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PB 42 of 2011 Lists as made
This instrument amends the National Health (Listing of Pharmaceutical Benefits) Instrument 2010 (No. PB 108 of 2010) to provide for additions, deletions and changes to forms, brands, responsible persons, circumstances for prescribing, and to the maximum quantities and number of repeats that may be prescribed.
Administered by: Health
Registered 15 Jun 2011
Tabling HistoryDate
Tabled HR21-Jun-2011
Tabled Senate21-Jun-2011
Date of repeal 19 Mar 2014
Repealed by Health (Spent and Redundant Instruments) Repeal Regulation 2014

 

PB 42 of 2011

National Health (Listing of Pharmaceutical Benefits) Amendment Instrument 2011
(No.7)1

National Health Act 1953

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        10 June                                          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. 7).

            (2)        This Instrument may also be cited as PB 42 of 2011.

2          Commencement

            This Instrument commences on 1 July 2011.

3          Amendment of the National Health (Listing of Pharmaceutical Benefits) Instrument 2010 (PB 108 of 2010)

            Schedule 1 amends the National Health (Listing of Pharmaceutical Benefits) Instrument 2010 (PB 108 of 2010).



Schedule 1     Amendments

 

[1] Schedule 1, entry for Adalimumab in the form Injection 40 mg in 0.8 mL pre-filled pen with Max Quantity 2 and Number of Repeats 4

omit from the column headed “Purposes”:

P3568  P3569

substitute:

P3706  P3707

[2] Schedule 1, entry for Amiodarone in the form Tablet containing amiodarone hydrochloride 100 mg

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

 

 

 

Amiodarone Sandoz

SZ

MP NP

C1350

 

30

5

 

(b)           omit from the column headed “Responsible Person” for the brand “Cardinorm”:              SZ          substitute:             HX               

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

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

 

 

 

Amiodarone Sandoz

SZ

MP NP

C1350

 

30

5

 

(b)           omit from the column headed “Responsible Person” for the brand “Cardinorm”:                              SZ          substitute:                HX         

[4] Schedule 1, entry for Aprepitant

omit from the column headed “Number of Repeats”:                  0              substitute:             5             

[5] Schedule 1,  entry for "BCG-Tice" (BacillusCalmette-Guérin/Tice strain)

omit from the column headed “Responsible Person”:                 SH        substitute:          MK

[6] Schedule 1, entry for Betamethasone

(a)           omit from the column headed “Responsible Person” (wherever occurring):         SH          substitute:             MK

(b)           omit from the column headed “Responsible Person” (wherever occurring):         EX          substitute:             FR


[7] Schedule 1, entry for Bleomycin

omit:

 

 

 

Blenamax

QA

MP
See Note 1

C1139 C1198

 

10

0

 

[8] Schedule 1, entry for Carboplatin

omit from the column headed “Responsible Person” (wherever occurring):         IT         substitute:          SZ

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

omit:

 

 

 

Kredex

MD

MP NP

C1735 C3234

 

60

5

 

[10]         Schedule 1, entry for Chorionic Gonadotrophin

omit from the column headed “Responsible Person” (wherever occurring):         SH        substitute:          MK

[11]         Schedule 1, entry for Cisplatin

omit from the column headed “Responsible Person”:                 IT         substitute:          SZ

[12]         Schedule 1, entry for Docetaxel

omit from the column headed “Responsible Person” (wherever occurring):         IT         substitute:          HX


[13]         Schedule 1, entry for Docetaxel in the form Solution concentrate for I.V. infusion 20 mg in 1 mL

substitute:

 

Solution concentrate for I.V. infusion 20 mg in 1 mL

Injection

Oncotaxel 20

TA

MP

See Note 1

C1194 C1742 C2416 C2439 C2732 C3051 C3292 C3428

P3051

1

0

 

 

 

 

Taxotere

SW

MP

See Note 1

C1194 C1742 C2416 C2439 C2732 C3051 C3292 C3428

P3051

1

0

 

 

 

 

Oncotaxel 20

TA

MP

See Note 1

C1194 C1742 C2416 C2439 C2732 C3051 C3292 C3428

P1194 P1742 P2416 P2439 P2732 P3292 P3428

2

0

 

 

 

 

Taxotere

SW

MP

See Note 1

C1194 C1742 C2416 C2439 C2732 C3051 C3292 C3428

P1194 P1742 P2416 P2439 P2732 P3292 P3428

2

0

 

[14]         Schedule 1, entry for Docetaxel in the form Solution concentrate for I.V. infusion 80 mg in 4 mL

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

 

 

 

Oncotaxel 80

TA

MP

See Note 1

C1194 C1742 C2416 C2439 C2732 C3051 C3292 C3428

 

1

0

 

[15]         Schedule 1, after entry for Docetaxel in the form Solution concentrate for I.V. infusion 80 mg in 4 mL

insert in the columns in the order indicated:

 

Solution concentrate for I.V. infusion 140 mg in 7 mL

Injection

Oncotaxel 140

TA

MP

See Note 1

 

C1194 C1742 C2416 C2439 C2732 C3051 C3292 C3428

 

1

0

 

 


[16]         Schedule 1, entry for Dothiepin in the form Tablet containing dothiepin hydrochloride 75 mg

omit:

 

 

 

Prothiaden

AB

MP NP

 

 

30

2

 

 

[17]         Schedule 1, entry for Doxorubicin

omit from the column headed “Responsible Person” (wherever occurring):         IT         substitute:          SZ

[18]         Schedule 1, entry for Dutasteride

omit from the column headed “Authorised Prescriber”:            MP         substitute:             MP NP

[19]         Schedule 1, entry for Epirubicin

omit from the column headed “Responsible Person” (wherever occurring):         IT            substitute:             SZ

[20]         Schedule 1, entry for Eprosartan

omit from the column headed “Responsible Person” (wherever occurring):         SM       substitute:          AB

[21]         Schedule 1, entry for Eprosartan with Hydrochlorothiazide

omit from the column headed “Responsible Person”:                 SM       substitute:          AB

[22]         Schedule1, entry for Eptifibatide

omit from the column headed “Responsible Person” (wherever occurring):                         SH        substitute:          MK

[23]         Schedule 1, entry for Escitalopram in each of the forms: Tablet 10 mg (as oxalate) and Tablet 20 mg (as oxalate)

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

 

 

 

Escitalopram generichealth

GQ

MP NP

C1211

 

28

5

 

[24]         Schedule 1, entry for Etonogestrel

omit

 

 

 

Implanon

SH

MP NP

 

 

1

0

 

 

[25]         Schedule 1, entry for Etoposide

omit from the column headed “Responsible Person”:                 IT         substitute:          SZ

[26]         Schedule 1, entry for Ezetimibe

omit from the column headed “Circumstances”:

C2649 C2650 C2651 C2652 C2653 C2667 C2668 C2669

and insert in numerical order:

C3724 C3725 C3726 C3727 C3728 C3729 C3730 C3731

[27]         Schedule 1, entry for Ezetimibe with Simvastatin in the form Tablet 10 mg-10 mg

omit from the column headed “Circumstancess”:      C3194               substitute:            C3739

[28]         Schedule 1, entry for Ezetimibe with Simvastatin in the form Tablet 10 mg-20 mg

omit from the column headed “Circumstances”:       C3194               substitute:            C3739

[29]         Schedule 1, entry for Ezetimibe with Simvastatin in the form Tablet 10 mg-40 mg

omit from the column headed “Circumstances”:

C2654 C2655 C2656 C2657 C2658 C2678 C2679

and insert in numerical order:

C3732 C3733 C3734 C3735 C3736 C3737 C3738

[30]         Schedule 1, entry for Ezetimibe with Simvastatin in the form Tablet 10 mg-80 mg

omit from the column headed “Circumstances”:

C2654 C2655 C2656 C2657 C2658 C2678 C2679

and insert in numerical order:

C3732 C3733 C3734 C3735 C3736 C3737 C3738

[31]         Schedule 1, entry for Fenofibrate

omit from the column headed “Responsible Person” (wherever occurring):         SM       substitute:          AB

[32]         Schedule 1, entry for Flucloxacillin in each of the forms: Powder for oral liquid 125 mg (as sodium) per 5 mL, 100 mL and Powder for oral liquid 250 mg (as sodium) per 5 mL, 100 mL

omit from the column headed “Brand”:       Aspen Pharmacare Australia Pty Limited                     substitute:                Flucil


[33]         Schedule 1, entry for Fludarabine

omit from the column headed “Responsible Person”:                 IT         substitute:          SZ

[34]         Schedule 1, entry for Fluorouracil

omit from the column headed “Responsible Person” (wherever occurring):         IT         substitute:          SZ

[35]         Schedule 1, after entry for Fluorouracil in the form injection 1000 mg in 20 mL

insert in the columns in the order indicated:

 

Injection 2500 mg in 50 mL

Injection

Fluorouracil Ebewe

SZ

MP

See Note 1

 

 

2

0

 

 

Injection 5000 mg in 100 mL

Injection

Fluorouracil Ebewe

SZ

MP

See Note 1

 

 

1

0

 

[36]         Schedule 1, entry for Flutamide

omit from the column headed “Responsible Person”:                 SH        substitute:          MK

[37]         Schedule 1, entry for Fluvoxamine

omit from the column headed “Responsible Person” (wherever occurring):         SM       substitute:          AB

[38]         Schedule 1, entry for Folinic acid

omit from the column headed “Responsible Person” (wherever occurring):         IT         substitute:          SZ

