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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.
Administered by: Health
Registered 30 Aug 2011
Tabling HistoryDate
Tabled HR12-Sep-2011
Tabled Senate12-Sep-2011
Date of repeal 19 Mar 2014
Repealed by Health (Spent and Redundant Instruments) Repeal Regulation 2014

PB 57 of 2011

National Health (Listing of Pharmaceutical Benefits) Amendment Instrument 2011
(No.9)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 29 August 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. 9).

            (2)        This Instrument may also be cited as PB 57 of 2011.

2          Commencement

            This Instrument commences on 1 September 2011.  

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

            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)

omit:       Medicare Australia CEO                               substitute:             Chief Executive Medicare

[3] Paragraph 11(2)(b)

omit:       Medicare Australia CEO                               substitute:             Chief Executive Medicare

[4] Paragraph 12(1)(a)

omit:       Medicare Australia CEO                               substitute:             Chief Executive Medicare

[5] Paragraph 12(1)(b)

omit:       Medicare Australia CEO                               substitute:             Chief Executive Medicare

[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)

omit:       Medicare Australia CEO                               substitute:             Chief Executive Medicare

[9] Subsection 12(3)

omit:       Medicare Australia CEO                               substitute:             Chief Executive Medicare

[10]         Subsection 12(4)

omit:       Medicare Australia CEO                               substitute:             Chief Executive Medicare

[11]         Subsection 13(1)

omit:       Medicare Australia CEO                               substitute:             Chief Executive Medicare

[12]         Subparagraph 13(1)(b)(i)

omit:       Medicare Australia CEO                               substitute:             Chief Executive Medicare

[13]         Subsection 13(2)

omit:       Medicare Australia CEO (twice occurring)                              substitute:             Chief Executive Medicare

[14]         Subsection 13(3)

omit:       Medicare Australia CEO                               substitute:             Chief Executive Medicare

[15]         Subsection 13(4)

omit:       Medicare Australia CEO                               substitute:             Chief Executive Medicare

[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)

omit:       Medicare Australia CEO                               substitute:             Chief Executive Medicare

[18]         Subsection 13(6)

omit:       Medicare Australia CEO                               substitute:             Chief Executive Medicare

[19]         Subsection 14(2)

omit:       Medicare Australia CEO                               substitute:             Chief Executive Medicare

[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:

C2986

C2988

C2990

C2993

C2995

C3265

C3267

C3486

C3502

C3520

C3522

C3695

C3697

C3706

C3743

C3744

C3745

C3746

C3747

C3748

C3749

C3750

C3751

C3752

C3753

C3754

C3755

C3756

C3757

C3758

C3759

C3760

C3761

 

(b)           omit all codes from the column headed “Purposes” and substitute:

P2986

P2990

P2993

P3695

P3747

P3753

P3754

 

[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]

(a)           omit all codes from the column headed “Circumstances” and substitute:

C2986

C2988

C2990

C2993

C2995

C3265

C3267

C3486

C3502

C3520

C3522

C3695

C3697

C3706

C3743

C3744

C3745

C3746

C3747

C3748

C3749

C3750

C3751

C3752

C3753

C3754

C3755

C3756

C3757

C3758

C3759

C3760

C3761

 

(b)           omit all codes from the column headed “Purposes” and substitute:

P3486

P3502

P3520

P3706

P3743

P3745

P3749

P3751

[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]

(a)           omit all codes from the column headed “Circumstances” and substitute:

C2986

C2988

C2990

C2993

C2995

C3265

C3267

C3486

C3502

C3520

C3522

C3695

C3697

C3706

C3743

C3744

C3745

C3746

C3747

C3748

C3749

C3750

C3751

C3752

C3753

C3754

C3755

C3756

C3757

C3758

C3759

C3760

C3761

 

(b)           omit all codes from the column headed “Purposes” and substitute:

P3265

P3267

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]

(a)           omit all codes from the column headed “Circumstances” and substitute:

C2986

C2988

C2990

C2993

C2995

C3265

C3267

C3486

C3502

C3520

C3522

C3695

C3697

C3706

C3743

C3744

C3745

C3746

C3747

C3748

C3749

C3750

C3751

C3752

C3753

C3754

C3755

C3756

C3757

C3758

C3759

C3760

C3761

 

(b)           omit all codes from the column headed “Purposes” and substitute:

P2988

P2995

P3522

P3697

P3744

P3746

P3748

P3750

P3752

P3755

P3756

P3757

P3760

P3761

[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]

(a)           omit all codes from the column headed “Circumstances” and substitute:

C2986

C2988

C2990

C2993

C2995

C3265

C3267

C3486

C3502

C3520

C3522

C3695

C3697

C3706

C3743

C3744

C3745

C3746

C3747

C3748

C3749

C3750

C3751

C3752

C3753

C3754

C3755

C3756

C3757

C3758

C3759

C3760

C3761

 

