed to achieve an adequate response to a trial of at least 6 months of intensive treatment with DMARDs which, if 3 or more of methotrexate, hydroxychloroquine, leflunomide and sulfasalazine are contraindicated according to the relevant TGA-approved Product Information or cannot be tolerated at the doses specified above, must include at least 3 months continuous treatment with each of at least 2 DMARDs, with one or more of the following DMARDs being used in place of the DMARDS which are contraindicated or not tolerated: (i) azathioprine at a dose of at least 1 mg/kg per day; and/or (ii) cyclosporin at a dose of at least 2 mg/kg/day; and/or (iii) sodium aurothiomalate at a dose of 50 mg weekly; AND Patient must not have failed more than 4 PBS-subsidised bDMARD treatments for this condition in a lifetime; AND Patient must not receive more than 24 weeks of treatment under this restriction. For the purposes of this restriction bDMARD means abatacept, adalimumab, baricitinib, certolizumab pegol, etanercept, golimumab, infliximab, rituximab, tocilizumab or tofacitinib. If methotrexate is contraindicated according to the TGA-approved Product Information or cannot be tolerated at a 20 mg weekly dose,the application must include details of the contraindication or intolerance including severity to methotrexate. The maximum tolerated dose of methotrexate must be documented in the application, if applicable. The application must include details of the DMARDs trialled, their doses and duration of treatment, and all relevant contraindications and/or intolerances including severity. The requirement to trial at least 2 DMARDs for periods of at least 3 months each can be met using single agents sequentially or by using one or more combinations of DMARDs. If the requirement to trial 6 months of intensive DMARD therapy with at least 2 DMARDs cannot be met because of contraindications and/or intolerances of a severity necessitating permanent treatment withdrawal to all of the DMARDs specified above, details of the contraindication or intolerance including severity and dose for each DMARD must be provided in the authority application. An adequate response to treatment is defined as: an ESR no greater than 25 mm per hour or a CRP level no greater than 15 mg per L or either marker reduced by at least 20% from baseline; AND either of the following: (a) a reduction in the total active (swollen and tender) joint count by at least 50% from baseline, where baseline is at least 20 active joints; or (b) a reduction in the number of the following active joints, from at least 4, by at least 50%: (i) elbow, wrist, knee and/or ankle (assessed as swollen and tender); and/or (ii) shoulder and/or hip (assessed as pain in passive movement and restriction of passive movement, where pain and limitation of movement are due to active disease and not irreversible damage such as joint destruction or bony overgrowth). Where the baseline active joint count is based on total active joints (i.e. more than 20 active joints), response will be determined according to the reduction in the total number of active joints. Where the baseline is determined on total number of major joints, the response must be demonstrated on the total number of major joints. If only an ESR or CRP level is provided with the initial application, the same marker will be used to determine response. All applications for treatment with this drug for this condition under this restriction must include baseline joint count and ESR and/or CRP as determined at the completion of a 6 month intensive DMARD trial but prior to ceasing DMARD therapy, and measurement of response to the prior course of non-PBS-subsidised therapy with this drug. This assessment must be submitted no later than 4 weeks from the cessation of that treatment course. If the requirement to demonstrate an elevated ESR or CRP cannot be met, the application must state the reasons why this criterion cannot be satisfied. A patient may qualify for PBS-subsidised treatment under this restriction once only. The authority application must be made in writing and must include: (1) a completed authority prescription form; and (2) a completed Rheumatoid Arthritis PBS Authority Application - Supporting Information Form.	Compliance with Written Authority Required procedures