[39]         Schedule 1, entry for Follitropin Beta

omit from the column headed “Responsible Person” (wherever occurring):         SH        substitute:          MK

[40]         Schedule 1, entry for Ganirelix

omit from the column headed “Responsible Person” (wherever occurring):         SH        substitute:          MK

[41]         Schedule 1, entry for Gemcitabine

omit from the column headed “Responsible Person” (wherever occurring):         IT         substitute:          SZ

[42]         Schedule 1, entry for Glyceryl Trinitrate

omit from the column headed “Responsible Person” (wherever occurring):         SH        substitute:          MK


[43]         Schedule 1, entry for Hydromorphone in the form Tablet (modified release) containing hydromorphone hydrochloride 4 mg

omit from the column headed “Authorised Prescriber”:            MP NP PDP                  substitute:          MP NP

[44]         Schedule 1, entry for Hydromorphone in the form Tablet (modified release) containing hydromorphone hydrochloride 8 mg

omit from the column headed “Authorised Prescriber”:            MP NP PDP                  substitute:          MP NP

[45]         Schedule 1, entry for Hydromorphone in the form Tablet (modified release) containing hydromorphone hydrochloride 16 mg

omit from the column headed “Authorised Prescriber”:            MP NP PDP                  substitute:          MP NP

[46]         Schedule 1, entry for Hydromorphone in the form Tablet (modified release) containing hydromorphone hydrochloride 32 mg

omit from the column headed “Authorised Prescriber”:            MP NP PDP                  substitute:          MP NP

[47]         Schedule 1, entry for Hydromorphone in the form Tablet (modified release) containing hydromorphone hydrochloride 64 mg

omit from the column headed “Authorised Prescriber”:            MP NP PDP                  substitute:          MP NP

[48]         Schedule 1, entry for Hydromorphone in the form Injection containing hydromorphone hydrochloride 2 mg in 1 mL

omit from the column headed “Authorised Prescriber”:            MP NP PDP                  substitute:          MP NP

[49]         Schedule 1, entry for Hydromorphone in the form Injection containing hydromorphone hydrochloride 10 mg in 1 mL

omit from the column headed “Authorised Prescriber”:            MP NP PDP                  substitute:          MP NP

[50]         Schedule 1, entry for Hydromorphone in the form Injection containing hydromorphone hydrochloride 50 mg in 5 mL

omit from the column headed “Authorised Prescriber”:            MP NP PDP                  substitute:          MP NP

[51]         Schedule 1, entry for Idarubicin

omit from the column headed “Responsible Person” (wherever occurring):         IT            substitute:             SZ

[52]         Schedule 1, entry for Interferon Alfa-2b

omit from the column headed “Responsible Person” (wherever occurring):         SH        substitute:          MK

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

(a)           omit from the column headed “Responsible Person” (wherever occurring):         IT            substitute:             SZ

(b)        omit

 

 

 

Irinotecan Sandoz

SZ

MP

See Note 1

C3184

 

1

3

 

 


[54]         Schedule 1, entry for Irinotecan in the form I.V. injection containing irinotecan hydrochloride trihydrate 100 mg in 5 mL

(a)           omit from the column headed “Responsible Person” (wherever occurring):         IT            substitute:             SZ

(b)        omit

 

 

 

Irinotecan Sandoz

SZ

MP

See Note 1

C3184

 

2

3

 

[55]         Schedule 1, after entry for Lacosamide in the form Tablet 200 mg

insert in the columns in the order indicated:

 

Oral solution 15 mg per mL, 200 mL

Oral

Vimpat

UC

MP NP

C3303 C3304

 

2

5

 

[56]         Schedule 1, entry for Lactulose

omit from the column headed “Responsible Person” (wherever occurring):         SM       substitute:          AB

[57]         Schedule 1, entry for Lercanidipine

omit from the column headed “Responsible Person” (wherever occurring):         SM       substitute:          AB

[58]         Schedule 1, entry for Lercanidipine with enalapril

omit from the column headed “Responsible Person” (wherever occurring):         SM       substitute:          AB

[59]         Schedule 1, entry for Methotrexate

omit from the column headed “Responsible Person” (wherever occurring):         IT            substitute:             SZ

[60]         Schedule 1, entry for Metronidazole in the form Tablet 400 mg

omit

 

 

 

Metrogyl 400

AF

PDP

 

 

5

0

 

 

 

 

 

 

MP NP

 

 

5

2

 

[61]         Schedule 1, entry for Mianserin

omit from the column headed “Responsible Person” (wherever occurring):       SH        substitute:          MK

[62]         Schedule 1, entry for Mirtazapine

omit from the column headed “Responsible Person” (wherever occurring):         SH          substitute:             MK

[63]         Schedule 1, entry for Mitozantrone

omit from the column headed “Responsible Person”:                 IT            substitute:             SZ

[64]         Schedule 1, entry for Mometasone

(a)           omit from the column headed “Responsible Person” (wherever occurring):         SH          substitute:             MK

(b)           omit from the column headed “Responsible Person” (wherever occurring):         EX          substitute:             FR

[65]         Schedule 1, entry for Morphine in the form Tablet containing morphine sulfate 5 mg (controlled release)

omit from the column headed “Authorised Prescriber”:            MP NP PDP                  substitute:          MP NP

[66]         Schedule 1, entry for Morphine in the form Tablet containing morphine sulfate 10 mg (controlled release)

omit from the column headed “Authorised Prescriber” (twice occurring):            MP NP PDP                  substitute:          MP NP

[67]         Schedule 1, entry for Morphine in the form Tablet containing morphine sulfate 15 mg (controlled release)

omit from the column headed “Authorised Prescriber”:            MP NP PDP                  substitute:          MP NP

[68]         Schedule 1, entry for Morphine in the form Tablet containing morphine sulfate 30 mg (controlled release)

omit from the column headed “Authorised Prescriber” (twice occurring):            MP NP PDP                  substitute:          MP NP

[69]         Schedule 1, entry for Morphine in the form Tablet containing morphine sulfate 60 mg (controlled release)

omit from the column headed “Authorised Prescriber” (twice occurring):            MP NP PDP                  substitute:          MP NP

[70]         Schedule 1, entry for Morphine in the form Tablet containing morphine sulfate 100 mg (controlled release)

omit from the column headed “Authorised Prescriber” (twice occurring):            MP NP PDP                  substitute:          MP NP

[71]         Schedule 1, entry for Morphine in the form Capsule containing morphine sulfate 10 mg (containing sustained release pellets)

omit from the column headed “Authorised Prescriber”:            MP NP PDP                  substitute:          MP NP

[72]         Schedule 1, entry for Morphine in the form Capsule containing morphine sulfate 20 mg (containing sustained release pellets)

omit from the column headed “Authorised Prescriber”:            MP NP PDP                  substitute:          MP NP

[73]         Schedule 1, entry for Morphine in the form Capsule containing morphine sulfate 30 mg (controlled release)

omit from the column headed “Authorised Prescriber”:            MP NP PDP                  substitute:          MP NP

[74]         Schedule 1, entry for Morphine in the form Capsule containing morphine sulfate 50 mg (containing sustained release pellets)

omit from the column headed “Authorised Prescriber”:            MP NP PDP                  substitute:          MP NP


[75]         Schedule 1, entry for Morphine in the form Capsule containing morphine sulfate 60 mg (controlled release)

omit from the column headed “Authorised Prescriber”:            MP NP PDP                  substitute:          MP NP

[76]         Schedule 1, entry for Morphine in the form Capsule containing morphine sulfate 90 mg (controlled release)

omit from the column headed “Authorised Prescriber”:            MP NP PDP                  substitute:          MP NP

[77]         Schedule 1, entry for Morphine in the form Capsule containing morphine sulfate 100 mg (containing sustained release pellets)

omit from the column headed “Authorised Prescriber”:            MP NP PDP                  substitute:          MP NP

[78]         Schedule 1, entry for Morphine in the form Capsule containing morphine sulfate 120 mg (controlled  release)

omit from the column headed “Authorised Prescriber”:            MP NP PDP                  substitute:          MP NP

[79]         Schedule 1, entry for Morphine in the form Sachet containing controlled release granules for oral suspension, containing morphine sulfate 20 mg per sachet

omit from the column headed “Authorised Prescriber”:            MP NP PDP                  substitute:          MP NP

[80]         Schedule 1, entry for Morphine in the form Sachet containing controlled release granules for oral suspension, containing morphine sulfate 30 mg per sachet

omit from the column headed “Authorised Prescriber”:            MP NP PDP                  substitute:          MP NP

[81]         Schedule 1, entry for Morphine in the form Sachet containing controlled release granules for oral suspension, containing morphine sulfate 60 mg per sachet

omit from the column headed “Authorised Prescriber”:            MP NP PDP                  substitute:          MP NP

[82]         Schedule 1, entry for Morphine in the form Sachet containing controlled release granules for oral suspension, containing morphine sulfate 100 mg per sachet

omit from the column headed “Authorised Prescriber”:            MP NP PDP                  substitute:          MP NP

[83]         Schedule 1, entry for Moxonidine

omit from the column headed “Responsible Person” (wherever occurring):         SM       substitute:          AB

[84]         Schedule 1, entry for Nandrolone Decanoate

omit from the column headed “Responsible Person”:                 SH        substitute:          MK


[85]         Schedule 1, entry for Norfloxacin

omit:

 

 

 

Norflohexal

HX

MP NP

C1002 C1070

 

14

1

 

[86]         Schedule 1, entry for Oestradiol

(a)        omit from the column headed “Responsible Person”  :               SM       substitute:          AB

