Source: https://www.legislation.gov.au/Details/F2011L01773
Timestamp: 2019-12-13 04:00:44
Document Index: 424704773

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National Health (Listing of Pharmaceutical Benefits) Amendment Instrument 2011 (No. 9) (No. PB 57 of 2011)
Details: F2011L01773
- F2011L01773
PB 57 of 2011 Lists as made
This instrument amends the National Health (Listing of Pharmaceutical Benefits) Instrument 2010 (No. PB 108 of 2010) to change all references to Medicare Australia CEO to Chief Executive Medicare and also provides 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 for various pharmaceutical benefits.
Registered 30 Aug 2011
PB 57 of 2011
(No.9)1
Dated 29 August 2011
(1) This Instrument is the National Health (Listing of Pharmaceutical Benefits) Amendment Instrument 2011 (No. 9).
(2) This Instrument may also be cited as PB 57 of 2011.
This Instrument commences on 1 September 2011.
Schedule 1 and Schedule 2 amend the National Health (Listing of Pharmaceutical Benefits) Instrument 2010 (PB 108 of 2010).
Schedule 1 Amendments relating to Medicare references
[1] Section 4, text of Note
omit: Medicare Australia CEO substitute: Chief Executive Medicare
[2] Paragraph 11(2)(a)
[3] Paragraph 11(2)(b)
[4] Paragraph 12(1)(a)
[5] Paragraph 12(1)(b)
[6] Paragraph 12(1)(c)
omit: Medicare Australia CEO (wherever occurring) substitute: Chief Executive Medicare
[7] Paragraph 12(1)(d)
omit: Medicare Australia CEO (twice occurring) substitute: Chief Executive Medicare
[8] Subsection 12(2)
[9] Subsection 12(3)
[10] Subsection 12(4)
[11] Subsection 13(1)
[12] Subparagraph 13(1)(b)(i)
[13] Subsection 13(2)
[14] Subsection 13(3)
[15] Subsection 13(4)
[16] Paragraph 13(4)(a)
(a) omit: Medicare Australia CEO substitute: Chief Executive Medicare
(b) omit: CEO substitute: Chief Executive Medicare
[17] Subsection 13(5)
[18] Subsection 13(6)
[19] Subsection 14(2)
[20] Schedule 1, entry for Adalimumab in the form Injection 40 mg in 0.8 mL pre-filled syringe [Max Quantity 2; Number of Repeats 2]
(a) omit all codes from the column headed “Circumstances” and substitute:
C2995
C3697
C3743
C3759
(b) omit all codes from the column headed “Purposes” and substitute:
P3695
P3753
[21] Schedule 1, entry for Adalimumab in the form Injection 40 mg in 0.8 mL pre-filled syringe [Max Quantity 2; Number of Repeats 3]
[22] Schedule 1, entry for Adalimumab in the form Injection 40 mg in 0.8 mL pre-filled syringe [Max Quantity 2; Number of Repeats 4]
P3758
P3759
[23] Schedule 1, entry for Adalimumab in the form Injection 40 mg in 0.8 mL pre-filled syringe [Max Quantity 2; Number of Repeats 5]
[24] Schedule 1, entry for Adalimumab in the form Injection 40 mg in 0.8 mL pre-filled pen [Max Quantity 2; Number of Repeats 2]
[25] Schedule 1, entry for Adalimumab in the form Injection 40 mg in 0.8 mL pre-filled pen [Max Quantity 2; Number of Repeats 3]
[26] Schedule 1, entry for Adalimumab in the form Injection 40 mg in 0.8 mL pre-filled pen [Max Quantity 2; Number of Repeats 4]
[27] Schedule 1, entry for Adalimumab in the form Injection 40 mg in 0.8 mL pre-filled pen [Max Quantity 2; Number of Repeats 5]
[28] Schedule 1, entry for Adalimumab in the form Injection 40 mg in 0.8 mL pre-filled syringe, 6
[29] Schedule 1, entry for Adalimumab in the form Injection 40 mg in 0.8 mL pre-filled pen, 6
[30] Schedule 1, entry for Bortezomib in the form Powder for injection 3.5 mg (with any determined brand of sodium chloride injection as the required solvent) [Max Quantity 4; Number of Repeats 2]
(b) omit both codes from the column headed “Purposes” and substitute:
[31] Schedule 1, entry for Bortezomib in the form Powder for injection 3.5 mg (with any determined brand of sodium chloride injection as the required solvent) [Max Quantity 4; Number of Repeats 3]
[32] Schedule 1, entry for Certolizumab pegol
[33] Schedule 1, entry for Etanercept in the form Injection set containing 4 vials powder for injection 25 mg and 4 pre-filled syringes solvent 1 mL [Max Quantity 2; Number of Repeats 3]
C3770
C3773
[34] Schedule 1, entry for Etanercept in the form Injection set containing 4 vials powder for injection 25 mg and 4 pre-filled syringes solvent 1 mL [Max Quantity 2; Number of Repeats 5]
[35] Schedule 1, entry for Etanercept in the form Injections 50 mg in 1 mL single use pre-filled syringes, 4 [Max Quantity 1; Number of Repeats 3]
[36] Schedule 1, entry for Etanercept in the form Injections 50 mg in 1 mL single use pre-filled syringes, 4 [Max Quantity 1;