	C7899	P7899	Severe active rheumatoid arthritis Continuing treatment Must be treated by a rheumatologist; OR Must be treated by a clinical immunologist with expertise in the management of rheumatoid arthritis. Patient must have a documented history of severe active rheumatoid arthritis; AND Patient must have demonstrated an adequate response to treatment with this drug; AND Patient must have received this drug as their most recent course of PBS-subsidised biological disease modifying anti-rheumatic drug (bDMARD) treatment; AND Patient must not receive more than 24 weeks of treatment per continuing treatment course authorised under this restriction. Patient must be aged 18 years or older. For the purposes of this restriction bDMARD means abatacept, adalimumab, baricitinib, certolizumab pegol, etanercept, golimumab, infliximab, rituximab, tocilizumab or tofacitinib. An adequate response to treatment is defined as: an ESR no greater than 25 mm per hour or a CRP level no greater than 15 mg per L or either marker reduced by at least 20% from baseline; AND either of the following: (a) a reduction in the total active (swollen and tender) joint count by at least 50% from baseline, where baseline is at least 20 active joints; or (b) a reduction in the number of the following active joints, from at least 4, by at least 50%: (i) elbow, wrist, knee and/or ankle (assessed as swollen and tender); and/or (ii) shoulder and/or hip (assessed as pain in passive movement and restriction of passive movement, where pain and limitation of movement are due to active disease and not irreversible damage such as joint destruction or bony overgrowth). Where the baseline active joint count is based on total active joints (i.e. more than 20 active joints), response will be determined according to the reduction in the total number of active joints. Where the baseline is determined on total number of major joints, the response must be demonstrated on the total number of major joints. If only an ESR or CRP level is provided with the initial application, the same marker will be used to determine response. The authority application must be made in writing and must include: (1) a completed authority prescription form; and (2) a completed Rheumatoid Arthritis PBS Authority Application - Supporting Information Form. All applications for continuing treatment with this drug must include a measurement of response to the prior course of therapy. This assessment must be submitted no later than 4 weeks from the cessation of that treatment course. If the application is the first application for continuing treatment with this drug, it must be accompanied by an assessment of response to a minimum of 12 weeks of treatment with an initial treatment course. Where a response assessment is not undertaken and submitted within these timeframes, the patient will be deemed to have failed to respond to treatment with this drug. If a patient fails to demonstrate a response to treatment with this drug under this restriction they will not be eligible to receive further PBS-subsidised treatment with this drug for this condition.	Compliance with Written Authority Required procedures
	C7905	P7905	Severe active rheumatoid arthritis Initial treatment - Initial 1 (new patient or patient recommencing treatment after a break of more than 24 months) or Initial 2 (change or recommencement of treatment after break of less than 24 months) - balance of supply. Must be treated by a rheumatologist; OR Must be treated by a clinical immunologist with expertise in the management of rheumatoid arthritis. Patient must have received insufficient therapy with this drug for this condition under the Initial 1 (new patient or patient recommencing treatment after break of more than 24 months) restriction to complete 16 weeks treatment; OR Patient must have received insufficient therapy with this drug for this condition under the Initial 2 (change or recommencement of treatment after break of less than 24 months) restriction to complete 16 weeks treatment; AND The treatment must provide no more than the balance of up to 16 weeks treatment available under the above restrictions. Patient must be aged 18 years or older.	Compliance with Authority Required procedures
	C7907	P7907	Severe active rheumatoid arthritis Initial treatment - Initial 1 (new patient or patient recommencing treatment after a break of more than 24 months) Must be treated by a rheumatologist; OR Must be treated by a clinical immunologist with expertise in the management of rheumatoid arthritis. Patient must be aged 18 years or older. Patient must have severe active rheumatoid arthritis; AND Patient must have received no PBS-subsidised treatment with a biological disease modifying anti-rheumatic drug (bDMARD) for this condition in the previous 24 months; AND Patient must not have failed previous PBS-subsidised treatment with this drug for this condition, and have not already failed, or ceased to respond to, PBS-subsidised bDMARD treatment for this condition 5 times; AND Patient must have failed, in the 24 months immediately prior to the date of the application, to achieve an adequate response to a trial of at least 6 months of intensive treatment with disease modifying