(b)           omit from the column headed “Responsible Person” :                                SH          substitute:             MK

[87]         Schedule 1, entry for Oestradiol and Oestradiol with Dydrogesterone

omit from the column headed “Responsible Person”  :               SM       substitute:          AB

[88]         Schedule 1, entry for Oestriol

omit from the column headed “Responsible Person” (wherever occurring):         SH        substitute:          MK

[89]         Schedule 1, entry for Olmesartan

omit from the column headed “Responsible Person” (wherever occurring):         SH        substitute:          MK

[90]         Schedule 1, entry for Olmesartan with amlodipine

omit from the column headed “Responsible Person” (wherever occurring):         SH        substitute:          MK

[91]         Schedule 1, entry for Olmesartan with Hydrochlorothiazide

omit from the column headed “Responsible Person”  :               SH        substitute:          MK

[92]         Schedule 1, after item for entry for Olsalazine

insert:

Omalizumab

Powder for injection 150 mg with diluent

Injection

Xolair

NV

MP
See Note 1

See Note 3

See Note 3

See Note 3

See Note 3

D

[93]         Schedule 1, entry for Omeprazole and Clarithromycin and Amoxycillin

omit:

 

 

 

Klacid Hp 7

AB

MP NP

C1096

 

1

0

 

 


[94]         Schedule 1, entry for Oxaliplatin

omit from the column headed “Responsible Person” (wherever occurring):         IT            substitute:             SZ

[95]         Schedule 1, entry for  Oxycodone in the form Capsule containing oxycodone hydrochloride 20 mg

omit from the column headed “Authorised Prescriber”:            MP NP PDP                  substitute:          MP NP

[96]         Schedule 1, entry for Oxycodone in the form Tablet containing oxycodone hydrochloride 5 mg (controlled release)

omit from the column headed “Authorised Prescriber”:            MP NP PDP                  substitute:          MP NP

[97]         Schedule 1, entry for Oxycodone in the form Tablet containing oxycodone hydrochloride 10 mg (controlled release)

omit from the column headed “Authorised Prescriber”:            MP NP PDP                  substitute:          MP NP

[98]         Schedule 1, entry for Oxycodone in the form Tablet containing oxycodone hydrochloride 15 mg (controlled release)

omit from the column headed “Authorised Prescriber”:            MP NP PDP                  substitute:          MP NP

[99]         Schedule 1, entry for Oxycodone in the form Tablet containing oxycodone hydrochloride 20 mg (controlled release)

omit from the column headed “Authorised Prescriber”:            MP NP PDP                  substitute:          MP NP

[100]       Schedule 1, entry for Oxycodone in the form Tablet containing oxycodone hydrochloride 30 mg (controlled release)

omit from the column headed “Authorised Prescriber”:            MP NP PDP                  substitute:          MP NP

[101]       Schedule 1, entry for Oxycodone in the form Tablet containing oxycodone hydrochloride 40 mg (controlled release)

omit from the column headed “Authorised Prescriber”:            MP NP PDP                  substitute:          MP NP

[102]       Schedule 1, entry for Oxycodone in the form Tablet containing oxycodone hydrochloride 80 mg (controlled release)

omit from the column headed “Authorised Prescriber”:            MP NP PDP                  substitute:          MP NP

[103]       Schedule 1, entry for Paclitaxel

omit from the column headed “Responsible Person” (wherever occurring):         IT            substitute:             SZ

[104]       Schedule 1, entry for Pancreatic Extract

omit from the column headed “Responsible Person” (wherever occurring):         SM       substitute:          AB

[105]       Schedule 1, entry for Peginterferon Alfa-2b

omit from the column headed “Responsible Person” (wherever occurring):         SH        substitute:          MK


[106]       Schedule 1, entry for Phenoxymethylpenicillin in each of the forms: Capsule 250 mg phenoxymethylpenicillin (as potassium) and Capsule 500 mg phenoxymethylpenicillin (as potassium)

omit from the column headed “Responsible Person” (wherever occurring):         AS        substitute:          VT

[107]       Schedule 1, entry for Posaconazole

omit from the column headed “Responsible Person”:                 SH        substitute:          MK

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

(a)        omit

 

 

 

Chem mart Prazosin

CH

MP NP

 

 

100

5

 

(b)        omit

 

 

 

GenRx Prazosin

GX

MP NP

 

 

100

5

 

(c)        omit

 

 

 

Terry White Chemists Prazosin

TW

MP NP

 

 

100

5

 

[109]       Schedule 1, entry for Prednisolone in each of the forms: Tablet 5 mg and Tablet 25 mg

                omit from the column headed “Responsible Person” (wherever occurring):         FM       substitute:          VT

[110]       Schedule 1, entry for Prednisone in each of the forms: Tablet 5 mg and Tablet 25 mg

                omit from the column headed “Responsible Person” (wherever occurring):         FM       substitute:          VT

[111]       Schedule 1, entry for Quinapril in each of the forms: Tablet 5 mg (as hydrochloride) and Tablet 10 mg (as hydrochloride)

(a)        omit

 

 

 

Quinapril-DP

GN

MP NP

 

 

30

5

 

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

 

 

 

Aquinafil

GN

MP NP

 

 

30

5

 

[112]       Schedule 1, entry for Quinapril in the form Tablet 20 mg (as hydrochloride)

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

 

 

 

Aquinafil

GN

MP NP

 

 

30

5

 

[113]       Schedule 1, entry for Ribavirin And Peginterferon Alfa-2b

omit from the column headed “Responsible Person” (wherever occurring):         SH          substitute:             MK

[114]       Schedule 1, entry for Risedronic Acid in the form Tablet containing risedronate sodium 35 mg

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

 

 

 

Risedronate Sandoz

SZ

MP NP

C2645 C2646 C3070

 

4

5

 

[115]       Schedule 1, entry for Risedronic Acid and Calcium in the form Pack containing 4 tablets risedronate sodium 35 mg and 24 tablets calcium 500 mg (as carbonate)

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

 

 

 

Acris Combi

AF

MP NP

C2645 C2646 C3070

 

1

5

 

[116]       Schedule 1, entry for Rosiglitazone

omit from the column headed “Circumstances”(wherever occurring):   C3540               substitute:            C3722

[117]       Schedule 1, entry for Rosiglitazone with Metformin

omit from the column headed “Circumstances”(wherever occurring):   C3544               substitute:            C3723

[118]       Schedule 1, entry for Temozolomide

                omit from the column headed “Responsible Person” (wherever occurring):         SH        substitute:          MK

[119]       Schedule 1, entry for Testosterone

                omit from the column headed “Responsible Person” (wherever occurring):         SH        substitute:          MK

[120]       Schedule 1, entry for Toremifene

                omit from the column headed “Responsible Person”:                 SH        substitute:          MK


[121]       Schedule 1, entry for Tramadol in the form Tablet (sustained release) containing tramadol hydrochloride 50 mg

omit from the column headed “Authorised Prescriber”:            MP NP PDP      substitute:          MP NP

[122]       Schedule 1, entry for Tramadol in the form Tablet (sustained release) containing tramadol hydrochloride 100 mg

omit from the column headed “Authorised Prescriber” (wherever occurring):     MP NP PDP      substitute:          MP NP

[123]       Schedule 1, entry for Tramadol in the form Tablet (extended release) containing tramadol hydrochloride 100 mg

omit from the column headed “Authorised Prescriber”:            MP NP PDP      substitute:          MP NP

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

(a)        omit from the column headed “Brand”:       Tramahexal SR substitute:          Tramadol Sandoz SR

(b)           omit from the column headed “Authorised Prescriber” (wherever occurring):     MP NP PDP      substitute:          MP NP

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

omit from the column headed “Authorised Prescriber” (wherever occurring):     MP NP PDP      substitute:          MP NP

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

omit from the column headed “Authorised Prescriber”:            MP NP PDP      substitute:          MP NP

[127]       Schedule 1, entry for Tramadol in the form Tablet (extended release) containing tramadol hydrochloride 300 mg

omit from the column headed “Authorised Prescriber”:            MP NP PDP      substitute:          MP NP

[128]       Schedule 1, entry for Valaciclovir in the form Tablet 500 mg (as hydrochloride) with Max Quantity 20 and Number of Repeats 0

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

 

 

 

Valvala

NV

MP NP

C3622 C3624 C3631 C3632

P3632

20

0

 

(b)        omit from the column headed “Responsible Person”:                 GM       substitute:          GN

(c)        omit from the column headed “Responsible Person”:                 RE        substitute:          GM


[129]       Schedule 1, entry for Valaciclovir in the form Tablet 500 mg (as hydrochloride) with Max Quantity 30 and Number of Repeats 5

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

 

 

 

Valvala

NV

MP NP

C3622 C3624 C3631 C3632

P3624

30

5

 

(b)        omit from the column headed “Responsible Person”:                 GM       substitute:          GN

(c)        omit from the column headed “Responsible Person”:                 RE        substitute:          GM

[130]       Schedule 1, entry for Valaciclovir in the form Tablet 500 mg (as hydrochloride) with Max Quantity 42 and Number of Repeats 0

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

 

 

 

Valvala

NV

MP NP

C3622 C3624 C3631 C3632

P3622 P3631

42

0

 

(b)        omit from the column headed “Responsible Person”:                 GM       substitute:          GN

(c)        omit from the column headed “Responsible Person”:                 RE        substitute:          GM

[131]       Schedule 1, entry for Valaciclovir in the form Tablet 500 mg (as hydrochloride) with Max Quantity 500 and Number of Repeats 2

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

 

 

 

Valaciclovir RBX

RA

MP
See Note 1

C1494 C3419

 