(b)           omit all codes from the column headed “Purposes” and substitute:

P2986

P2990

P2993

P3695

P3747

P3753

P3754

 

[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]

(a)           omit all codes from the column headed “Circumstances” and substitute:

C2986

C2988

C2990

C2993

C2995

C3265

C3267

C3486

C3502

C3520

C3522

C3695

C3697

C3706

C3743

C3744

C3745

C3746

C3747

C3748

C3749

C3750

C3751

C3752

C3753

C3754

C3755

C3756

C3757

C3758

C3759

C3760

C3761

 

(b)           omit all codes from the column headed “Purposes” and substitute:

P3486

P3502

P3520

P3706

P3743

P3745

P3749

P3751

[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]

(a)           omit all codes from the column headed “Circumstances” and substitute:

C2986

C2988

C2990

C2993

C2995

C3265

C3267

C3486

C3502

C3520

C3522

C3695

C3697

C3706

C3743

C3744

C3745

C3746

C3747

C3748

C3749

C3750

C3751

C3752

C3753

C3754

C3755

C3756

C3757

C3758

C3759

C3760

C3761

 

(b)           omit all codes from the column headed “Purposes” and substitute:

P3265

P3267

P3758

P3759

[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]

(a)           omit all codes from the column headed “Circumstances” and substitute:

C2986

C2988

C2990

C2993

C2995

C3265

C3267

C3486

C3502

C3520

C3522

C3695

C3697

C3706

C3743

C3744

C3745

C3746

C3747

C3748

C3749

C370

C3751

C3752

C3753

C3754

C3755

C3756

C3757

C3758

C3759

C3760

C3761

 

(b)           omit all codes from the column headed “Purposes” and substitute:

P2988

P2995

P3522

P3697

P3744

P3746

P3748

P3750

P3752

P3755

P3756

P3757

P3760

P3761

[28]         Schedule 1, entry for Adalimumab in the form Injection 40 mg in 0.8 mL pre-filled syringe, 6

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

C2986

C2990

C2993

C3695

C3747

C3753

C3754

 

[29]         Schedule 1, entry for Adalimumab in the form Injection 40 mg in 0.8 mL pre-filled pen, 6

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

C2986

C2990

C2993

C3695

C3747

C3753

C3754

 

[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]

(a)           omit all codes from the column headed “Circumstances” and substitute:

C3762

C3763

C3764

C3765

C3766

C3767

(b)           omit both codes from the column headed “Purposes” and substitute:

P3764

P3767

[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]

(a)           omit all codes from the column headed “Circumstances” and substitute:

C3762

C3763

C3764

C3765

C3766

C3767

(b)           omit all codes from the column headed “Purposes” and substitute:

P3762

P3763

P3765

P3766

[32]         Schedule 1, entry for Certolizumab pegol

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

C3476

C3714

C3768

C3769

[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]

(a)           omit all codes from the column headed “Circumstances” and substitute:

C3273

C3275

C3489

C3510

C3524

C3708

C3770

C3771

C3772

C3773

C3774

C3775

C3776

C3777

C3778

C3779

C3780

C3781

(b)           omit all codes from the column headed “Purposes” and substitute:

P3273

P3275

P3489

P3510

P3524

P3708

P3770

P3772

P3774

P3776

P3778

P3779

[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]

(a)           omit all codes from the column headed “Circumstances” and substitute:

C3273

C3275

C3489

C3510

C3524

C3708

C3770

C3771

C3772

C3773

C3774

C3775

C3776

C3777

C3778

C3779

C3780

C3781

(b)           omit all codes from the column headed “Purposes” and substitute:

P3771

P3773

P3775

P3777

P3780

P3781

[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]

(a)           omit all codes from the column headed “Circumstances” and substitute:

C3273

C3275

C3489

C3510

C3524

C3708

C3770

C3771

C3772

C3773

C3774

C3775

C3776

C3777

C3778

C3779

C3780

C3781

(b)           omit all codes from the column headed “Purposes” and substitute:

P3273

P3275

P3489

P3510

P3524

P3708

P3770

P3772

P3774

P3776

P3778

P3779

 


[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]

(a)           omit all codes from the column headed “Circumstances” and substitute:

C3273

C3275

C3489

C3510

C3524

C3708

C3770

C3771

C3772

C3773

C3774

C3775

C3776

C3777

C3778

C3779

C3780

C3781

(b)           omit all codes from the column headed “Purposes” and substitute:

P3771

P3773

P3775

P3777

P3780

P3781

[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]

(a)           omit all codes from the column headed “Circumstances” and substitute:

C3273

C3275

C3489

C3510

C3524

C3708

C3770

C3771

C3772

C3773

C3774

C3775

C3776

C3777

C3778

C3779

C3780

C3781

(b)           omit all codes from the column headed “Purposes” and substitute:

P3273

P3275

P3489

P3510

P3524

P3708

P3770

P3772

P3774

P3776

P3778

P3779

[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]

(a)           omit all codes from the column headed “Circumstances” and substitute:

C3273

C3275

C3489

C3510

C3524

C3708

C3770

C3771

C3772

C3773

C3774

C3775

C3776

C3777

C3778

C3779

C3780

C3781

(b)           omit all codes from the column headed “Purposes” and substitute:

P3771

P3773

P3775

P3777

P3780

P3781

 


[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]

(a)           omit all codes from the column headed “Circumstances” and substitute:

C3484

C3495

C3497

C3516

C3518

C3718

C3782

C3783

C3784

C3785

C3786

C3787

(b)           omit all codes from the column headed “Purposes” and substitute:

P3495

P3516

P3718

P3782

P3784

P3786

[40]         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 5]

(a)           omit all codes from the column headed “Circumstances” and substitute:

C3484

C3495

C3497

C3516

C3518

C3718

C3782

C3783

C3784

C3785

C3786

C3787

 


(b)           omit all codes from the column headed “Purposes” and substitute:

P3484

P3497

P3518

P3783

P3785

P3787

[41]         Schedule 1, entry for Golimumab in the form Injection 50 mg in 0.5 mL single use pre-filled pen [Max Quantity 1;
Number of Repeats 3]

(a)           omit all codes from the column headed “Circumstances” and substitute:

C3484

C3495

C3497

C3516

C3518

C3718

C3782

C3783

C3784

C3785

C3786

C3787

(b)           omit all codes from the column headed “Purposes” and substitute:

P3495

P3516

P3718

P3782

P3784

P3786

[42]         Schedule 1, entry for Golimumab in the form Injection 50 mg in 0.5 mL single use pre-filled pen [Max Quantity 1;
Number of Repeats 5]

(a)           omit all codes from the column headed “Circumstances” and substitute:

C3484

C3495

C3497

C3516

C3518

C3718

C3782

C3783

C3784

C3785

C3786

C3787

(b)           omit all codes from the column headed “Purposes” and substitute:

P3484

P3497

P3518

P3783

P3785

P3787

[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]

(a)           omit all codes from the column headed “Circumstances” and substitute:

C3248

C3250

C3789

C3790

C3791

C3792

(b)           omit both codes from the column headed “Purposes” and substitute:

P3791

P3792

[45]         Schedule 1, entry for Ustekinumab in the form Injection 45 mg in 0.5 mL [Max Quantity 1; Number of Repeats 2]

(a)           omit all codes from the column headed “Circumstances” and substitute:

C3248

C3250

C3789

C3790

C3791

C3792

(b)           omit all codes from the column headed “Purposes” and substitute:

P3248

P3250

P3789

P3790

 


[46]         Schedule 1, entry for Verteporfin

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

C3793

C3794

C3795

 

[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

(c)           omit from the column headed “Circumstances and Purposes”: Medicare Australia CEO              substitute:                Chief Executive Medicare

[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

(c)           omit from the column headed “Circumstances and Purposes”: Medicare Australia CEO (twice occurring)            

            substitute:             Chief Executive Medicare


[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

(c)           omit from the column headed “Circumstances and Purposes”: Medicare Australia CEO (twice occurring)            

            substitute:             Chief Executive Medicare

[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

(c)           omit from the column headed “Circumstances and Purposes”: Medicare Australia CEO              substitute:                Chief Executive Medicare

[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

(c)           omit from the column headed “Circumstances and Purposes”: Medicare Australia CEO              substitute:                Chief Executive Medicare

[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

(c)           omit from the column headed “Circumstances and Purposes”: Medicare Australia CEO (twice occurring)            

            substitute:             Chief Executive Medicare

[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

(c)           omit from the column headed “Circumstances and Purposes”: Medicare Australia CEO (twice occurring)            

            substitute:             Chief Executive Medicare


[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

(c)           omit from the column headed “Circumstances and Purposes”: Medicare Australia CEO              substitute:                Chief Executive Medicare

[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

(c)           omit from the column headed “Circumstances and Purposes”: Medicare Australia CEO (twice occurring)            

            substitute:             Chief Executive Medicare

[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

(c)           omit from the column headed “Circumstances and Purposes”: Medicare Australia CEO (twice occurring)            

            substitute:             Chief Executive Medicare

[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

(c)           omit from the column headed “Circumstances and Purposes”: Medicare Australia CEO (twice occurring)            

            substitute:             Chief Executive Medicare

[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

(c)           omit from the column headed “Circumstances and Purposes”: Medicare Australia CEO              substitute:                Chief Executive Medicare


