National Health (Listing of Pharmaceutical Benefits) Amendment Instrument 2010 (No. 1) (No. PB 120 of 2010) (Cth)

PB 120 of 2010

National Health (Listing of Pharmaceutical Benefits) Amendment Instrument 2010
(No. 1)¹

National Health Act 1953

I, FELICITY McNEILL, Acting First Assistant Secretary, Department of Health and Ageing, delegate of the Minister for Health and Ageing, make this Instrument under sections 84AF, 85, 85A, 88 and 101 of the National Health Act 1953.

Dated 15 December 2010

FELICITY McNEILL

Acting First Assistant Secretary

Pharmaceutical Benefits Division

Department of Health and Ageing

1          Name of Instrument

(1)        This Instrument is the National Health (Listing of Pharmaceutical Benefits) Amendment Instrument 2010 (No. 1).

(2)        This Instrument may also be cited as PB 120 of 2010.

2          Commencement

This Instrument commences on 1 January 2011.

3          Amendment of PB 108 of 2010

Schedule 1 amends PB 108 of 2010.

Schedule 1     Amendments

[1] Schedule 1, entry for Abacavir

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

C1820  C1821  C3309  C3310

insert:

C3586  C3587  C3588  C3589

[2] Schedule 1, entry for Abacavir with Lamivudine

omit from the column headed “Circumstances”:

C1822  C1823  C3311  C3312

insert:

C3590  C3591  C3592  C3593

[3] Schedule 1, entry for Abacavir with Lamivudine and Zidovudine

omit from the column headed “Circumstances”:

C1822  C1823  C3311  C3312

insert:

C3590  C3591  C3592  C3593

[4] Schedule 1, entry for Aciclovir

substitute:

Aciclovir	Tablet 200 mg	Oral	Acihexal	SZ	MP NP	C3632 C3633	P3632	50	0
Acyclo-V 200	AF	MP NP	C3632 C3633	P3632	50	0
GenRx Aciclovir	GX	MP NP	C3632 C3633	P3632	50	0
Lovir	GM	MP NP	C3632 C3633	P3632	50	0

Zovirax 200 mg	GK	MP NP	C3632 C3633	P3632	50	0
Aciclovir 200	CR	MP NP	C3633	P3633	90	5
Acihexal	SZ	MP NP	C3632 C3633	P3633	90	5
Acyclo-V 200	AF	MP NP	C3632 C3633	P3633	90	5
Chem mart Aciclovir	CH	MP NP	C3633	P3633	90	5
GenRx Aciclovir	GX	MP NP	C3632 C3633	P3633	90	5
Lovir	GM	MP NP	C3632 C3633	P3633	90	5
Ozvir	RA	MP NP	C3633	P3633	90	5
Terry White Chemists Aciclovir	TW	MP NP	C3633	P3633	90	5
Zovirax 200 mg	GK	MP NP	C3632 C3633	P3633	90	5
Tablet 800 mg	Oral	Aciclovir 800	CR	MP NP	C3622 C3631	P3622 P3631	35	0
Acihexal	SZ	MP NP	C3622 C3630 C3631	P3622 P3631	35	0
Acyclo-V 800	AF	MP NP	C3622 C3630 C3631	P3622 P3631	35	0
GenRx Aciclovir	GX	MP NP	C3622 C3631	P3622 P3631	35	0
Zovirax 800 mg	GK	MP NP	C3622 C3631	P3622 P3631	35	0
Acihexal	SZ	MP NP	C3622 C3630 C3631	P3630	120	5
Acyclo-V 800	AF	MP NP	C3622 C3630 C3631	P3630	120	5
Eye ointment 30 mg per g, 4.5 g	Application to the eye	Zovirax	GK	MP NP AO	C1715	1	0

[5] Schedule 1, after entry for Amlodipine with valsartan in the form Tablet 5 mg (as besylate)-160 mg

insert:

Tablet 5 mg (as besylate)-320 mg Oral Exforge 5/320 NV MP NP C3307 28 5

[6] Schedule 1, after entry for Amlodipine with valsartan in the form Tablet 10 mg (as besylate)-160 mg

insert:

Tablet 10 mg (as besylate)-320 mg Oral Exforge 10/320 NV MP NP C3307 28 5

[7] Schedule 1, entry for Aprepitant

omit from the column headed “Circumstances”:

C2071  C2330  C3446

insert:

C3619  C3620  C3621

[8] Schedule 1, entry for Atazanavir

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

C1832  C1833  C3315  C3316

insert:

C3586  C3587  C3588  C3589

[9] Schedule 1, entry for Azathioprine in the form Tablet 25 mg

omit from the column headed “Brand”:         Azahexal            and insert:            Azathioprine Sandoz

[10]        Schedule 1, entry for Benzydamine

substitute:

Benzydamine	Mouth and throat rinse containing benzydamine hydrochloride 22.5 mg per 15 mL, 500 mL	Oral application	Difflam	IA	MP NP	C1669 C3634 C3635	P3635	1	0
PDP	C1669	1	0
MP NP	C1669 C3634 C3635	P1669	1	1
MP NP	C1669 C3634 C3635	P3634	1	3

[11]        Schedule 1, entry for Bisacodyl

substitute:

Bisacodyl	Tablet 5 mg	Oral	Bisalax	AS	MP NP	C1025 C1122 C1221 C1254 C1263 C1268 C1400 C3642 C3643	P3643	200	0
Lax-Tab	AE	MP NP	C1025 C1122 C1221 C1254 C1263 C1268 C1400 C3642 C3643	P3643	200	0
Bisalax	AS	MP NP	C1025 C1122 C1221 C1254 C1263 C1268 C1400 C3642 C3643	P1025 P1122 P1221 P1254 P1263 P1268 P1400	200	2
Lax-Tab	AE	MP NP	C1025 C1122 C1221 C1254 C1263 C1268 C1400 C3642 C3643	P1025 P1122 P1221 P1254 P1263 P1268 P1400	200	2
Bisalax	AS	MP NP	C1025 C1122 C1221 C1254 C1263 C1268 C1400 C3642 C3643	P3642	200	3
Lax-Tab	AE	MP NP	C1025 C1122 C1221 C1254 C1263 C1268 C1400 C3642 C3643	P3642	200	3

Tablets 5 mg, 200	Oral	Bisalax	AS	MP See Note 1	See Note 3	See Note 3	See Note 3	See Note 3	PB
Lax-Tab	AE	MP See Note 1	See Note 3	See Note 3	See Note 3	See Note 3	PB
Suppositories 10 mg, 10	Rectal	Dulcolax	BY	MP NP See Note 1	C1025 C1122 C1221 C1254 C1263 C1268 C1400 C3642 C3643 See Note 2	P3643 See Note 2	3 See Note 2	0 See Note 2
Petrus Bisacodyl Suppositories	PP	MP NP See Note 1	C1025 C1122 C1221 C1254 C1263 C1268 C1400 C3642 C3643 See Note 2	P3643 See Note 2	3 See Note 2	0 See Note 2
Dulcolax	BY	MP NP See Note 1	C1025 C1122 C1221 C1254 C1263 C1268 C1400 C3642 C3643 See Note 2	P3642 See Note 2	3 See Note 2	3 See Note 2
Petrus Bisacodyl Suppositories	PP	MP NP See Note 1	C1025 C1122 C1221 C1254 C1263 C1268 C1400 C3642 C3643 See Note 2	P3642 See Note 2	3 See Note 2	3 See Note 2
Dulcolax	BY	MP NP See Note 1	C1025 C1122 C1221 C1254 C1263 C1268 C1400 C3642 C3643 See Note 2	P1025 P1122 P1221 P1254 P1263 P1268 P1400 See Note 2	3 See Note 2	5 See Note 2
Petrus Bisacodyl Suppositories	PP	MP NP See Note 1	C1025 C1122 C1221 C1254 C1263 C1268 C1400 C3642 C3643 See Note 2	P1025 P1122 P1221 P1254 P1263 P1268 P1400 See Note 2	3 See Note 2	5 See Note 2

Suppositories 10 mg, 12	Rectal	Petrus Bisacodyl Suppositories	PP	MP NP See Note 1	C1025 C1122 C1221 C1254 C1263 C1268 C1400 C3642 C3643 See Note 2	P3643 See Note 2	3 See Note 2	0 See Note 2
MP NP See Note 1	C1025 C1122 C1221 C1254 C1263 C1268 C1400 C3642 C3643 See Note 2	P3642 See Note 2	3 See Note 2	3 See Note 2
MP NP See Note 1	C1025 C1122 C1221 C1254 C1263 C1268 C1400 C3642 C3643 See Note 2	P1025 P1122 P1221 P1254 P1263 P1268 P1400 See Note 2	3 See Note 2	4 See Note 2
Enemas 10 mg in 5 mL, 25	Rectal	Bisalax	AS	MP NP See Note 1	C1025 C1122 C1221 C1254 C1263 C1268 C1400 C3642 C3643 See Note 2	P3643 See Note 2	1 See Note 2	0 See Note 2
MP NP See Note 1	C1025 C1122 C1221 C1254 C1263 C1268 C1400 C3642 C3643 See Note 2	P1025 P1122 P1221 P1254 P1263 P1268 P1400 See Note 2	1 See Note 2	2 See Note 2
Petrus Bisacodyl Suppositories	PP	NP	C1025 C1122 C1221 C1254 C1263 C1268 C1400 C3642 C3643 See Note 2	P3642 See Note 2	3 See Note 2	5 See Note 2

[12]        Schedule 1, entry for Carvedilol in the form Tablet 3.125 mg

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

APO-Carvedilol TX MP NP C1735 C3234 30 0

[13]        Schedule 1, entry for Carmellose

omit:

Mouth spray containing carmellose sodium 10 mg per mL, 25 mL	Oral application	Aquae	HA	MP NP	C1899 C1900 C1901	P1901	1	0
MP NP	C1899 C1900 C1901	P1899 P1900	1	3
Mouth spray containing carmellose sodium 10 mg per mL, 100 mL	Oral application	Aquae	HA	MP NP	C1899 C1900 C1901	P1901	1	0
MP NP	C1899 C1900 C1901	P1899 P1900	1	3

insert in the columns in the order indicated:

Mouth spray containing carmellose sodium 10 mg per mL, 25 mL	Oral application	Aquae	HA	MP NP	C3636 C3637	P3637	1	0
MP NP	C3636 C3637	P3636	1	3
Mouth spray containing carmellose sodium 10 mg per mL, 100 mL	Oral application	Aquae	HA	MP NP	C3636 C3637	P3637	1	0
MP NP	C3636 C3637	P3636	1	3

[14]        Schedule 1, entry for Clonazepam

substitute:

Clonazepam	Tablet 500 micrograms	Oral	Paxam 0.5	AF	MP NP	C1574 C3657 C3658	P3658	100	0
Rivotril	RO	MP NP	C1574 C3657 C3658	P3658	100	0
Paxam 0.5	AF	MP NP	C1574 C3657 C3658	P3657	100	3
Rivotril	RO	MP NP	C1574 C3657 C3658	P3657	100	3
Paxam 0.5	AF	MP NP	C1574 C3657 C3658	P1574	200	2
Rivotril	RO	MP NP	C1574 C3657 C3658	P1574	200	2
Tablet 2 mg	Oral	Paxam 2	AF	MP NP	C1574 C3657 C3658	P3658	100	0
Rivotril	RO	MP NP	C1574 C3657 C3658	P3658	100	0
Paxam 2	AF	MP NP	C1574 C3657 C3658	P3657	100	3
Rivotril	RO	MP NP	C1574 C3657 C3658	P3657	100	3
Paxam 2	AF	MP NP	C1574 C3657 C3658	P3657	200	2
Rivotril	RO	MP NP	C1574 C3657 C3658	P1574	200	2
Oral liquid 2.5 mg per mL, 10 mL	Oral	Rivotril	RO	MP NP	C1574 C3657 C3658	P1574 P3658	2	0
RO	MP NP	C1574 C3657 C3658	P3657	2	3
Injection 1 mg in 2 mL (set containing solution 1 mg in 1 mL and 1 mL diluent)	Injection	Rivotril	RO	MP NP	C1093	5	0

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

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

Clopidogrel Actavis GQ MP NP C1719 C1720 C1721 C1722 C1723 C1724 28 5

[16]        Schedule 1, entry for Darunavir

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

C3279  C3335

insert:

C3594 C3595

[17]        Schedule 1, entry for Diazepam

substitute:

Diazepam	Tablet 2 mg	Oral	Antenex 2	AF	MP NP PDP	50	0
MP NP	P3656	50	0
Valium	RO	MP NP PDP	50	0
MP NP	P3656	50	0
Valpam 2	SI	MP NP PDP	50	0
MP NP	P3656	50	0
Antenex 2	AF	MP NP	P3655	50	3
Valium	RO	MP NP	P3655	50	3
Valpam 2	SI	MP NP	P3655	50	3
Tablet 5 mg	Oral	Antenex 5	AF	MP NP PDP	50	0
MP NP	P3656	50	0
Diazepam-GA	GM	MP NP PDP	50	0
MP NP	P3656	50	0
Ranzepam	RA	MP NP PDP	50	0
MP NP	P3656	50	0
Valium	RO	MP NP PDP	50	0
MP NP	P3656	50	0
Valpam 5	SI	MP NP PDP	50	0
MP NP	P3656	50	0
Antenex 5	AF	MP NP	P3655	50	3
Diazepam-GA	GM	MP NP	P3655	50	3
Ranzepam	RA	MP NP	P3655	50	3
Valium	RO	MP NP	P3655	50	3
Valpam 5	SI	MP NP	P3655	50	3
Injection 10 mg in 2 mL	Injection	Hospira Pty Limited	HH	MP NP PDP	5	0

[18]        Schedule 1, entry for Diclofenac

substitute:

Diclofenac	Tablet (enteric coated) containing diclofenac sodium 25 mg	Oral	APO-Diclofenac	TX	MP NP	C1036 C1054 C3645 C3646	P3646	100	0
PDP	C1036 C1054	100	0
Chem mart Diclofenac	CH	MP NP	C1036 C1054 C3645 C3646	P3646	100	0
PDP	C1036 C1054	100	0
Clonac 25	SI	MP NP	C1036 C1054 C3645 C3646	P3646	100	0
PDP	C1036 C1054	100	0
Diclofenac-GA	GM	MP NP	C1036 C1054 C3645 C3646	P3646	100	0
PDP	C1036 C1054	100	0
Diclofenac Sandoz	SZ	MP NP	C1036 C1054 C3645 C3646	P3646	100	0
PDP	C1036 C1054	100	0
Fenac 25	AF	MP NP	C1036 C1054 C3645 C3646	P3646	100	0
PDP	C1036 C1054	100	0
Terry White Chemists Diclofenac	TW	MP NP	C1036 C1054 C3645 C3646	P3646	100	0
PDP	C1036 C1054	100	0
Voltaren 25	NV	MP NP	C1036 C1054 C3645 C3646	P3646	100	0
PDP	C1036 C1054	100	0
APO-Diclofenac	TX	MP NP	C1036 C1054 C3645 C3646	P1036 P1054 P3645	100	3
Chem mart Diclofenac	CH	MP NP	C1036 C1054 C3645 C3646	P1036 P1054 P3645	100	3
Clonac 25	SI	MP NP	C1036 C1054 C3645 C3646	P1036 P1054 P3645	100	3
Diclofenac-GA	GM	MP NP	C1036 C1054 C3645 C3646	P1036 P1054 P3645	100	3
Diclofenac-GA	GM	MP NP	C1036 C1054 C3645 C3646	P1036 P1054 P3645	100	3
Fenac 25	AF	MP NP	C1036 C1054 C3645 C3646	P1036 P1054 P3645	100	3
Terry White Chemists Diclofenac	TW	MP NP	C1036 C1054 C3645 C3646	P1036 P1054 P3645	100	3
Voltaren 25	NV	MP NP	C1036 C1054 C3645 C3646	P1036 P1054 P3645	100	3
Tablet (enteric coated) containing diclofenac sodium 50 mg	Oral	APO-Diclofenac	TX	MP NP	C1036 C1054 C3645 C3646	P3646	50	0
PDP	C1036 C1054	P1036 P1054	50	0
Chem mart Diclofenac	CH	MP NP	C1036 C1054 C3645 C3646	P3646	50	0
PDP	C1036 C1054	P1036 P1054	50	0
Clonac 50	SI	MP NP	C1036 C1054 C3645 C3646	P3646	50	0
PDP	C1036 C1054	P1036 P1054	50	0
Diclofenac-GA	GM	MP NP	C1036 C1054 C3645 C3646	P3646	50	0
PDP	C1036 C1054	P1036 P1054	50	0
Diclofenac Sandoz	SZ	MP NP	C1036 C1054 C3645 C3646	P3646	50	0
PDP	C1036 C1054	P1036 P1054	50	0
Fenac	AF	MP NP	C1036 C1054 C3645 C3646	P3646	50	0
PDP	C1036 C1054	P1036 P1054	50	0
Terry White Chemists Diclofenac	TW	MP NP	C1036 C1054 C3645 C3646	P3646	50	0
PDP	C1036 C1054	P1036 P1054	50	0
Voltaren 50	NV	MP NP	C1036 C1054 C3645 C3646	P3646	50	0
PDP	C1036 C1054	P1036 P1054	50	0
APO-Diclofenac	TX	MP NP	C1036 C1054 C3645 C3646	P1036 P1054 P3645	50	3
Chem mart Diclofenac	CH	MP NP	C1036 C1054 C3645 C3646	P1036 P1054 P3645	50	3
Clonac 50	SI	MP NP	C1036 C1054 C3645 C3646	P1036 P1054 P3645	50	3
Diclofenac-GA	GM	MP NP	C1036 C1054 C3645 C3646	P1036 P1054 P3645	50	3
Diclofenac Sandoz	SZ	MP NP	C1036 C1054 C3645 C3646	P1036 P1054 P3645	50	3
Fenac	AF	MP NP	C1036 C1054 C3645 C3646	P1036 P1054 P3645	50	3
Terry White Chemists Diclofenac	TW	MP NP	C1036 C1054 C3645 C3646	P1036 P1054 P3645	50	3
Voltaren 50	NV	MP NP	C1036 C1054 C3645 C3646	P1036 P1054 P3645	50	3
Suppository containing diclofenac sodium 100 mg	Rectal	Voltaren 100	NV	MP NP	P3666	40	0
PDP	40	0
MP NP MW	40	3
MP NP	P3665	40	3

[19]        Schedule 1, entry for Didanosine

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

C1820  C1821  C3309  C3310

insert:

C3586  C3587  C3588  C3589

[20]        Schedule 1, after entry for Docetaxel in the form Injection set containing 1 single use vial concentrate for I.V. infusion 80 mg (anhydrous) in 2 mL with solvent

insert in the columns in the order indicated:

Solution concentrate for I.V. infusion 20 mg in 1 mL	Injection	Taxotere	SW	MP See Note 1	C1194 C1742 C2416 C2439 C2732 C3051 C3292 C3428	P3051	1	0
MP See Note 1	C1194 C1742 C2416 C2439 C2732 C3051 C3292 C3428	P1194 P1742 P2416 P2439 P2732 P3292 P3428	2	0
Solution concentrate for I.V. infusion 80 mg in 4 mL	Injection	Taxotere	SW	MP See Note 1	C1194 C1742 C2416 C2439 C2732 C3051 C3292 C3428	1	0

[21]        Schedule 1, entry for Efavirenz

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

C1820  C1821  C3309  C3310

insert:

C3586  C3587  C3588  C3589

[22]        Schedule 1, entry for Emtricitabine

omit from the column headed “Circumstances”:

C1820  C1821  C3309  C3310

insert:

C3586  C3587  C3588  C3589

[23]        Schedule 1, entry for Enalapril in the form Tablet containing enalapril maleate 5 mg

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

Enalapril-GA GM MP NP 30 5

[24]        Schedule 1, entry for Enfuvirtide

omit from the column headed “Circumstances”:

C2007  C2008  C3350  C3351

insert:

C3596  C3597

[25]        Schedule 1, entry for Etravirine

omit from the column headed “Circumstances”:

C2956  C3354

substitute:

C3596  C3597

[26]        Schedule 1, entry for Famciclovir

substitute:

Famciclovir	Tablet 125 mg	Oral	APO-Famciclovir	TX	MP NP	C3624	40	1
Ezovir	AF	MP NP	C3624	40	1
Famvir	NV	MP NP	C3624	40	1
Favic 125	SI	MP NP	C3624	40	1
Tablet 250 mg	Oral	APO-Famciclovir	TX	MP NP	C3622 C3623 C3624	P3624	20	1
Ezovir	AF	MP NP	C3622 C3623 C3624	P3624	20	1
Famciclovir Sandoz	SZ	MP NP	C3622 C3623 C3624	P3624	20	1
Famvir	NV	MP NP	C3622 C3623 C3624	P3624	20	1
Favic 250	SI	MP NP	C3622 C3623 C3624	P3624	20	1
APO-Famciclovir	TX	MP NP	C3622 C3623 C3624	P3622	21	0
Ezovir	AF	MP NP	C3622 C3623 C3624	P3622	21	0
Famciclovir Sandoz	SZ	MP NP	C3622 C3623 C3624	P3622	21	0
Famvir	NV	MP NP	C3622 C3623 C3624	P3622	21	0
Favic 250	SI	MP NP	C3622 C3623 C3624	P3622	21	0
APO-Famciclovir	TX	MP NP	C3622 C3623 C3624	P3623	56	5
Ezovir	AF	MP NP	C3622 C3623 C3624	P3623	56	5
Famciclovir Sandoz	SZ	MP NP	C3622 C3623 C3624	P3623	56	5
Famvir	NV	MP NP	C3622 C3623 C3624	P3623	56	5
Favic 250	SI	MP NP	C3622 C3623 C3624	P3623	56	5
Tablet 500 mg	Oral	Famvir	NV	MP NP	C3625 C3626 C3627 C3628 C3629	P3625	30	0
Favic 500	SI	MP NP	C3625 C3626 C3627 C3628 C3629	P3625	30	0
Ezovir	AF	MP NP	C3625 C3626 C3627 C3628 C3629	P3626 P3627 P3628 P3629	56	5
Famvir	NV	MP NP	C3625 C3626 C3627 C3628 C3629	P3626 P3627 P3628 P3629	56	5
Favic 500	SI	MP NP	C3625 C3626 C3627 C3628 C3629	P3626 P3627 P3628 P3629	56	5

[27]        Schedule 1, omit entry for Fentanyl in the forms Lozenges 200 micrograms (as citrate), 3; Lozenges 400 micrograms (as citrate), 3; Lozenges 600 micrograms (as citrate), 3; Lozenges 800 micrograms (as citrate), 3; Lozenges 1200 micrograms (as citrate), 3; and Lozenges 1600 micrograms (as citrate), 3

insert in the columns in the order indicated:

Fentanyl	Lozenges 200 micrograms (as citrate), 3	Buccal	Actiq	OA	MP NP	C3663 C3664	P3663	3	0
MP NP	C3663 C3664	P3664	20	0
Lozenges 400 micrograms (as citrate), 3	Buccal	Actiq	OA	MP NP	C3663 C3664	P3663	3	0
MP NP	C3663 C3664	P3664	20	0
Lozenges 600 micrograms (as citrate), 3	Buccal	Actiq	OA	MP NP	C3663 C3664	P3663	3	0
MP NP	C3663 C3664	P3664	20	0
Lozenges 800 micrograms (as citrate), 3	Buccal	Actiq	OA	MP NP	C3663 C3664	P3663	3	0
MP NP	C3663 C3664	P3664	20	0
Lozenges 1200 micrograms (as citrate), 3	Buccal	Actiq	OA	MP NP	C3663 C3664	P3663	3	0
MP NP	C3663 C3664	P3664	20	0
Lozenges 1600 micrograms (as citrate), 3	Buccal	Actiq	OA	MP NP	C3663 C3664	P3663	3	0
MP NP	C3663 C3664	P3664	20	0

[28]        Schedule 1, entry for Fluconazole

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

C1199  C1854  C1855  C3240  C3295  C3296

insert:

C3613  C3614  C3615  C3616  C3617  C3618

[29]        Schedule 1, entry for Fosamprenavir in the form Tablet 700 mg (as calcium)

omit from the column headed “Responsible Person”: GK          and insert:            VI

[30]        Schedule 1, entry for Fosamprenavir

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

C1832  C1833  C3315  C3316

insert:

C3586  C3587  C3588  C3589

[31]        Schedule 1, entry for Frusemide in the form Injection 20 mg in 2 mL

omit from the column headed “Brand”:         Frusehexal        and insert:            Frusemide Sandoz

[32]        Schedule 1, entry for Gabapentin in the form Tablet 600 mg

omit:

Gabahexal 600mg SZ MP NP C2664 100 5

[33]        Schedule 1, entry for Gemcitabine in the form Powder for I.V. infusion 200 mg (as hydrochloride)

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

Gemcitabine Kabi PK MP
See Note 1 C1193 C1194 C1740 C2069 C2141 4 2

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

Gemcitabine Sun ZF MP
See Note 1 C1193 C1194 C1740 C2069 C2141 4 2

[34]        Schedule 1, entry for Gemcitabine in the form Powder for I.V. infusion 1 g (as hydrochloride)

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

Gemcitabine Kabi PK MP
See Note 1 C1193 C1194 C1740 C2069 C2141 2 2

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

Gemcitabine Sun ZF MP
See Note 1 C1193 C1194 C1740 C2069 C2141 2 2

[35]        Schedule 1, entry for Gemcitabine in the form Powder for I.V. infusion 2 g (as hydrochloride)

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

Gemcitabine Kabi PK MP
See Note 1 C1193 C1194 C1740 C2069 C2141 1 2

[36]        Schedule 1, entry for Gestrinone

omit from the column headed “Circumstances”:          C1377    and insert:            C3652

[37]        Schedule 1, entry for Glucose Indicator—Blood in the form Test strips, 50 (Bionime Rightest)

omit from the column headed “Responsible Person”: CQ          and insert:            QB

[38]        Schedule 1, entry for Glycerol

substitute:

Glycerol	Suppositories 700 mg, 12	Rectal	Petrus Pharmaceuticals Pty Ltd	PP	MP NP See Note 1	C1025 C1122 C1221 C1254 C1263 C1268 C1400 C3642 C3643 See Note 2	P3643 See Note 2	3 See Note 2	0 See Note 2
MP NP See Note 1	C1025 C1122 C1221 C1254 C1263 C1268 C1400 C3642 C3643 See Note 2	P3642 See Note 2	3 See Note 2	3 See Note 2
MP NP See Note 1	C1025 C1122 C1221 C1254 C1263 C1268 C1400 C3642 C3643 See Note 2	P1025 P1122 P1221 P1254 P1263 P1268 P1400 See Note 2	3 See Note 2	5 See Note 2
Suppositories 1.4 g, 12	Rectal	Petrus Pharmaceuticals Pty Ltd	PP	MP NP See Note 1	C1025 C1122 C1221 C1254 C1263 C1268 C1400 C3642 C3643 See Note 2	P3643 See Note 2	3 See Note 2	0 See Note 2
MP NP See Note 1	C1025 C1122 C1221 C1254 C1263 C1268 C1400 C3642 C3643 See Note 2	P3642 See Note 2	3 See Note 2	3 See Note 2
MP NP See Note 1	C1025 C1122 C1221 C1254 C1263 C1268 C1400 C3642 C3643 See Note 2	P1025 P1122 P1221 P1254 P1263 P1268 P1400 See Note 2	3 See Note 2	5 See Note 2
Suppositories 2.8 g, 12	Rectal	Petrus Pharmaceuticals Pty Ltd	PP	MP NP See Note 1	C1025 C1122 C1221 C1254 C1263 C1268 C1400 C3642 C3643 See Note 2	P3643 See Note 2	3 See Note 2	0 See Note 2
MP NP See Note 1	C1025 C1122 C1221 C1254 C1263 C1268 C1400 C3642 C3643 See Note 2	P3642 See Note 2	3 See Note 2	3 See Note 2
MP NP See Note 1	C1025 C1122 C1221 C1254 C1263 C1268 C1400 C3642 C3643 See Note 2	P1025 P1122 P1221 P1254 P1263 P1268 P1400 See Note 2	3 See Note 2	5 See Note 2

[39]        Schedule 1, entry for Granisetron

substitute:

Granisetron	Tablet 2 mg (as hydrochloride)	Oral	Kytril	HH	MP NP See Note 1	C3050 C3611 See Note 2	P3050 See Note 2	2 See Note 2	0 See Note 2
MP NP See Note 1	C3050 C3611 See Note 2	P3611 See Note 2	5 See Note 2	1 See Note 2
Concentrated injection 3 mg (as hydrochloride) in 3 mL	Injection	Granisetron Kabi	PK	MP NP See Note 1	C3050 C3611 See Note 2	1 See Note 2	0 See Note 2
Kytril	HH	MP NP See Note 1	C3050 C3611 See Note 2	1 See Note 2	0 See Note 2

