National Health (Listing of Pharmaceutical Benefits) Amendment Instrument 2014 (No. 9) (PB 61 of 2014) (Cth)

Case

PB 61 of 2014

National Health (Listing of Pharmaceutical Benefits) Amendment Instrument 2014
(No. 9)


National Health Act 1953

I, FELICITY McNEILL, First Assistant Secretary, Pharmaceutical Benefits Division, Department of Health, delegate of the Minister for Health, make this Instrument under sections 84AF, 84AK, 85, 85A, 88 and 101 of the National Health Act 1953.

Dated 15 August 2014

FELICITY McNEILL

First Assistant Secretary

Pharmaceutical Benefits Division

Department of Health

1          Name of Instrument

(1)        This Instrument is the National Health (Listing of Pharmaceutical    Benefits) Amendment Instrument 2014 (No. 9).

(2)        This Instrument may also be cited as PB 61 of 2014.

2          Commencement

This Instrument commences on 1 September 2014.

3          Amendment of National Health (Listing of Pharmaceutical Benefits) Instrument 2012 (PB 71 of 2012)

Schedule 1 amends the National Health (Listing of Pharmaceutical Benefits) Instrument 2012 (PB 71 of 2012).

Schedule 1     Amendments

  1. Schedule 1, entry for Adalimumab in the form Injection 40 mg in 0.8 mL pre-filled syringe [Maximum Quantity: 2; Number of Repeats: 2]

(a)omit from the column headed “Circumstances”:           C3502

(b)omit:         C3751  C3752

(c)insert in numerical order:     C4609  C4610  C4629  C4642  C4643

  1. Schedule 1, entry for Adalimumab in the form Injection 40 mg in 0.8 mL pre-filled syringe [Maximum Quantity: 2; Number of Repeats: 3]

(a)omit from the column headed “Circumstances”:           C3502

(b)omit:         C3751  C3752

(c)insert in numerical order:     C4609  C4610  C4629  C4642  C4643

(d)omit from the column headed “Purposes”:      P3502 

(e)omit:         P3751

(f)insert in numerical order:     P4609 P4610 P4629

  1. Schedule 1, entry for Adalimumab in the form Injection 40 mg in 0.8 mL pre-filled syringe [Maximum Quantity: 2; Number of Repeats: 4]

(a)omit from the column headed “Circumstances”:           C3502

(b)omit:         C3751  C3752

(c)insert in numerical order:     C4609  C4610  C4629  C4642  C4643

  1. Schedule 1, entry for Adalimumab in the form Injection 40 mg in 0.8 mL pre-filled syringe [Maximum Quantity: 2; Number of Repeats: 5]

(a)omit from the column headed “Circumstances”:           C3502

(b)omit:         C3751  C3752

(c)insert in numerical order:     C4609  C4610  C4629  C4642  C4643

(d)omit from the column headed “Purposes”:      P3752

(e)insert in numerical order:     P4642 P4643

  1. Schedule 1, entry for Adalimumab in the form Injection 40 mg in 0.8 mL pre-filled pen [Maximum Quantity: 2; Number of Repeats: 2]

(a)omit from the column headed “Circumstances”:           C3502

(b)omit:         C3751  C3752

(c)insert in numerical order:     C4609  C4610  C4629  C4642  C4643

  1. Schedule 1, entry for Adalimumab in the form Injection 40 mg in 0.8 mL pre-filled pen [Maximum Quantity: 2; Number of Repeats: 3]

(a)omit from the column headed “Circumstances”:           C3502

(b)omit:         C3751  C3752

(c)insert in numerical order:     C4609  C4610  C4629  C4642  C4643

(d)omit from the column headed “Purposes”:      P3502 

(e)omit:         P3751

(f)insert in numerical order:     P4609 P4610 P4629

  1. Schedule 1, entry for Adalimumab in the form Injection 40 mg in 0.8 mL pre-filled pen [Maximum Quantity: 2; Number of Repeats: 4]

(a)omit from the column headed “Circumstances”:           C3502

(b)omit:         C3751  C3752

(c)insert in numerical order:     C4609  C4610  C4629  C4642  C4643

  1. Schedule 1, entry for Adalimumab in the form Injection 40 mg in 0.8 mL pre-filled pen [Maximum Quantity: 2; Number of Repeats: 5]