[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

(c)           omit from the column headed “Circumstances and Purposes”: Medicare Australia CEO (twice occurring)            

            substitute:             Chief Executive Medicare

[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

(c)           omit from the column headed “Circumstances and Purposes”: Medicare Australia CEO (twice occurring)            

            substitute:             Chief Executive Medicare

[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

(c)           omit from the column headed “Circumstances and Purposes”: Medicare Australia CEO              substitute:                Chief Executive Medicare

[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

(c)           omit from the column headed “Circumstances and Purposes”: Medicare Australia CEO (twice occurring)            

            substitute:             Chief Executive Medicare

[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

(c)           omit from the column headed “Circumstances and Purposes”: Medicare Australia CEO              substitute:                Chief Executive Medicare


[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

(c)           omit from the column headed “Circumstances and Purposes”: Medicare Australia CEO              substitute:                Chief Executive Medicare

[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

(c)           omit from the column headed “Circumstances and Purposes”: Medicare Australia CEO              substitute:                Chief Executive Medicare

[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

(c)           omit from the column headed “Circumstances and Purposes”: Medicare Australia CEO (twice occurring)            

            substitute:             Chief Executive Medicare

[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

(c)           omit from the column headed “Circumstances and Purposes”: Medicare Australia CEO (twice occurring)            

            substitute:             Chief Executive Medicare

[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

(c)           omit from the column headed “Circumstances and Purposes”: Medicare Australia CEO (twice occurring)            

            substitute:             Chief Executive Medicare

[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)            

            substitute:             Chief Executive Medicare

[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

display existing and re-numbered (amended) Circumstances and Purposes in numerical order

[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

(c)           omit from the column headed “Circumstances and Purposes”: Medicare Australia CEO              substitute:                Chief Executive Medicare

[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

(c)           omit from the column headed “Circumstances and Purposes”: Medicare Australia CEO              substitute:                Chief Executive Medicare


[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

(c)           omit from the column headed “Circumstances and Purposes”: Medicare Australia CEO (twice occurring)            

            substitute:             Chief Executive Medicare

[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

(c)           omit from the column headed “Circumstances and Purposes”: Medicare Australia CEO (twice occurring)            

            substitute:             Chief Executive Medicare

[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

(c)           omit from the column headed “Circumstances and Purposes”: Medicare Australia CEO              substitute:                Chief Executive Medicare

[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

(c)           omit from the column headed “Circumstances and Purposes”: Medicare Australia CEO (twice occurring)            

            substitute:             Chief Executive Medicare

[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

(c)           omit from the column headed “Circumstances and Purposes”: Medicare Australia CEO (twice occurring)            

            substitute:             Chief Executive Medicare


[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

(c)           omit from the column headed “Circumstances and Purposes”: Medicare Australia CEO (twice occurring)            

            substitute:             Chief Executive Medicare

[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

(c)           omit from the column headed “Circumstances and Purposes”: Medicare Australia CEO              substitute:                Chief Executive Medicare

[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

(c)           omit from the column headed “Circumstances and Purposes”: Medicare Australia CEO (twice occurring)            

            substitute:             Chief Executive Medicare

[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

(c)           omit from the column headed “Circumstances and Purposes”: Medicare Australia CEO (twice occurring)            

            substitute:             Chief Executive Medicare

[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

(c)           omit from the column headed “Circumstances and Purposes”: Medicare Australia CEO              substitute:                Chief Executive Medicare


[89]         Schedule 4, Part 1, entry for Etanercept

display existing and re-numbered (amended) Circumstances and Purposes in numerical order

[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

(c)           omit from the column headed “Circumstances and Purposes”: Medicare Australia CEO              substitute:                Chief Executive Medicare

[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

(c)           omit from the column headed “Circumstances and Purposes”: Medicare Australia CEO (twice occurring)            

            substitute:             Chief Executive Medicare

[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

(c)           omit from the column headed “Circumstances and Purposes”: Medicare Australia CEO (twice occurring)            

            substitute:             Chief Executive Medicare

[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

(c)           omit from the column headed “Circumstances and Purposes”: Medicare Australia CEO (twice occurring)            

            substitute:             Chief Executive Medicare

[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

(c)           omit from the column headed “Circumstances and Purposes”: Medicare Australia CEO (twice occurring)            

            substitute:             Chief Executive Medicare

[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

(c)           omit from the column headed “Circumstances and Purposes”: Medicare Australia CEO              substitute:                Chief Executive Medicare

[96]         Schedule 4, Part 1, entry for Golimumab

display existing and re-numbered (amended) Circumstances and Purposes in numerical order

[97]         Schedule 4, Part 1, entry for Ranibizumab [Circumstances Code C2822]

(a)           omit from the column headed “Circumstances Code”:           C2822                substitute:          C3788