Number of Repeats 5]
[37] Schedule 1, entry for Etanercept in the form Injection 50 mg in 1 mL single use auto-injector, 4 [Max Quantity 1; Number of Repeats 3]
[38] Schedule 1, entry for Etanercept in the form Injection 50 mg in 1 mL single use auto-injector, 4 [Max Quantity 1; Number of Repeats 5]
[39] Schedule 1, entry for Golimumab in the form Injection 50 mg in 0.5 mL single use pre-filled syringe [Max Quantity 1;
Number of Repeats 3]
[40] Schedule 1, entry for Golimumab in the form Injection 50 mg in 0.5 mL single use pre-filled syringe [Max Quantity 1;
[41] Schedule 1, entry for Golimumab in the form Injection 50 mg in 0.5 mL single use pre-filled pen [Max Quantity 1;
[42] Schedule 1, entry for Golimumab in the form Injection 50 mg in 0.5 mL single use pre-filled pen [Max Quantity 1;
[43] Schedule 1, entry for Ranibizumab
omit from the column headed “Circumstances”: C2822 substitute: C3788
[44] Schedule 1, entry for Ustekinumab in the form Injection 45 mg in 0.5 mL [Max Quantity 1; Number of Repeats 1]
C3791
C3792
[45] Schedule 1, entry for Ustekinumab in the form Injection 45 mg in 0.5 mL [Max Quantity 1; Number of Repeats 2]
[46] Schedule 1, entry for Verteporfin
[47] Schedule 4, Part 1, entry for Adalimumab [Circumstances Code C2987]
(a) omit from the column headed “Circumstances Code”: C2987 substitute: C3753
(b) omit from the column headed “Purposes Code”: P2987 substitute: P3753
(c) omit from the column headed “Circumstances and Purposes”: Medicare Australia CEO substitute: Chief Executive Medicare
[48] Schedule 4, Part 1, entry for Adalimumab [Circumstances Code C2989]
(a) omit from the column headed “Circumstances Code”: C2989 substitute: C3755
(b) omit from the column headed “Purposes Code”: P2989 substitute: P3755
(c) omit from the column headed “Circumstances and Purposes”: Medicare Australia CEO (twice occurring)
substitute: Chief Executive Medicare
[49] Schedule 4, Part 1, entry for Adalimumab [Circumstances Code C2991]
(a) omit from the column headed “Circumstances Code”: C2991 substitute: C3754
(b) omit from the column headed “Purposes Code”: P2991 substitute: P3754
[50] Schedule 4, Part 1, entry for Adalimumab [Circumstances Code C2992]
(a) omit from the column headed “Circumstances Code”: C2992 substitute: C3756
(b) omit from the column headed “Purposes Code”: P2992 substitute: P3756
[51] Schedule 4, Part 1, entry for Adalimumab [Circumstances Code C2994]
(a) omit from the column headed “Circumstances Code”: C2994 substitute: C3757
(b) omit from the column headed “Purposes Code”: P2994 substitute: P3757
[52] Schedule 4, Part 1, entry for Adalimumab [Circumstances Code C3266]
(a) omit from the column headed “Circumstances Code”: C3266 substitute: C3758
(b) omit from the column headed “Purposes Code”: P3266 substitute: P3758
[53] Schedule 4, Part 1, entry for Adalimumab [Circumstances Code C3268]
(a) omit from the column headed “Circumstances Code”: C3268 substitute: C3759
(b) omit from the column headed “Purposes Code”: P3268 substitute: P3759
[54] Schedule 4, Part 1, entry for Adalimumab [Circumstances Code C3270]
(a) omit from the column headed “Circumstances Code”: C3270 substitute: C3760
(b) omit from the column headed “Purposes Code”: P3270 substitute: P3760
[55] Schedule 4, Part 1, entry for Adalimumab [Circumstances Code C3272]
(a) omit from the column headed “Circumstances Code”: C3272 substitute: C3761
(b) omit from the column headed “Purposes Code”: P3272 substitute: P3761
[56] Schedule 4, Part 1, entry for Adalimumab [Circumstances Code C3487]
(a) omit from the column headed “Circumstances Code”: C3487 substitute: C3749
(b) omit from the column headed “Purposes Code”: P3487 substitute: P3749
[57] Schedule 4, Part 1, entry for Adalimumab [Circumstances Code C3488]
(a) omit from the column headed “Circumstances Code”: C3488 substitute: C3750
(b) omit from the column headed “Purposes Code”: P3488 substitute: P3750
[58] Schedule 4, Part 1, entry for Adalimumab [Circumstances Code C3503]
(a) omit from the column headed “Circumstances Code”: C3503 substitute: C3751
(b) omit from the column headed “Purposes Code”: P3503 substitute: P3751
[59] Schedule 4, Part 1, entry for Adalimumab [Circumstances Code C3504]
(a) omit from the column headed “Circumstances Code”: C3504 substitute: C3752
(b) omit from the column headed “Purposes Code”: P3504 substitute: P3752
[60] Schedule 4, Part 1, entry for Adalimumab [Circumstances Code C3521]
(a) omit from the column headed “Circumstances Code”: C3521 substitute: C3743