[40]        Schedule 1, entry for Hyoscine

substitute:

Hyoscine	Injection containing hyoscine butylbromide 20 mg in 1 mL	Injection	Buscopan	BY	MP NP	C3638 C3639	P3639	30	0
MP NP	C3638 C3639	P3638	30	3

[41]        Schedule 1, entry for Hypromellose

omit:

Oral gel 20 mg per g, 100 g	Oral application	Aquae Gel	HA	MP NP	C1899 C1900 C1901	P1901	1	0
MP NP	C1899 C1900 C1901	P1899 P1900	1	3

insert in the columns in the order indicated:

Oral gel 20 mg per g, 100 g	Oral application	Aquae Gel	HA	MP NP	C3636 C3637	P3637	1	0
MP NP	C3636 C3637	P3636	1	3

[42]        Schedule 1, entry for Ibuprofen

substitute:

Ibuprofen	Tablet 400 mg	Oral	Brufen	AB	MP NP MW PDP	30	0
MP NP	P3666	90	0
PDP	P1036 P1054	90	0
MP NP	P1036 P1054 P3665	90	3

[43]        Schedule 1, entry for Indinavir

omit from the column headed “Circumstances”:

C1820  C1821  C3309  C3310

insert:

C3586  C3587  C3588  C3589

[44]        Schedule 1, entry for Indomethacin

substitute:

Indomethacin	Capsule 25 mg	Oral	Arthrexin	AF	MP NP	C1036 C1054 C3645 C3646	P3646	100	0
PDP	C1036 C1054	100	0
Indocid	AS	MP NP	C1036 C1054 C3645 C3646	P3646	100	0
PDP	C1036 C1054	100	0
Arthrexin	AF	MP NP	C1036 C1054 C3645 C3646	P1036 P1054 P3645	100	3
Indocid	AS	MP NP	C1036 C1054 C3645 C3646	P1036 P1054 P3645	100	3
Suppository 100 mg	Rectal	Indocid	AS	MP NP	P3666	40	0
PDP	40	0
MP NP	40	3
MP NP	P3665	40	3

[45]        Schedule 1, entry for Itraconazole

omit all codes from the column headed “Circumstances” and substitute the following codes:

C3607  C3608  C3609  C3610  C3612  C3613  C3614

[46]        Schedule 1, omit entry for Ketoconazole in the form Tablet 200 mg

insert:

Tablet 200 mg	Oral	Nizoral	JC	MP NP	C3604 C3605 C3606	P3606	10	0
MP NP	C3604 C3605 C3606	P3604 P3605	30	5

[47]        Schedule 1, entry for Lactulose

substitute:

Lactulose	Solution BP 3.34 g per 5 mL, 500 mL	Oral	Actilax	AF	MP NP	C1150 C1613 C3642 C3643	P3643	3	0
Duphalac	SM	MP NP	C1150 C1613 C3642 C3643	P3643	3	0
Genlac	SI	MP NP	C1150 C1613 C3642 C3643	P3643	3	0
GenRx Lactulose	GX	MP NP	C1150 C1613 C3642 C3643	P3643	3	0
Lac-Dol	GM	MP NP	C1150 C1613 C3642 C3643	P3643	3	0
Lactocur	SZ	MP NP	C1150 C1613 C3642 C3643	P3643	3	0
Actilax	AF	MP NP	C1150 C1613 C3642 C3643	P3642	3	3
Duphalac	SM	MP NP	C1150 C1613 C3642 C3643	P3642	3	3
Genlac	SI	MP NP	C1150 C1613 C3642 C3643	P3642	3	3
GenRx Lactulose	GX	MP NP	C1150 C1613 C3642 C3643	P3642	3	3
Lac-Dol	GM	MP NP	C1150 C1613 C3642 C3643	P3642	3	3
Lactocur	SZ	MP NP	C1150 C1613 C3642 C3643	P3642	3	3
Actilax	AF	MP NP	C1150 C1613 C3642 C3643	P1150 P1613	1	5
Duphalac	SM	MP NP	C1150 C1613 C3642 C3643	P1150 P1613	1	5
Genlac	SI	MP NP	C1150 C1613 C3642 C3643	P1150 P1613	1	5
GenRx Lactulose	GX	MP NP	C1150 C1613 C3642 C3643	P1150 P1613	1	5
Lac-Dol	GM	MP NP	C1150 C1613 C3642 C3643	P1150 P1613	1	5
Lactocur	SZ	MP NP	C1150 C1613 C3642 C3643	P1150 P1613	1	5

[48]        Schedule 1, entry for Lamivudine in each of the forms Tablet 150 mg; Tablet 300 mg; and Oral solution 10 mg per mL, 240 mL

omit from the column headed “Circumstances”:

C1820  C1821  C3309  C3310

insert:

C3586  C3587  C3588  C3589

[49]        Schedule 1, entry for Lamivudine with Zidovudine

omit from the column headed “Circumstances”:

C1820  C1821  C3309  C3310

insert:

C3586  C3587  C3588  C3589

[50]        Schedule 1, entry for Lercanidipine in the forms Tablet containing lercanidipine hydrochloride 10 mg and Tablet containing lercanidipine hydrochloride 20 mg

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

Lercan SI MP NP 28 5

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

Lercanidipine Sandoz SZ MP NP 28 5

[51]        Schedule 1, entry for Lopinavir with Ritonavir

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

C1832  C1833  C3315  C3316

insert:

C3586  C3587  C3588  C3589

[52]        Schedule 1, entry for Macrogol 3350

substitute:

Macrogol 3350	Sachets containing powder for oral solution 13.125 g with electrolytes, 30	Oral	Movicol	NE	MP NP See Note 1	C1263 C1613 C2693 C2823 C3642 C3643 See Note 2	P3643 See Note 2	2 See Note 2	0 See Note 2
MP NP See Note 1	C1263 C1613 C2693 C2823 C3642 C3643 See Note 2	P3642 See Note 2	2 See Note 2	3 See Note 2
MP NP See Note 1	C1263 C1613 C2693 C2823 C3642 C3643 See Note 2	P1263 P1613 P2693 P2823 See Note 2	1 See Note 2	5 See Note 2
Powder for oral solution 510 g	Oral	MediHealth ClearLax	ON	MP NP	C1263 C1613 C2693 C2823 C3642 C3643	P3643	2	0
OsmoLax	KY	MP NP	C1263 C1613 C2693 C2823 C3642 C3643	P3643	2	0
MediHealth ClearLax	ON	MP NP	C1263 C1613 C2693 C2823 C3642 C3643	P3642	2	3
OsmoLax	KY	MP NP	C1263 C1613 C2693 C2823 C3642 C3643	P3642	2	3
MediHealth ClearLax	ON	MP NP	C1263 C1613 C2693 C2823 C3642 C3643	P1263 P1613 P2693 P2823	1	5
OsmoLax	KY	MP NP	C1263 C1613 C2693 C2823 C3642 C3643	P1263 P1613 P2693 P2823	1	5

[53]        Schedule 1, entry for Maraviroc

(a)           omit from the column headed “Responsible Person” (twice occurring):                VI            and insert:            PF

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

C3286  C3406

insert:

C3598  C3599

[54]        Schedule 1, after entry for Mesalazine in the form Suppository 1 g

insert in the columns in the order indicated:

Suppository 1g (moulded) Rectal Salofalk OA MP NP C1978 30 1

[55]        Schedule 1, entry for Metformin in the form Tablet (extended release) containing metformin hydrochloride 1 g

omit from the column headed “Responsible Person”: AF          and insert:            AL

[56]        Schedule 1, entry for Methadone

omit:

Oral liquid containing methadone hydrochloride 25 mg per 5 mL, 200 mL	Oral	Biodone Forte	MW	MP NP See Note 1	See Note 2	See Note 2	See Note 2	See Note 2	PB
Sigma Pharmaceuticals (Australia) Pty Ltd	SI	MP NP See note 1	C2348 C2349 C2350 See Note 2	P2350 See Note 2	1 See Note 2	0 See Note 2
MP NP	C2348 C2349 C2350 See Note 2	P2348 P2349 See Note 2	1 See Note 2	2 See Note 2

insert in the columns in the order indicated:

Oral liquid containing methadone hydrochloride 25 mg per 5 mL, 200 mL	Oral	Biodone Forte	MW	MP NP See Note 1	See Note 3	See Note 3	See Note 3	See Note 3	PB
Sigma Pharmaceuticals (Australia) Pty Ltd	SI	MP NP See Note 1	C3659 C3660 See Note 2	P3660 See Note 2	1 See Note 2	0 See Note 2
MP NP See Note 1	C3659 C3660 See Note 2	P3659 See Note 2	1 See Note 2	2 See Note 2

[57]        Schedule 1, entry for Methylnaltrexone

substitute:

Methylnaltrexone	Solution for injection containing methylnaltrexone bromide 12 mg in 0.6 mL	Injection	Relistor	WX	MP NP	C3235 C3238	P3235	3	0
MP NP	C3235 C3238	P3238	7	0

[58]        Schedule 1, entry for Morphine

(a)     omit:

Tablet containing morphine sulfate 10 mg	Oral	Sevredol	MF	MP NP	C1789 C2351 C2352 C2353	P1789 P2353	20	0
MP NP	C1789 C2351 C2352 C2353	P2351 P2352	20	2
Tablet containing morphine sulfate 20 mg	Oral	Sevredol	MF	MP NP	C1789 C2351 C2352 C2353	P1789 P2353	20	0
MP NP	C1789 C2351 C2352 C2353	P2351 P2352	20	2

insert in the columns in the order indicated:

Tablet containing morphine sulfate 10 mg	Oral	Sevredol	MF	MP NP	C1789 C3661 C3662	P1789 P3662	20	0
MP NP	C1789 C3661 C3662	P1789 P3661	20	2
Tablet containing morphine sulfate 20 mg	Oral	Sevredol	MF	MP NP	C1789 C3661 C3662	P1789 P3662	20	0
MP NP	C1789 C3661 C3662	P1789 P3661	20	2

(b)     omit:

Tablet containing morphine sulfate 200 mg (controlled release)	Oral	MS Contin	MF	MP NP	C1499 C2348 C2349 C2350	P1499 P2350	20	0
MP NP	C1499 C2348 C2349 C2350	P2348 P2349	20	2

insert in the columns in the order indicated:

Tablet containing morphine sulfate 200 mg (controlled release)	Oral	MS Contin	MF	MP NP	C1499 C3659 C3600	P1499 P3660	20	0
MP NP	C1499 C3659 C3600	P3659	20	2

[59]        Schedule 1, entry for Naproxen

substitute:

Naproxen	Tablet 250 mg	Oral	Inza 250	AF	MP NP	C1036 C1054 C3645 C3646	P3646	100	0
PDP	C1036 C1054	100	0
Naprosyn	RO	MP NP	C1036 C1054 C3645 C3646	P3646	100	0
PDP	C1036 C1054	100	0
Inza 250	AF	MP NP	C1036 C1054 C3645 C3646	P1036 P1054 P3645	100	3
Naprosyn	RO	MP NP	C1036 C1054 C3645 C3646	P1036 P1054 P3645	100	3
Tablet containing naproxen sodium 550 mg	Oral	Anaprox 550	RO	MP NP	C1036 C1054 C3645 C3646	P3646	50	0
PDP	C1036 C1054	50	0
Crysanal	MD	MP NP	C1036 C1054 C3645 C3646	P3646	50	0
PDP	C1036 C1054	50	0
Anaprox 550	RO	MP NP	C1036 C1054 C3645 C3646	P1036 P1054 P3645	50	3
Crysanal	MD	MP NP	C1036 C1054 C3645 C3646	P1036 P1054 P3645	50	3
Tablet 500 mg	Oral	Inza 500	AF	MP NP	C1036 C1054 C3645 C3646	P3646	50	0
PDP	C1036 C1054	50	0
Naprosyn	RO	MP NP	C1036 C1054 C3645 C3646	P3646	50	0
PDP	C1036 C1054	P1036 P1054	50	0
Inza 500	AF	MP NP	C1036 C1054 C3645 C3646	P1036 P1054 P3645	50	3
Naprosyn	RO	MP NP	C1036 C1054 C3645 C3646	P1036 P1054 P3645	50	3
Tablet 750 mg (sustained release)	Oral	Naprosyn SR750	RO	MP NP	C1036 C1054 C3645 C3646	P3646	28	0
PDP	C1036 C1054	28	0
Proxen SR 750	MD	MP NP	C1036 C1054 C3645 C3646	P3646	28	0
PDP	C1036 C1054	28	0
Naprosyn SR750	RO	MP NP	C1036 C1054 C3645 C3646	P1036 P1054 P3645	28	3
Proxen SR 750	MD	MP NP	C1036 C1054 C3645 C3646	P1036 P1054 P3645	28	3
Tablet 1 g (sustained release)	Oral	Naprosyn SR1000	RO	MP NP	C1036 C1054 C3645 C3646	P3646	28	0
PDP	C1036 C1054	28	0
Proxen SR 1000	MD	MP NP	C1036 C1054 C3645 C3646	P3646	28	0
PDP	C1036 C1054	28	0
Naprosyn SR1000	RO	MP NP	C1036 C1054 C3645 C3646	P1036 P1054 P3645	28	3
Proxen SR 1000	MD	MP NP	C1036 C1054 C3645 C3646	P1036 P1054 P3645	28	3
Oral suspension 125 mg per 5 mL, 474 mL	Oral	Naprosyn	RO	MP NP	C2270 C2271 C3647 C3648	P3648	1	0
MP NP	C2270 C2271 C3647 C3648	P2270 P2271 P3647	1	3

[60]        Schedule 1, entry for Nevirapine

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

C1820  C1821  C3309  C3310

insert:

C3586  C3587  C3588  C3589

[61]        Schedule 1, entry for Nitrazepam

substitute:

Nitrazepam	Tablet 5 mg	Oral	Alodorm	AF	MP NP PDP	25	0
Mogadon	VT	MP NP PDP	25	0
Alodorm	AF	MP NP	P3654	50	0
Mogadon	VT	MP NP	P3654	50	0
Alodorm	AF	MP NP	P3653	50	3
Mogadon	VT	MP NP	P3653	50	3
Alodorm	AF	MP NP	P1123 P1126 P1216 P1235	50	5
Mogadon	VT	MP NP	P1123 P1126 P1216 P1235	50	5

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

insert in the columns in the order indicated:

Capsule 20 mg	Oral	Omepro-GA	GM	MP NP	C1177 C1337 C1476 C1533	P1177	30	1
Pemzo	SI	MP NP	C1177 C1337 C1476 C1533	P1177	30	1
Pharmacor Omeprazole 20	CR	MP NP	C1177 C1337 C1476 C1533	P1177	30	1
Probitor	SZ	MP NP	C1177 C1337 C1476 C1533	P1177	30	1
Omepro-GA	GM	MP NP	C1177 C1337 C1476 C1533	P1337 P1476 P1533	30	5
Pemzo	SI	MP NP	C1177 C1337 C1476 C1533	P1337 P1476 P1533	30	5
Pharmacor Omeprazole 20	CR	MP NP	C1177 C1337 C1476 C1533	P1337 P1476 P1533	30	5
Probitor	SZ	MP NP	C1177 C1337 C1476 C1533	P1337 P1476 P1533	30	5

[63]        Schedule 1, entry for Omeprazole and Clarithromycin and Amoxycillin in the form Pack containing 14 capsules omeprazole 20 mg, 14 tablets clarithromycin 500 mg and 28 capsules amoxycillin 500 mg (as trihydrate)

omit:

Klacid Hp 7 AB MP NP C1096 30 5

[64]        Schedule 1, entry for Ondansetron

substitute:

Ondansetron	Tablet 4 mg (as hydrochloride dihydrate)	Oral	APO-Ondansetron	TX	MP NP See Note 1	C3050 C3611 See Note 2	P3050 See Note 2	4 See Note 2	0 See Note 2
Ondaz	SZ	MP NP See Note 1	C3050 C3611 See Note 2	P3050 See Note 2	4 See Note 2	0 See Note 2
Onsetron 4	ZP	MP NP See Note 1	C3050 C3611 See Note 2	P3050 See Note 2	4 See Note 2	0 See Note 2
Zofran	GK	MP NP See Note 1	C3050 C3611 See Note 2	P3050 See Note 2	4 See Note 2	0 See Note 2
APO-Ondansetron	TX	MP NP	C3050 C3611	P3611	10	1
Ondaz	SZ	MP NP	C3050 C3611	P3611	10	1
Onsetron 4	ZP	MP NP	C3050 C3611	P3611	10	1
Zofran	GK	MP NP	C3050 C3611	P3611	10	1
Tablet 8 mg (as hydrochloride dihydrate)	Oral	APO-Ondansetron	TX	MP NP See Note 1	C3050 C3611 See Note 2	P3050 See Note 2	4 See Note 2	0 See Note 2
Ondaz	SZ	MP NP See Note 1	C3050 C3611 See Note 2	P3050 See Note 2	4 See Note 2	0 See Note 2
Onsetron 8	ZP	MP NP See Note 1	C3050 C3611 See Note 2	P3050 See Note 2	4 See Note 2	0 See Note 2
Zofran	GK	MP NP See Note 1	C3050 C3611 See Note 2	P3050 See Note 2	4 See Note 2	0 See Note 2
APO-Ondansetron	TX	MP NP	C3050 C3611	P3611	10	1
Ondaz	SZ	MP NP	C3050 C3611	P3611	10	1
Onsetron 8	ZP	MP NP	C3050 C3611	P3611	10	1
Zofran	GK	MP NP	C3050 C3611	P3611	10	1
Wafer 4 mg	Oral	Ondaz Zydis	SZ	MP NP See Note 1	C3050 C3611 See Note 2	P3050 See Note 2	4 See Note 2	0 See Note 2
Zofran Zydis	GK	MP NP See Note 1	C3050 C3611 See Note 2	P3050 See Note 2	4 See Note 2	0 See Note 2
Ondaz Zydis	SZ	MP NP	C3050 C3611	P3611	10	1
Zofran Zydis	GK	MP NP	C3050 C3611	P3611	10	1
Wafer 8 mg	Oral	Ondaz Zydis	SZ	MP NP See Note 1	C3050 C3611 See Note 2	P3050 See Note 2	4 See Note 2	0 See Note 2
Zofran Zydis	GK	MP NP See Note 1	C3050 C3611 See Note 2	P3050 See Note 2	4 See Note 2	0 See Note 2
Ondaz Zydis	SZ	MP NP	C3050 C3611	P3611	10	1
Zofran Zydis	GK	MP NP	C3050 C3611	P3611	10	1
Syrup 4 mg (as hydrochloride dihydrate) per 5 mL, 50 mL	Oral	Zofran syrup 50 mL	GK	MP NP See Note 1	C3050 C3611 See Note 2	P3050 See Note 2	1 See Note 2	0 See Note 2
MP NP	C3050 C3611	P3611	1	1
I.V. injection 4 mg (as hydrochloride dihydrate) in 2 mL	Injection	Ondansetron-Claris	AE	MP NP See Note 1	C3050 C3611 See Note 2	See Note 2	1 See Note 2	0 See Note 2
Ondaz	SZ	MP NP See Note 1	C3050 C3611 See Note 2	See Note 2	1 See Note 2	0 See Note 2
Onsetron	ZP	MP NP See Note 1	C3050 C3611 See Note 2	See Note 2	1 See Note 2	0 See Note 2
Pfizer Australia Pty Ltd	PF	MP NP See Note 1	C3050 C3611 See Note 2	See Note 2	1 See Note 2	0 See Note 2
Zofran	GK	MP NP See Note 1	C3050 C3611 See Note 2	See Note 2	1 See Note 2	0 See Note 2
I.V. injection 8 mg (as hydrochloride dihydrate) in 4 mL	Injection	Ondansetron-Claris	AE	MP NP See Note 1	C3050 C3611 See Note 2	See Note 2	1 See Note 2	0 See Note 2
Ondaz	SZ	MP NP See Note 1	C3050 C3611 See Note 2	See Note 2	1 See Note 2	0 See Note 2
Onsetron	ZP	MP NP See Note 1	C3050 C3611 See Note 2	See Note 2	1 See Note 2	0 See Note 2
Pfizer Australia Pty Ltd	PF	MP NP See Note 1	C3050 C3611 See Note 2	See Note 2	1 See Note 2	0 See Note 2
Zofran	GK	MP NP See Note 1	C3050 C3611 See Note 2	See Note 2	1 See Note 2	0 See Note 2

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

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

Oxaliplatin Kabi PK MP
See Note 1 C2717 C3449 C3450 1 2

[66]        Schedule 1, entry for Oxaliplatin in the forms Powder for I.V. infusion 50 mg and Powder for I.V. infusion 100 mg

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

Xalox WQ MP
See Note 1 C2717 C3449 C3450 1 2

[67]        Schedule 1, entry for Oxazepam

substitute:

Oxazepam	Tablet 15 mg	Oral	Alepam 15	AF	MP NP PDP	25	0
Serepax	SI	MP NP PDP	25	0
Alepam 15	AF	MP NP	P3656	50	0
Serepax	SI	MP NP	P3656	50	0
Alepam 15	AF	MP NP	P3655	50	3
Serepax	SI	MP NP	P3655	50	3
Alepam 15	AF	MP NP	P1123 P1126 P1216	50	5
Serepax	SI	MP NP	P1123 P1126 P1216	50	5
Tablet 30 mg	Oral	Alepam 30	AF	MP NP PDP	25	0
APO-Oxazepam	TX	MP NP PDP	25	0
Murelax	FM	MP NP PDP	25	0
Serepax	SI	MP NP PDP	25	0
Alepam 30	AF	MP NP	P3656	50	0
APO-Oxazepam	TX	MP NP	P3656	50	0
Murelax	FM	MP NP	P3656	50	0
Serepax	SI	MP NP	P3656	50	0
Alepam 30	AF	MP NP	P3655	50	3
APO-Oxazepam	TX	MP NP	P3655	50	3
Murelax	FM	MP NP	P3655	50	3
Serepax	SI	MP NP	P3655	50	3
Alepam 30	AF	MP NP	P1123 P1126 P1216	50	5
APO-Oxazepam	TX	MP NP	P1123 P1126 P1216	50	5
Murelax	FM	MP NP	P1123 P1126 P1216	50	5
Serepax	SI	MP NP	P1123 P1126 P1216	50	5

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

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

Paclitaxel Kabi PK MP
See Note 1 C1194 C1293 C1742 C2417 C2439 C3428 5 0

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

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

Paclitaxel Kabi PK MP
See Note 1 C1194 C1293 C1742 C2417 C2439 C3428 2 0

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

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

Paclitaxel Kabi PK MP
See Note 1 C1194 C1293 C1742 C2417 C2439 C3428 1 0

[71]        Schedule 1, entry for Paracetamol

(a)        omit:

Tablet 665 mg (modified release)	Oral	Panadol Osteo	GC	MP NP	C1890 C1891 C1892 C2094	P1892	192	0
MP NP	C1890 C1891 C1892 C2094	P1890 P1891	192	3
MP NP	C1890 C1891 C1892 C2094	P2094	192	5

insert in the columns in the order indicated:

Tablet 665 mg (modified release)	Oral	Panadol Osteo	GC	MP NP	C2094 C3649 C3650	P3650	192	0
MP NP	C2094 C3649 C3650	P3649	192	3
MP NP	C2094 C3649 C3650	P2094	192	5

(b)        omit:

Suppositories 500 mg, 24	Rectal	Panadol	GC	MP NP	C1890 C1891 C1892	P1892	1	0
MP NP	C1890 C1891 C1892	P1890 P1891	1	3

insert in the columns in the order indicated:

Suppositories 500 mg, 24	Rectal	Panadol	GC	MP NP	C3649 C3650	P3650	4	0
MP NP	C3649 C3650	P3649	4	3

[72]        Schedule 1, entry for Promethazine

omit:

Tablet containing promethazine hydrochloride 10 mg	Oral	Phenergan	SW	MP NP	C1896 C1897 C1898	P1898	50	0
MP NP	C1896 C1897 C1898	P1896 P1897	50	3
Tablet containing promethazine hydrochloride 25 mg	Oral	Phenergan	SW	MP NP	C1896 C1897 C1898	P1898	50	0
MP NP	C1896 C1897 C1898	P1896 P1897	50	3
Oral liquid containing promethazine hydrochloride 5 mg per 5 mL, 100 mL	Oral	Phenergan	SW	MP NP	C1896 C1897 C1898	P1898	1	0
MP NP	C1896 C1897 C1898	P1896 P1897	1	3

insert in the columns in the order indicated:

Tablet containing promethazine hydrochloride 10 mg	Oral	Phenergan	SW	MP NP	C3640 C3641	P3641	50	0
MP NP	C3640 C3641	P3640	50	3
Tablet containing promethazine hydrochloride 25 mg	Oral	Phenergan	SW	MP NP	C3640 C3641	P3641	50	0
MP NP	C3640 C3641	P3640	50	3
Oral liquid containing promethazine hydrochloride 5 mg per 5 mL, 100 mL	Oral	Phenergan	SW	MP NP	C3640 C3641	P3641	1	0
MP NP	C3640 C3641	P3640	1	3

[73]        Schedule 1, after entry for Quetiapine in the form Tablet (modified release) 50 mg (as fumarate)

insert in the columns in the order indicated:

Tablet (modified release) 150 mg (as fumarate) Oral Seroquel XR AP MP NP C1589 C2044 C2765 60 5

[74]        Schedule 1, entry for Raltegravir

omit from the column headed “Circumstances”:

C3505  C3506  C3507  C3508

insert:

C3586  C3587  C3588  C3589

[75]        Schedule 1, entry for Ramipril in the forms Capsule 2.5 mg and Capsule 10 mg

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

Ramipril-GA GM MP NP 30 5

[76]        Schedule 1, entry for Ranitidine in the form Tablet 300 mg (as hydrochloride)

omit:

Ranihexal HX MP NP 30 5

[77]        Schedule 1, entry for Ritonavir

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

C1820  C1821  C3309  C3310

insert:

C3586  C3587  C3588  C3589

[78]        Schedule 1, entry for Saquinavir

omit from the column headed “Circumstances”:

C1820  C1821  C3309  C3310

insert:

C3586  C3587  C3588  C3589

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

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

Omnitrope SZ MP
See Note 1 See Note 3 See Note 3 See Note 3 See Note 3 D

[80]        Schedule 1, entry for Sorbitol with Sodium Citrate and Sodium Lauryl Sulfoacetate

substitute:

Sorbitol with Sodium Citrate and Sodium Lauryl Sulfoacetate	Enemas 3.125 g-450 mg-45 mg in 5 mL, 12	Rectal	Micolette	AE	MP NP See Note 1	C1025 C1122 C1221 C1254 C1263 C1268 C1400 C3642 C3643 See Note 2	P3643 See Note 2	2 See Note 2	0 See Note 2
Microlax	JT	MP NP See Note 1	C1025 C1122 C1221 C1254 C1263 C1268 C1400 C3642 C3643 See Note 2	P3643 See Note 2	2 See Note 2	0 See Note 2
Micolette	AE	MP NP See Note 1	C1025 C1122 C1221 C1254 C1263 C1268 C1400 C3642 C3643 See Note 2	P1025 P1122 P1221 P1254 P1263 P1268 P1400 See Note 2	2 See Note 2	2 See Note 2
Microlax	JT	MP NP See Note 1	C1025 C1122 C1221 C1254 C1263 C1268 C1400 C3642 C3643 See Note 2	P1025 P1122 P1221 P1254 P1263 P1268 P1400 See Note 2	2 See Note 2	2 See Note 2
Micolette	AE	MP NP See Note 1	C1025 C1122 C1221 C1254 C1263 C1268 C1400 C3642 C3643 See Note 2	P3642 See Note 2	2 See Note 2	3 See Note 2
Microlax	JT	MP NP See Note 1	C1025 C1122 C1221 C1254 C1263 C1268 C1400 C3642 C3643 See Note 2	P3642 See Note 2	2 See Note 2	3 See Note 2

[81]        Schedule 1, entry for Stavudine

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

C1820  C1821  C3309  C3310

insert:

C3586  C3587  C3588  C3589

[82]        Schedule 1, entry for Sterculia with Frangula Bark

substitute:

Sterculia with Frangula Bark	Granules 620 mg-80 mg per g, 500 g	Oral	Normacol Plus	NE	MP NP See Note 1	C1025 C1122 C1221 C1254 C1263 C1268 C1400 C3642 C3643 See Note 2	P3643 See Note 2	1 See Note 2	0 See Note 2
MP NP See Note 1	C1025 C1122 C1221 C1254 C1263 C1268 C1400 C3642 C3643 See Note 2	P1025 P1122 P1221 P1254 P1263 P1268 P1400 See Note 2	1 See Note 2	1 See Note 2
MP NP See Note 1	C1025 C1122 C1221 C1254 C1263 C1268 C1400 C3642 C3643 See Note 2	P3642 See Note 2	1 See Note 2	3 See Note 2