(b)           omit from the column headed “Circumstances and Purposes”: Medicare Australia CEO (twice occurring)            

            substitute:             Chief Executive Medicare

[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

(c)           omit from the column headed “Circumstances and Purposes”: Medicare Australia CEO              substitute:                Chief Executive Medicare

[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

(c)           omit from the column headed “Circumstances and Purposes”: Medicare Australia CEO              substitute:                Chief Executive Medicare

[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

(c)           omit from the column headed “Circumstances and Purposes”: Medicare Australia CEO (twice occurring)            

            substitute:             Chief Executive Medicare


[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

(c)           omit from the column headed “Circumstances and Purposes”: Medicare Australia CEO (twice occurring)            

            substitute:             Chief Executive Medicare

[102]       Schedule 4, Part 1, entry for Ustekinumab

display existing and re-numbered (amended) Circumstances and Purposes in numerical order

[103]       Schedule 4, Part 1, entry for Verteporfin [Circumstances Code C2683]

(a)           omit from the column headed “Circumstances Code”:           C2683                substitute:          C3793

(b)           omit from the column headed “Circumstances and Purposes”: Medicare Australia CEO (twice occurring)            

            substitute:             Chief Executive Medicare

[104]       Schedule 4, Part 1, entry for Verteporfin [Circumstances Code C2684]

(a)           omit from the column headed “Circumstances Code”:           C2684                substitute:          C3794

(b)           omit from the column headed “Circumstances and Purposes”: Medicare Australia CEO (twice occurring)            

            substitute:             Chief Executive Medicare

[105]       Schedule 4, Part 1, entry for Verteporfin [Circumstances Code C2685]

(a)           omit from the column headed “Circumstances Code”:           C2685                substitute:          C3795

(b)           omit from the column headed “Circumstances and Purposes”: Medicare Australia CEO              substitute:                Chief Executive Medicare


 

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)

omit:

 

 

 

Parlodel

NV

MP

C1001 C1255 C1841 C1842 C1843 C1844

 

60

5

 

[3] Schedule 1, entry for Bromocriptine in the form Capsule 10 mg (as mesylate)

omit:

 

 

 

Parlodel

NV

MP

C1001 C1255 C1841 C1842 C1843 C1844

 

100

5

 

[4] Schedule 1, after entry for Buprenorphine with naloxone in the form Tablet (sublingual) 8 mg (as hydrochloride)-2 mg (as hydrochloride)

insert in the columns in the order indicated:

 

Film (soluble) 2 mg (as hydrochloride)-0.5 mg (as hydrochloride)

Sublingual

Suboxone Film 2/0.5

RC

MP NP

See Note 1

See Note 3

See Note 3

See Note 3

See Note 3

D

 

Film (soluble) 8 mg (as hydrochloride)-2 mg (as hydrochloride)

Sublingual

Suboxone Film 8/2

RC

MP NP

See Note 1

See Note 3

See Note 3

See Note 3

See Note 3

D

[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

insert in the columns in the order indicated:

 

Gel containing calcipotriol 50 micrograms with betamethasone 500 micrograms (as dipropionate) per g, 30 g

Application

Daivobet 50/500 gel

LO

MP NP

C3827

 

1

1

 

[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]

(a)        omit all codes from the column headed “Circumstances” and substitute:

C2713

C2714

C2715

C3843

C3844

 

(b)        omit all codes from the column headed “Purposes” and substitute:

P2713

P2714

P3843

P3844

[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]

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

C2713

C2714

C2715

C3843

C3844

 

[10]         Schedule 1, entry for Cetuximab Solution for I.V. infusion 500 mg in 100 mL [Max Quantity 1; Number of Repeats 0]

(a)        omit all codes from the column headed “Circumstances” and substitute:

C2713

C2714

C2715

C3843

C3844

 

(b)        omit all codes from the column headed “Purposes” and substitute:

P2713

P2714

P3843

P3844

[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]

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

C2713

C2714

C2715

C3843

C3844

 

[12]         Schedule 1, entry for Cimetidine

omit:

 

Tablet 200 mg

Oral

Magicul 200

AF

MP NP

 

 

120

5

 

[13]         Schedule 1, entry for Ciprofloxacin in the form Eye drops 3 mg (as hydrochloride) per mL, 5 mL

substitute:

 

Eye drops 3 mg (as hydrochloride) per mL, 5 mL

Application to the eye

CiloQuin

IQ

MP

C1031

 

2

0

 

 

 

 

 

 

AO

C3830

 

2

0

 

 

 

 

Ciloxan

AQ

MP

C1031

 

2

0

 

 

 

 

 

 

AO

C3830

 

2

0

 

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

insert in the columns in the order indicated:

 

Tablet 75 mg

Oral

Clopidogrel-DRLA

RZ

MP NP

C1719 C1720

C1721 C1722

C1723 C1724

 

28

5

 

 


[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
pre-filled syringe

insert in the columns in the order indicated:

 