(b) omit from the column headed “Purposes Code”: P3521 substitute: P3743
[61] Schedule 4, Part 1, entry for Adalimumab [Circumstances Code C3523]
(a) omit from the column headed “Circumstances Code”: C3523 substitute: C3744
(b) omit from the column headed “Purposes Code”: P3523 substitute: P3744
[62] Schedule 4, Part 1, entry for Adalimumab [Circumstances Code C3570]
(a) omit from the column headed “Circumstances Code”: C3570 substitute: C3746
(b) omit from the column headed “Purposes Code”: P3570 substitute: P3746
[63] Schedule 4, Part 1, entry for Adalimumab [Circumstances Code C3696]
(a) omit from the column headed “Circumstances Code”: C3696 substitute: C3747
(b) omit from the column headed “Purposes Code”: P3696 substitute: P3747
[64] Schedule 4, Part 1, entry for Adalimumab [Circumstances Code C3698]
(a) omit from the column headed “Circumstances Code”: C3698 substitute: C3748
(b) omit from the column headed “Purposes Code”: P3698 substitute: P3748
[65] Schedule 4, Part 1, entry for Adalimumab [Circumstances Code C3707]
(a) omit from the column headed “Circumstances Code”: C3707 substitute: C3745
(b) omit from the column headed “Purposes Code”: P3707 substitute: P3745
[66] Schedule 4, Part 1, entry for Adalimumab
display existing and re-numbered (amended) Circumstances and Purposes in numerical order
[67] Schedule 4, Part 1, entry for Bortezomib [Circumstances Code C3196]
(a) omit from the column headed “Circumstances Code”: C3196 substitute: C3765
(b) omit from the column headed “Purposes Code”: P3196 substitute: P3765
[68] Schedule 4, Part 1, entry for Bortezomib [Circumstances Code C3681]
(a) omit from the column headed “Circumstances Code”: C3681 substitute: C3766
(b) omit from the column headed “Purposes Code”: P3681 substitute: P3766
[69] Schedule 4, Part 1, entry for Bortezomib [Circumstances Code C3682]
(a) omit from the column headed “Circumstances Code”: C3682 substitute: C3767
(b) omit from the column headed “Purposes Code”: P3682 substitute: P3767
(c) omit from the column headed “Circumstances and Purposes”, paragraph (g): authorization substitute: authorisation
(d) omit from the column headed “Circumstances and Purposes”: Medicare Australia CEO substitute: Chief Executive Medicare
[70] Schedule 4, Part 1, entry for Bortezomib [Circumstances Code C3683]
(a) omit from the column headed “Circumstances Code”: C3683 substitute: C3762
(b) omit from the column headed “Purposes Code”: P3683 substitute: P3762
[71] Schedule 4, Part 1, entry for Bortezomib [Circumstances Code C3684]
(a) omit from the column headed “Circumstances Code”: C3684 substitute: C3763
(b) omit from the column headed “Purposes Code”: P3684 substitute: P3763
[72] Schedule 4, Part 1, entry for Bortezomib [Circumstances Code C3685]
(a) omit from the column headed “Circumstances Code”: C3685 substitute: C3764
(b) omit from the column headed “Purposes Code”: P3685 substitute: P3764
[73] Schedule 4, Part 1, entry for Bortezomib
display re-numbered (amended) Circumstances and Purposes in numerical order
[74] Schedule 4, Part 1, entry for Certolizumab pegol [Circumstances Code C3564]
(a) omit from the column headed “Circumstances Code”: C3564 substitute: C3768
(b) omit from the column headed “Circumstances and Purposes”: Medicare Australia CEO (twice occurring)
[75] Schedule 4, Part 1, entry for Certolizumab pegol [Circumstances Code C3715]
(a) omit from the column headed “Circumstances Code”: C3715 substitute: C3769
(b) omit from the column headed “Circumstances and Purposes”: Medicare Australia CEO substitute: Chief Executive Medicare
[76] Schedule 4, Part 1, entry for Certolizumab pegol
[77] Schedule 4, Part 1, entry for Etanercept [Circumstances Code C3274]
(a) omit from the column headed “Circumstances Code”: C3274 substitute: C3778
(b) omit from the column headed “Purposes Code”: P3274 substitute: P3778
[78] Schedule 4, Part 1, entry for Etanercept [Circumstances Code C3276]
(a) omit from the column headed “Circumstances Code”: C3276 substitute: C3779
(b) omit from the column headed “Purposes Code”: P3276 substitute: P3779
[79] Schedule 4, Part 1, entry for Etanercept [Circumstances Code C3277]
(a) omit from the column headed “Circumstances Code”: C3277 substitute: C3780
(b) omit from the column headed “Purposes Code”: P3277 substitute: P3780
[80] Schedule 4, Part 1, entry for Etanercept [Circumstances Code C3278]
(a) omit from the column headed “Circumstances Code”: C3278 substitute: C3781
