I, FELICITY McNEILL, Acting First Assistant Secretary, Pharmaceutical Benefits Division, 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 20 January 2011

 

 

 

 

 

 

 

 

 

 

 

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 2011 (No. 2).

            (2)        This Instrument may also be cited as PB 1 of 2011.

2          Commencement

                        This Instrument commences on 1 February 2011.

3          Amendment of PB 108 of 2010

                        Schedule 1 amends PB 108 of 2010.

Schedule 1     Amendments

 

[1] Schedule 1, entry for Alprazolam in each of the forms: Tablet 1 mg (Alprazolam-GA); and Tablet 2 mg (Alprazolam-GA)

omit from the column headed “Responsible Person”: GM         and insert:            GN

[2] Schedule 1, entry for Alprazolam in each of the forms: Tablet 1 mg; and Tablet 2 mg

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

Ralozam

GM

MP NP

C1975

50

2

[3] Schedule 1, after entry for Amino acid synthetic formula supplemented with long chain polyunsaturated fatty acids

insert in the columns in the order indicated:

Amino acid synthetic formula supplemented with long chain polyunsaturated fatty acids and medium chain triglycerides

Oral powder 400 g (Neocate LCP + MCT)

Oral

Neocate LCP + MCT

SB

MP NP

C1687 C1688 C2805 C2806 C2807 C2808 C2809 C2810

8

5

[4] Schedule 1, entry for Apomorphine in the form Injection containing apomorphine hydrochloride 50 mg in 5 mL

omit from the column headed “Brand”:         APO-go                and insert:            Apomine

[5] Schedule 1, entry for Aspirin in the form Tablet 100 mg (DBL Aspirin 100 mg)

omit from the column headed “Responsible Person”: YT          and insert:            GY

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

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

Mayne Pharma Aspirin

YT

MP NP

112

1

[7] Schedule 1, after entry for Aurothiomalate

insert in the columns in the order indicated:

Azacitidine

Powder for injection 100 mg

Injection

Vidaza

CJ

MP See Note 1

See Note 3

See Note 3

See Note 3

See Note 3

D

[8] Schedule 1, entry for Azithromycin in the form Tablet 500 mg (as dihydrate)

(a)           insert in the columns in the order indicated, and in alphabetical order after the first instance of the brand “Zithromax”:

Zitrocin

GM

MP NP

C1405 C1838 C1839

P1838 P1839

2

0

(b)           insert in the columns in the order indicated, and in alphabetical order after the second instance of the brand “Zithromax”:

Zitrocin

GM

MP NP

C1405 C1838 C1839

P1405

2

2

[9] Schedule 1, entry for Bethanechol

omit from the column headed “Responsible Person”: HA          and insert:            YN

[10]         Schedule 1, entry for Cabergoline

omit:

	Tablet 500 micrograms	Oral	Dostinex	PF	NP	C1289		2	0
					MP	C1289 C2659 C2660 C2661 C2662	P1289	2	0
					MP	C1289 C2659 C2660 C2661 C2662	P2659 P2660 P2661 P2662	8	5
			Tinexa	SI	MP	C2659 C2660 C2661 C2662	P2659 P2660 P2661 P2662	8	5

substitute:

	Tablet 500 micrograms	Oral	Dostan	GM	NP	C1289		2	0
					MP	C1289 C2659 C2660 C2661 C2662	P1289	2	0
			Dostinex	PF	NP	C1289		2	0
					MP	C1289 C2659 C2660 C2661 C2662	P1289	2	0
			Dostan	GM	MP	C1289 C2659 C2660 C2661 C2662	P2659 P2660 P2661 P2662	8	5
			Dostinex	PF	MP	C1289 C2659 C2660 C2661 C2662	P2659 P2660 P2661 P2662	8	5
			Tinexa	SI	MP	C2659 C2660 C2661 C2662	P2659 P2660 P2661 P2662	8	5

[11]         Schedule 1, entry for Cabergoline in each of the forms: Tablet 1 mg; and Tablet 2 mg