(a)omit from the column headed “Circumstances”:           C3502

(b)omit:         C3751  C3752

(c)insert in numerical order:     C4609  C4610  C4629  C4642  C4643

(d)omit from the column headed “Purposes”:      P3752

(e)insert in numerical order:     P4642 P4643

  1. Schedule 1, entry for Alendronic Acid in the form Tablet 70 mg (as alendronate sodium)

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

Alendronate AN EA MP NP C4122 C4123 C4133 4 5 4

  1. Schedule 1, entry for Amoxycillin in the form Capsule 250 mg (as trihydrate) [Maximum Quantity: 20; Number of Repeats: 0]

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

Amoxycillin AN EA PDP 20 0 20

  1. Schedule 1, entry for Amoxycillin in the form Capsule 250 mg (as trihydrate) [Maximum Quantity: 20; Number of Repeats: 1]

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

Amoxycillin AN EA MP NP MW 20 1 20

  1. Schedule 1, entry for Amoxycillin in the form Capsule 500 mg (as trihydrate) [Maximum Quantity: 20; Number of Repeats: 0]

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

Amoxycillin AN EA PDP 20 0 20

  1. Schedule 1, entry for Amoxycillin in the form Capsule 500 mg (as trihydrate) [Maximum Quantity: 20; Number of Repeats: 1]

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

Amoxycillin AN EA MP NP MW 20 1 20

  1. Schedule 1, entry for Amoxycillin with Clavulanic Acid in the form Tablet containing 500 mg amoxycillin (as trihydrate) with 125 mg clavulanic acid (as potassium clavulanate) [Maximum Quantity: 10; Number of Repeats: 0]

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

Amoxiclav AN 500/125 EA PDP C1836 C1837 10 0 10

  1. Schedule 1, entry for Amoxycillin with Clavulanic Acid in the form Tablet containing 500 mg amoxycillin (as trihydrate) with 125 mg clavulanic acid (as potassium clavulanate) [Maximum Quantity: 10; Number of Repeats: 1]

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

Amoxiclav AN 500/125 EA MP NP MW C1836 C1837 10 1 10

  1. Schedule 1, entry for Amoxycillin with Clavulanic Acid in the form Tablet containing 875 mg amoxycillin (as trihydrate) with 125 mg clavulanic acid (as potassium clavulanate) [Maximum Quantity: 10; Number of Repeats: 0]

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

Amoxiclav AN 875/125 EA PDP C1836 C1837 10 0 10

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

AmoxyClav RBX 875/125 RA PDP C1836 C1837 10 0 10

  1. Schedule 1, entry for Amoxycillin with Clavulanic Acid in the form Tablet containing 875 mg amoxycillin (as trihydrate) with 125 mg clavulanic acid (as potassium clavulanate) [Maximum Quantity: 10; Number of Repeats: 1]

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

Amoxiclav AN 875/125 EA MP NP C1836 C1837 10 1 10

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

AmoxyClav RBX 875/125 RA MP NP C1836 C1837 10 1 10

  1. Schedule 1, entry for Anastrozole

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

Anastrozole AN EA MP NP C2213 30 5 30

  1. Schedule 1, entry for Aprepitant

omit from the column headed “Section 100/Prescriber Bag only”:         C(100)

  1. Schedule 1, entry for Atenolol in the form Tablet 50 mg

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

Atenolol AN EA MP NP 30 5 30

  1. Schedule 1, entry for Atorvastatin in the form Tablet 10 mg (as calcium) [Maximum Quantity: 30; Number of Repeats: 5]

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

Atorvastatin AN EA MP C1540 C3047 P1540 30 5 30
NP C1540 30 5 30

  1. Schedule 1, entry for Atorvastatin in the form Tablet 10 mg (as calcium) [Maximum Quantity: 30; Number of Repeats: 11]

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

Atorvastatin AN EA MP C1540 C3047 P3047 30 11 30

  1. Schedule 1, entry for Atorvastatin in the form Tablet 20 mg (as calcium) [Maximum Quantity: 30; Number of Repeats: 5]

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

Atorvastatin AN EA MP C1540 C3047 P1540 30 5 30
NP C1540 30 5 30

  1. Schedule 1, entry for Atorvastatin in the form Tablet 20 mg (as calcium) [Maximum Quantity: 30; Number of Repeats: 11]