(b) omit from the column headed “Purposes Code”: P3278 substitute: P3781
[81] Schedule 4, Part 1, entry for Etanercept [Circumstances Code C3490]
(a) omit from the column headed “Circumstances Code”: C3490 substitute: C3776
(b) omit from the column headed “Purposes Code”: P3490 substitute: P3776
[82] Schedule 4, Part 1, entry for Etanercept [Circumstances Code C3491]
(a) omit from the column headed “Circumstances Code”: C3491 substitute: C3777
(b) omit from the column headed “Purposes Code”: P3491 substitute: P3777
[83] Schedule 4, Part 1, entry for Etanercept [Circumstances Code C3511]
(a) omit from the column headed “Circumstances Code”: C3511 substitute: C3774
(b) omit from the column headed “Purposes Code”: P3511 substitute: P3774
[84] Schedule 4, Part 1, entry for Etanercept [Circumstances Code C3512]
(a) omit from the column headed “Circumstances Code”: C3512 substitute: C3775
(b) omit from the column headed “Purposes Code”: P3512 substitute: P3775
[85] Schedule 4, Part 1, entry for Etanercept [Circumstances Code C3525]
(a) omit from the column headed “Circumstances Code”: C3525 substitute: C3770
(b) omit from the column headed “Purposes Code”: P3525 substitute: P3770
[86] Schedule 4, Part 1, entry for Etanercept [Circumstances Code C3526]
(a) omit from the column headed “Circumstances Code”: C3526 substitute: C3771
(b) omit from the column headed “Purposes Code”: P3526 substitute: P3771
[87] Schedule 4, Part 1, entry for Etanercept [Circumstances Code C3567]
(a) omit from the column headed “Circumstances Code”: C3567 substitute: C3773
(b) omit from the column headed “Purposes Code”: P3567 substitute: P3773
[88] Schedule 4, Part 1, entry for Etanercept [Circumstances Code C3709]
(a) omit from the column headed “Circumstances Code”: C3709 substitute: C3772
(b) omit from the column headed “Purposes Code”: P3709 substitute: P3772
[89] Schedule 4, Part 1, entry for Etanercept
[90] Schedule 4, Part 1, entry for Golimumab [Circumstances Code C3496]
(a) omit from the column headed “Circumstances Code”: C3496 substitute: C3784
(b) omit from the column headed “Purposes Code”: P3496 substitute: P3784
[91] Schedule 4, Part 1, entry for Golimumab [Circumstances Code C3498]
(a) omit from the column headed “Circumstances Code”: C3498 substitute: C3785
(b) omit from the column headed “Purposes Code”: P3498 substitute: P3785
[92] Schedule 4, Part 1, entry for Golimumab [Circumstances Code C3517]
(a) omit from the column headed “Circumstances Code”: C3517 substitute: C3786
(b) omit from the column headed “Purposes Code”: P3517 substitute: P3786
[93] Schedule 4, Part 1, entry for Golimumab [Circumstances Code C3519]
(a) omit from the column headed “Circumstances Code”: C3519 substitute: C3787
(b) omit from the column headed “Purposes Code”: P3519 substitute: P3787
[94] Schedule 4, Part 1, entry for Golimumab [Circumstances Code C3578]
(a) omit from the column headed “Circumstances Code”: C3578 substitute: C3783
(b) omit from the column headed “Purposes Code”: P3578 substitute: P3783
[95] Schedule 4, Part 1, entry for Golimumab [Circumstances Code C3719]
(a) omit from the column headed “Circumstances Code”: C3719 substitute: C3782
(b) omit from the column headed “Purposes Code”: P3719 substitute: P3782
[96] Schedule 4, Part 1, entry for Golimumab
[97] Schedule 4, Part 1, entry for Ranibizumab [Circumstances Code C2822]
(a) omit from the column headed “Circumstances Code”: C2822 substitute: C3788
[98] Schedule 4, Part 1, entry for Ustekinumab [Circumstances Code C3249]
(a) omit from the column headed “Circumstances Code”: C3249 substitute: C3789
(b) omit from the column headed “Purposes Code”: P3249 substitute: P3789
[99] Schedule 4, Part 1, entry for Ustekinumab [Circumstances Code C3251]
(a) omit from the column headed “Circumstances Code”: C3251 substitute: C3790
(b) omit from the column headed “Purposes Code”: P3251 substitute: P3790
[100] Schedule 4, Part 1, entry for Ustekinumab [Circumstances Code C3253]
(a) omit from the column headed “Circumstances Code”: C3253 substitute: C3791
(b) omit from the column headed “Purposes Code”: P3253 substitute: P3791
[101] Schedule 4, Part 1, entry for Ustekinumab [Circumstances Code C3255]
(a) omit from the column headed “Circumstances Code”: C3255 substitute: C3792
(b) omit from the column headed “Purposes Code”: P3255 substitute: P3792
[102] Schedule 4, Part 1, entry for Ustekinumab
[103] Schedule 4, Part 1, entry for Verteporfin [Circumstances Code C2683]