anti-rheumatic drugs (DMARDs) which must include at least 3 months continuous treatment with each of at least 2 DMARDs, one of which must be methotrexate at a dose of at least 20 mg weekly and one of which must be: (i) hydroxychloroquine at a dose of at least 200 mg daily; or (ii) leflunomide at a dose of at least 10 mg daily; or (iii) sulfasalazine at a dose of at least 2 g daily; OR Patient must have failed, in the 24 months immediately prior to the date of the application, to achieve an adequate response to a trial of at least 6 months of intensive treatment with DMARDs which, if methotrexate is contraindicated according to the Therapeutic Goods Administration (TGA)-approved Product Information or cannot be tolerated at a 20 mg weekly dose, must include at least 3 months continuous treatment with each of at least 2 of the following DMARDs: (i) hydroxychloroquine at a dose of at least 200 mg daily; and/or (ii) leflunomide at a dose of at least 10 mg daily; and/or (iii) sulfasalazine at a dose of at least 2 g daily; OR Patient must have failed, in the 24 months immediately prior to the date of the application, to achieve an adequate response to a trial of at least 6 months of intensive treatment with DMARDs which, if 3 or more of methotrexate, hydroxychloroquine, leflunomide and sulfasalazine are contraindicated according to the relevant TGA-approved Product Information or cannot be tolerated at the doses specified above, must include at least 3 months continuous treatment with each of at least 2 DMARDs, with one or more of the following DMARDs being used in place of the DMARDS which are contraindicated or not tolerated: (i) azathioprine at a dose of at least 1 mg/kg per day; and/or (ii) cyclosporin at a dose of at least 2 mg/kg/day; and/or (iii) sodium aurothiomalate at a dose of 50 mg weekly; AND Patient must not receive more than 16 weeks of treatment under this restriction. For the purposes of this restriction bDMARD means abatacept, adalimumab, baricitinib, certolizumab pegol, etanercept, golimumab, infliximab, rituximab, tocilizumab or tofacitinib. If methotrexate is contraindicated according to the TGA-approved Product Information or cannot be tolerated at a 20 mg weekly dose, the application must include details of the contraindication or intolerance including severity to methotrexate. The maximum tolerated dose of methotrexate must be documented in the application, if applicable. The application must include details of the DMARDs trialled, their doses and duration of treatment, and all relevant contraindications and/or intolerances including severity. The requirement to trial at least 2 DMARDs for periods of at least 3 months each can be met using single agents sequentially or by using one or more combinations of DMARDs. If the requirement to trial 6 months of intensive DMARD therapy with at least 2 DMARDs cannot be met because of contraindications and/or intolerances of a severity necessitating permanent treatment withdrawal to all of the DMARDs specified above, details of the contraindication or intolerance including severity and dose for each DMARD must be provided in the authority application. The authority application must be made in writing and must include: (1) a completed authority prescription form; and (2) a completed Rheumatoid Arthritis PBS Authority Application - Supporting Information Form. Assessment of a patient's response to an initial course of treatment must be made after at least 12 weeks of treatment so that there is adequate time for a response to be demonstrated. This assessment, which will be used to determine eligibility for continuing treatment, must be submitted no later than 1 month from the date of completion of this initial course of treatment. Where a response assessment is not undertaken and submitted within these timeframes, the patient will be deemed to have failed to respond to treatment with this drug. Applications for a patient who has received PBS-subsidised treatment with this drug and who wishes to re-commence therapy with this drug, must be accompanied by evidence of a response to the patient's most recent course of PBS-subsidised treatment with this drug, within the timeframes specified below. Where the most recent course of PBS-subsidised treatment with this drug was approved under either of the initial 1 or 2 treatment restrictions, the patient must have been assessed for response following a minimum of 12 weeks of therapy. This assessment must be submitted no later than 4 weeks from the date that course was ceased. If a patient fails to demonstrate a response to treatment with this drug under this restriction they will not be eligible to receive further PBS-subsidised treatment with this drug for this condition. The following criteria