500

2

C

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

 

 

 

Valvala

NV

MP
See Note 1

C1494 C3419

 

500

2

C

(c)        omit from the column headed “Responsible Person”:                 RE        substitute:          GM

[132]       Schedule 1, entry for Vancomycin in the form Powder for injection 500 mg (500,000 I.U.) (as hydrochloride) with Max Quantity 2 and Number of Repeats 0

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

 

 

 

Vycin IV

WQ

MP

C1091 C1302 C1464

P1302

2

0

 

 

 

 

 

 

PDP

C1302

 

2

0

 

 


[133]       Schedule 1, entry for Vancomycin in the form Powder for injection 500 mg (500,000 I.U.) (as hydrochloride) with Max Quantity 5 and Number of Repeats 0

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

 

 

 

Vycin IV

WQ

MP

C1091 C1302 C1464

P1091 P1464

5

0

 

[134]       Schedule 1, entry for Vancomycin in the form Powder for injection 1 g (1,000,000 I.U.) (as hydrochloride) with Max Quantity 1 and Number of Repeats 0

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

 

 

 

Vycin IV

WQ

MP

C1091 C1302 C1464

P1302

1

0

 

 

 

 

 

 

PDP

C1302

 

1

0

 

[135]       Schedule 1, entry for Vancomycin in the form Powder for injection 1 g (1,000,000 I.U.) (as hydrochloride) with Max Quantity 3 and Number of Repeats 0

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

 

 

 

Vycin IV

WQ

MP

C1091 C1302 C1464

P1091 P1464

3

0

 

[136]       Schedule 1, entry for Vinorelbine in the form Solution for I.V. infusion 10 mg (as tartrate) in 1 mL

(a)           omit from the column headed “Responsible Person”:                 IT            substitute:             SZ

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

 

 

 

Vinorelbine Kabi

PK

MP

See Note 1

C1194 C1741

 

16

2

 

(c)        omit from the column headed “Responsible Person” for the brand “Vinorelbine Link” :                  PK          substitute:                 FU


[137]       Schedule 1, entry for Vinorelbine in the form Solution for I.V. infusion 50 mg (as tartrate) in 5 mL

(a)           omit from the column headed “Responsible Person”:                 IT            substitute:             SZ

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

 

 

 

Vinorelbine Kabi

PK

MP

See Note 1

C1194 C1741

 

4

2

 

(c)        omit from the column headed “Responsible Person” for the brand “Vinorelbine Link” :                  PK          substitute:                 FU

[138]       Schedule 1, entry for Zonisamide

omit from the column headed “Authorised Prescriber” (wherever occurring):                     MP                         substitute:             MP NP

[139]       Schedule 3

omit:

EX

Schering-Plough Pty Limited

 57 000 235 245

[140]       Schedule 3, after details relevant to Responsible Person code FR

insert:

FU

Fresenius Kabi Australia Pty Limited

 39 109 383 593

[141]       Schedule 3

omit:

IT

InterPharma Pty Ltd

 19 099 877 899

[142]       Schedule 3

omit:

RE

GlaxoSmithKline Australia Pty Ltd

 47 100 162 481

 


[143]       Schedule 3

omit:

SM

Abbott Products Pty Ltd

 41 007 401 201

[144]       Schedule 4, Part 1, entry for Ezetimibe

omit:

 

C2649

 

Treatment, in conjunction with dietary therapy and exercise, for co-administration with an HMG CoA reductase inhibitor (statin) in patients whose cholesterol levels are inadequately controlled with a statin and who have coronary heart disease.

Inadequate control with a statin is defined as follows:

(1) where the patient falls into a category for which the General Statement for Lipid-Lowering Drugs includes an initial cholesterol threshold for PBS-subsidy (i.e. a patient not in a very high risk category), a cholesterol level in excess of that threshold after at least 3 months of treatment at a daily dose of 40 mg or greater of a statin, in conjunction with dietary therapy and exercise.  The dose and duration of statin treatment and the cholesterol level which shows inadequate control must be documented in the patient's medical records when ezetimibe is initiated.  The cholesterol level which shows inadequate control must be no more than 2 months old when ezetimibe is initiated; or

(2) where the patient falls into a category for which the General Statement for Lipid-Lowering Drugs allows PBS-subsidised treatment with a statin at any cholesterol level (i.e. a very high risk category patient), a cholesterol level in excess of 4 mmol per L after at least 3 months of treatment at a daily dose of 40 mg or greater of a statin, in conjunction with dietary therapy and exercise.  The dose and duration of statin treatment and the cholesterol level which shows inadequate control must be documented in the patient's medical records when ezetimibe is initiated.  The cholesterol level which shows inadequate control must be no more than 2 months old when ezetimibe is
initiated

Compliance with Authority Required procedures - Streamlined Authority Code 2649

 

C2650

 

Treatment, in conjunction with dietary therapy and exercise, for co-administration with an HMG CoA reductase inhibitor (statin) in patients whose cholesterol levels are inadequately controlled with a statin and who have diabetes mellitus.

Inadequate control with a statin is defined as follows:

(1) where the patient falls into a category for which the General Statement for Lipid-Lowering Drugs includes an initial cholesterol threshold for PBS-subsidy (i.e. a patient not in a very high risk category), a cholesterol level in excess of that threshold after at least 3 months of treatment at a daily dose of 40 mg or greater of a statin, in conjunction with dietary therapy and exercise.  The dose and duration of statin treatment and the cholesterol level which shows inadequate control must be documented in the patient's medical records when ezetimibe is initiated.  The cholesterol level which shows inadequate control must be no more than 2 months old when ezetimibe is initiated; or

(2) where the patient falls into a category for which the General Statement for Lipid-Lowering Drugs allows PBS-subsidised treatment with a statin at any cholesterol level (i.e. a very high risk category patient), a cholesterol level in excess of 4 mmol per L after at least 3 months of treatment at a daily dose of 40 mg or greater of a statin, in conjunction with dietary therapy and exercise.  The dose and duration of statin treatment and the cholesterol level which shows inadequate control must be documented in the patient's medical records when ezetimibe is initiated.  The cholesterol level which shows inadequate control must be no more than 2 months old when ezetimibe is initiated

Compliance with Authority Required procedures - Streamlined Authority Code 2650

 

C2651

 

Treatment, in conjunction with dietary therapy and exercise, for co-administration with an HMG CoA reductase inhibitor (statin) in patients whose cholesterol levels are inadequately controlled with a statin and who have peripheral vascular disease.

Inadequate control with a statin is defined as follows:

(1) where the patient falls into a category for which the General Statement for Lipid-Lowering Drugs includes an initial cholesterol threshold for PBS-subsidy (i.e. a patient not in a very high risk category), a cholesterol level in excess of that threshold after at least 3 months of treatment at a daily dose of 40 mg or greater of a statin, in conjunction with dietary therapy and exercise.  The dose and duration of statin treatment and the cholesterol level which shows inadequate control must be documented in the patient's medical records when ezetimibe is initiated.  The cholesterol level which shows inadequate control must be no more than 2 months old when ezetimibe is initiated; or

(2) where the patient falls into a category for which the General Statement for Lipid-Lowering Drugs allows PBS-subsidised treatment with a statin at any cholesterol level (i.e. a very high risk category patient), a cholesterol level in excess of 4 mmol per L after at least 3 months of treatment at a daily dose of 40 mg or greater of a statin, in conjunction with dietary therapy and exercise.  The dose and duration of statin treatment and the cholesterol level which shows inadequate control must be documented in the patient's medical records when ezetimibe is initiated.  The cholesterol level which shows inadequate control must be no more than 2 months old when ezetimibe is
initiated

Compliance with Authority Required procedures - Streamlined Authority Code 2651

 

C2652

 

Treatment, in conjunction with dietary therapy and exercise, for co-administration with an HMG CoA reductase inhibitor (statin) in patients whose cholesterol levels are inadequately controlled with a statin and who have heterozygous familial hypercholesterolaemia.

Inadequate control with a statin is defined as follows:

(1) where the patient falls into a category for which the General Statement for Lipid-Lowering Drugs includes an initial cholesterol threshold for PBS-subsidy (i.e. a patient not in a very high risk category), a cholesterol level in excess of that threshold after at least 3 months of treatment at a daily dose of 40 mg or greater of a statin, in conjunction with dietary therapy and exercise.  The dose and duration of statin treatment and the cholesterol level which shows inadequate control must be documented in the patient's medical records when ezetimibe is initiated.  The cholesterol level which shows inadequate control must be no more than 2 months old when ezetimibe is initiated; or

(2) where the patient falls into a category for which the General Statement for Lipid-Lowering Drugs allows PBS-subsidised treatment with a statin at any cholesterol level (i.e. a very high risk category patient), a cholesterol level in excess of 4 mmol per L after at least 3 months of treatment at a daily dose of 40 mg or greater of a statin, in conjunction with dietary therapy and exercise.  The dose and duration of statin treatment and the cholesterol level which shows inadequate control must be documented in the patient's medical records when ezetimibe is initiated.  The cholesterol level which shows inadequate control must be no more than 2 months old when ezetimibe is initiated

Compliance with Authority Required procedures - Streamlined Authority Code 2652


 

C2653

 

Treatment, in conjunction with dietary therapy and exercise, for co-administration with an HMG CoA reductase inhibitor (statin) in patients whose cholesterol levels are inadequately controlled with a statin and who have symptomatic cerebrovascular disease.