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

Cobasol

GM

MP NP

C1255

30

5

[12]         Schedule 1, entry for Cefepime in each of the forms: Powder for injection 1 g (as hydrochloride) (with any determined brand of sodium chloride injection as the required solvent); and Powder for injection 2 g (as hydrochloride) (with any determined brand of sodium chloride injection as the required solvent)

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

DBL Cefepime

HH

MP NP

C1427

10

0

[13]         Schedule 1, entry for Doxorubicin ─ Pegylated Liposomal

omit from the column headed “Responsible Person”: SH          and insert:            JC        (twice occurring)

[14]         Schedule 1, after entry for Duloxetine

insert in the columns in the order indicated:

Dutasteride

Capsule 500 micrograms

Oral

Avodart

GK

MP

C3667

30

5

[15]         Schedule 1, entry for Enalapril in each of the forms: Tablet containing enalapril maleate 5 mg; Tablet containing enalapril maleate
10 mg; and Tablet containing enalapril maleate 20 mg

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

Acetec

AL

MP NP

30

5

(b)        omit:

Enahexal

HX

MP NP

30

5

[16]         Schedule 1, entry for Famotidine

omit:

Famohexal

HX

MP NP

60

5

[17]         Schedule 1, entry for Fluconazole in the form Solution for I.V. infusion 100 mg in 50 mL (Fluconazole Hexal)

omit from the column headed “Responsible Person”: SZ          and insert:            HX

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

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

Fluconazole Sandoz

SZ

MP NP

C3613 C3614 C3615 C3616 C3617 C3618

7

0

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

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

Fluvoxamine GA

GM

MP NP

C1211 C1241

30

5

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

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

Gemplan

WQ

MP See Note 1

C1193 C1194 C1740 C2069 C2141

4

2

 

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

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

Gemplan

WQ

MP See Note 1

C1193 C1194 C1740 C2069 C2141

2

2

[22]         Schedule 1, entry for Hydrocortisone

omit:

Eye ointment containing hydrocortisone acetate 5 mg per g, 5 g

Application to the eye

Hycor

SI

AO MP NP

1

0

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

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

Lercadip

GM

MP NP

28

5

[24]         Schedule 1, entry for Lisinopril in the form Tablet 10 mg

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

Lisinopril Sandoz

SZ

MP NP

30

5

[25]         Schedule 1, entry for Metformin in the form Tablet containing metformin hydrochloride 1 g

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

APO-Metformin 1000

TX

MP NP

90

5

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

Chem mart Metformin 1000

CH

MP NP

90

5

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

Terry White Chemists Metformin 1000

TW

MP NP

90

5

[26]         Schedule 1, entry for Nicotine

substitute:

Nicotine	Transdermal patch 24.9 mg	Transdermal	Nicorette Patch	JT	MP NP	C3042 C3447 C3448		28	2
	Transdermal patch 52.5 mg	Transdermal	Nicotinell Step 1	NC	MP NP	C3447 C3448		28	2
	Transdermal patch 114 mg	Transdermal	Nicabate P	GC	MP NP	C3447 C3448		28	2

[27]         Schedule 1, entry for Ondansetron in the form Tablet 4 mg (as hydrochloride dihydrate)

(a)           insert in the columns in the order indicated, and in alphabetical order after the first instance of the brand “APO-Ondansetron”:

Ondansetron-DRLA

RZ

MP NP See Note 1

C3050 C3611 See Note 2

P3050 See Note 2

4 See Note 2

0 See Note 2

(b)           insert in the columns in the order indicated, and in alphabetical order after the second instance of the brand “APO-Ondansetron”:

Ondansetron-DRLA

RZ

MP NP

C3050 C3611

P3611

10

1

[28]         Schedule 1, entry for Ondansetron in the form Tablet 8 mg (as hydrochloride dihydrate)

(a)           insert in the columns in the order indicated, and in alphabetical order after the first instance of the brand “APO-Ondansetron”:

Ondansetron-DRLA

RZ

MP NP See Note 1

C3050 C3611 See Note 2

P3050 See Note 2

4 See Note 2

0 See Note 2

(b)           insert in the columns in the order indicated, and in alphabetical order after the second instance of the brand “APO-Ondansetron”:

Ondansetron-DRLA

RZ

MP NP

C3050 C3611

P3611

10

1

[29]         Schedule 1, entry for Perindopril with amlodipine in the form Tablet containing 5 mg perindopril arginine with 5 mg amlodipine (as besylate)

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

Reaptan 5/5

RX

MP NP

C3307 C3308

30

5

 

[30]         Schedule 1, entry for Perindopril with amlodipine in the form Tablet containing 5 mg perindopril arginine with 10 mg amlodipine (as besylate)

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

Reaptan 5/10

RX

MP NP

C3307 C3308

30

5

[31]         Schedule 1, entry for Perindopril with amlodipine in the form Tablet containing 10 mg perindopril arginine with 5 mg amlodipine (as besylate)

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

Reaptan 10/5

RX

MP NP

C3307 C3308

30

5

[32]         Schedule 1, entry for Perindopril with amlodipine in the form Tablet containing 10 mg perindopril arginine with 10 mg amlodipine (as besylate)

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

Reaptan 10/10

RX

MP NP

C3307 C3308

30

5

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

(a)           insert in the columns in the order indicated, and in alphabetical after the first instance of the brand “Risperidone-GA”:

Risperidone Sandoz

SZ

MP NP

C1589 C2061 C3083

P2061 P3083

60

2

(b)           insert in the columns in the order indicated, and in alphabetical after the second instance of the brand “Risperidone-GA”:

Risperidone Sandoz

SZ

MP NP

C1589 C2061 C3083

P1589

60

5

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

(a)           insert in the columns in the order indicated, and in alphabetical after the first instance of the brand “Risperidone generichealth”:

Risperidone Sandoz

SZ

MP NP

C1589 C2061 C2272 C3083

P2061 P3083

60

2

(b)           insert in the columns in the order indicated, and in alphabetical after the second instance of the brand “Risperidone generichealth”:

Risperidone Sandoz

SZ

MP NP

C1589 C2061 C2272 C3083

P1589 P2272

60

5

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

(a)           insert in the columns in the order indicated, and in alphabetical after the first instance of the brand “Risperidone generichealth”:

Risperidone Sandoz

SZ

MP NP

C1589 C2272 C3083

P3083

60

2

(b)           insert in the columns in the order indicated, and in alphabetical after the second instance of the brand “Risperidone generichealth”:

Risperidone Sandoz

SZ

MP NP

C1589 C2272 C3083

P1589 P2272

60

5

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

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

Risperidone Sandoz

SZ

MP NP

C1589 C2272

60

5

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

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

Risperidone Sandoz

SZ

MP NP

C1589 C2272

60

5

[38]         Schedule 1, entry for Sertraline in the form Tablet 50 mg (as hydrochloride)

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

Sertracor 50

MI

MP NP

C1211

30

5

[39]         Schedule 1, entry for Sertraline in the form Tablet 100 mg (as hydrochloride)

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

Sertracor 100

MI

MP NP

C1211

30

5

[40]         Schedule 1, entry for Stavudine

omit:

Powder for oral solution 1 mg per mL, 200 mL

Oral

Zerit

BQ

MP See Note 1

C3586 C3587 C3588 C3589

24

5

D

 

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

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

Sumatriptan-GA

GM

MP NP

C3233

4

5

[42]         Schedule 1, entry for Tramadol in the form Tablet (sustained release) containing tramadol hydrochloride 200 mg

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

[43]         Schedule 1, entry for Trastuzumab

insert as first entry in the columns in the order indicated:

Powder for I.V. infusion 60 mg

Injection

Herceptin

RO

MP See Note 1

See Note 3

See Note 3

See Note 3

See Note 3

D

[44]         Schedule 1, entry for Valaciclovir in the form Tablet 500 mg (as hydrochloride)