Injection containing dalteparin sodium 12,500 I.U. (anti-Xa) in 0.5 mL single dose pre-filled syringe

Injection

Fragmin

PF

MP NP

 

 

10

1

 

[18]         Schedule 1, entry for Deferasirox

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

C3828

C3829

[19]         Schedule 1, entry for Dexamethasone

omit:

 

Eye drops 1 mg per mL, 5 mL

Application to the eye

Maxidex

AQ

MP NP

 

 

1

2

 

substitute:

 

Eye drops 1 mg per mL, 5 mL

Application to the eye

Maxidex

AQ

AO

 

 

1

0

 

 

 

 

 

 

MP NP

 

 

1

2

 

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

(a)           omit:

 

 

 

Vibramycin

PF

PDP

 

 

7

0

 

(b)           omit:

 

 

 

Vibramycin

PF

MP NP

 

 

7

1

 

(c)           omit:

 

 

 

Vibramycin

PF

MP NP

 

P1459

21

0

 

(d)           omit:

 

 

 

Vibramycin

PF

MP NP

 

P1279

28

0

 

[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

insert in the columns in the order indicated:

 

 

 

 

 

MP NP

 

P1148

20

3

 

[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

insert in the columns in the order indicated:

 

 

 

 

 

MP NP

 

P1148

20

3

 

[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-DRLA

RZ

MP NP

C1211

 

28

5

 

[24]         Schedule 1, entry for Exemestane in the form Tablet 25 mg

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

 

 

 

Exemestane Pfizer

FZ

MP NP

C1541 C2457

 

30

5

 

 


[25]         Schedule 1, after entry for Fentanyl in the form Lozenges 1600 micrograms (as citrate), 30

insert in the columns in the order indicated:

 

Transdermal patch 1.28 mg

Transdermal

Denpax

AF

MP NP

C1062

 

5

0

 

 

Transdermal patch 2.063 mg

Transdermal

Fenpatch 12

ZP

MP NP

C1062

 

5

0

 

[26]         Schedule 1, after entry for Fentanyl in the form Transdermal patch 2.55 mg

insert in the columns in the order indicated:

 

Transdermal patch 4.125 mg

Transdermal

Fenpatch 25

ZP

MP NP

C1062

 

5

0

 

[27]         Schedule 1, after entry for Fentanyl in the form Transdermal patch 7.65 mg

insert in the columns in the order indicated:

 

Transdermal patch 8.25 mg

Transdermal

Fenpatch 50

ZP

MP NP

C1062

 

5

0

 

[28]         Schedule 1, after entry for Fentanyl in the form Transdermal patch 10.20 mg

insert in the columns in the order indicated:

 

Transdermal patch 12.375 mg

Transdermal

Fenpatch 75

ZP

MP NP

C1062

 

5

0

 

[29]         Schedule 1, after entry for Fentanyl in the form Transdermal patch 12.6 mg

insert in the columns in the order indicated:

 

Transdermal patch 16.5 mg

Transdermal

Fenpatch 100

ZP

MP NP

C1062

 

5

0

 

[30]         Schedule 1, after entry for Fentanyl in the form Transdermal patch 16.8 mg

insert in the columns in the order indicated:

Ferrous fumarate

Tablet 200 mg (equivalent to 67.5 mg iron)

Oral

Ferro-tab

AE

MP NP

 

 

60

1

 

[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)

insert:

Fingolimod

Capsule 500 micrograms (as hydrochloride)

Oral

Gilenya

NV

MP

C3845 C3846

 

28

5

 

[33]         Schedule 1, after entry for Fluconazole in the form Capsule 200 mg (Ozole)

insert in the columns in the order indicated:

 

Powder for oral suspension 50 mg in 5 mL, 35 mL

Oral

Diflucan

PF

MP NP

C3835 C3836

C3837 C3838

C3839 C3840

 

1

0

 

[34]         Schedule 1, entry for Flupenthixol Decanoate

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

 

Oily I.M. injection 20 mg in 1 mL

Injection

Fluanxol Depot

LU

MP NP

 

 

5

0

 

[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

omit:

 

 

 

Gantin

AW

MP NP

C2664

 

100

5

 

[37]         Schedule 1, entry for Gentamicin

omit:

 

Eye drops 3 mg (as sulfate) per mL, 5 mL

Application to the eye

Genoptic

AG

MP

C1188 C1391

C1714

 

1

2

 

substitute:

 

Eye drops 3 mg (as sulfate) per mL, 5 mL

Application to the eye

Genoptic

AG

MP

C1188 C1391

C1714

 

1

2

 

 

 

 

 

 

AO

C1391 C1714

 

1

2

 

[38]         Schedule 1, after entry for Glucose Indicator—Blood in the form Test strips, 50 (SensoCard)

insert in the columns in the order indicated:

 