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

Atorvastatin AN EA MP C1540 C3047 P3047 30 11 30

  1. Schedule 1, entry for Atorvastatin in the form Tablet 40 mg (as calcium) [Maximum Quantity: 30; Number of Repeats: 5]

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

Atorvastatin AN EA MP C1540 C3047 P1540 30 5 30
NP C1540 30 5 30

  1. Schedule 1, entry for Atorvastatin in the form Tablet 40 mg (as calcium) [Maximum Quantity: 30; Number of Repeats: 11]

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

Atorvastatin AN EA MP C1540 C3047 P3047 30 11 30

  1. Schedule 1, entry for Atorvastatin in the form Tablet 80 mg (as calcium) [Maximum Quantity: 30; Number of Repeats: 5]

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

Atorvastatin AN EA MP C1540 C3047 P1540 30 5 30
NP C1540 30 5 30

  1. Schedule 1, entry for Atorvastatin in the form Tablet 80 mg (as calcium) [Maximum Quantity: 30; Number of Repeats: 11]

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

Atorvastatin AN EA MP C1540 C3047 P3047 30 11 30

  1. Schedule 1, entry for Azathioprine in the form Tablet 50 mg

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

Azathioprine AN EA MP NP 100 5 100

  1. Schedule 1, entry for Bicalutamide

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

Bicalutamide AN EA MP NP C3674 28 5 28

  1. Schedule 1, entry for Bisoprolol in each of the forms: Tablet containing bisoprolol fumarate 2.5 mg; Tablet containing bisoprolol fumarate 5 mg; and Tablet containing bisoprolol fumarate 10 mg

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

Bisoprolol AN EA MP NP C3234 28 5 28

  1. Schedule 1, entry for Calcitriol

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

Calcitriol AN EA MP NP C1165 C1166 C1167 C1467 C2636 100 3 100

  1. Schedule 1, entry for Candesartan in each of the forms: Tablet containing candesartan cilexetil 4 mg; Tablet containing candesartan cilexetil 8 mg; Tablet containing candesartan cilexetil 16 mg; and Tablet containing candesartan cilexetil 32 mg

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

Candesartan AN EA MP NP 30 5 30

  1. Schedule 1, entry for Candesartan with Hydrochlorothiazide in the form Tablet containing candesartan cilexetil 16 mg with hydrochlorothiazide 12.5 mg

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

Candesartan HCTZ AN 16/12.5 EA MP NP C4374 30 5 30

  1. Schedule 1, entry for Candesartan with Hydrochlorothiazide in the form Tablet containing candesartan cilexetil 32 mg with hydrochlorothiazide 12.5 mg

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

Candesartan HCTZ AN 32/12.5 EA MP NP C4374 30 5 30

  1. Schedule 1, entry for Candesartan with Hydrochlorothiazide in the form Tablet containing candesartan cilexetil 32 mg with hydrochlorothiazide 25 mg

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

Candesartan HCTZ AN 32/25 EA MP NP C4374 30 5 30

  1. Schedule 1, entry for Carboplatin in each of the forms: Solution for I.V. injection 50 mg in 5 mL; Solution for I.V. injection 150 mg
    in 15 mL; and Solution for I.V. injection 450 mg in 45 mL

omit:

Carboplatin Ebewe SZ MP See Note 3 See
Note 3 		1 D(100)

  1. Schedule 1, entry for Carvedilol in the form Tablet 3.125 mg

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

Carvedilol AN EA MP NP C1735 C3234 30 0 30

  1. Schedule 1, entry for Carvedilol in each of the forms: Tablet 6.25 mg; Tablet 12.5 mg; and Tablet 25 mg

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

Carvedilol AN EA MP NP C1735 C3234 60 5 60

  1. Schedule 1, entry for Cephalexin in the form Capsule 250 mg (anhydrous) [Maximum Quantity: 20; Number of Repeats: 0]

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

Cephalexin AN EA PDP 20 0 20

  1. Schedule 1, entry for Cephalexin in the form Capsule 250 mg (anhydrous) [Maximum Quantity: 20; Number of Repeats: 1]

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

Cephalexin AN EA MP NP MW 20 1 20

  1. Schedule 1, entry for Cephalexin in the form Capsule 250 mg (anhydrous) [Maximum Quantity: 40; Number of Repeats: 2]

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

Cephalexin AN EA MP P4243 40 2 20

  1. Schedule 1, entry for Cephalexin in the form Capsule 500 mg (anhydrous) [Maximum Quantity: 20; Number of Repeats: 0]

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

Cephalex 500 NJ PDP 20 0 20

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

Cephalexin AN EA PDP 20 0 20

  1. Schedule 1, entry for Cephalexin in the form Capsule 500 mg (anhydrous) [Maximum Quantity: 20; Number of Repeats: 1]

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

Cephalex 500 NJ MP NP MW 20 1 20

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

Cephalexin AN EA MP NP MW 20 1 20

  1. Schedule 1, entry for Cephazolin in the form Powder for injection 1 g (as sodium)

omit:

Cephazolin Alphapharm AF MP NP C1169 C1846 C1847 C3132 10 0 10

  1. Schedule 1, entry for Certolizumab pegol

insert in numerical order in the column headed “Circumstances”:         C4605  C4606  C4614  C4642  C4643

  1. Schedule 1, entry for Ciprofloxacin in each of the forms: Tablet 500 mg (as hydrochloride); and Tablet 750 mg (as hydrochloride)

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

Ciprofloxacin AN EA MP NP C1431 C1432 C1572 C1573 14 0 14

  1. Schedule 1, entry for Citalopram in each of the forms: Tablet 20 mg (as hydrobromide); and Tablet 40 mg (as hydrobromide)

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

Citalopram AN EA MP NP C1211 28 5 28

  1. Schedule 1, entry for Clarithromycin in the form Tablet 250 mg

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

Clarithromycin AN EA MP NP 14 1 14

  1. Schedule 1, entry for Clopidogrel in the form Tablet 75 mg (as hydrogen sulfate)

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

Clopidogrel AN EA MP NP C1719 C1720 C1721 C1722 C1723 C1724 C4165 C4166 28 5 28

  1. Schedule 1, entry for Cyproterone in the form Tablet containing cyproterone acetate 50 mg [Maximum Quantity: 20;
    Number of Repeats: 5]

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

Cyproterone AN EA MP C1014 C1230 C1404 P1230 20 5 20

  1. Schedule 1, entry for Cyproterone in the form Tablet containing cyproterone acetate 50 mg [Maximum Quantity: 100;
    Number of Repeats: 5]

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

Cyproterone AN EA MP C1014 C1230 C1404 P1014 P1404 100 5 50

  1. Schedule 1, entry for Cyproterone in the form Tablet containing cyproterone acetate 100 mg

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

Cyproterone AN EA MP C1014 C1404 50 5 50

  1. Schedule 1, entry for Darunavir

omit:

Tablet 400 mg (as ethanolate) Oral Prezista JC MP
See Note 1 		C4313 C4346 120 5 60 D(100)

  1. Schedule 1, entry for Diltiazem in the form Tablet containing diltiazem hydrochloride 60 mg

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

Diltiazem AN EA MP NP 90 5 90

  1. Schedule 1, entry for Donepezil in each of the forms: Tablet containing donepezil hydrochloride 5 mg; and Tablet containing donepezil hydrochloride 10 mg

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

Donepezil AN EA MP NP C4219 C4220 C4224 28 5 28

  1. Schedule 1, entry for Dorzolamide with timolol

omit from the column headed “Determined Quantity” (twice occurring)                :               1

  1. Schedule 1, entry for Duloxetine in the form Capsule 30 mg (as hydrochloride)

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

Duloxetine AN EA MP NP C1211 28 0 28

  1. Schedule 1, entry for Duloxetine in the form Capsule 60 mg (as hydrochloride)

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

Duloxetine AN EA MP NP C1211 28 5 28

  1. Schedule 1, entry for Epirubicin in the form Solution for injection containing epirubicin hydrochloride 50 mg in 25 mL

(a)omit from the column headed “Brand”:               Epirubicin Actavis 50   substitute:             Epirubicin ACT

(b)omit from the column headed “Responsible Person”:      UA        substitute:             VN

  1. Schedule 1, entry for Epirubicin in the form Solution for injection containing epirubicin hydrochloride 200 mg in 100 mL

(a)omit from the column headed “Brand”:               Epirubicin Actavis 200             substitute:             Epirubicin ACT

(b)omit from the column headed “Responsible Person”:      UA        substitute:             VN

  1. 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 AN EA MP NP C1211 28 5 28

  1. Schedule 1, entry for Etanercept in the form Injection 50 mg in 1 mL single use auto-injector, 4 [Maximum Quantity: 1; Number of Repeats: 3]