Inadequate control with a statin is defined as follows:

(1) where the patient falls into a category for which the General Statement for Lipid-Lowering Drugs includes an initial cholesterol threshold for PBS-subsidy (i.e. a patient not in a very high risk category), a cholesterol level in excess of that threshold after at least 3 months of treatment at a daily dose of 40 mg or greater of a statin, in conjunction with dietary therapy and exercise.  The dose and duration of statin treatment and the cholesterol level which shows inadequate control must be documented in the patient's medical records when ezetimibe is initiated.  The cholesterol level which shows inadequate control must be no more than 2 months old when ezetimibe is initiated; or

(2) where the patient falls into a category for which the General Statement for Lipid-Lowering Drugs allows PBS-subsidised treatment with a statin at any cholesterol level (i.e. a very high risk category patient), a cholesterol level in excess of 4 mmol per L after at least 3 months of treatment at a daily dose of 40 mg or greater of a statin, in conjunction with dietary therapy and exercise.  The dose and duration of statin treatment and the cholesterol level which shows inadequate control must be documented in the patient's medical records when ezetimibe is initiated.  The cholesterol level which shows inadequate control must be no more than 2 months old when ezetimibe is
initiated

Compliance with Authority Required procedures - Streamlined Authority Code 2653

 

C2667

 

Treatment, in conjunction with dietary therapy and exercise, for co-administration with an HMG CoA reductase inhibitor (statin) in patients whose cholesterol levels are inadequately controlled with a statin and who have family history of coronary heart disease.

Inadequate control with a statin is defined as follows:

(1) where the patient falls into a category for which the General Statement for Lipid-Lowering Drugs includes an initial cholesterol threshold for PBS-subsidy (i.e. a patient not in a very high risk category), a cholesterol level in excess of that threshold after at least 3 months of treatment at a daily dose of 40 mg or greater of a statin, in conjunction with dietary therapy and exercise.  The dose and duration of statin treatment and the cholesterol level which shows inadequate control must be documented in the patient's medical records when ezetimibe is initiated.  The cholesterol level which shows inadequate control must be no more than 2 months old when ezetimibe is initiated; or

(2) where the patient falls into a category for which the General Statement for Lipid-Lowering Drugs allows PBS-subsidised treatment with a statin at any cholesterol level (i.e. a very high risk category patient), a cholesterol level in excess of 4 mmol per L after at least 3 months of treatment at a daily dose of 40 mg or greater of a statin, in conjunction with dietary therapy and exercise.  The dose and duration of statin treatment and the cholesterol level which shows inadequate control must be documented in the patient's medical records when ezetimibe is initiated.  The cholesterol level which shows inadequate control must be no more than 2 months old when ezetimibe is initiated

Compliance with Authority Required procedures - Streamlined Authority Code 2667

 

C2668

 

Treatment, in conjunction with dietary therapy and exercise, for co-administration with an HMG CoA reductase inhibitor (statin) in patients whose cholesterol levels are inadequately controlled with a statin and who have hypertension.

Inadequate control with a statin is defined as follows:

(1) where the patient falls into a category for which the General Statement for Lipid-Lowering Drugs includes an initial cholesterol threshold for PBS-subsidy (i.e. a patient not in a very high risk category), a cholesterol level in excess of that threshold after at least 3 months of treatment at a daily dose of 40 mg or greater of a statin, in conjunction with dietary therapy and exercise.  The dose and duration of statin treatment and the cholesterol level which shows inadequate control must be documented in the patient's medical records when ezetimibe is initiated.  The cholesterol level which shows inadequate control must be no more than 2 months old when ezetimibe is initiated; or

(2) where the patient falls into a category for which the General Statement for Lipid-Lowering Drugs allows PBS-subsidised treatment with a statin at any cholesterol level (i.e. a very high risk category patient), a cholesterol level in excess of 4 mmol per L after at least 3 months of treatment at a daily dose of 40 mg or greater of a statin, in conjunction with dietary therapy and exercise.  The dose and duration of statin treatment and the cholesterol level which shows inadequate control must be documented in the patient's medical records when ezetimibe is initiated.  The cholesterol level which shows inadequate control must be no more than 2 months old when ezetimibe is
initiated

Compliance with Authority Required procedures - Streamlined Authority Code 2668

 

C2669

 

Patients eligible for PBS-subsidised lipid-lowering medication (according to the criteria set out in the General Statement for Lipid-Lowering Drugs) where treatment with an HMG CoA reductase inhibitor (statin) must be discontinued or reduced to a dose of 20 mg or less per day, because the patient developed a clinically important product-related adverse event during treatment with a statin.

A clinically important product-related adverse event is defined as follows:

(i) Severe myalgia (muscle symptoms without creatine kinase elevation) which is proven to be temporally associated with statin treatment; or

(ii) Myositis (clinically important creatine kinase elevation, with or without muscle symptoms) demonstrated by results twice the upper limit of normal on a single reading or a rising pattern on consecutive measurements and which is unexplained by other causes; or

(iii) Unexplained, persistent elevations of serum transaminases (greater than 3 times the upper limit of normal) during treatment with a statin

Compliance with Authority Required procedures - Streamlined Authority Code 2669

insert in the columns in the order indicated:

 

C3724

 

Treatment, in conjunction with dietary therapy and exercise, for co-administration with an HMG CoA reductase inhibitor (statin) in patients whose cholesterol levels are inadequately controlled with a statin and who have coronary heart disease.
Inadequate control with a statin is defined as follows:
(1) where the patient falls into a category for which the General Statement for Lipid-Lowering Drugs includes an initial cholesterol threshold for PBS-subsidy (i.e. a patient not in a very high risk category), a cholesterol level in excess of that threshold after at least 3 months of treatment at a maximum tolerated dose of a statin, in conjunction with dietary therapy and exercise. The dose and duration of statin treatment and the cholesterol level which shows inadequate control must be documented in the patient's medical records when ezetimibe is initiated. The cholesterol level which shows inadequate control must be no more than 2 months old when ezetimibe is initiated; or
(2) where the patient falls into a category for which the General Statement for Lipid-Lowering Drugs allows PBS-subsidised treatment with a statin at any cholesterol level (i.e. a very high risk category patient), a cholesterol level in excess of 4 mmol per L after at least 3 months of treatment at a maximum tolerated dose of a statin, in conjunction with dietary therapy and exercise. The dose and duration of statin treatment and the cholesterol level which shows inadequate control must be documented in the patient's medical records when ezetimibe is initiated. The cholesterol level which shows inadequate control must be no more than 2 months old when ezetimibe is initiated

Compliance with Authority Required procedures - Streamlined Authority Code 3724


 

C3725

 

Treatment, in conjunction with dietary therapy and exercise, for co-administration with an HMG CoA reductase inhibitor (statin) in patients whose cholesterol levels are inadequately controlled with a statin and who have diabetes mellitus.
Inadequate control with a statin is defined as follows:
(1) where the patient falls into a category for which the General Statement for Lipid-Lowering Drugs includes an initial cholesterol threshold for PBS-subsidy (i.e. a patient not in a very high risk category), a cholesterol level in excess of that threshold after at least 3 months of treatment at a maximum tolerated dose of a statin, in conjunction with dietary therapy and exercise. The dose and duration of statin treatment and the cholesterol level which shows inadequate control must be documented in the patient's medical records when ezetimibe is initiated. The cholesterol level which shows inadequate control must be no more than 2 months old when ezetimibe is initiated; or
(2) where the patient falls into a category for which the General Statement for Lipid-Lowering Drugs allows PBS-subsidised treatment with a statin at any cholesterol level (i.e. a very high risk category patient), a cholesterol level in excess of 4 mmol per L after at least 3 months of treatment at a maximum tolerated dose of a statin, in conjunction with dietary therapy and exercise. The dose and duration of statin treatment and the cholesterol level which shows inadequate control must be documented in the patient's medical records when ezetimibe is initiated. The cholesterol level which shows inadequate control must be no more than 2 months old when ezetimibe is initiated

Compliance with Authority Required procedures - Streamlined Authority Code 3725


 

C3726

 

Treatment, in conjunction with dietary therapy and exercise, for co-administration with an HMG CoA reductase inhibitor (statin) in patients whose cholesterol levels are inadequately controlled with a statin and who have peripheral vascular disease.
Inadequate control with a statin is defined as follows:
(1) where the patient falls into a category for which the General Statement for Lipid-Lowering Drugs includes an initial cholesterol threshold for PBS-subsidy (i.e. a patient not in a very high risk category), a cholesterol level in excess of that threshold after at least 3 months of treatment at a maximum tolerated dose of a statin, in conjunction with dietary therapy and exercise. The dose and duration of statin treatment and the cholesterol level which shows inadequate control must be documented in the patient's medical records when ezetimibe is initiated. The cholesterol level which shows inadequate control must be no more than 2 months old when ezetimibe is initiated; or
(2) where the patient falls into a category for which the General Statement for Lipid-Lowering Drugs allows PBS-subsidised treatment with a statin at any cholesterol level (i.e. a very high risk category patient), a cholesterol level in excess of 4 mmol per L after at least 3 months of treatment at a maximum tolerated dose of a statin, in conjunction with dietary therapy and exercise. The dose and duration of statin treatment and the cholesterol level which shows inadequate control must be documented in the patient's medical records when ezetimibe is initiated. The cholesterol level which shows inadequate control must be no more than 2 months old when ezetimibe is initiated

Compliance with Authority Required procedures - Streamlined Authority Code 3726


 

C3727

 