indicate failure to achieve an adequate response and must be demonstrated in all patients at the time of the initial application: an elevated erythrocyte sedimentation rate (ESR) greater than 25 mm per hour or a C-reactive protein (CRP) level greater than 15 mg per L; AND either (a) a total active joint count of at least 20 active (swollen and tender) joints; or (b) at least 4 active joints from the following list of major joints: (i) elbow, wrist, knee and/or ankle (assessed as swollen and tender); and/or (ii) shoulder and/or hip (assessed as pain in passive movement and restriction of passive movement, where pain and limitation of movement are due to active disease and not irreversible damage such as joint destruction or bony overgrowth). The joint count and ESR and/or CRP must be determined at the completion of the 6 month intensive DMARD trial, but prior to ceasing DMARD therapy. All measures must be no more than one month old at the time of initial application. If the above requirement to demonstrate an elevated ESR or CRP cannot be met, the application must state the reasons why this criterion cannot be satisfied. Where the baseline joint count is based on total active joints (i.e. more than 20 active joints), response will be determined according to the reduction in the total number of active joints. Where the baseline is determined on total number of major joints, the response must be demonstrated on the total number of major joints. If only an ESR or CRP is provided with the initial application, the same marker will be used to determine response.	Compliance with Written Authority Required procedures
	C7925	P7925	Severe active rheumatoid arthritis Initial treatment - Initial 2 (change or re-commencement of treatment after break of less than 24 months) Must be treated by a rheumatologist; OR Must be treated by a clinical immunologist with expertise in the management of rheumatoid arthritis. Patient must have a documented history of severe active rheumatoid arthritis; AND Patient must have received prior PBS-subsidised biological disease modifying anti-rheumatic drug (bDMARD) treatment for this condition and are eligible to receive further bDMARD therapy; AND Patient must not receive more than 16 weeks of treatment under this restriction. Patient must be aged 18 years or older. For the purposes of this restriction bDMARD means abatacept, adalimumab, baricitinib, certolizumab pegol, etanercept, golimumab, infliximab, rituximab, tocilizumab or tofacitinib. The authority application must be made in writing and must include: (a) a completed authority prescription form and (b) a completed Rheumatoid Arthritis PBS Authority Application - Supporting Information Form. Application for a patient who has received PBS-subsidised treatment with this drug and who wishes to re-commence therapy with this drug, must be accompanied by evidence of a response to the patient's most recent course of PBS-subsidised treatment with this drug, within the timeframes specified below. Where the most recent course of PBS-subsidised treatment with this drug was approved under either of the initial 1 or 2 treatment restrictions, the patient must have been assessed for response following a minimum of 12 weeks of therapy. This assessment must be submitted no later than 4 weeks from the date that course was ceased. If a patient fails to demonstrate a response to treatment with this drug under this restriction will not be eligible to receive further PBS-subsidised treatment with this drug for this condition. Where a response assessment is not undertaken and submitted within these timeframes, the patient will be deemed to have failed to respond to treatment with this drug. If a patient who has demonstrated a response to a course of rituximab must have a PBS-subsidised biological therapy treatment-free period of at least 22 weeks, immediately following the second infusion, before swapping to an alternate bDMARD. An adequate response to treatment is defined as: an ESR no greater than 25 mm per hour or a CRP level no greater than 15 mg per L or either marker reduced by at least 20% from baseline; AND either of the following: (a) a reduction in the total active (swollen and tender) joint count by at least 50% from baseline, where baseline is at least 20 active joints; or (b) a reduction in the number of the following active joints, from at least 4, by at least 50%: (i) elbow, wrist, knee and/or ankle (assessed as swollen and tender); and/or (ii) shoulder and/or hip (assessed as pain in passive movement and restriction of passive movement, where pain and limitation of movement are due to active disease and not irreversible damage such as joint destruction or bony overgrowth).	Compliance with Written Authority Required procedures