(a) omit from the column headed “Circumstances Code”: C2683 substitute: C3793
[104] Schedule 4, Part 1, entry for Verteporfin [Circumstances Code C2684]
(a) omit from the column headed “Circumstances Code”: C2684 substitute: C3794
[105] Schedule 4, Part 1, entry for Verteporfin [Circumstances Code C2685]
(a) omit from the column headed “Circumstances Code”: C2685 substitute: C3795
Schedule 2 Amendments relating to PBS changes
[1] Schedule 1, omit entry for Amiloride
[2] Schedule 1, entry for Bromocriptine in the form Capsule 5 mg (as mesylate)
[3] Schedule 1, entry for Bromocriptine in the form Capsule 10 mg (as mesylate)
[4] Schedule 1, after entry for Buprenorphine with naloxone in the form Tablet (sublingual) 8 mg (as hydrochloride)-2 mg (as hydrochloride)
Film (soluble) 2 mg (as hydrochloride)-0.5 mg (as hydrochloride)
Suboxone Film 2/0.5
Film (soluble) 8 mg (as hydrochloride)-2 mg (as hydrochloride)
Suboxone Film 8/2
[5] Schedule 1, entry for Calcipotriol
omit from the column headed “Responsible Person” (twice occurring): CS substitute: LO
[6] Schedule 1, entry for Calcipotriol with betamethasone in the form Ointment containing calcipotriol 50 micrograms with betamethasone 500 micrograms (as dipropionate) per g, 30 g
omit from the column headed “Responsible Person”: CS substitute: LO
[7] Schedule 1, after entry for Calcipotriol with betamethasone in the form Ointment containing calcipotriol 50 micrograms with betamethasone 500 micrograms (as dipropionate) per g, 30 g
Gel containing calcipotriol 50 micrograms with betamethasone 500 micrograms (as dipropionate) per g, 30 g
[8] Schedule 1, entry for Cetuximab in the form Solution for I.V. infusion 100 mg in 20 mL [Max Quantity 1; Number of Repeats 0]
C3843
[9] Schedule 1, entry for Cetuximab in the form Solution for I.V. infusion 100 mg in 20 mL [Max Quantity 1; Number of Repeats 6]
[10] Schedule 1, entry for Cetuximab Solution for I.V. infusion 500 mg in 100 mL [Max Quantity 1; Number of Repeats 0]
[11] Schedule 1, entry for Cetuximab in the form Solution for I.V. infusion 500 mg in 100 mL [Max Quantity 1; Number of Repeats 6]
[12] Schedule 1, entry for Cimetidine
Magicul 200
[13] Schedule 1, entry for Ciprofloxacin in the form Eye drops 3 mg (as hydrochloride) per mL, 5 mL
CiloQuin
[14] Schedule 1, after entry for Clopidogrel in the form Tablet 75 mg (as besilate) (Clovix 75)
Clopidogrel-DRLA
C1719 C1720
C1721 C1722
C1723 C1724
[15] Schedule 1, omit entry for Clotrimazole
[16] Schedule 1, entry for Dalteparin in each of the forms: Injection containing dalteparin sodium 2,500 I.U. (anti-Xa) in 0.2 mL single dose pre-filled syringe; and Injection containing dalteparin sodium 5,000 I.U. (anti-Xa) in 0.2 mL single dose pre-filled syringe
(a) omit from the column headed “Max Quantity”: 10 substitute: 20
(b) omit from the column headed “Number of Repeats”: 1 substitute: 0
[17] Schedule 1, after entry for Dalteparin in the form Injection containing dalteparin sodium 10,000 I.U. (anti-Xa) in 1 mL single dose
[18] Schedule 1, entry for Deferasirox
omit all codes from the column headed “Circumstances” (all instances) and substitute:
[19] Schedule 1, entry for Dexamethasone
[20] Schedule 1, entry for Doxycycline in the form Tablet 100 mg (as hydrochloride)
[21] Schedule 1, after entry for Enoxaparin in the form Injection containing enoxaparin sodium 80 mg (8,000 I.U. anti-Xa) in 0.8 mL pre-filled syringe
[22] Schedule 1, after entry for Enoxaparin in the form Injection containing enoxaparin sodium 100 mg (10,000 I.U. anti-Xa) in 1 mL pre-filled syringe
[23] Schedule 1, entry for Escitalopram in each of the forms: Tablet 10 mg (as oxalate); and Tablet 20 mg (as oxalate)
[24] Schedule 1, entry for Exemestane in the form Tablet 25 mg
C1541 C2457
[25] Schedule 1, after entry for Fentanyl in the form Lozenges 1600 micrograms (as citrate), 30
Denpax
Fenpatch 12
[26] Schedule 1, after entry for Fentanyl in the form Transdermal patch 2.55 mg
Fenpatch 25
[27] Schedule 1, after entry for Fentanyl in the form Transdermal patch 7.65 mg
Fenpatch 50
[28] Schedule 1, after entry for Fentanyl in the form Transdermal patch 10.20 mg
Fenpatch 75
[29] Schedule 1, after entry for Fentanyl in the form Transdermal patch 12.6 mg
Fenpatch 100
[30] Schedule 1, after entry for Fentanyl in the form Transdermal patch 16.8 mg
Tablet 200 mg (equivalent to 67.5 mg iron)