Treatment, in conjunction with dietary therapy and exercise, for co-administration with an HMG CoA reductase inhibitor (statin) in patients whose cholesterol levels are inadequately controlled with a statin and who have heterozygous familial hypercholesterolaemia.
Inadequate control with a statin is defined as follows:
(1) where the patient falls into a category for which the General Statement for Lipid-Lowering Drugs includes an initial cholesterol threshold for PBS-subsidy (i.e. a patient not in a very high risk category), a cholesterol level in excess of that threshold after at least 3 months of treatment at a maximum tolerated dose of a statin, in conjunction with dietary therapy and exercise. The dose and duration of statin treatment and the cholesterol level which shows inadequate control must be documented in the patient's medical records when ezetimibe is initiated. The cholesterol level which shows inadequate control must be no more than 2 months old when ezetimibe is initiated; or
(2) where the patient falls into a category for which the General Statement for Lipid-Lowering Drugs allows PBS-subsidised treatment with a statin at any cholesterol level (i.e. a very high risk category patient), a cholesterol level in excess of 4 mmol per L after at least 3 months of treatment at a maximum tolerated dose of a statin, in conjunction with dietary therapy and exercise. The dose and duration of statin treatment and the cholesterol level which shows inadequate control must be documented in the patient's medical records when ezetimibe is initiated. The cholesterol level which shows inadequate control must be no more than 2 months old when ezetimibe is initiated

Compliance with Authority Required procedures - Streamlined Authority Code 3727


 

C3728

 

Treatment, in conjunction with dietary therapy and exercise, for co-administration with an HMG CoA reductase inhibitor (statin) in patients whose cholesterol levels are inadequately controlled with a statin and who have symptomatic cerebrovascular disease.
Inadequate control with a statin is defined as follows:
(1) where the patient falls into a category for which the General Statement for Lipid-Lowering Drugs includes an initial cholesterol threshold for PBS-subsidy (i.e. a patient not in a very high risk category), a cholesterol level in excess of that threshold after at least 3 months of treatment at a maximum tolerated dose of a statin, in conjunction with dietary therapy and exercise. The dose and duration of statin treatment and the cholesterol level which shows inadequate control must be documented in the patient's medical records when ezetimibe is initiated. The cholesterol level which shows inadequate control must be no more than 2 months old when ezetimibe is initiated; or
(2) where the patient falls into a category for which the General Statement for Lipid-Lowering Drugs allows PBS-subsidised treatment with a statin at any cholesterol level (i.e. a very high risk category patient), a cholesterol level in excess of 4 mmol per L after at least 3 months of treatment at a maximum tolerated dose of a statin, in conjunction with dietary therapy and exercise. The dose and duration of statin treatment and the cholesterol level which shows inadequate control must be documented in the patient's medical records when ezetimibe is initiated. The cholesterol level which shows inadequate control must be no more than 2 months old when ezetimibe is initiated

Compliance with Authority Required procedures - Streamlined Authority Code 3728


 

C3729

 

Treatment, in conjunction with dietary therapy and exercise, for co-administration with an HMG CoA reductase inhibitor (statin) in patients whose cholesterol levels are inadequately controlled with a statin and who have family history of coronary heart disease.
Inadequate control with a statin is defined as follows:
(1) where the patient falls into a category for which the General Statement for Lipid-Lowering Drugs includes an initial cholesterol threshold for PBS-subsidy (i.e. a patient not in a very high risk category), a cholesterol level in excess of that threshold after at least 3 months of treatment at a maximum tolerated dose of a statin, in conjunction with dietary therapy and exercise. The dose and duration of statin treatment and the cholesterol level which shows inadequate control must be documented in the patient's medical records when ezetimibe is initiated. The cholesterol level which shows inadequate control must be no more than 2 months old when ezetimibe is initiated; or
(2) where the patient falls into a category for which the General Statement for Lipid-Lowering Drugs allows PBS-subsidised treatment with a statin at any cholesterol level (i.e. a very high risk category patient), a cholesterol level in excess of 4 mmol per L after at least 3 months of treatment at a maximum tolerated dose of a statin, in conjunction with dietary therapy and exercise. The dose and duration of statin treatment and the cholesterol level which shows inadequate control must be documented in the patient's medical records when ezetimibe is initiated. The cholesterol level which shows inadequate control must be no more than 2 months old when ezetimibe is initiated

Compliance with Authority Required procedures - Streamlined Authority Code 3729


 

C3730

 

Treatment, in conjunction with dietary therapy and exercise, for co-administration with an HMG CoA reductase inhibitor (statin) in patients whose cholesterol levels are inadequately controlled with a statin and who have hypertension.
Inadequate control with a statin is defined as follows:
(1) where the patient falls into a category for which the General Statement for Lipid-Lowering Drugs includes an initial cholesterol threshold for PBS-subsidy (i.e. a patient not in a very high risk category), a cholesterol level in excess of that threshold after at least 3 months of treatment at a maximum tolerated dose of a statin, in conjunction with dietary therapy and exercise. The dose and duration of statin treatment and the cholesterol level which shows inadequate control must be documented in the patient's medical records when ezetimibe is initiated. The cholesterol level which shows inadequate control must be no more than 2 months old when ezetimibe is initiated; or
(2) where the patient falls into a category for which the General Statement for Lipid-Lowering Drugs allows PBS-subsidised treatment with a statin at any cholesterol level (i.e. a very high risk category patient), a cholesterol level in excess of 4 mmol per L after at least 3 months of treatment at a maximum tolerated dose of a statin, in conjunction with dietary therapy and exercise. The dose and duration of statin treatment and the cholesterol level which shows inadequate control must be documented in the patient's medical records when ezetimibe is initiated. The cholesterol level which shows inadequate control must be no more than 2 months old when ezetimibe is initiated

Compliance with Authority Required procedures - Streamlined Authority Code 3730


 

C3731

 

Patients eligible for PBS-subsidised lipid-lowering medication (according to the criteria set out in the General Statement for Lipid-Lowering Drugs) where treatment with an HMG CoA reductase inhibitor (statin) must be discontinued or reduced because the patient developed a clinically important product-related adverse event during treatment with a statin.
A clinically important product-related adverse event is defined as follows:
(i) Severe myalgia (muscle symptoms without creatine kinase elevation) which is proven to be temporally associated with statin treatment; or
(ii) Myositis (clinically important creatine kinase elevation, with or without muscle symptoms) demonstrated by results twice the upper limit of normal on a single reading or a rising pattern on consecutive measurements and which is unexplained by other causes; or
(iii) Unexplained, persistent elevations of serum transaminases (greater than 3 times the upper limit of normal) during treatment with a statin

Compliance with Authority Required procedures - Streamlined Authority Code 3731


[145]       Schedule 4, Part 1, entry for Ezetimibe with Simvastatin

omit:

 

C2654

 

Treatment, in conjunction with dietary therapy and exercise, in patients whose cholesterol levels are inadequately controlled with an HMG CoA reductase inhibitor (statin) and who have coronary heart disease.

Inadequate control with a statin is defined as follows:

(1) where the patient falls into a category for which the General Statement for Lipid-Lowering Drugs includes an initial cholesterol threshold for PBS-subsidy (i.e. a patient not in a very high risk category), a cholesterol level in excess of that threshold after at least 3 months of treatment at a daily dose of 40 mg or greater of a statin, in conjunction with dietary therapy and exercise.  The dose and duration of statin treatment and the cholesterol level which shows inadequate control must be documented in the patient's medical records when the ezetimibe component is initiated.  The cholesterol level which shows inadequate control must be no more than 2 months old when the ezetimibe component is initiated; or

(2) where the patient falls into a category for which the General Statement for Lipid-Lowering Drugs allows PBS-subsidised treatment with a statin at any cholesterol level (i.e. a very high risk category patient), a cholesterol level in excess of 4 mmol per L after at least 3 months of treatment at a daily dose of 40 mg or greater of a statin, in conjunction with dietary therapy and exercise.  The dose and duration of statin treatment and the cholesterol level which shows inadequate control must be documented in the patient's medical records when the ezetimibe component is initiated.  The cholesterol level which shows inadequate control must be no more than 2 months old when the ezetimibe component is initiated

Compliance with Authority Required procedures - Streamlined Authority Code 2654

 

C2655

 

Treatment, in conjunction with dietary therapy and exercise, in patients whose cholesterol levels are inadequately controlled with an HMG CoA reductase inhibitor (statin) and who have diabetes mellitus.

Inadequate control with a statin is defined as follows:

(1) where the patient falls into a category for which the General Statement for Lipid-Lowering Drugs includes an initial cholesterol threshold for PBS-subsidy (i.e. a patient not in a very high risk category), a cholesterol level in excess of that threshold after at least 3 months of treatment at a daily dose of 40 mg or greater of a statin, in conjunction with dietary therapy and exercise.  The dose and duration of statin treatment and the cholesterol level which shows inadequate control must be documented in the patient's medical records when the ezetimibe component is initiated.  The cholesterol level which shows inadequate control must be no more than 2 months old when the ezetimibe component is initiated; or

(2) where the patient falls into a category for which the General Statement for Lipid-Lowering Drugs allows PBS-subsidised treatment with a statin at any cholesterol level (i.e. a very high risk category patient), a cholesterol level in excess of 4 mmol per L after at least 3 months of treatment at a daily dose of 40 mg or greater of a statin, in conjunction with dietary therapy and exercise.  The dose and duration of statin treatment and the cholesterol level which shows inadequate control must be documented in the patient's medical records when the ezetimibe component is initiated.  The cholesterol level which shows inadequate control must be no more than 2 months old when the ezetimibe component is initiated

Compliance with Authority Required procedures - Streamlined Authority Code 2655

 

C2656

 

Treatment, in conjunction with dietary therapy and exercise, in patients whose cholesterol levels are inadequately controlled with an HMG CoA reductase inhibitor (statin) and who have peripheral vascular disease.