[83]        Schedule 1, entry for Sulindac

substitute:

Sulindac	Tablet 100 mg	Oral	Aclin	AF	MP NP	C1036 C1054 C3645 C3646	P3646	100	0
PDP	C1036 C1054	P1036 P1054	100	0
MP NP	C1036 C1054 C3645 C3646	P1036 P1054 P3645	100	3
Tablet 200 mg	Oral	Aclin 200	AF	MP NP	C1036 C1054 C3645 C3646	P3646	50	0
PDP	C1036 C1054	P1036 P1054	50	0
MP NP	C1036 C1054 C3645 C3646	P1036 P1054 P3645	50	3

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

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

APO-Sumatriptan TX MP NP C3233 4 5

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

Chem mart Sumatriptan CH MP NP C3233 4 5

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

Terry White Chemists Sumatriptan TW MP NP C3233 4 5

[85]        Schedule 1, entry for Temazepam

substitute:

Temazepam	Tablet 10 mg	Oral	APO-Temazepam	TX	PDP MP NP	25	0
Normison	SI	PDP MP NP	25	0
Temaze	AF	PDP MP NP	25	0
Temtabs	FM	PDP MP NP	25	0
APO-Temazepam	TX	MP NP	P3654	50	0
Normison	SI	MP NP	P3654	50	0
Temaze	AF	MP NP	P3654	50	0
Temtabs	FM	MP NP	P3654	50	0
APO-Temazepam	TX	MP NP	P3653	50	3
Normison	SI	MP NP	P3653	50	3
Temaze	AF	MP NP	P3653	50	3
Temtabs	FM	MP NP	P3653	50	3
APO-Temazepam	TX	MP NP	P1123 P1126 P1216	50	5
Normison	SI	MP NP	P1123 P1126 P1216	50	5
Temaze	AF	MP NP	P1123 P1126 P1216	50	5
Temtabs	FM	MP NP	P1123 P1126 P1216	50	5

[86]        Schedule 1, entry for Tenofovir

omit from the column headed “Circumstances”:

C1820  C1821  C2931  C3203  C3309  C3310  C3313  C3417

insert:

C2931  C3203  C3313  C3417  C3586  C3587  C3588  C3589

[87]        Schedule 1, entry for Tenofovir with Emtricitabine

omit from the column headed “Circumstances”:

C1820  C1821  C3309  C3310

insert:

C3586  C3587  C3588  C3589

[88]        Schedule 1, entry for Tenofovir with emtricitabine and efavirenz

omit from the column headed “Circumstances”:

C1820  C1821  C3309  C3310

insert:

C3586  C3587  C3588  C3589

[89]        Schedule 1, entry for Testosterone

omit:

Injection containing testosterone esters (20 mg testosterone propionate, 40 mg testosterone phenylpropionate, 40 mg testosterone isocaproate) in 1 mL Injection Sustanon 100 SH MP C1021 C1022 C1226 3 3

[90]        Schedule 1, entry for Tipranavir in the form Capsule 250 mg

omit from the column headed “Circumstances”:

C2700  C3418

insert:

C3600  C3601

[91]        Schedule 1, entry for Tipranavir in the form Oral liquid 100 mg per mL, 95 mL

omit from the column headed “Circumstances”:

C3500  C3501

insert:

C3602  C3603

[92]        Schedule 1, entry for Tramadol in the form Tablet (sustained release) containing tramadol hydrochloride 150 mg

omit from the column headed “Brand”:         Tramahexal      and insert:            Tramadol Sandoz SR

[93]        Schedule 1, entry for Valaciclovir

substitute:

Valaciclovir	Tablet 500 mg (as hydrochloride)	Oral	Valtrex	GK	MP NP	C3622 C3631 C3632 C3633	P3632	20	0
MP NP	C3622 C3631 C3632 C3633	P3633	30	5
MP NP	C3622 C3631 C3632 C3633	P3622 P3631	42	0
MP See Note 1	C1494 C3419	500	2	C

[94]        Schedule 1, entry for Zidovudine

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

C1820  C1821  C3309  C3310

insert:

C3586  C3587  C3588  C3589

[95]        Schedule 3, omit Responsible person code CQ and relevant details

[96]        Schedule 3, after details relevant to Responsible person code PZ

insert:

QB Bionime Australia Pty Ltd  84 142 133 677

[97]        Schedule 3, after details relevant to Responsible person code YT

insert:

ZF Sun Pharmaceutical Industries Pty Ltd  64 130119603

[98]        Schedule 4, entry for Abacavir

substitute:

Abacavir	C3586	Where the patient is receiving treatment at/from a private hospital Initial treatment of human immunodeficiency virus (HIV) infection in combination with other antiretroviral agents in a patient with a CD4 count of less than 500 per cubic millimetre or symptomatic HIV disease	Compliance with Written or Telephone Authority Required procedures
C3587	Where the patient is receiving treatment at/from a private hospital Continuing treatment of human immunodeficiency virus (HIV) infection in combination with other antiretroviral agents where the patient has previously received PBS-subsidised therapy for HIV infection	Compliance with Written or Telephone Authority Required procedures
C3588	Where the patient is receiving treatment at/from a public hospital Initial treatment of human immunodeficiency virus (HIV) infection in combination with other antiretroviral agents in a patient with a CD4 count of less than 500 per cubic millimetre or symptomatic HIV disease	Compliance with Written or Telephone Authority Required procedures - Streamlined Authority Code 3588
C3589	Where the patient is receiving treatment at/from a public hospital Continuing treatment of human immunodeficiency virus (HIV) infection in combination with other antiretroviral agents where the patient has previously received PBS-subsidised therapy for HIV infection	Compliance with Written or Telephone Authority Required procedures - Streamlined Authority Code 3589

[99]        Schedule 4, entry for Abacavir with Lamivudine

substitute:

Abacavir with Lamivudine	C3590	Where the patient is receiving treatment at/from a private hospital Initial treatment of human immunodeficiency virus (HIV) infection in combination with other antiretroviral agents in a patient over 12 years of age, weighing 40 kg or more, with a CD4 count of less than 500 per cubic millimetre or symptomatic HIV disease	Compliance with Written or Telephone Authority Required procedures
C3591	Where the patient is receiving treatment at/from a private hospital Continuing treatment of human immunodeficiency virus (HIV) infection in combination with other antiretroviral agents where the patient over 12 years of age, weighing 40 kg or more, has previously received PBS-subsidised therapy for HIV infection	Compliance with Written or Telephone Authority Required procedures
C3592	Where the patient is receiving treatment at/from a public hospital Initial treatment of human immunodeficiency virus (HIV) infection in combination with other antiretroviral agents in a patient over 12 years of age, weighing 40 kg or more, with a CD4 count of less than 500 per cubic millimetre or symptomatic HIV disease	Compliance with Written or Telephone Authority Required procedures - Streamlined Authority Code 3592
C3593	Where the patient is receiving treatment at/from a public hospital Continuing treatment of human immunodeficiency virus (HIV) infection in combination with other antiretroviral agents where the patient over 12 years of age, weighing 40 kg or more, has previously received PBS-subsidised therapy for HIV infection	Compliance with Written or Telephone Authority Required procedures - Streamlined Authority Code 3593

[100]      Schedule 4, entry for Abacavir with Lamivudine and Zidovudine

substitute:

Abacavir with Lamivudine and Zidovudine	C3590	Where the patient is receiving treatment at/from a private hospital Initial treatment of human immunodeficiency virus (HIV) infection in combination with other antiretroviral agents in a patient over 12 years of age, weighing 40 kg or more, with a CD4 count of less than 500 per cubic millimetre or symptomatic HIV disease	Compliance with Written or Telephone Authority Required procedures
C3591	Where the patient is receiving treatment at/from a private hospital Continuing treatment of human immunodeficiency virus (HIV) infection in combination with other antiretroviral agents where the patient over 12 years of age, weighing 40 kg or more, has previously received PBS-subsidised therapy for HIV infection	Compliance with Written or Telephone Authority Required procedures
C3592	Where the patient is receiving treatment at/from a public hospital Initial treatment of human immunodeficiency virus (HIV) infection in combination with other antiretroviral agents in a patient over 12 years of age, weighing 40 kg or more, with a CD4 count of less than 500 per cubic millimetre or symptomatic HIV disease	Compliance with Written or Telephone Authority Required procedures - Streamlined Authority Code 3592
C3593	Where the patient is receiving treatment at/from a public hospital Continuing treatment of human immunodeficiency virus (HIV) infection in combination with other antiretroviral agents where the patient over 12 years of age, weighing 40 kg or more, has previously received PBS-subsidised therapy for HIV infection	Compliance with Written or Telephone Authority Required procedures - Streamlined Authority Code 3593

[101]      Schedule 4, entry for Aciclovir

substitute:

Aciclovir	C1715	Herpes simplex keratitis.
C3622	P3622	Treatment of patients with herpes zoster within 72 hours of the onset of the rash	Compliance with Authority Required procedures - Streamlined Authority Code 3622
C3630	P3630	Patients with advanced human immunodeficiency virus disease (CD4 cell counts of less than 150 million per L)	Compliance with Authority Required procedures - Streamlined Authority Code 3630
C3631	P3631	Herpes zoster ophthalmicus	Compliance with Authority Required procedures - Streamlined Authority Code 3631
C3632	P3632	Moderate to severe initial genital herpes	Compliance with Authority Required procedures - Streamlined Authority Code 3632
C3633	P3633	Episodic treatment or suppressive therapy of moderate to severe recurrent genital herpes, where the diagnosis is confirmed microbiologically (by viral culture, antigen detection or nucleic acid amplification by polymerase chain reaction) but where commencement of treatment need not await confirmation of diagnosis	Compliance with Authority Required procedures - Streamlined Authority Code 3633

[102]      Schedule 4, entry for Aprepitant

substitute:

Aprepitant	C3619	Management of nausea and vomiting associated with cytotoxic chemotherapy being used to treat malignancy, in combination with a 5-hydroxytryptamine type 3 receptor antagonist and dexamethasone, where any 1 of the following chemotherapy agents are to be administered: (a) altretamine; (b) carmustine; (c) cisplatin, when a single dose constitutes a cycle of chemotherapy; (d) cyclophosphamide, at a dose of 1500 mg per square metre per day or greater; (e) dacarbazine; (f) procarbazine, when a single dose constitutes a cycle of chemotherapy; (g) streptozocin; and where treatment with aprepitant is limited to an initial dose of 125 mg and 2 subsequent doses of 80 mg per cycle of cytotoxic chemotherapy	Compliance with Authority Required procedures - Streamlined Authority Code 3619
C3620	Management of nausea and vomiting associated with cytotoxic chemotherapy being used to treat breast cancer, in combination with a 5-hydroxytryptamine type 3 receptor antagonist and dexamethasone, where cyclophosphamide and an anthracycline are to be co-administered, and where treatment with aprepitant is limited to an initial dose of 125 mg and 2 subsequent doses of 80 mg per cycle of cytotoxic chemotherapy	Compliance with Authority Required procedures - Streamlined Authority Code 3620
C3621	Management of nausea and vomiting associated with moderately emetogenic cytotoxic chemotherapy being used to treat malignancy, in combination with a 5-hydroxytryptamine type 3 receptor (5HT3) antagonist and dexamethasone on day 1, where the patient has had a prior episode of chemotherapy induced nausea or vomiting where any 1 of the following intravenous chemotherapy agents is to be administered: (a) arsenic trioxide; (b) azacitidine; (c) carboplatin; (d) cyclophosphamide, at a dose of less than 1500 mg per square metre per day; (e) cytarabine, at a dose of greater than 1 g per square metre per day; (f) dactinomycin; (g) daunorubicin; (h) doxorubicin; (i) epirubicin; (j) fotemustine; (k) idarubicin; (l) ifosfamide; (m) irinotecan; (n) melphalan; (o) methotrexate, at a dose of 250 mg to 1 g per square metre; (p) oxaliplatin; (q) raltitrexed; and where treatment with aprepitant is limited to an initial dose of 125 mg and 2 subsequent doses of 80 mg per cycle of cytotoxic chemotherapy, and where concomitant use of a 5HT3 antagonist should not occur with aprepitant on days 2 and 3 of any chemotherapy cycle	Compliance with Authority Required procedures - Streamlined Authority Code 3621

[103]      Schedule 4, entry for Atazanavir

substitute:

Atazanavir	C3586	Where the patient is receiving treatment at/from a private hospital Initial treatment of human immunodeficiency virus (HIV) infection in combination with other antiretroviral agents in a patient with a CD4 count of less than 500 per cubic millimetre or symptomatic HIV disease	Compliance with Written or Telephone Authority Required procedures
C3587	Where the patient is receiving treatment at/from a private hospital Continuing treatment of human immunodeficiency virus (HIV) infection in combination with other antiretroviral agents where the patient has previously received PBS-subsidised therapy for HIV infection	Compliance with Written or Telephone Authority Required procedures
C3588	Where the patient is receiving treatment at/from a public hospital Initial treatment of human immunodeficiency virus (HIV) infection in combination with other antiretroviral agents in a patient with a CD4 count of less than 500 per cubic millimetre or symptomatic HIV disease	Compliance with Written or Telephone Authority Required procedures - Streamlined Authority Code 3588
C3589	Where the patient is receiving treatment at/from a public hospital Continuing treatment of human immunodeficiency virus (HIV) infection in combination with other antiretroviral agents where the patient has previously received PBS-subsidised therapy for HIV infection	Compliance with Written or Telephone Authority Required procedures - Streamlined Authority Code 3589

[104]      Schedule 4, entry for Benzydamine

substitute:

Benzydamine	C1669	P1669	Radiation induced mucositis
C3634	P3634	Initial supply, for up to 4 months, for a palliative care patient where a painful mouth is a problem	Compliance with Authority Required procedures - Streamlined Authority Code 3634
C3635	P3635	Continuing supply for a palliative care patient where a painful mouth is a problem	Compliance with Authority Required procedures - Streamlined Authority Code 3635

[105]      Schedule 4, entry for Bisacodyl

substitute:

Bisacodyl	C1025	P1025	Anorectal congenital abnormalities
C1122	P1122	For use by a patient who is receiving long-term nursing care and in respect of whom a Carer Allowance is payable as a disabled adult
C1221	P1221	Megacolon
C1254	P1254	Paraplegic and quadriplegic patients and others with severe neurogenic impairment of bowel function
C1263	P1263	Patients receiving palliative care
C1268	P1268	Patients who are receiving long-term nursing care on account of age, infirmity or other condition in hospitals, nursing homes or residential facilities
C1400	P1400	Terminal malignant neoplasia
C3642	P3642	Initial supply, for up to 4 months, for a palliative care patient where constipation is a problem	Compliance with Authority Required procedures - Streamlined Authority Code 3642
C3643	P3643	Continuing supply for a palliative care patient where constipation is a problem	Compliance with Authority Required procedures - Streamlined Authority Code 3643