1. Schedule 4, entry for Fluconazole

substitute:

Fluconazole	C5978	Cryptococcal meningitis The treatment must be maintenance therapy; AND Patient must be immunosuppressed.	Compliance with Authority Required procedures - Streamlined Authority Code 5978
	C5989	Oesophageal candidiasis Patient must be immunosuppressed.	Compliance with Authority Required procedures - Streamlined Authority Code 5989
	C6002	Cryptococcal meningitis	Compliance with Authority Required procedures - Streamlined Authority Code 6002
	C6006	Cryptococcal meningitis Patient must be unable to take a solid dose form of fluconazole.	Compliance with Authority Required procedures - Streamlined Authority Code 6006
	C6023	Oropharyngeal candidiasis Patient must be immunosuppressed.	Compliance with Authority Required procedures - Streamlined Authority Code 6023
	C6030	Oropharyngeal candidiasis The treatment must be for prophylaxis; AND Patient must be immunosuppressed.	Compliance with Authority Required procedures - Streamlined Authority Code 6030
	C6031	Oropharyngeal candidiasis Patient must be immunosuppressed; AND Patient must be unable to take a solid dose form of fluconazole.	Compliance with Authority Required procedures - Streamlined Authority Code 6031
	C6032	Oropharyngeal candidiasis The treatment must be for prophylaxis; AND Patient must be immunosuppressed; AND Patient must be unable to take a solid dose form of fluconazole.	Compliance with Authority Required procedures - Streamlined Authority Code 6032
	C6045	Cryptococcal meningitis The treatment must be maintenance therapy; AND Patient must be immunosuppressed; AND Patient must be unable to take a solid dose form of fluconazole.	Compliance with Authority Required procedures - Streamlined Authority Code 6045
	C6046	Oesophageal candidiasis Patient must be immunosuppressed; AND Patient must be unable to take a solid dose form of fluconazole.	Compliance with Authority Required procedures - Streamlined Authority Code 6046
	C6956	Cryptococcal meningitis	Compliance with Authority Required procedures - Streamlined Authority Code 6956
	C6965	Oropharyngeal candidiasis The treatment must be for prophylaxis; AND Patient must be immunosuppressed.	Compliance with Authority Required procedures - Streamlined Authority Code 6965
	C6969	Oesophageal candidiasis Patient must be immunosuppressed.	Compliance with Authority Required procedures - Streamlined Authority Code 6969
	C6974	Oropharyngeal candidiasis Patient must be immunosuppressed.	Compliance with Authority Required procedures - Streamlined Authority Code 6974
	C6978	Cryptococcal meningitis The treatment must be maintenance therapy; AND Patient must be immunosuppressed.	Compliance with Authority Required procedures - Streamlined Authority Code 6978
	C7897	Fungal infection The condition must be serious or life-threatening	Compliance with Authority Required procedures - Streamlined Authority Code 7897
	C7898	Fungal infection The condition must be serious or life-threatening.	Compliance with Authority Required procedures - Streamlined Authority Code 7898
	C7934	Fungal infection The condition must be serious or life-threatening; AND Patient must be unable to take a solid dose form of fluconazole	Compliance with Authority Required procedures - Streamlined Authority Code 7934

1. Schedule 4, after entry for Grazoprevir with elbasvir

insert:

Guanfacine	C7874	Attention deficit hyperactivity disorder Continuing treatment Patient must have previously received PBS-subsidised treatment with this drug for this condition.	Compliance with Authority Required procedures - Streamlined Authority Code 7874
	C7889	Attention deficit hyperactivity disorder Initial treatment Must be treated by a paediatrician or psychiatrist. The condition must be or have been diagnosed according to the DSM-5 criteria; AND Patient must have a contraindication to dexamfetamine, methylphenidate or lisdexamfetamine as specified in TGA-approved Product Information; OR Patient must have a comorbid mood disorder that has developed or worsened as a result of dexamfetamine, methylphenidate or lisdexamfetamine treatment and is of a severity necessitating treatment withdrawal; OR Patient must be at an unacceptable medical risk of a severity necessitating permanent stimulant treatment withdrawal if given a stimulant treatment with another agent; OR Patient must have experienced adverse reactions of a severity necessitating permanent treatment withdrawal following treatment with dexamfetamine, methylphenidate and lisdexamfetamine (not simultaneously). Patient must be or have been diagnosed between the ages of 6 and 17 years inclusive.	Compliance with Authority Required procedures - Streamlined Authority Code 7889