Inadequate control with a statin is defined as follows:

(1) where the patient falls into a category for which the General Statement for Lipid-Lowering Drugs includes an initial cholesterol threshold for PBS-subsidy (i.e. a patient not in a very high risk category), a cholesterol level in excess of that threshold after at least 3 months of treatment at a daily dose of 40 mg or greater of a statin, in conjunction with dietary therapy and exercise.  The dose and duration of statin treatment and the cholesterol level which shows inadequate control must be documented in the patient's medical records when the ezetimibe component is initiated.  The cholesterol level which shows inadequate control must be no more than 2 months old when the ezetimibe component is initiated; or

(2) where the patient falls into a category for which the General Statement for Lipid-Lowering Drugs allows PBS-subsidised treatment with a statin at any cholesterol level (i.e. a very high risk category patient), a cholesterol level in excess of 4 mmol per L after at least 3 months of treatment at a daily dose of 40 mg or greater of a statin, in conjunction with dietary therapy and exercise.  The dose and duration of statin treatment and the cholesterol level which shows inadequate control must be documented in the patient's medical records when the ezetimibe component is initiated.  The cholesterol level which shows inadequate control must be no more than 2 months old when the ezetimibe component is initiated

Compliance with Authority Required procedures - Streamlined Authority Code 2656

 

C2657

 

Treatment, in conjunction with dietary therapy and exercise, in patients whose cholesterol levels are inadequately controlled with an HMG CoA reductase inhibitor (statin) and who have heterozygous familial hypercholesterolaemia.

Inadequate control with a statin is defined as follows:

(1) where the patient falls into a category for which the General Statement for Lipid-Lowering Drugs includes an initial cholesterol threshold for PBS-subsidy (i.e. a patient not in a very high risk category), a cholesterol level in excess of that threshold after at least 3 months of treatment at a daily dose of 40 mg or greater of a statin, in conjunction with dietary therapy and exercise.  The dose and duration of statin treatment and the cholesterol level which shows inadequate control must be documented in the patient's medical records when the ezetimibe component is initiated.  The cholesterol level which shows inadequate control must be no more than 2 months old when the ezetimibe component is initiated; or

(2) where the patient falls into a category for which the General Statement for Lipid-Lowering Drugs allows PBS-subsidised treatment with a statin at any cholesterol level (i.e. a very high risk category patient), a cholesterol level in excess of 4 mmol per L after at least 3 months of treatment at a daily dose of 40 mg or greater of a statin, in conjunction with dietary therapy and exercise.  The dose and duration of statin treatment and the cholesterol level which shows inadequate control must be documented in the patient's medical records when the ezetimibe component is initiated.  The cholesterol level which shows inadequate control must be no more than 2 months old when the ezetimibe component is initiated

Compliance with Authority Required procedures - Streamlined Authority Code 2657

 

C2658

 

Treatment, in conjunction with dietary therapy and exercise, in patients whose cholesterol levels are inadequately controlled with an HMG CoA reductase inhibitor (statin) and who have cerebrovascular disease which has become symptomatic.

Inadequate control with a statin is defined as follows:

(1) where the patient falls into a category for which the General Statement for Lipid-Lowering Drugs includes an initial cholesterol threshold for PBS-subsidy (i.e. a patient not in a very high risk category), a cholesterol level in excess of that threshold after at least 3 months of treatment at a daily dose of 40 mg or greater of a statin, in conjunction with dietary therapy and exercise.  The dose and duration of statin treatment and the cholesterol level which shows inadequate control must be documented in the patient's medical records when the ezetimibe component is initiated.  The cholesterol level which shows inadequate control must be no more than 2 months old when the ezetimibe component is initiated; or

(2) where the patient falls into a category for which the General Statement for Lipid-Lowering Drugs allows PBS-subsidised treatment with a statin at any cholesterol level (i.e. a very high risk category patient), a cholesterol level in excess of 4 mmol per L after at least 3 months of treatment at a daily dose of 40 mg or greater of a statin, in conjunction with dietary therapy and exercise.  The dose and duration of statin treatment and the cholesterol level which shows inadequate control must be documented in the patient's medical records when the ezetimibe component is initiated.  The cholesterol level which shows inadequate control must be no more than 2 months old when the ezetimibe component is initiated

Compliance with Authority Required procedures - Streamlined Authority Code 2658

 

C2678

 

Treatment, in conjunction with dietary therapy and exercise, in patients whose cholesterol levels are inadequately controlled with an HMG CoA reductase inhibitor (statin) and who have family history of coronary heart disease.

Inadequate control with a statin is defined as follows:

(1) where the patient falls into a category for which the General Statement for Lipid-Lowering Drugs includes an initial cholesterol threshold for PBS-subsidy (i.e. a patient not in a very high risk category), a cholesterol level in excess of that threshold after at least 3 months of treatment at a daily dose of 40 mg or greater of a statin, in conjunction with dietary therapy and exercise.  The dose and duration of statin treatment and the cholesterol level which shows inadequate control must be documented in the patient's medical records when the ezetimibe component is initiated.  The cholesterol level which shows inadequate control must be no more than 2 months old when the ezetimibe component is initiated; or

(2) where the patient falls into a category for which the General Statement for Lipid-Lowering Drugs allows PBS-subsidised treatment with a statin at any cholesterol level (i.e. a very high risk category patient), a cholesterol level in excess of 4 mmol per L after at least 3 months of treatment at a daily dose of 40 mg or greater of a statin, in conjunction with dietary therapy and exercise.  The dose and duration of statin treatment and the cholesterol level which shows inadequate control must be documented in the patient's medical records when the ezetimibe component is initiated.  The cholesterol level which shows inadequate control must be no more than 2 months old when the ezetimibe component is initiated

Compliance with Authority Required procedures - Streamlined Authority Code 2678

 

C2679

 

Treatment, in conjunction with dietary therapy and exercise, in patients whose cholesterol levels are inadequately controlled with an HMG CoA reductase inhibitor (statin) and who have hypertension.

Inadequate control with a statin is defined as follows:

(1) where the patient falls into a category for which the General Statement for Lipid-Lowering Drugs includes an initial cholesterol threshold for PBS-subsidy (i.e. a patient not in a very high risk category), a cholesterol level in excess of that threshold after at least 3 months of treatment at a daily dose of 40 mg or greater of a statin, in conjunction with dietary therapy and exercise.  The dose and duration of statin treatment and the cholesterol level which shows inadequate control must be documented in the patient's medical records when the ezetimibe component is initiated.  The cholesterol level which shows inadequate control must be no more than 2 months old when the ezetimibe component is initiated; or

(2) where the patient falls into a category for which the General Statement for Lipid-Lowering Drugs allows PBS-subsidised treatment with a statin at any cholesterol level (i.e. a very high risk category patient), a cholesterol level in excess of 4 mmol per L after at least 3 months of treatment at a daily dose of 40 mg or greater of a statin, in conjunction with dietary therapy and exercise.  The dose and duration of statin treatment and the cholesterol level which shows inadequate control must be documented in the patient's medical records when the ezetimibe component is initiated.  The cholesterol level which shows inadequate control must be no more than 2 months old when the ezetimibe component is initiated

Compliance with Authority Required procedures - Streamlined Authority Code 2679

insert in the columns in the order indicated:

 

C3732

 

Treatment, in conjunction with dietary therapy and exercise, in patients whose cholesterol levels are inadequately controlled with an HMG CoA reductase inhibitor (statin) and who have coronary heart disease.
Inadequate control with a statin is defined as follows:
(1) where the patient falls into a category for which the General Statement for Lipid-Lowering Drugs includes an initial cholesterol threshold for PBS-subsidy (i.e. a patient not in a very high risk category), a cholesterol level in excess of that threshold after at least 3 months of treatment at a maximum tolerated dose of a statin, in conjunction with dietary therapy and exercise. The dose and duration of statin treatment and the cholesterol level which shows inadequate control must be documented in the patient's medical records when the ezetimibe component is initiated. The cholesterol level which shows inadequate control must be no more than 2 months old when the ezetimibe component is initiated; or
(2) where the patient falls into a category for which the General Statement for Lipid-Lowering Drugs allows PBS-subsidised treatment with a statin at any cholesterol level (i.e. a very high risk category patient), a cholesterol level in excess of 4 mmol per L after at least 3 months of treatment at a maximum tolerated dose of a statin, in conjunction with dietary therapy and exercise. The dose and duration of statin treatment and the cholesterol level which shows inadequate control must be documented in the patient's medical records when the ezetimibe component is initiated. The cholesterol level which shows inadequate control must be no more than 2 months old when the ezetimibe component is initiated

Compliance with Authority Required procedures - Streamlined Authority Code 3732


 

C3733

 