(a)        insert in the columns in the order indicated, and in alphabetical order after the first instance of the brand “Valtrex”:

Zelitrex

RE

MP NP

C3622 C3631 C3632 C3633

P3632

20

0

(b)           insert in the columns in the order indicated, and in alphabetical order after the second instance of the brand “Valtrex”:

Zelitrex

RE

MP NP

C3622 C3631 C3632 C3633

P3633

30

5

(c)        insert in the columns in the order indicated, and in alphabetical order after the third instance of the brand “Valtrex”:

Zelitrex

RE

MP NP

C3622 C3631 C3632 C3633

P3622 P3631

42

0

 

[45]         Schedule 1, entry for Vancomycin in the form Powder for injection 500 mg (500,000 I.U.) (as hydrochloride)

(a)           insert in the columns in the order indicated, and in alphabetical order after the first instance of the brand “Vancocin CP”:

			Vancomycin Alphapharm	AF	MP	C1091 C1302 C1464	P1302	2	0
					PDP	C1302		2	0

(b)           insert in the columns in the order indicated, and in alphabetical order after the second instance of the brand “Vancocin CP”:

Vancomycin Alphapharm

AF

MP

C1091 C1302 C1464

P1091 P1464

5

0

[46]         Schedule 1, entry for Vancomycin in the form Powder for injection 1 g (1,000,000 I.U.) (as hydrochloride)

(a)        insert in the columns in the order indicated, and in alphabetical order after the first instance of the brand “Hospira Pty Limited”:

			Vancomycin Alphapharm	AF	MP	C1091 C1302 C1464	P1302	1	0
					PDP	C1302		1	0

(b)        insert in the columns in the order indicated, and in alphabetical order after the second instance of the brand “Hospira Pty Limited”:

Vancomycin Alphapharm

AF

MP

C1091 C1302 C1464

P1091 P1464

3

0

[47]         Schedule 1, entry for Varenicline

omit:

Tablet 1 mg (as tartrate)

Oral

Champix

PF

MP NP

C2776

112

0

substitute:

	Tablet 1 mg (as tartrate)	Oral	Champix	PF	MP NP	C3670 C3671	P3671	56	2
					MP NP	C3670 C3671	P3670	112	0

[48]         Schedule 3, after details relevant to Responsible person code GX

insert:

GY

Mayne Pharma International Pty Ltd

88 007 870 984

 

[49]         Schedule 3, details relevant to Responsible person code PL

omit:

Virgo Unit Trust

insert:

The Trustee for Virgo Unit Trust (trading as Phebra)

[50]         Schedule 3, after details relevant to Responsible person code RD

insert:

RE

GlaxoSmithKline Australia Pty Ltd

47 100 162 481

[51]         Schedule 3, after details relevant to Responsible person code RO

insert:

RX

Servier Laboratories (Aust.) Pty Ltd

54 004 838 500

[52]         Schedule 4, Part 1, after entry for Amino acid synthetic formula supplemented with long chain polyunsaturated fatty acids

insert in the columns in the order indicated:

 