1. Schedule 4, entry for Imatinib

(a)in the entry for Circumstances Code C6896, insert in the column headed “Circumstances and Purposes” after the word “chemotherapy”: or corticosteroids

(b)omit:

C6907 P6907 Acute lymphoblastic leukaemia
Continuing treatment
Patient must have previously received PBS-subsidised treatment with this drug for this condition; AND
The condition must be expressing the Philadelphia chromosome; OR
The condition must have the transcript BCR-ABL; AND
The treatment must be for maintenance of first complete remission; AND
The treatment must be in combination with chemotherapy.
Imatinib is available with a lifetime maximum of 24 months for continuing treatment with imatinib therapy for patients with acute lymphoblastic leukaemia reimbursed through the PBS. Compliance with Authority Required procedures

(c)insert in numerical order after existing text:

C7884 P7884 Acute lymphoblastic leukaemia
Continuing treatment
Patient must have previously received PBS-subsidised treatment with this drug for this condition; AND
The condition must be expressing the Philadelphia chromosome; OR
The condition must have the transcript BCR-ABL; AND
The treatment must be for maintenance of first complete remission; AND
The treatment must be in combination with chemotherapy or corticosteroids.
Imatinib is available with a lifetime maximum of 24 months for continuing treatment with imatinib therapy for patients with acute lymphoblastic leukaemia reimbursed through the PBS. Compliance with Authority Required procedures

1. Schedule 4, entry for Itraconazole

(a)insert in the column headed “Authority Requirements (part of Circumstances; or Conditions)” for Circumstances Code C5988:

Compliance with Authority Required procedures - Streamlined Authority Code 5988

(b)insert in the column headed “Authority Requirements (part of Circumstances; or Conditions)” for Circumstances Code C6005:

Compliance with Authority Required procedures - Streamlined Authority Code 6005

(c)insert in the column headed “Authority Requirements (part of Circumstances; or Conditions)” for Circumstances Code C6016:

Compliance with Authority Required procedures - Streamlined Authority Code 6016

(d)insert in the column headed “Authority Requirements (part of Circumstances; or Conditions)” for Circumstances Code C6022:

Compliance with Authority Required procedures - Streamlined Authority Code 6022

(e)insert in the column headed “Authority Requirements (part of Circumstances; or Conditions)” for Circumstances Code C6035:

Compliance with Authority Required procedures - Streamlined Authority Code 6035

(f)insert in the column headed “Authority Requirements (part of Circumstances; or Conditions)” for Circumstances Code C6037:

Compliance with Authority Required procedures - Streamlined Authority Code 6037

(g)insert in the column headed “Authority Requirements (part of Circumstances; or Conditions)” for Circumstances Code C6057:

Compliance with Authority Required procedures - Streamlined Authority Code 6057

1. Schedule 4, entry for Nivolumab

(a)omit:

C6996 Locally advanced or metastatic non-small cell lung cancer
Initial treatment
Patient must not have received prior treatment with a programmed cell death-1 (PD-1) inhibitor for this condition; AND
Patient must have a WHO performance status of 0 or 1; AND
The treatment must be the sole PBS-subsidised treatment for this condition; AND
The condition must have progressed on or after prior platinum based chemotherapy.
The patient's body weight must be documented in the patient's medical records at the time treatment is initiated Compliance with Authority Required procedures - Streamlined Authority Code 6996