[106]      Schedule 4, entry for Carmellose

substitute:

Carmellose	C1359	Severe dry eye syndrome in patients who are sensitive to preservatives in multi-dose eye drops	Compliance with Authority Required procedures - Streamlined Authority Code 1359
C1362	P1362	Severe dry eye syndrome, including Sjogren's syndrome.
C2802	Severe dry eye syndrome in patients who are sensitive to preservatives in multi-dose eye drops	Compliance with Authority Required procedures
C3036	P3036	For use in patients who have severe dry eye syndrome, including Sjogren's syndrome, and who are receiving treatment under a GP Management Plan or Team Care Arrangements where Medicare benefits were or are payable for the preparation of the Plan or coordination of the Arrangements
C3636	P3636	Initial supply, for up to 4 months, for a palliative care patient where dry mouth is a symptom	Compliance with Authority Required procedures - Streamlined Authority Code 3636
C3637	P3637	Continuing supply for a palliative care patient where dry mouth is a symptom	Compliance with Authority Required procedures - Streamlined Authority Code 3637

[107]      Schedule 4, entry for Clonazepam

substitute:

Clonazepam	C1093	Epilepsy.
C1574	P1574	Neurologically proven epilepsy	Compliance with Authority Required procedures
C3657	P3657	Initial supply, for up to 4 months, for a palliative care patient for the prevention of epilepsy	Compliance with Authority Required procedures
C3658	P3658	Continuing supply for a palliative care patient for the prevention of epilepsy	Compliance with Authority Required procedures

[108]      Schedule 4, entry for Darunavir

substitute:

Darunavir	C3594	Where the patient is receiving treatment at/from a private hospital Treatment of human immunodeficiency virus (HIV) infection, in addition to optimised background therapy in combination with other antiretroviral agents, and co-administered with 100 mg ritonavir twice daily in an antiretroviral experienced patient who, after at least one antiretroviral regimen, has experienced virological failure or clinical failure or genotypic resistance Virological failure is defined as a viral load greater than 400 copies per mL on two consecutive occasions, while clinical failure is linked to emerging signs and symptoms of progressing HIV infection or treatment-limiting toxicity	Compliance with Written or Telephone Authority Required procedures
C3595	Where the patient is receiving treatment at/from a public hospital Treatment of human immunodeficiency virus (HIV) infection, in addition to optimised background therapy in combination with other antiretroviral agents, and co-administered with 100 mg ritonavir twice daily in an antiretroviral experienced patient who, after at least one antiretroviral regimen, has experienced virological failure or clinical failure or genotypic resistance Virological failure is defined as a viral load greater than 400 copies per mL on two consecutive occasions, while clinical failure is linked to emerging signs and symptoms of progressing HIV infection or treatment-limiting toxicity	Compliance with Written or Telephone Authority Required procedures - Streamlined Authority Code 3595

[109]      Schedule 4, entry for Diazepam

substitute:

Diazepam	P3655	Initial supply, for up to 4 months, for a palliative care patient where anxiety is a problem (Authority Required)
P3656	Continuing supply for a palliative care patient where anxiety is a problem (Authority Required)

[110]      Schedule 4, entry for Diclofenac

substitute:

Diclofenac	C1036	P1036	Bone pain due to malignant disease
C1054	P1054	Chronic arthropathies (including osteoarthritis) with an inflammatory component
C3645	P3645	Initial supply, for up to 4 months, for a palliative care patient where severe pain is a problem	Compliance with Authority Required procedures - Streamlined Authority Code 3645
C3646	P3646	Continuing supply for a palliative care patient where severe pain is a problem	Compliance with Authority Required procedures - Streamlined Authority Code 3646
P3665	Initial supply, for up to 4 months, for a palliative care patient where severe pain is a problem (Authority Required)
P3666	Continuing supply for a palliative care patient where severe pain is a problem. (Authority Required)

[111]      Schedule 4, entry for Didanosine

substitute:

Didanosine	C3586	Where the patient is receiving treatment at/from a private hospital Initial treatment of human immunodeficiency virus (HIV) infection in combination with other antiretroviral agents in a patient with a CD4 count of less than 500 per cubic millimetre or symptomatic HIV disease	Compliance with Written or Telephone Authority Required procedures
C3587	Where the patient is receiving treatment at/from a private hospital Continuing treatment of human immunodeficiency virus (HIV) infection in combination with other antiretroviral agents where the patient has previously received PBS-subsidised therapy for HIV infection	Compliance with Written or Telephone Authority Required procedures
C3588	Where the patient is receiving treatment at/from a public hospital Initial treatment of human immunodeficiency virus (HIV) infection in combination with other antiretroviral agents in a patient with a CD4 count of less than 500 per cubic millimetre or symptomatic HIV disease	Compliance with Written or Telephone Authority Required procedures - Streamlined Authority Code 3588
C3589	Where the patient is receiving treatment at/from a public hospital Continuing treatment of human immunodeficiency virus (HIV) infection in combination with other antiretroviral agents where the patient has previously received PBS-subsidised therapy for HIV infection	Compliance with Written or Telephone Authority Required procedures - Streamlined Authority Code 3589

[112]      Schedule 4, entry for Dipyridamole

substitute:

Dipyridamole	C1725	Prevention of recurrence of ischaemic stroke or transient cerebral ischaemic events in patients receiving therapy with low-dose aspirin
C1726	Prevention of recurrence of ischaemic stroke or transient cerebral ischaemic events in patients where low-dose aspirin poses an unacceptable risk of gastrointestinal bleeding
C1727	Prevention of recurrence of ischaemic stroke or transient cerebral ischaemic events in patients where there is a history of anaphylaxis, urticaria or asthma within 4 hours of ingestion of aspirin, other salicylates, or non-steroidal anti-inflammatory drugs

[113]      Schedule 4, entry for Efavirenz

substitute:

Efavirenz	C3586	Where the patient is receiving treatment at/from a private hospital Initial treatment of human immunodeficiency virus (HIV) infection in combination with other antiretroviral agents in a patient with a CD4 count of less than 500 per cubic millimetre or symptomatic HIV disease	Compliance with Written or Telephone Authority Required procedures
C3587	Where the patient is receiving treatment at/from a private hospital Continuing treatment of human immunodeficiency virus (HIV) infection in combination with other antiretroviral agents where the patient has previously received PBS-subsidised therapy for HIV infection	Compliance with Written or Telephone Authority Required procedures
C3588	Where the patient is receiving treatment at/from a public hospital Initial treatment of human immunodeficiency virus (HIV) infection in combination with other antiretroviral agents in a patient with a CD4 count of less than 500 per cubic millimetre or symptomatic HIV disease	Compliance with Written or Telephone Authority Required procedures - Streamlined Authority Code 3588
C3589	Where the patient is receiving treatment at/from a public hospital Continuing treatment of human immunodeficiency virus (HIV) infection in combination with other antiretroviral agents where the patient has previously received PBS-subsidised therapy for HIV infection	Compliance with Written or Telephone Authority Required procedures - Streamlined Authority Code 3589

[114]      Schedule 4, entry for Emtricitabine

substitute:

Emtricitabine	C3586	Where the patient is receiving treatment at/from a private hospital Initial treatment of human immunodeficiency virus (HIV) infection in combination with other antiretroviral agents in a patient with a CD4 count of less than 500 per cubic millimetre or symptomatic HIV disease	Compliance with Written or Telephone Authority Required procedures
C3587	Where the patient is receiving treatment at/from a private hospital Continuing treatment of human immunodeficiency virus (HIV) infection in combination with other antiretroviral agents where the patient has previously received PBS-subsidised therapy for HIV infection	Compliance with Written or Telephone Authority Required procedures
C3588	Where the patient is receiving treatment at/from a public hospital Initial treatment of human immunodeficiency virus (HIV) infection in combination with other antiretroviral agents in a patient with a CD4 count of less than 500 per cubic millimetre or symptomatic HIV disease	Compliance with Wrtten or Telephone Authority Required procedures - Streamlined Authority Code 3588
C3589	Where the patient is receiving treatment at/from a public hospital Continuing treatment of human immunodeficiency virus (HIV) infection in combination with other antiretroviral agents where the patient has previously received PBS-subsidised therapy for HIV infection	Compliance with Wrtten or Telephone Authority Required procedures - Streamlined Authority Code 3589

[115]      Schedule 4, entry for Enfuvirtide

substitute:

Enfuvirtide	C3596	Where the patient is receiving treatment at/from a private hospital Treatment of human immunodeficiency virus (HIV) infection, in addition to optimised background therapy in combination with other antiretroviral agents in an antiretroviral experienced patient who, after each of at least three different antiretroviral regimens that have included one drug from at least 3 different antiretroviral classes, has experienced virological failure or clinical failure or genotypic resistance. Virological failure is defined as a viral load greater than 400 copies per mL on two consecutive occasions, while clinical failure is linked to emerging signs and symptoms of progressing HIV infection or treatment-limiting toxicity	Compliance with Written or Telephone Authority Required procedures
C3597	Where the patient is receiving treatment at/from a public hospital Treatment of human immunodeficiency virus (HIV) infection, in addition to optimised background therapy in combination with other antiretroviral agents in an antiretroviral experienced patient who, after each of at least three different antiretroviral regimens that have included one drug from at least 3 different antiretroviral classes, has experienced virological failure or clinical failure or genotypic resistance. Virological failure is defined as a viral load greater than 400 copies per mL on two consecutive occasions, while clinical failure is linked to emerging signs and symptoms of progressing HIV infection or treatment-limiting toxicity	Compliance with Written or Telephone Authority Required procedures - Streamlined Authority Code 3597

[116]      Schedule 4, entry for Etravirine

substitute:

Etravirine	C3596	Where the patient is receiving treatment at/from a private hospital Treatment of human immunodeficiency virus (HIV) infection, in addition to optimised background therapy in combination with other antiretroviral agents in an antiretroviral experienced patient who, after each of at least three different antiretroviral regimens that have included one drug from at least 3 different antiretroviral classes, has experienced virological failure or clinical failure or genotypic resistance. Virological failure is defined as a viral load greater than 400 copies per mL on two consecutive occasions, while clinical failure is linked to emerging signs and symptoms of progressing HIV infection or treatment-limiting toxicity	Compliance with Written or Telephone Authority Required procedures
C3597	Where the patient is receiving treatment at/from a public hospital Treatment of human immunodeficiency virus (HIV) infection, in addition to optimised background therapy in combination with other antiretroviral agents in an antiretroviral experienced patient who, after each of at least three different antiretroviral regimens that have included one drug from at least 3 different antiretroviral classes, has experienced virological failure or clinical failure or genotypic resistance Virological failure is defined as a viral load greater than 400 copies per mL on two consecutive occasions, while clinical failure is linked to emerging signs and symptoms of progressing HIV infection or treatment-limiting toxicity	Compliance with Written or Telephone Authority Required procedures - Streamlined Authority Code 3597

[117]      Schedule 4, entry for Famciclovir

substitute:

Famciclovir	C3622	P3622	Treatment of patients with herpes zoster within 72 hours of the onset of the rash	Compliance with Authority Required procedures - Streamlined Authority Code 3622
C3623	P3623	Suppressive therapy of moderate to severe recurrent genital herpes, where the diagnosis is confirmed microbiologically (by viral culture, antigen detection or nucleic acid amplification by polymerase chain reaction) but where commencement of treatment need not await confirmation of diagnosis	Compliance with Authority Required procedures - Streamlined Authority Code 3623
C3624	P3624	Episodic treatment of moderate to severe recurrent genital herpes, where the diagnosis is confirmed microbiologically (by viral culture, antigen detection or nucleic acid amplification by polymerase chain reaction) but where commencement of treatment need not await confirmation of diagnosis	Compliance with Authority Required procedures - Streamlined Authority Code 3624
C3625	P3625	Treatment of immunocompromised patients with herpes zoster within 72 hours of the onset of the rash	Compliance with Authority Required procedures - Streamlined Authority Code 3625
C3626	P3626	Episodic treatment or suppressive therapy of moderate to severe recurrent genital herpes in immunocompromised patients, where the diagnosis is confirmed microbiologically (by viral culture, antigen detection or nucleic acid amplification by polymerase chain reaction) but where commencement of treatment need not await confirmation of diagnosis	Compliance with Authority Required procedures - Streamlined Authority Code 3626
C3627	P3627	Episodic treatment of moderate to severe recurrent oral or labial herpes in a patient with human immunodeficiency virus infection and a CD4 cell count of less than 500 million per L, where the diagnosis is confirmed microbiologically (by viral culture, antigen detection or nucleic acid amplification by polymerase chain reaction) but where commencement of treatment need not await confirmation of diagnosis	Compliance with Authority Required procedures - Streamlined Authority Code 3627
C3628	P3628	Suppressive therapy of moderate to severe recurrent oral or labial herpes in a patient with human immunodeficiency virus infection and a CD4 cell count of less than 150 million per L, where the diagnosis is confirmed microbiologically (by viral culture, antigen detection or nucleic acid amplification by polymerase chain reaction) but where commencement of treatment need not await confirmation of diagnosis	Compliance with Authority Required procedures - Streamlined Authority Code 3628
C3629	P3629	Suppressive therapy of moderate to severe recurrent oral or labial herpes in a patient with human immunodeficiency virus infection and other opportunistic infections or Acquired Immunodeficiency Syndrome defining tumours, where the diagnosis is confirmed microbiologically (by viral culture, antigen detection or nucleic acid amplification by polymerase chain reaction) but where commencement of treatment need not await confirmation of diagnosis	Compliance with Authority Required procedures - Streamlined Authority Code 3629

[118]      Schedule 4, entry for Fentanyl

substitute:

Fentanyl	C1062	Chronic severe disabling pain not responding to non-narcotic analgesics
C3663	P3663	Initial supply for dose titration for breakthrough pain in a palliative care patient with cancer who is receiving opioids for their persistent pain and where further escalation in the dose of morphine for breakthrough pain results in intolerable adverse effects	Compliance with Authority Required procedures
C3664	P3664	Continuing supply for breakthrough pain in a palliative care patient with cancer who is receiving opioids for their persistent pain and where further escalation in the dose of morphine for breakthrough pain results in intolerable adverse effects	Compliance with Authority Required procedures

[137]      Schedule 4, entry for Mesalazine

omit from the column headed “Circumstances and Purposes” (all instances):