(a)omit from the column headed “Circumstances”:           C3510

(b)omit:         C3774  C3775

(c)insert in numerical order:     C4609  C4610  C4629  C4642  C4643

(d)omit from the column headed “Purposes”:      P3510

(e)omit:         P3774

(f)insert in numerical order:     P4609 P4610 P4629

  1. Schedule 1, entry for Etanercept in the form Injection 50 mg in 1 mL single use auto-injector, 4 [Maximum Quantity: 1; Number of Repeats: 5]

(a)omit from the column headed “Circumstances”:           C3510

(b)omit:         C3774  C3775

(c)insert in numerical order:     C4609  C4610  C4629  C4642  C4643

(d)omit from the column headed “Purposes”:      P3775

(e)insert in numerical order:     P4642 P4643

  1. Schedule 1, entry for Etanercept in the form Injections 50 mg in 1 mL single use pre-filled syringes, 4 [Maximum Quantity: 1; Number of Repeats: 3]

(a)omit from the column headed “Circumstances”:           C3510

(b)omit:         C3774  C3775

(c)insert in numerical order:     C4609  C4610  C4629  C4642  C4643

(d)omit from the column headed “Purposes”:      P3510

(e)omit:         P3774

(f)insert in numerical order:     P4609 P4610 P4629

  1. Schedule 1, entry for Etanercept in the form Injections 50 mg in 1 mL single use pre-filled syringes, 4 [Maximum Quantity: 1; Number of Repeats: 5]

(a)omit from the column headed “Circumstances”:           C3510

(b)omit:         C3774  C3775

(c)insert in numerical order:     C4609  C4610  C4629  C4642  C4643

(d)omit from the column headed “Purposes”:      P3775

(e)insert in numerical order:     P4642 P4643

  1. 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 [Maximum Quantity: 2; Number of Repeats: 3]

(a)omit from the column headed “Circumstances”:           C3510

(b)omit:         C3774  C3775

(c)insert in numerical order:     C4609  C4610  C4629  C4642  C4643

(d)omit from the column headed “Purposes”:      P3510

(e)omit:         P3774

(f)insert in numerical order:     P4609 P4610 P4629

  1. 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 [Maximum Quantity: 2; Number of Repeats: 5]

(a)omit from the column headed “Circumstances”:           C3510

(b)omit:         C3774  C3775

(c)insert in numerical order:     C4609  C4610  C4629  C4642  C4643

(d)omit from the column headed “Purposes”:      P3775

(e)insert in numerical order:     P4642 P4643

  1. Schedule 1, entry for Everolimus

omit:

Tablet 5 mg Oral Afinitor NV MP C4334 C4351 C4557 30 5 30
Tablet 10 mg Oral Afinitor NV MP C4334 C4351 C4557 30 5 30

substitute:

Tablet 5 mg Oral Afinitor NV MP C4334 C4351 C4557 C4604 C4632 P4604 30 2 30
MP C4334 C4351 C4557 C4604 C4632 P4334 P4351 P4557 P4632 30 5 30
Tablet 10 mg Oral Afinitor NV MP C4334 C4351 C4557 C4604 C4632 P4604 30 2 30
MP C4334 C4351 C4557 C4604 C4632 P4334 P4351 P4557 P4632 30 5 30

  1. 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 AN EA MP C1541 C2457 C4552 30 5 30
NP C1541 C2457 30 5 30

  1. Schedule 1, entry for Famciclovir in the form Tablet 125 mg

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

Famciclovir AN EA MP NP C3624 40 1 40

  1. Schedule 1, entry for Famciclovir in the form Tablet 250 mg [Maximum Quantity: 20; Number of Repeats: 1]

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

Famciclovir AN EA MP NP C3622 C3623 C3624 P3624 20 1 20

  1. Schedule 1, entry for Famciclovir in the form Tablet 250 mg [Maximum Quantity: 21; Number of Repeats: 0]

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

Famciclovir AN EA MP NP C3622 C3623 C3624 P3622 21 0 21

  1. Schedule 1, entry for Famciclovir in the form Tablet 250 mg [Maximum Quantity: 56; Number of Repeats: 5]

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

Famciclovir AN EA MP NP C3622 C3623 C3624 P3623 56 5 56

  1. Schedule 1, entry for Famciclovir in the form Tablet 500 mg [Maximum Quantity: 30; Number of Repeats: 0]

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

Famciclovir AN EA MP NP C3625 C3626 C3627 C3628 C3629 P3625 30 0 30

  1. Schedule 1, entry for Famciclovir in the form Tablet 500 mg [Maximum Quantity: 56; Number of Repeats: 5]

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

Famciclovir AN EA MP NP C3625 C3626 C3627 C3628 C3629 P3626 P3627 P3628 P3629 56 5 56