Amino acid synthetic formula supplemented with long chain polyunsaturated fatty acids and medium chain triglycerides	C1687		Severe intestinal malabsorption including short bowel syndrome where protein hydrolysate formulae have failed	Compliance with Authority Required procedures
	C1688		Severe intestinal malabsorption including short bowel syndrome where the patient has been receiving parenteral nutrition	Compliance with Authority Required procedures
	C2805		Initial treatment, for up to 3 months, for combined intolerance (not infant colic) to cows' milk protein, soy protein and protein hydrolysate formulae in a child up to the age of 2 years, where combined intolerance is demonstrated when the child has failed to respond to a strict cows' milk protein free and strict soy protein free diet with a protein hydrolysate (with or without medium chain triglycerides) as the principal formula, and where the date of birth of the patient is included in the authority application	Compliance with Authority Required procedures
	C2806		Initial treatment, in consultation with a paediatric gastroenterologist or specialist allergist, for up to 3 months, of a child up to the age of 2 years with severe intolerance (not infant colic) to cows' milk protein, and where the date of birth of the patient is included in the authority application	Compliance with Authority Required procedures
	C2807		Continuing treatment for combined intolerance (not infant colic) to cows' milk protein, soy protein and protein hydrolysate formulae in a child up to the age of 2 years, where the child has been assessed by a suitably qualified allergist or paediatrician, and where the date of birth of the patient is included in the authority application	Compliance with Authority Required procedures
	C2808		Treatment for combined intolerance (not infant colic) to cows' milk protein, soy protein and protein hydrolysate formulae in a child aged 2 years and over, where the child is assessed by a suitably qualified allergist or paediatrician at intervals not greater than 6 months, and where the date of birth of the patient is included in the authority application	Compliance with Authority Required procedures
	C2809		Continuing treatment for severe intolerance (not infant colic) to cows' milk protein in a child up to the age of 2 years, where the child has been assessed by a paediatric gastroenterologist or specialist allergist and soy protein and protein hydrolysate formulae are not tolerated or not likely to be tolerated, and where the date of birth of the patient is included in the authority application	Compliance with Authority Required procedures
	C2810		Treatment for severe intolerance (not infant colic) to cows' milk protein in a child aged 2 years and over, where the child is assessed by a paediatric gastroenterologist or specialist allergist at intervals not greater than 6 months, and where the date of birth of the patient is included in the authority application	Compliance with Authority Required procedures

[53]         Schedule 4, Part 1, after entry for Duloxetine

insert in the columns in the order indicated:

 

Dutasteride

C3667

Treatment, in combination with an alpha-antagonist, of lower urinary tract symptoms due to benign prostatic hyperplasia where treatment is initiated by a urologist

Compliance with Authority Required procedures - Streamlined Authority Code 3667

 

[54]         Schedule 4, Part 1, entry for Nicotine

substitute:

 

Nicotine	C3042		Nicotine dependence in an Aboriginal or a Torres Strait Islander person as the sole PBS-subsidised therapy	Compliance with Authority Required procedures
	C3447		Short-term sole PBS-subsidised therapy as an aid to achieving abstinence in a patient who has indicated they are ready to cease smoking and who has entered a comprehensive support and counselling program, and where details of the program are specified in the initial authority application	Compliance with Authority Required procedures
	C3448		Short-term sole PBS-subsidised therapy as an aid to achieving abstinence in a patient who has indicated they are ready to cease smoking and who is entering a comprehensive support and counselling program during the same consultation at which the authority application is made, and where details of the program are specified in the initial authority application	Compliance with Authority Required procedures

[55]         Schedule 4, Part 1, entry for Varenicline

substitute:

 

Varenicline	C2774		Commencement of short-term, sole PBS-subsidised therapy as an aid to achieving abstinence in a patient who has indicated they are ready to cease smoking and who has entered a comprehensive support and counselling program, and where details of the program are specified in the authority application	Compliance with Authority Required procedures
	C2775		Commencement of short-term, sole PBS-subsidised therapy as an aid to achieving abstinence in a patient who has indicated they are ready to cease smoking and who is entering a comprehensive support and counselling program during the same consultation at which the authority application is made, and where details of the program are specified in the authority application	Compliance with Authority Required procedures
	C3670	P3670	Continuation of short-term sole PBS-subsidised therapy as an aid to achieving abstinence in a patient who has previously been issued with an authority prescription for this drug and who is enrolled in a comprehensive support and counselling program	Compliance with Authority Required procedures
	C3671	P3671	Completion of short-term sole PBS-subsidised therapy as an aid to achieving long-term abstinence after completion of an initial 12-week PBS-subsidised course in a patient who has ceased smoking, and who is enrolled in a comprehensive support and counselling program	Compliance with Authority Required procedures

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

¹Note

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

See http://www.frli.gov.au