Crohn’s disease

and substitute:

Crohn disease

[138]      Schedule 4, entry for Methadone

substitute:

Methadone	C1358	Severe disabling pain not responding to non-narcotic analgesics
C3659	P3659	Initial supply, for up to 3 months, for a palliative care patient with chronic severe disabling pain not responding to non-narcotic analgesics	Compliance with Authority Required procedures
C3660	P3660	Continuing supply for a palliative care patient with chronic severe disabling pain not responding to non-narcotic analgesics	Compliance with Authority Required procedures

[139]      Schedule 4, entry for Methylnaltrexone

substitute:

Methylnaltrexone	C3235	P3235	Initial supply, in combination with oral laxatives, for a palliative care patient with opioid-induced constipation who has failed to respond to laxatives	Compliance with Authority Required procedures
C3238	P3238	Continuing supply, in combination with oral laxatives, for a palliative care patient with opioid-induced constipation who has demonstrated a response to methylnaltrexone	Compliance with Authority Required procedures

[140]      Schedule 4, entry for Morphine

substitute:

Morphine	C1062	Chronic severe disabling pain not responding to non-narcotic analgesics
C1358	Severe disabling pain not responding to non-narcotic analgesics.
C1499	P1499	Chronic severe disabling pain due to cancer	Compliance with Authority Required procedures
C1789	P1789	Severe disabling pain due to cancer not responding to non-narcotic analgesics
C3659	P3659	Initial supply, for up to 3 months, for a palliative care patient with chronic severe disabling pain not responding to non-narcotic analgesics	Compliance with Authority Required procedures
C3660	P3660	Continuing supply for a palliative care patient with chronic severe disabling pain not responding to non-narcotic analgesics	Compliance with Authority Required procedures
C3661	P3661	Initial supply, for up to 3 months, for a palliative care patient with severe disabling pain not responding to non-narcotic analgesics	Compliance with Authority Required procedures
C3662	P3662	Continuing supply for a palliative care patient with severe disabling pain not responding to non-narcotic analgesics	Compliance with Authority Required procedures

[141]      Schedule 4, entry for Naproxen

substitute:

Naproxen	C1036	P1036	Bone pain due to malignant disease
C1054	P1054	Chronic arthropathies (including osteoarthritis) with an inflammatory component
C3645	P3645	Initial supply, for up to 4 months, for a palliative care patient where severe pain is a problem	Compliance with Authority Required procedures - Streamlined Authority Code 3645
C3646	P3646	Continuing supply for a palliative care patient where severe pain is a problem	Compliance with Authority Required procedures - Streamlined Authority Code 3646
C3647	P3647	Initial supply, for up to 4 months, for a palliative care patient where severe pain is a problem in patients unable to take a solid dose form of a non-steroidal anti-inflammatory agent	Compliance with Authority Required procedures - Streamlined Authority Code 3647
C3648	P3648	Continuing supply for a palliative care patient where severe pain is a problem in patients unable to take a solid dose form of a non-steroidal anti-inflammatory agent	Compliance with Authority Required procedures - Streamlined Authority Code 3648

[142]      Schedule 4, entry for Nevirapine

substitute:

Nevirapine	C3586	Where the patient is receiving treatment at/from a private hospital Initial treatment of human immunodeficiency virus (HIV) infection in combination with other antiretroviral agents in a patient with a CD4 count of less than 500 per cubic millimetre or symptomatic HIV disease	Compliance with Written or Telephone Authority Required procedures
C3587	Where the patient is receiving treatment at/from a private hospital Continuing treatment of human immunodeficiency virus (HIV) infection in combination with other antiretroviral agents where the patient has previously received PBS-subsidised therapy for HIV infection	Compliance with Written or Telephone Authority Required procedures
C3588	Where the patient is receiving treatment at/from a public hospital Initial treatment of human immunodeficiency virus (HIV) infection in combination with other antiretroviral agents in a patient with a CD4 count of less than 500 per cubic millimetre or symptomatic HIV disease	Compliance with Written or Telephone Authority Required procedures - Streamlined Authority Code 3588
C3589	Where the patient is receiving treatment at/from a public hospital Continuing treatment of human immunodeficiency virus (HIV) infection in combination with other antiretroviral agents where the patient has previously received PBS-subsidised therapy for HIV infection	Compliance with Written or Telephone Authority Required procedures - Streamlined Authority Code 3589

[143]      Schedule 4, entry for Nitrazepam

substitute:

Nitrazepam	P1123	For use by a patient who is receiving long-term nursing care and in respect of whom a Carer Allowance is payable as a disabled adult and who has been demonstrated, within the past 6 months, to be benzodiazepine dependent by an unsuccessful attempt at gradual withdrawal (Authority Required)
P1126	For use by patients who are receiving long-term nursing care on account of age, infirmity or other condition in hospitals, nursing homes or residential facilities and who have been demonstrated, within the past 6 months, to be benzodiazepine dependent by an unsuccessful attempt at gradual withdrawal (Authority Required)
P1216	Malignant neoplasia (late stage) (Authority Required)
P1235	Myoclonic epilepsy (Authority Required)
P3653	Initial supply, for up to 4 months, for a palliative care patient where insomnia is a problem (Authority Required)
P3654	Continuing supply for a palliative care patient where insomnia is a problem (Authority Required)

[144]      Schedule 4, entry for Ondansetron

substitute:

Ondansetron	C3050	P3050	Management of nausea and vomiting associated with cytotoxic chemotherapy being used to treat malignancy which occurs within 48 hours of chemotherapy administration
C3611	P3611	Management of nausea and vomiting associated with radiotherapy being used to treat malignancy	Compliance with Authority Required procedures - Streamlined Authority Code 3611

[145]      Schedule 4, entry for Oxazepam

substitute:

Oxazepam	P1123	For use by a patient who is receiving long-term nursing care and in respect of whom a Carer Allowance is payable as a disabled adult and who has been demonstrated, within the past 6 months, to be benzodiazepine dependent by an unsuccessful attempt at gradual withdrawal (Authority Required)
P1126	For use by patients who are receiving long-term nursing care on account of age, infirmity or other condition in hospitals, nursing homes or residential facilities and who have been demonstrated, within the past 6 months, to be benzodiazepine dependent by an unsuccessful attempt at gradual withdrawal (Authority Required)
P1216	Malignant neoplasia (late stage) (Authority Required)
P3655	Initial supply, for up to 4 months, for a palliative care patient where anxiety is a problem (Authority Required)
P3656	Continuing supply for a palliative care patient where anxiety is a problem (Authority Required)

[146]      Schedule 4, entry for Paracetamol

substitute:

Paracetamol	C2046	P2046	Chronic arthropathies
C2094	P2094	Relief of persistent pain associated with osteoarthritis
C3649	P3649	Initial supply, for up to 4 months, for a palliative care patient for analgesia or fever where alternative therapy cannot be tolerated	Compliance with Authority Required procedures - Streamlined Authority Code 3649
C3650	P3650	Continuing supply for a palliative care patient for analgesia or fever where alternative therapy cannot be tolerated	Compliance with Authority Required procedures - Streamlined Authority Code 3650

[147]      Schedule 4, entry for Promethazine

substitute:

Promethazine	C3640	P3640	Initial supply, for up to 4 months, for a palliative care patient where nausea and/or vomiting is a problem	Compliance with Authority Required procedures - Streamlined Authority Code 3640
C3641	P3641	Continuing supply for a palliative care patient where nausea and/or vomiting is a problem	Compliance with Authority Required procedures - Streamlined Authority Code 3641

[148]      Schedule 4, entry for Raltegravir

substitute:

Raltegravir	C3586	Where the patient is receiving treatment at/from a private hospital Initial treatment of human immunodeficiency virus (HIV) infection in combination with other antiretroviral agents in a patient with a CD4 count of less than 500 per cubic millimetre or symptomatic HIV disease	Compliance with Written or Telephone Authority Required procedures
C3587	Where the patient is receiving treatment at/from a private hospital Continuing treatment of human immunodeficiency virus (HIV) infection in combination with other antiretroviral agents where the patient has previously received PBS-subsidised therapy for HIV infection	Compliance with Written or Telephone Authority Required procedures
C3588	Where the patient is receiving treatment at/from a public hospital Initial treatment of human immunodeficiency virus (HIV) infection in combination with other antiretroviral agents in a patient with a CD4 count of less than 500 per cubic millimetre or symptomatic HIV disease	Compliance with Written or Telephone Authority Required procedures - Streamlined Authority Code 3588
C3589	Where the patient is receiving treatment at/from a public hospital Continuing treatment of human immunodeficiency virus (HIV) infection in combination with other antiretroviral agents where the patient has previously received PBS-subsidised therapy for HIV infection	Compliance with Written or Telephone Authority Required procedures - Streamlined Authority Code 3589

[149]      Schedule 4, entry for Ritonavir

substitute:

Ritonavir	C3586	Where the patient is receiving treatment at/from a private hospital Initial treatment of human immunodeficiency virus (HIV) infection in combination with other antiretroviral agents in a patient with a CD4 count of less than 500 per cubic millimetre or symptomatic HIV disease	Compliance with Written or Telephone Authority Required procedures
C3587	Where the patient is receiving treatment at/from a private hospital Continuing treatment of human immunodeficiency virus (HIV) infection in combination with other antiretroviral agents where the patient has previously received PBS-subsidised therapy for HIV infection	Compliance with Written or Telephone Authority Required procedures
C3588	Where the patient is receiving treatment at/from a public hospital Initial treatment of human immunodeficiency virus (HIV) infection in combination with other antiretroviral agents in a patient with a CD4 count of less than 500 per cubic millimetre or symptomatic HIV disease	Compliance with Written or Telephone Authority Required procedures - Streamlined Authority Code 3588
C3589	Where the patient is receiving treatment at/from a public hospital Continuing treatment of human immunodeficiency virus (HIV) infection in combination with other antiretroviral agents where the patient has previously received PBS-subsidised therapy for HIV infection	Compliance with Written or Telephone Authority Required procedures - Streamlined Authority Code 3589

[150]      Schedule 4, entry for Saquinavir

substitute:

Saquinavir	C3586	Where the patient is receiving treatment at/from a private hospital Initial treatment of human immunodeficiency virus (HIV) infection in combination with other antiretroviral agents in a patient with a CD4 count of less than 500 per cubic millimetre or symptomatic HIV disease	Compliance with Written or Telephone Authority Required procedures
C3587	Where the patient is receiving treatment at/from a private hospital Continuing treatment of human immunodeficiency virus (HIV) infection in combination with other antiretroviral agents where the patient has previously received PBS-subsidised therapy for HIV infection	Compliance with Written or Telephone Authority Required procedures
C3588	Where the patient is receiving treatment at/from a public hospital Initial treatment of human immunodeficiency virus (HIV) infection in combination with other antiretroviral agents in a patient with a CD4 count of less than 500 per cubic millimetre or symptomatic HIV disease	Compliance with Written or Telephone Authority Required procedures - Streamlined Authority Code 3588
C3589	Where the patient is receiving treatment at/from a public hospital Continuing treatment of human immunodeficiency virus (HIV) infection in combination with other antiretroviral agents where the patient has previously received PBS-subsidised therapy for HIV infection	Compliance with Written or Telephone Authority Required procedures - Streamlined Authority Code 3589

[151]      Schedule 4, entry for Sorbitol with Sodium Citrate and Sodium Lauryl Sulfoacetate

substitute:

Sorbitol With Sodium Citrate And Sodium Lauryl Sulfoacetate	C1025	P1025	Anorectal congenital abnormalities
C1122	P1122	For use by a patient who is receiving long-term nursing care and in respect of whom a Carer Allowance is payable as a disabled adult
C1221	P1221	Megacolon
C1254	P1254	Paraplegic and quadriplegic patients and others with severe neurogenic impairment of bowel function
C1263	P1263	Patients receiving palliative care
C1268	P1268	Patients who are receiving long-term nursing care on account of age, infirmity or other condition in hospitals, nursing homes or residential facilities
C1400	P1400	Terminal malignant neoplasia
C3642	P3642	Initial supply, for up to 4 months, for a palliative care patient where constipation is a problem	Compliance with Authority Required procedures - Streamlined Authority Code 3642
C3643	P3643	Continuing supply for a palliative care patient where constipation is a problem	Compliance with Authority Required procedures - Streamlined Authority Code 3643

[152]      Schedule 4, entry for Stavudine

substitute:

Stavudine	C3586	Where the patient is receiving treatment at/from a private hospital Initial treatment of human immunodeficiency virus (HIV) infection in combination with other antiretroviral agents in a patient with a CD4 count of less than 500 per cubic millimetre or symptomatic HIV disease	Compliance with Written or Telephone Authority Required procedures
C3587	Where the patient is receiving treatment at/from a private hospital Continuing treatment of human immunodeficiency virus (HIV) infection in combination with other antiretroviral agents where the patient has previously received PBS-subsidised therapy for HIV infection	Compliance with Written or Telephone Authority Required procedures
C3588	Where the patient is receiving treatment at/from a public hospital Initial treatment of human immunodeficiency virus (HIV) infection in combination with other antiretroviral agents in a patient with a CD4 count of less than 500 per cubic millimetre or symptomatic HIV disease	Compliance with Written or Telephone Authority Required procedures - Streamlined Authority Code 3588
C3589	Where the patient is receiving treatment at/from a public hospital Continuing treatment of human immunodeficiency virus (HIV) infection in combination with other antiretroviral agents where the patient has previously received PBS-subsidised therapy for HIV infection	Compliance with Written or Telephone Authority Required procedures - Streamlined Authority Code 3589

[153]      Schedule 4, entry for Sterculia with Frangula Bark

substitute:

Sterculia With Frangula Bark	C1025	P1025	Anorectal congenital abnormalities
C1122	P1122	For use by a patient who is receiving long-term nursing care and in respect of whom a Carer Allowance is payable as a disabled adult
C1221	P1221	Megacolon
C1254	P1254	Paraplegic and quadriplegic patients and others with severe neurogenic impairment of bowel function
C1263	P1263	Patients receiving palliative care
C1268	P1268	Patients who are receiving long-term nursing care on account of age, infirmity or other condition in hospitals, nursing homes or residential facilities
C1400	P1400	Terminal malignant neoplasia
C3642	P3642	Initial supply, for up to 4 months, for a palliative care patient where constipation is a problem	Compliance with Authority Required procedures - Streamlined Authority Code 3642
C3643	P3643	Continuing supply for a palliative care patient where constipation is a problem	Compliance with Authority Required procedures - Streamlined Authority Code 3643

[154]      Schedule 4, entry for Sulindac

substitute:

Sulindac	C1036	P1036	Bone pain due to malignant disease
C1054	P1054	Chronic arthropathies (including osteoarthritis) with an inflammatory component
C3645	P3645	Initial supply, for up to 4 months, for a palliative care patient where severe pain is a problem	Compliance with Authority Required procedures - Streamlined Authority Code 3645
C3646	P3646	Continuing supply for a palliative care patient where severe pain is a problem	Compliance with Authority Required procedures - Streamlined Authority Code 3646

[155]      Schedule 4, entry for Temazepam

substitute:

Temazepam	P1123	For use by a patient who is receiving long-term nursing care and in respect of whom a Carer Allowance is payable as a disabled adult and who has been demonstrated, within the past 6 months, to be benzodiazepine dependent by an unsuccessful attempt at gradual withdrawal (Authority Required)
P1126	For use by patients who are receiving long-term nursing care on account of age, infirmity or other condition in hospitals, nursing homes or residential facilities and who have been demonstrated, within the past 6 months, to be benzodiazepine dependent by an unsuccessful attempt at gradual withdrawal (Authority Required)
P1216	Malignant neoplasia (late stage) (Authority Required)
P3653	Initial supply, for up to 4 months, for a palliative care patient where insomnia is a problem (Authority Required)
P3654	Continuing supply for a palliative care patient where insomnia is a problem (Authority Required)

[156]      Schedule 4, entry for Tenofovir

substitute:

Tenofovir	C2931	Where the patient is receiving treatment at/from a private hospital Chronic hepatitis B Chronic hepatitis B in a patient who has failed antihepadnaviral therapy and who satisfies all of the following criteria: (1)(a) Repeatedly elevated serum ALT levels while on concurrent antihepadnaviral therapy of greater than or equal to 6 months duration in conjunction with documented chronic hepatitis B infection; or (b) Repeatedly elevated HBV DNA levels one log greater than the nadir value or failure to achieve a 1 log reduction in HBV DNA within 3 months, whilst on previous antihepadnaviral therapy except in patients with evidence of poor compliance; (2) Female patients of child-bearing age are not pregnant, not breast-feeding, and are using an effective form of contraception Persons with Child's class B or C cirrhosis (ascites, variceal bleeding, encephalopathy, albumin less than 30 g per L, bilirubin greater than 30 micromoles per L) should have their treatment discussed with a transplant unit prior to initiating therapy	Compliance with Written or Telephone Authority Required procedures
C3203	Where the patient is receiving treatment at/from a private hospital Chronic hepatitis B Treatment, as sole PBS-subsidised therapy, of chronic hepatitis B in a patient who is nucleoside analogue naive and satisfies all of the following criteria: (1) Histological evidence of chronic hepatitis on liver biopsy (except in patients with coagulation disorders considered severe enough to prevent liver biopsy); (2)(a) Abnormal serum ALT levels in conjunction with documented chronic hepatitis B infection; or (b) Elevated HBV DNA levels in conjunction with documented chronic hepatitis B infection; (3) Female patients of child-bearing age are not pregnant, not breast-feeding, and are using an effective form of contraception Persons with Child's class B or C cirrhosis (ascites, variceal bleeding, encephalopathy, albumin less than 30 g per L, bilirubin greater than 30 micromoles per L) should have their treatment discussed with a transplant unit prior to initiating therapy	Compliance with Written or Telephone Authority Required procedures
C3313	Where the patient is receiving treatment at/from a public hospital Chronic hepatitis B Chronic hepatitis B in a patient who has failed antihepadnaviral therapy and who satisfies all of the following criteria: (1)(a) Repeatedly elevated serum ALT levels while on concurrent antihepadnaviral therapy of greater than or equal to 6 months duration in conjunction with documented chronic hepatitis B infection; or (b) Repeatedly elevated HBV DNA levels one log greater than the nadir value or failure to achieve a 1 log reduction in HBV DNA within 3 months, whilst on previous antihepadnaviral therapy except in patients with evidence of poor compliance; (2) Female patients of child-bearing age are not pregnant, not breast-feeding, and are using an effective form of contraception Persons with Child's class B or C cirrhosis (ascites, variceal bleeding, encephalopathy, albumin less than 30 g per L, bilirubin greater than 30 micromoles per L) should have their treatment discussed with a transplant unit prior to initiating therapy	Compliance with Written or Telephone Authority Required procedures - Streamlined Authority Code 3313
C3417	Where the patient is receiving treatment at/from a public hospital Chronic hepatitis B Treatment, as sole PBS-subsidised therapy, of chronic hepatitis B in a patient who is nucleoside analogue naive and satisfies all of the following criteria: (1) Histological evidence of chronic hepatitis on liver biopsy (except in patients with coagulation disorders considered severe enough to prevent liver biopsy); (2)(a) Abnormal serum ALT levels in conjunction with documented chronic hepatitis B infection; or (b) Elevated HBV DNA levels in conjunction with documented chronic hepatitis B infection; (3) Female patients of child-bearing age are not pregnant, not breast-feeding, and are using an effective form of contraception Persons with Child's class B or C cirrhosis (ascites, variceal bleeding, encephalopathy, albumin less than 30 g per L, bilirubin greater than 30 micromoles per L) should have their treatment discussed with a transplant unit prior to initiating therapy	Compliance with Written or Telephone Authority Required procedures - Streamlined Authority Code 3417
C3586	Where the patient is receiving treatment at/from a private hospital Initial treatment of human immunodeficiency virus (HIV) infection in combination with other antiretroviral agents in a patient with a CD4 count of less than 500 per cubic millimetre or symptomatic HIV disease	Compliance with Written or Telephone Authority Required procedures
C3587	Where the patient is receiving treatment at/from a private hospital Continuing treatment of human immunodeficiency virus (HIV) infection in combination with other antiretroviral agents where the patient has previously received PBS-subsidised therapy for HIV infection	Compliance with Written or Telephone Authority Required procedures
C3588	Where the patient is receiving treatment at/from a public hospital Initial treatment of human immunodeficiency virus (HIV) infection in combination with other antiretroviral agents in a patient with a CD4 count of less than 500 per cubic millimetre or symptomatic HIV disease	Compliance with Written or Telephone Authority Required procedures - Streamlined Authority Code 3588
C3589	Where the patient is receiving treatment at/from a public hospital Continuing treatment of human immunodeficiency virus (HIV) infection in combination with other antiretroviral agents where the patient has previously received PBS-subsidised therapy for HIV infection	Compliance with Written or Telephone Authority Required procedures - Streamlined Authority Code 3589

[157]      Schedule 4, entry for Tenofovir with Emtricitabine

substitute:

Tenofovir with Emtricitabine	C3586	Where the patient is receiving treatment at/from a private hospital Initial treatment of human immunodeficiency virus (HIV) infection in combination with other antiretroviral agents in a patient with a CD4 count of less than 500 per cubic millimetre or symptomatic HIV disease	Compliance with Written or Telephone Authority Required procedures
C3587	Where the patient is receiving treatment at/from a private hospital Continuing treatment of human immunodeficiency virus (HIV) infection in combination with other antiretroviral agents where the patient has previously received PBS-subsidised therapy for HIV infection	Compliance with Written or Telephone Authority Required procedures
C3588	Where the patient is receiving treatment at/from a public hospital Initial treatment of human immunodeficiency virus (HIV) infection in combination with other antiretroviral agents in a patient with a CD4 count of less than 500 per cubic millimetre or symptomatic HIV disease	Compliance with Written or Telephone Authority Required procedures - Streamlined Authority Code 3588
C3589	Where the patient is receiving treatment at/from a public hospital Continuing treatment of human immunodeficiency virus (HIV) infection in combination with other antiretroviral agents where the patient has previously received PBS-subsidised therapy for HIV infection	Compliance with Written or Telephone Authority Required procedures - Streamlined Authority Code 3589

[158]      Schedule 4, entry for Tenofovir with emtricitabine and efavirenz

substitute:

Tenofovir with emtricitabine and efavirenz	C3586	Where the patient is receiving treatment at/from a private hospital Initial treatment of human immunodeficiency virus (HIV) infection in combination with other antiretroviral agents in a patient with a CD4 count of less than 500 per cubic millimetre or symptomatic HIV disease	Compliance with Written or Telephone Authority Required procedures
C3587	Where the patient is receiving treatment at/from a private hospital Continuing treatment of human immunodeficiency virus (HIV) infection in combination with other antiretroviral agents where the patient has previously received PBS-subsidised therapy for HIV infection	Compliance with Written or Telephone Authority Required procedures
C3588	Where the patient is receiving treatment at/from a public hospital Initial treatment of human immunodeficiency virus (HIV) infection in combination with other antiretroviral agents in a patient with a CD4 count of less than 500 per cubic millimetre or symptomatic HIV disease	Compliance with Written or Telephone Authority Required procedures - Streamlined Authority Code 3588
C3589	Where the patient is receiving treatment at/from a public hospital Continuing treatment of human immunodeficiency virus (HIV) infection in combination with other antiretroviral agents where the patient has previously received PBS-subsidised therapy for HIV infection	Compliance with Written or Telephone Authority Required procedures - Streamlined Authority Code 3589

[159]      Schedule 4, entry for Tipranavir

substitute:

Tipranavir	C3600	Where the patient is receiving treatment at/from a private hospital Treatment of human immunodeficiency virus (HIV) infection, in addition to optimised background therapy in combination with other antiretroviral agents, and co-administered with 200 mg ritonavir twice daily in an antiretroviral experienced patient who, after each of at least three different antiretroviral regimens that have included one drug from at least 3 different antiretroviral classes, has experienced virological failure or clinical failure or genotypic resistance Virological failure is defined as a viral load greater than 400 copies per mL on two consecutive occasions, while clinical failure is linked to emerging signs and symptoms of progressing HIV infection or treatment-limiting toxicity	Compliance with Written or Telephone Authority Required procedures
C3601	Where the patient is receiving treatment at/from a public hospital Treatment of human immunodeficiency virus (HIV) infection, in addition to optimised background therapy in combination with other antiretroviral agents, and co-administered with 200 mg ritonavir twice daily in an antiretroviral experienced patient who, after each of at least three different antiretroviral regimens that have included one drug from at least 3 different antiretroviral classes, has experienced virological failure or clinical failure or genotypic resistance Virological failure is defined as a viral load greater than 400 copies per mL on two consecutive occasions, while clinical failure is linked to emerging signs and symptoms of progressing HIV infection or treatment-limiting toxicity	Compliance with Written or Telephone Authority Authority Required procedures - Streamlined Authority Code 3601
C3602	Where the patient is receiving treatment at/from a private hospital Treatment of human immunodeficiency virus (HIV) infection, in addition to optimised background therapy in combination with other antiretroviral agents, and co-administered with ritonavir in an antiretroviral experienced patient who, after each of at least three different antiretroviral regimens that have included one drug from at least 3 different antiretroviral classes, has experienced virological failure or clinical failure or genotypic resistance. Virological failure is defined as a viral load greater than 400 copies per mL on two consecutive occasions, while clinical failure is linked to emerging signs and symptoms of progressing HIV infection or treatment-limiting toxicity	Compliance with Written or Telephone Authority Authority Required procedures
C3603	Where the patient is receiving treatment at/from a public hospital Treatment of human immunodeficiency virus (HIV) infection, in addition to optimised background therapy in combination with other antiretroviral agents, and co-administered with ritonavir in an antiretroviral experienced patient who, after each of at least three different antiretroviral regimens that have included one drug from at least 3 different antiretroviral classes, has experienced virological failure or clinical failure or genotypic resistance. Virological failure is defined as a viral load greater than 400 copies per mL on two consecutive occasions, while clinical failure is linked to emerging signs and symptoms of progressing HIV infection or treatment-limiting toxicity	Compliance with Written or Telephone Authority Authority Required procedures - Streamlined Authority Code 3603

[160]      Schedule 4, entry for Valaciclovir

substitute:

Valaciclovir	C1494	Where the patient is receiving treatment at/from a private hospital Prophylaxis of cytomegalovirus infection and disease following renal transplantation in patients at risk of cytomegalovirus disease	Compliance with Authority Required procedures
C3419	Where the patient is receiving treatment at/from a public hospital Prophylaxis of cytomegalovirus infection and disease following renal transplantation in patients at risk of cytomegalovirus disease	Compliance with Authority Required procedures - Streamlined Authority Code 3419
C3622	P3622	Treatment of patients with herpes zoster within 72 hours of the onset of the rash	Compliance with Authority Required procedures - Streamlined Authority Code 3622
C3631	P3631	Herpes zoster ophthalmicus	Compliance with Authority Required procedures - Streamlined Authority Code 3631
C3632	P3632	Moderate to severe initial genital herpes	Compliance with Authority Required procedures - Streamlined Authority Code 3632
C3633	P3633	Episodic treatment or suppressive therapy of moderate to severe recurrent genital herpes, where the diagnosis is confirmed microbiologically (by viral culture, antigen detection or nucleic acid amplification by polymerase chain reaction) but where commencement of treatment need not await confirmation of diagnosis	Compliance with Authority Required procedures - Streamlined Authority Code 3633

[161]      Schedule 4, entry for Zidovudine

substitute:

Zidovudine	C3586	Where the patient is receiving treatment at/from a private hospital Initial treatment of human immunodeficiency virus (HIV) infection in combination with other antiretroviral agents in a patient with a CD4 count of less than 500 per cubic millimetre or symptomatic HIV disease	Compliance with Written or Telephone Authority Required procedures
C3587	Where the patient is receiving treatment at/from a private hospital Continuing treatment of human immunodeficiency virus (HIV) infection in combination with other antiretroviral agents where the patient has previously received PBS-subsidised therapy for HIV infection	Compliance with Written or Telephone Authority Required procedures
C3588	Where the patient is receiving treatment at/from a public hospital Initial treatment of human immunodeficiency virus (HIV) infection in combination with other antiretroviral agents in a patient with a CD4 count of less than 500 per cubic millimetre or symptomatic HIV disease	Compliance with Written or Telephone Authority Required procedures - Streamlined Authority Code 3588
C3589	Where the patient is receiving treatment at/from a public hospital Continuing treatment of human immunodeficiency virus (HIV) infection in combination with other antiretroviral agents where the patient has previously received PBS-subsidised therapy for HIV infection	Compliance with Written or Telephone Authority Required procedures - Streamlined Authority Code 3589

¹Note

All legislative instruments and compilations are registered on the Federal Register of Legislative Instruments kept under the Legislative Instruments Act 2003.

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Citations

National Health (Listing of Pharmaceutical Benefits) Amendment Instrument 2010 (No. 1) (No. PB 120 of 2010) (Cth)

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