[31] Schedule 1, entry for Filgrastim in each of the forms Injection 120 micrograms in 0.2 mL single use pre-filled syringe (Nivestim); Injection 300 micrograms in 1 mL; Injection 300 micrograms in 0.5 mL single use pre-filled syringe (Neupogen); Injection 300 micrograms in 0.5 mL single use pre-filled syringe (Nivestim); Injection 480 micrograms in 1.6 mL; Injection 480 micrograms in 0.5 mL single use pre-filled syringe (Neupogen); and Injection 480 micrograms in 0.5 mL single use pre-filled syringe (Nivestim)
insert in numerical order in the column headed “Circumstances”:
C3833 C3834
[32] Schedule 1, after entry for Filgrastim in the form Injection 480 micrograms in 0.5 mL single use pre-filled syringe (Nivestim)
C3845 C3846
[33] Schedule 1, after entry for Fluconazole in the form Capsule 200 mg (Ozole)
C3835 C3836
C3837 C3838
C3839 C3840
[34] Schedule 1, entry for Flupenthixol Decanoate
Oily I.M. injection 20 mg in 1 mL
[35] Schedule 1, entry for Folinic acid
omit from the column headed “Authorised Prescriber” (all instances): NP
[36] Schedule 1, entry for Gabapentin in the form Capsule 100 mg
[37] Schedule 1, entry for Gentamicin
C1188 C1391
C1391 C1714
[38] Schedule 1, after entry for Glucose Indicator—Blood in the form Test strips, 50 (SensoCard)
Test strips, 50 (TRUEbalance)
Test strips, 50 (TRUEresult)
[39] Schedule 1, entry for Imatinib in the form Tablet 100 mg (as mesylate) [Max Quantity 60; Number of Repeats 2]
(a) omit from the column headed “Circumstances”:
C3232 C3451
(b) insert in numerical order in the column headed “Circumstances”:
C3847 C3848
C3849 C3850
(c) omit from the column headed “Purposes”:
P3232 P3451
(d) insert in numerical order in the column headed “Purposes”:
P3849 P3850
[40] Schedule 1, entry for Imatinib in the form Tablet 100 mg (as mesylate) [Max Quantity 60; Number of Repeats 5]
(c) insert in numerical order in the column headed “Purposes”:
P3847 P3848
[41] Schedule 1, entry for Imatinib in the form Tablet 400 mg (as mesylate) [Max Quantity 30; Number of Repeats 2]
[42] Schedule 1, entry for Imatinib in the form Tablet 400 mg (as mesylate) [Max Quantity 30; Number of Repeats 5]
[43] Schedule 1, entry for Isosorbide Dinitrate
[44] Schedule 1, entry for Leflunomide in the form Tablet 10 mg [for the brands APO-Leflunomide; Lunava 10]
(a) omit from the column headed “Purposes”: 30 (leave column blank)
(b) omit from the column headed “Max Quantity”: 5 substitute: 30
(c) insert in the column headed “Number of Repeats”: 5
[45] Schedule 1, entry for Leflunomide in the form Tablet 20 mg [for the brands APO-Leflunomide; Lunava 20]
[46] Schedule 1, entry for Mesalazine in the form Suppository 1 g
omit from the column headed “Max Quantity”: 28 substitute: 30
[47] Schedule 1, entry for Minocycline
Akamin 100
[48] Schedule 1, omit entry for Neomycin
[49] Schedule 1, after entry for Ofloxacin in the form Eye drops 3 mg per mL, 5 mL
[50] Schedule 1, entry for Ondansetron in each of the forms: I.V. injection 4 mg (as hydrochloride dihydrate) in 2 mL; and I.V. injection 8 mg (as hydrochloride dihydrate) in 4 mL
[51] Schedule 1, entry for Pegfilgrastim in the form Injection 6 mg in 0.6 mL single use pre-filled syringe
[52] Schedule 1, entry for Perindopril in the form Tablet containing perindopril erbumine 2 mg
Idaprex 2
[53] Schedule 1, entry for Perindopril in the form Tablet containing perindopril erbumine 4 mg
Idaprex 4
[54] Schedule 1, entry for Perindopril in the form Tablet containing perindopril erbumine 8 mg
Idaprex 8
[55] Schedule 1, entry for Perindopril with Indapamide in the form Tablet containing perindopril erbumine 4 mg with indapamide hemihydrate 1.25 mg
[56] Schedule 1, entry for Pramipexole in the form Tablet (extended release) containing pramipexole hydrochloride 375 micrograms
omit from the column headed “Number of Repeats”: 0 substitute: 5
[57] Schedule 1, entry for Prednisolone with Phenylephrine
C1077 C1465
[58] Schedule 1, entry for Quinapril in each of the forms: Tablet 5 mg (as hydrochloride); Tablet 10 mg (as hydrochloride); and Tablet 20 mg (as hydrochloride)
omit from the column headed “Responsible Person”: AL substitute: FZ
[59] Schedule 1, entry for Risperidone in each of the forms: I.M. injection (modified release), set containing 1 vial powder for injection 25 mg and 1 pre-filled syringe diluent 2 mL; I.M. injection (modified release), set containing 1 vial powder for injection 37.5 mg and 1 pre-filled syringe diluent 2 mL; and I.M. injection (modified release), set containing 1 vial powder for injection 50 mg and 1 pre-filled syringe diluent 2 mL
[60] Schedule 1, omit entry for Sulindac
[61] Schedule 1, entry for Tobramycin