Test strips, 50 (TRUEbalance)

For external use

TRUEbalance

NX

MP NP

 

 

2

5

 

 

 

 

 

 

MP

 

P3035

2

11

 

 

Test strips, 50 (TRUEresult)

For external use

TRUEresult

NX

MP NP

 

 

2

5

 

 

 

 

 

 

MP

 

P3035

2

11

 

[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]

(a)           omit from the column headed “Circumstances”:

C3232  C3451

(b)           insert in numerical order in the column headed “Circumstances”:

C3847  C3848

C3849  C3850

(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]

(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

[42]         Schedule 1, entry for Imatinib in the form Tablet 400 mg (as mesylate) [Max Quantity 30; Number of Repeats 5]

(a)           omit from the column headed “Circumstances”:

C3232  C3451

(b)           insert in numerical order in the column headed “Circumstances”:

C3847  C3848

C3849  C3850

(c)           insert in numerical order in the column headed “Purposes”:

P3847  P3848


[43]         Schedule 1, entry for Isosorbide Dinitrate

omit:

 

Tablet 10 mg

Oral

Sorbidin

AF

MP NP

 

 

200

2

 

[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]

(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

[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

omit:

 

Capsule 100 mg (as hydrochloride)

 

Akamin 100

AF

MP NP

 

 

11

0

 

[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

insert in the columns in the order indicated:

 

 

 

 

 

AO

C3830

 

2

0

 


[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

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

 

 

 

Ondansetron Alphapharm

AF

MP NP

See Note 1

C3050 C3611

See Note 2

See Note 2

1

See Note 2

0

See Note 2

 

[51]         Schedule 1, entry for Pegfilgrastim in the form Injection 6 mg in 0.6 mL single use pre-filled syringe

insert in numerical order in the column headed “Circumstances”:

C3833  C3834

[52]         Schedule 1, entry for Perindopril in the form Tablet containing perindopril erbumine 2 mg

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

 

 

 

Idaprex 2

SZ

MP NP

 

 

30

5

 

[53]         Schedule 1, entry for Perindopril in the form Tablet containing perindopril erbumine 4 mg

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

 

 

 

Idaprex 4

SZ

MP NP

 

 

30

5

 

[54]         Schedule 1, entry for Perindopril in the form Tablet containing perindopril erbumine 8 mg

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

 

 

 

Idaprex 8

SZ

MP NP

 

 

30

5

 

[55]         Schedule 1, entry for Perindopril with Indapamide in the form Tablet containing perindopril erbumine 4 mg with indapamide hemihydrate 1.25 mg

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

 

 

 

Idaprex Combi 4/1.25

SZ

MP NP

C3307

 

30

5

 

 


[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

substitute:

Prednisolone with Phenylephrine

Eye drops containing prednisolone acetate 10 mg with phenylephrine hydrochloride 1.2 mg per mL, 10 mL

Application to the eye

Prednefrin Forte

AG

AO

C1465

 

1

0

 

 

 

 

 

 

MP NP

C1077 C1465

 

1

2

 

[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

insert in numerical order in the column headed “Circumstances”:

C3841

[60]         Schedule 1, omit entry for Sulindac

[61]         Schedule 1, entry for Tobramycin

(a)           omit:

 

Eye drops 3 mg per mL, 5 mL

Application to the eye

Tobrex

AQ

MP

C1188 C1391

C1714

 

1

2

 

substitute:

 

Eye drops 3 mg per mL, 5 mL

Application to the eye

Tobrex

AQ

MP

C1188 C1391

C1714

 

1

2

 

 

 

 

 

 

AO

C1391 C1714

 

1

2

 

(b)           omit:

 

Eye ointment 3 mg per g, 3.5 g

Application to the eye

Tobrex

AQ

MP

C1188 C1391

C1714

 

1

0

 

substitute:

 

Eye ointment 3 mg per g, 3.5 g

Application to the eye

Tobrex

AQ

MP

C1188 C1391

C1714

 

1

0

 

 

 

 

 

 

AO

C1391 C1714

 

1

0

 

[62]         Schedule 1, entry for Trimethoprim with Sulfamethoxazole

omit:

 

Tablet 80 mg-400 mg

Oral

Resprim

AF

PDP

 

 

10

0

 

 

 

 

Resprim

AF

MP NP

 

 

10

1

 

[63]         Schedule 1, after entry for Zonisamide in the form Capsule 100 mg

insert:

Zuclopenthixol Decanoate

Oily I.M. injection 200 mg in 1 mL

Injection

Clopixol Depot

LU

MP NP

 

 

5

0

 

[64]         Schedule 3

omit:

AW

Aspen Pharma Pty Ltd

 88 004 118 594

[65]         Schedule 3, after details relevant to Responsible Person code LN

insert:

LO

LEO Pharma Pty Ltd

 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:

 