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

C7567 Locally advanced or metastatic non-small cell lung cancer
Initial treatment
Patient must not have received prior treatment with a programmed cell death-1 (PD-1) inhibitor or a programmed cell death ligand-1 (PD-L1) inhibitor for this condition; AND
Patient must have a WHO performance status of 0 or 1; AND
The treatment must be the sole PBS-subsidised treatment for this condition; AND
The condition must have progressed on or after prior platinum based chemotherapy.
The patient's body weight must be documented in the patient's medical records at the time treatment is initiated. Compliance with Authority Required procedures - Streamlined Authority Code 7567

1. Schedule 4, after entry for Perampanel

insert:

Perfluorohexyloctane C6172 Severe dry eye syndrome
Patient must be sensitive to preservatives in multi-dose eye drops. Compliance with Authority Required procedures - Streamlined Authority Code 6172

1. Schedule 4, entry for Ponatinib

insert in numerical order after existing text:

C7901	P7901	Acute lymphoblastic leukaemia Continuing treatment Patient must have previously received PBS-subsidised treatment with this drug for this condition; AND The treatment must be the sole PBS-subsidised therapy for this condition; AND Patient must not have progressive disease while receiving PBS-subsidised treatment with this drug for this condition.	Compliance with Authority Required procedures
C7914	P7914	Acute lymphoblastic leukaemia Initial treatment The condition must be expressing the Philadelphia chromosome; OR The condition must have the transcript BCR-ABL; AND Patient must have failed prior treatment with PBS-subsidised dasatinib for this condition; OR Patient must have developed intolerance to PBS-subsidised dasatinib of a severity requiring treatment withdrawal; AND The treatment must be the sole PBS-subsidised therapy for this condition. Failure of treatment with dasatinib is defined as either: 1. Failure to achieve a complete morphological and cytogenetic remission after a minimum of 2 months treatment with PBS-subsidised dasatinib for this condition; or 2. Morphological or cytogenetic relapse of leukaemia after achieving a complete remission induced by PBS-subsidised dasatinib for this condition; or 3. Rising levels of BCR-ABL1 transcript on two consecutive occasions in a patient in complete remission while being treated with PBS-subsidised dasatinib for this condition. Patients must have active leukaemia, as defined by presence on current pathology assessments of either morphological infiltration of the bone marrow (greater than 5% lymphoblasts) or cerebrospinal fluid or other sites; OR the presence of cells bearing the Philadelphia chromosome on cytogenetic or FISH analysis in the bone marrow of patients in morphological remission; OR rising levels of BCR-ABL1 transcript on two consecutive occasions in a patient in complete remission while being treated with PBS-subsidised dasatinib for this condition. The authority application must be made in writing and must include: 1. a completed authority prescription form; and 2. a completed Acute Lymphoblastic Leukaemia ponatinib PBS Authority Application - Supporting Information Form; and 3. a pathology report demonstrating that the patient has active acute lymphoblastic leukaemia, manifest as cytogenetic evidence of the Philadelphia chromosome, or morphological evidence of acute lymphoblastic leukaemia plus qualitative RT-PCR evidence of BCR-ABL transcript. The date of the relevant pathology report(s) need(s) to be provided; or 4. pathology reports documenting rising levels of BCR-ABL1 transcript on two consecutive occasions in a patient in complete remission while being treated with PBS-subsidised dasatinib for this condition. The date of the relevant pathology report(s) need(s) to be provided	Compliance with Written Authority Required procedures
C7926	P7926	Acute lymphoblastic leukaemia Grandfather treatment Patient must have previously received non-PBS-subsidised therapy with this drug for this condition prior to 1 September 2018; AND The condition must be expressing the Philadelphia chromosome; OR The condition must have the transcript BCR-ABL; AND Patient must have failed prior treatment with PBS-subsidised dasatinib for this condition; OR Patient must have developed intolerance to PBS-subsidised dasatinib of a severity requiring treatment withdrawal; AND The treatment must be the sole PBS-subsidised therapy for this condition. Failure of treatment with dasatinib is defined as either: 1. Failure to achieve a complete morphological and cytogenetic remission after a minimum of 2 months treatment with PBS-subsidised dasatinib for this condition; or 2. Morphological or cytogenetic relapse of leukaemia after achieving a complete remission induced by PBS-subsidised dasatinib for this condition; or 3. Rising levels of BCR-ABL1 transcript on two consecutive occasions in a patient in complete remission while being treated with PBS-subsidised dasatinib for this condition. Patients must have active leukaemia, as defined by presence on current pathology assessments of either morphological infiltration of the bone marrow (greater than 5% lymphoblasts) or cerebrospinal fluid or other sites; OR the presence of cells bearing the Philadelphia chromosome on cytogenetic or FISH analysis in the bone marrow of patients in morphological remission; OR rising levels of BCR-ABL1 transcript on two consecutive occasions in a patient in complete remission while being treated with PBS-subsidised dasatinib for this condition. A patient may qualify for PBS-subsidised treatment under this restriction once only. For continuing PBS-subsidised treatment, a Grandfathered patient must qualify under the Continuing treatment criteria. The authority application must be made in writing and must include: 1. a completed authority prescription form; and 2. a completed Acute Lymphoblastic Leukaemia ponatinib PBS Authority Application - Supporting Information Form; and 3. a pathology report demonstrating that the patient had active acute lymphoblastic leukaemia, manifest as cytogenetic evidence of the Philadelphia chromosome, or morphological evidence of acute lymphoblastic leukaemia plus qualitative RT-PCR evidence of BCR-ABL transcript at the time treatment with ponatinib was initiated. The date of the relevant pathology report(s) need(s) to be provided; or 4. pathology reports documenting rising levels of BCR-ABL1 transcript on two consecutive occasions in a patient in complete remission while being treated with PBS-subsidised dasatinib for this condition. The date of the relevant pathology report(s) need(s) to be provided	Compliance with Written Authority Required procedures

