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.