[62] Schedule 1, entry for Trimethoprim with Sulfamethoxazole
Tablet 80 mg-400 mg
[63] Schedule 1, after entry for Zonisamide in the form Capsule 100 mg
Oily I.M. injection 200 mg in 1 mL
[64] Schedule 3
[65] Schedule 3, after details relevant to Responsible Person code LN
72 147 880 617
[66] Schedule 4, Part 1, entry for Calcipotriol with betamethasone
insert after existing text in the columns in the order indicated:
Chronic stable plaque type psoriasis vulgaris of the scalp in a patient who is not adequately controlled with either calcipotriol or potent topical corticosteroid monotherapy
[67] Schedule 4, Part 1, entry for Cetuximab
Initial PBS-subsidised treatment, as monotherapy or in combination with an irinotecan based therapy, of a patient with a World Health Organisation performance status of 2 or less and with K-RAS wild type metastatic colorectal cancer after failure of first-line chemotherapy
Continuing PBS-subsidised treatment, as monotherapy or in combination with an irinotecan based therapy, of a patient with K-RAS wild type metastatic colorectal cancer who has previously been issued with an authority prescription for cetuximab and who does not have progressive disease
[68] Schedule 4, Part 1, entry for Ciprofloxacin
Bacterial keratitis under the supervision and direction of an ophthalmologist
[69] Schedule 4, omit entry for Clotrimazole
[70] Schedule 4, Part 1, entry for Deferasirox
Chronic iron overload in patients with disorders of erythropoiesis
Compliance with Authority Required procedures - Streamlined Authority Code 3828
[71] Schedule 4, Part 1, entry for Filgrastim
A patient being treated with aggressive chemotherapy with the intention of achieving a cure or substantial remission in Hodgkin disease (first-line chemotherapy with escalated BEACOPP)
Compliance with Authority Required procedures - Streamlined Authority Code 3834
[72] Schedule 4, Part 1, after entry for Filgrastim
Initial treatment, as monotherapy, of clinically definite relapsing-remitting multiple sclerosis in an ambulatory (without assistance or support) patient who has experienced at least 2 documented attacks of neurological dysfunction, believed to be due to the multiple sclerosis, in the preceding 2 years. The diagnosis must be confirmed by magnetic resonance imaging (MRI) of the brain and/or spinal cord and the date of the scan included in the authority application, unless the authority application is accompanied by written certification provided by a radiologist that an MRI scan is contraindicated because of the risk of physical (not psychological) injury to the patient. The authority will be limited to the maximum quantity and number of repeats indicated in Schedule 1
Continuing treatment, as monotherapy, of clinically definite relapsing-remitting multiple sclerosis in a patient previously issued with an authority prescription for this drug who does not show continuing progression of disability while on treatment with this drug and who has demonstrated compliance with, and an ability to tolerate, this therapy. Authorities will be limited to the maximum quantity and number of repeats indicated in Schedule 1
[73] Schedule 4, Part 1, entry for Fluconazole
Treatment of cryptococcal meningitis in a patient unable to take a solid dose form of fluconazole
Maintenance therapy in a patient with cryptococcal meningitis and immunosuppression unable to take a solid dose form of fluconazole
Treatment of oropharyngeal candidiasis in an immunosuppressed patient unable to take a solid dose form of fluconazole
C3838
Treatment of oesophageal candidiasis in an immunosuppressed patient unable to take a solid dose form of fluconazole
Prophylaxis of oropharyngeal candidiasis in an immunosuppressed patient unable to take a solid dose form of fluconazole
Treatment of serious and life-threatening candida infections in a patient unable to take a solid dose form of fluconazole
[74] Schedule 4, Part 1, entry for Imatinib
Continuing PBS-subsidised treatment, at a dose of up to 600 mg per day, of adult patients with a metastatic or unresectable malignant gastrointestinal stromal tumour who have previously been issued with an authority prescription for this drug, and where the patient has not failed to respond, or is not intolerant, to imatinib