1. Schedule 4, entry for Quetiapine

(a)omit:

C4385	Bipolar I disorder The treatment must be maintenance therapy; AND The treatment must be for dose titration purposes.	Compliance with Authority Required procedures - Streamlined Authority Code 4385
C4391	Schizophrenia The treatment must be for dose titration purposes.	Compliance with Authority Required procedures - Streamlined Authority Code 4391
C4396	Acute mania The condition must be associated with bipolar I disorder; AND The treatment must be as monotherapy; AND The treatment must be for dose titration purposes.	Compliance with Authority Required procedures - Streamlined Authority Code 4396

(b)insert in numerical order after existing text:

C7893	Bipolar I disorder The treatment must be maintenance therapy.	Compliance with Authority Required procedures - Streamlined Authority Code 7893
C7916	Schizophrenia	Compliance with Authority Required procedures - Streamlined Authority Code 7916
C7927	Acute mania The condition must be associated with bipolar I disorder; AND The treatment must be as monotherapy.	Compliance with Authority Required procedures - Streamlined Authority Code 7927

1. Schedule 5, entry for Doxycycline in the form Tablet 100 mg (as monohydrate) [GRP-14639]

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

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

1. Schedule 5, entry for Doxycycline in the form Tablet 50 mg (as monohydrate) [GRP-15635]

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

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

1. Schedule 5, entry for Olanzapine in the form Tablet 20 mg (orally disintegrating) [GRP-15643]

insert in alphabetical order in the column headed “Brand”: PRYZEX ODT

1. Schedule 5, entry for Olanzapine in the form Tablet 15 mg (orally disintegrating) [GRP-15953]

insert in alphabetical order in the column headed “Brand”: PRYZEX ODT

1. Schedule 5, entry for Perindopril with indapamide in the form Tablet containing perindopril erbumine 4 mg with indapamide hemihydrate 1.25 mg [GRP-15765]

(a)omit from the column headed “Brand”:         Chem mart Perindopril/ Indapamide 4/1.25

(b)omit from the column headed “Brand”:            Terry White Chemists Perindopril/ Indapamide 4/1.25