 

C3827

 

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

insert after existing text in the columns in the order indicated:

 

 

C3843

P3843

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

Compliance with Authority Required procedures

 

C3844

P3844

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

Compliance with Authority Required procedures

[68]         Schedule 4, Part 1, entry for Ciprofloxacin

insert after existing text in the columns in the order indicated:

 

 

C3830

 

Bacterial keratitis under the supervision and direction of an ophthalmologist

Compliance with Authority Required procedures

[69]         Schedule 4, omit entry for Clotrimazole

[70]         Schedule 4, Part 1, entry for Deferasirox

substitute:

 

Deferasirox

C3828

 

Where the patient is receiving treatment at/from a public hospital

Chronic iron overload in patients with disorders of erythropoiesis

Compliance with Authority Required procedures - Streamlined Authority Code 3828


 

C3829

 

Where the patient is receiving treatment at/from a private hospital

Chronic iron overload in patients with disorders of erythropoiesis

Compliance with Written or Telephone Authority Required procedures

[71]         Schedule 4, Part 1, entry for Filgrastim

insert after existing text in the columns in the order indicated:

 

 

C3833

 

Where the patient is receiving treatment at/from a private hospital

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 Written or Telephone Authority Required procedures

 

C3834

 

Where the patient is receiving treatment at/from a public hospital

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

insert:

 

Fingolimod

C3845

 

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

Compliance with Authority Required procedures

 

C3846

 

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

Compliance with Authority Required procedures

[73]         Schedule 4, Part 1, entry for Fluconazole

insert after existing text in the columns in the order indicated:

 

 

C3835

 

Treatment of cryptococcal meningitis in a patient unable to take a solid dose form of fluconazole

Compliance with Authority Required procedures

 

C3836

 

Maintenance therapy in a patient with cryptococcal meningitis and immunosuppression unable to take a solid dose form of fluconazole

Compliance with Authority Required procedures

 

C3837

 

Treatment of oropharyngeal candidiasis in an immunosuppressed patient unable to take a solid dose form of fluconazole

Compliance with Authority Required procedures

 

C3838

 

Treatment of oesophageal candidiasis in an immunosuppressed patient unable to take a solid dose form of fluconazole

Compliance with Authority Required procedures

 

C3839

 

Prophylaxis of oropharyngeal candidiasis in an immunosuppressed patient unable to take a solid dose form of fluconazole

Compliance with Authority Required procedures

 

C3840

 

Treatment of serious and life-threatening candida infections in a patient unable to take a solid dose form of fluconazole

Compliance with Authority Required procedures

[74]         Schedule 4, Part 1, entry for Imatinib

omit:

 

 

C3232

P3232

Gastrointestinal stromal tumour
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

Compliance with Written or Telephone Authority Required procedures

 

C3451

P3451

Gastrointestinal stromal tumour
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

Compliance with Written Authority Required procedures


substitute:

 

 

C3847

P3847

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.

Applications for authorisation must be in writing and must include:
(1) a completed authority prescription form; and
(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:
(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 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

Compliance with Written Authority Required procedures


 

C3848

P3848

Resectable gastrointestinal stromal tumour
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.

Applications for authorisation must be in writing and must include:
(1) a completed authority prescription form; and
(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:
(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 pathology report must include the size and mitotic rate of the tumour, and the date of tumour resection must be documented

Compliance with Written Authority Required procedures


 

C3849

P3849

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:
(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

Compliance with Written Authority Required procedures


 

C3850

P3850

Metastatic or unresectable gastrointestinal stromal tumour
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

Compliance with Written or Telephone Authority Required procedures


[75]         Schedule 4, Part 1, entry for Ofloxacin

insert after existing text in the columns in the order indicated:

 

 

C3830

 

Bacterial keratitis under the supervision and direction of an ophthalmologist.

Compliance with Authority Required procedures

[76]         Schedule 4, Part 1, entry for Pegfilgrastim [Circumstances Code C2929]

omit text from column headed “Authority Required ─ Part of Circumstances” and substitute:

Compliance with Written or Telephone Authority Required procedures

[77]         Schedule 4, Part 1, entry for Pegfilgrastim [Circumstances Code C2930]

omit text from column headed “Authority Required ─ Part of Circumstances” and substitute:

Compliance with Written or Telephone Authority Required procedures

[78]         Schedule 4, Part 1, entry for Pegfilgrastim

insert after existing text in the columns in the order indicated:

 

 

C3833

 

Where the patient is receiving treatment at/from a private hospital

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 Written or Telephone Authority Required procedures

 

C3834

 

Where the patient is receiving treatment at/from a public hospital

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 C3834

[79]         Schedule 4, Part 1, entry for Risperidone

insert after existing text in the columns in the order indicated:

 

 

C3841

 

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

 

 

 

 

 

 

 

 

 

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.