Initial PBS-subsidised treatment, for up to 3 months, of adult patients with a metastatic or unresectable malignant gastrointestinal stromal tumour which has been histologically confirmed by the detection of CD117 on immunohistochemical staining, where patients commence treatment at a dose that does not exceed 400 mg per day for at least 3 months, and where the application for authorisation includes a completed copy of the appropriate Imatinib Mesylate (Glivec) PBS Authority Application for Use in the Treatment of Gastrointestinal Stromal Tumour - Supporting Information Form which includes the following:
(i) a copy of a pathology report from an Approved Pathology Authority supporting the diagnosis of a gastrointestinal stromal tumour and confirming the presence of CD117 on immunohistochemical staining; and
(ii) a copy of the most recent (within 2 months of the application) computed tomography (CT) scan, magnetic resonance imaging (MRI) or ultrasound assessment of the tumour or tumours, including whether or not there is evidence of metastatic disease; and
(iii) where the application for authority to prescribe is being sought on the basis of an unresectable tumour, written evidence in support of that claim
Resectable gastrointestinal stromal tumour
Adjuvant treatment of a patient at high risk of recurrence following complete resection of primary gastrointestinal stromal tumour (GIST) which has been histologically confirmed by the detection of CD117 on immunohistochemical staining, at a dose not exceeding 400 mg per day for a period of 12 months.
High risk of recurrence is defined as:
Primary GIST greater than 5 cm with a mitotic count of greater than 5/50 high power fields (HPF); or
Primary GIST greater than 10 cm with any mitotic rate; or
Primary GIST with a mitotic count of greater than 10/50 HPF.
(2) a completed Imatinib Mesylate (Glivec) PBS Authority Application for Use in Adjuvant Treatment of Gastrointestinal Stromal Tumour - Supporting Information Form which includes the following:
(ii) a copy of the pathology report must include the size and mitotic rate of the tumour, and the date of tumour resection must be documented, which must not be more than 3 months prior to the date of this application
Initial treatment of a patient who was receiving adjuvant imatinib mesylate for gastrointestinal stromal tumour (GIST) prior to 1 September 2011 and who meets the PBS eligibility criteria for adjuvant treatment with imatinib mesylate of a patient at high risk of recurrence following complete resection of primary GIST. The patient is eligible to receive sufficient imatinib at a dose of 400 mg per day to complete 12 months of combined PBS-subsidised and non-PBS-subsidised therapy.
(ii) a copy of the pathology report must include the size and mitotic rate of the tumour, and the date of tumour resection must be documented
Metastatic or unresectable gastrointestinal stromal tumour
Initial PBS-subsidised treatment, for up to 3 months, of a patient with a metastatic or unresectable malignant gastrointestinal stromal tumour which has been histologically confirmed by the detection of CD117 on immunohistochemical staining, where treatment is commenced at a dose that does not exceed 400 mg per day for at least 3 months, and where the application for authorisation is made in writing and includes a completed copy of the appropriate Imatinib Mesylate (Glivec) PBS Authority Application for Use in the Treatment of Metastatic or Unresectable Gastrointestinal Stromal Tumour - Supporting Information Form which includes the following:
Continuing PBS-subsidised treatment, at a dose of up to 600 mg per day, of a patient with a metastatic or unresectable malignant gastrointestinal stromal tumour who has previously been issued with an authority prescription for this drug, and where the patient has not failed to respond, or is not intolerant, to imatinib
[75] Schedule 4, Part 1, entry for Ofloxacin
Bacterial keratitis under the supervision and direction of an ophthalmologist.
[76] Schedule 4, Part 1, entry for Pegfilgrastim [Circumstances Code C2929]
omit text from column headed “Authority Required ─ Part of Circumstances” and substitute:
[77] Schedule 4, Part 1, entry for Pegfilgrastim [Circumstances Code C2930]
[78] Schedule 4, Part 1, entry for Pegfilgrastim
Compliance with Authority Required procedures - Streamlined Authority Code C3834
[79] Schedule 4, Part 1, entry for Risperidone
Maintenance treatment, in combination with lithium or sodium valproate, of treatment refractory bipolar I disorder
Compliance with Authority Required procedures - Streamlined Authority Code C3841
[80] Schedule 4, Part 1, omit entry for Sulindac