Treatment, in conjunction with dietary therapy and exercise, in patients whose cholesterol levels are inadequately controlled with an HMG CoA reductase inhibitor (statin) and who have diabetes mellitus.
Inadequate control with a statin is defined as follows:
(1) where the patient falls into a category for which the General Statement for Lipid-Lowering Drugs includes an initial cholesterol threshold for PBS-subsidy (i.e. a patient not in a very high risk category), a cholesterol level in excess of that threshold after at least 3 months of treatment at a maximum tolerated dose of a statin, in conjunction with dietary therapy and exercise. The dose and duration of statin treatment and the cholesterol level which shows inadequate control must be documented in the patient's medical records when the ezetimibe component is initiated. The cholesterol level which shows inadequate control must be no more than 2 months old when the ezetimibe component is initiated; or
(2) where the patient falls into a category for which the General Statement for Lipid-Lowering Drugs allows PBS-subsidised treatment with a statin at any cholesterol level (i.e. a very high risk category patient), a cholesterol level in excess of 4 mmol per L after at least 3 months of treatment at a maximum tolerated dose of a statin, in conjunction with dietary therapy and exercise. The dose and duration of statin treatment and the cholesterol level which shows inadequate control must be documented in the patient's medical records when the ezetimibe component is initiated. The cholesterol level which shows inadequate control must be no more than 2 months old when the ezetimibe component is initiated

Compliance with Authority Required procedures - Streamlined Authority Code 3733


 

C3734

 

Treatment, in conjunction with dietary therapy and exercise, in patients whose cholesterol levels are inadequately controlled with an HMG CoA reductase inhibitor (statin) and who have peripheral vascular disease.
Inadequate control with a statin is defined as follows:
(1) where the patient falls into a category for which the General Statement for Lipid-Lowering Drugs includes an initial cholesterol threshold for PBS-subsidy (i.e. a patient not in a very high risk category), a cholesterol level in excess of that threshold after at least 3 months of treatment at a maximum tolerated dose of a statin, in conjunction with dietary therapy and exercise. The dose and duration of statin treatment and the cholesterol level which shows inadequate control must be documented in the patient's medical records when the ezetimibe component is initiated. The cholesterol level which shows inadequate control must be no more than 2 months old when the ezetimibe component is initiated; or
(2) where the patient falls into a category for which the General Statement for Lipid-Lowering Drugs allows PBS-subsidised treatment with a statin at any cholesterol level (i.e. a very high risk category patient), a cholesterol level in excess of 4 mmol per L after at least 3 months of treatment at a maximum tolerated dose of a statin, in conjunction with dietary therapy and exercise. The dose and duration of statin treatment and the cholesterol level which shows inadequate control must be documented in the patient's medical records when the ezetimibe component is initiated. The cholesterol level which shows inadequate control must be no more than 2 months old when the ezetimibe component is initiated

Compliance with Authority Required procedures - Streamlined Authority Code 3734


 

C3735

 

Treatment, in conjunction with dietary therapy and exercise, in patients whose cholesterol levels are inadequately controlled with an HMG CoA reductase inhibitor (statin) and who have heterozygous familial hypercholesterolaemia.
Inadequate control with a statin is defined as follows:
(1) where the patient falls into a category for which the General Statement for Lipid-Lowering Drugs includes an initial cholesterol threshold for PBS-subsidy (i.e. a patient not in a very high risk category), a cholesterol level in excess of that threshold after at least 3 months of treatment at a maximum tolerated dose of a statin, in conjunction with dietary therapy and exercise. The dose and duration of statin treatment and the cholesterol level which shows inadequate control must be documented in the patient's medical records when the ezetimibe component is initiated. The cholesterol level which shows inadequate control must be no more than 2 months old when the ezetimibe component is initiated; or
(2) where the patient falls into a category for which the General Statement for Lipid-Lowering Drugs allows PBS-subsidised treatment with a statin at any cholesterol level (i.e. a very high risk category patient), a cholesterol level in excess of 4 mmol per L after at least 3 months of treatment at a maximum tolerated dose of a statin, in conjunction with dietary therapy and exercise. The dose and duration of statin treatment and the cholesterol level which shows inadequate control must be documented in the patient's medical records when the ezetimibe component is initiated. The cholesterol level which shows inadequate control must be no more than 2 months old when the ezetimibe component is initiated

Compliance with Authority Required procedures - Streamlined Authority Code 3735


 

C3736

 

Treatment, in conjunction with dietary therapy and exercise, in patients whose cholesterol levels are inadequately controlled with an HMG CoA reductase inhibitor (statin) and who have cerebrovascular disease which has become symptomatic.
Inadequate control with a statin is defined as follows:
(1) where the patient falls into a category for which the General Statement for Lipid-Lowering Drugs includes an initial cholesterol threshold for PBS-subsidy (i.e. a patient not in a very high risk category), a cholesterol level in excess of that threshold after at least 3 months of treatment at a maximum tolerated dose of a statin, in conjunction with dietary therapy and exercise. The dose and duration of statin treatment and the cholesterol level which shows inadequate control must be documented in the patient's medical records when the ezetimibe component is initiated. The cholesterol level which shows inadequate control must be no more than 2 months old when the ezetimibe component is initiated; or
(2) where the patient falls into a category for which the General Statement for Lipid-Lowering Drugs allows PBS-subsidised treatment with a statin at any cholesterol level (i.e. a very high risk category patient), a cholesterol level in excess of 4 mmol per L after at least 3 months of treatment at a maximum tolerated dose of a statin, in conjunction with dietary therapy and exercise. The dose and duration of statin treatment and the cholesterol level which shows inadequate control must be documented in the patient's medical records when the ezetimibe component is initiated. The cholesterol level which shows inadequate control must be no more than 2 months old when the ezetimibe component is initiated

Compliance with Authority Required procedures - Streamlined Authority Code 3736


 

C3737

 

Treatment, in conjunction with dietary therapy and exercise, in patients whose cholesterol levels are inadequately controlled with an HMG CoA reductase inhibitor (statin) and who have family history of coronary heart disease.
Inadequate control with a statin is defined as follows:
(1) where the patient falls into a category for which the General Statement for Lipid-Lowering Drugs includes an initial cholesterol threshold for PBS-subsidy (i.e. a patient not in a very high risk category), a cholesterol level in excess of that threshold after at least 3 months of treatment at a maximum tolerated dose of a statin, in conjunction with dietary therapy and exercise. The dose and duration of statin treatment and the cholesterol level which shows inadequate control must be documented in the patient's medical records when the ezetimibe component is initiated. The cholesterol level which shows inadequate control must be no more than 2 months old when the ezetimibe component is initiated; or
(2) where the patient falls into a category for which the General Statement for Lipid-Lowering Drugs allows PBS-subsidised treatment with a statin at any cholesterol level (i.e. a very high risk category patient), a cholesterol level in excess of 4 mmol per L after at least 3 months of treatment at a maximum tolerated dose of a statin, in conjunction with dietary therapy and exercise. The dose and duration of statin treatment and the cholesterol level which shows inadequate control must be documented in the patient's medical records when the ezetimibe component is initiated. The cholesterol level which shows inadequate control must be no more than 2 months old when the ezetimibe component is initiated

Compliance with Authority Required procedures - Streamlined Authority Code 3737


 

C3738

 

Treatment, in conjunction with dietary therapy and exercise, in patients whose cholesterol levels are inadequately controlled with an HMG CoA reductase inhibitor (statin) and who have hypertension.
Inadequate control with a statin is defined as follows:
(1) where the patient falls into a category for which the General Statement for Lipid-Lowering Drugs includes an initial cholesterol threshold for PBS-subsidy (i.e. a patient not in a very high risk category), a cholesterol level in excess of that threshold after at least 3 months of treatment at a maximum tolerated dose of a statin, in conjunction with dietary therapy and exercise. The dose and duration of statin treatment and the cholesterol level which shows inadequate control must be documented in the patient's medical records when the ezetimibe component is initiated. The cholesterol level which shows inadequate control must be no more than 2 months old when the ezetimibe component is initiated; or
(2) where the patient falls into a category for which the General Statement for Lipid-Lowering Drugs allows PBS-subsidised treatment with a statin at any cholesterol level (i.e. a very high risk category patient), a cholesterol level in excess of 4 mmol per L after at least 3 months of treatment at a maximum tolerated dose of a statin, in conjunction with dietary therapy and exercise. The dose and duration of statin treatment and the cholesterol level which shows inadequate control must be documented in the patient's medical records when the ezetimibe component is initiated. The cholesterol level which shows inadequate control must be no more than 2 months old when the ezetimibe component is initiated

Compliance with Authority Required procedures - Streamlined Authority Code 3738


 

C3739

 

Patients eligible for PBS-subsidised lipid-lowering medication (according to the criteria set out in the General Statement for Lipid-Lowering Drugs) where treatment with an HMG CoA reductase inhibitor (statin) must be reduced because the patient developed a clinically important product-related adverse event during treatment with a statin.
A clinically important product-related adverse event is defined as follows:
(i) Severe myalgia (muscle symptoms without creatine kinase elevation) which is proven to be temporally associated with statin treatment; or
(ii) Myositis (clinically important creatine kinase elevation, with or without muscle symptoms) demonstrated by results twice the upper limit of normal on a single reading or a rising pattern on consecutive measurements and which is unexplained by other causes; or
(iii) Unexplained, persistent elevations of serum transaminases (greater than 3 times the upper limit of normal) during treatment with a statin

Compliance with Authority Required procedures - Streamlined Authority Code 3739



[146]       Schedule 4, Part 1, entry for Rosiglitazone

(a)        omit from the column headed “Circumstances Code”:              C3540               substitute:          C3722

(b)        omit from the column headed “Authority Requirements- Part of Circumstances”:

Compliance with Authority Required procedures - Streamlined Authority Code 3540  

substitute:            

Compliance with Authority Required procedures

[147]       Schedule 4, Part 1, entry for Rosiglitazone with Metformin

(a)        omit from the column headed “Circumstances Code”:              C3544               substitute:          C3723

(b)        omit from the column headed “Authority Requirements- Part of Circumstances”:

Compliance with Authority Required procedures - Streamlined Authority Code 3544  

substitute:            

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.