  1. Schedule 1, entry for Famotidine in the form Tablet 20 mg

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

Famotidine AN EA MP NP 60 5 60

  1. Schedule 1, entry for Famotidine in the form Tablet 40 mg

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

Famotidine AN EA MP NP 30 5 30

  1. Schedule 1, entry for Fludarabine in the form Powder for I.V. injection containing fludarabine phosphate 50 mg

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

Fludarabine ACT VN MP C3887 See Note 3 See
Note 3 		1 PB(100)

  1. Schedule 1, entry for Fluoxetine in the form Capsule 20 mg (as hydrochloride)

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

Fluoxetine AN EA MP NP C1211 C1241 28 5 28

  1. Schedule 1, entry for Frusemide in each of the forms: Tablet 20 mg; and Tablet 40 mg

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

Frusemide AN EA MP NP 100 1 100

  1. Schedule 1, entry for Gabapentin in each of the forms: Tablet 600 mg; and Tablet 800 mg

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

Gabapentin AN EA MP NP C2664 100 5 100

  1. Schedule 1, entry for Gemcitabine

omit:

Solution concentrate for I.V. infusion 200 mg (as hydrochloride) in 5 mL Injection Gemcitabine Ebewe SZ MP See
Note 3 		See
Note 3 		1 D(100)
Solution concentrate for I.V. infusion 1 g (as hydrochloride) in 25 mL Injection Gemcitabine Ebewe SZ MP See
Note 3 		See
Note 3 		1 D(100)
Solution concentrate for I.V. infusion 2 g (as hydrochloride) in 50 mL Injection Gemcitabine Ebewe SZ MP See Note 3 See
Note 3 		1 D(100)

  1. Schedule 1, entry for Glimepiride in each of the forms: Tablet 1 mg; Tablet 2 mg; Tablet 3 mg; and Tablet 4 mg

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

Glimepiride AN EA MP NP 30 5 30

  1. Schedule 1, entry for Glucose

(a)omit:

I.V. infusion 69.5 mmol (anhydrous) per 250 mL, 250 mL Injection Glucose 5% Freeflex PK MP NP 5 1 1

(b)omit:

I.V. infusion 139 mmol (anhydrous) per 500 mL, 500 mL Injection Fresenius Kabi Australia Pty Limited PK PDP 5 0 1
Fresenius Kabi Australia Pty Limited PK MP NP 5 1 1
I.V. infusion 278 mmol (anhydrous) per 500 mL, 500 mL Injection Fresenius Kabi Australia Pty Limited PK MP NP 5 1 1

  1. Schedule 1, entry for Glucose Indicator—Blood

omit:

Test strips, 50 (Glucocard 01 Sensor) For external use Glucocard 01 Sensor OZ MP NP 2 5 1
MP P4241 2 11 1

  1. Schedule 1, entry for Golimumab in the form Injection 50 mg in 0.5 mL single use pre-filled syringe [Maximum Quantity: 1; Number of Repeats: 3]

(a)omit from the column headed “Circumstances”:           C3516  C3518

(b)omit:         C3786  C3787

(c)insert in numerical order:     C4609  C4610  C4629  C4642  C4643

(d)omit from the column headed “Purposes”:      P3516

(e)omit:         P3786

(f)insert in numerical order:     P4609 P4610 P4629

  1. Schedule 1, entry for Golimumab in the form Injection 50 mg in 0.5 mL single use pre-filled syringe [Maximum Quantity: 1; Number of Repeats: 5]

(a)omit from the column headed “Circumstances”:           C3516  C3518

(b)omit:         C3786  C3787

(c)insert in numerical order:     C4609  C4610  C4629  C4642  C4643

(d)omit from the column headed “Purposes”:      P3518

(e)omit:         P3787

(f)insert in numerical order:     P4642 P4643

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

(a)omit from the column headed “Circumstances”:           C3516  C3518

(b)omit:         C3786  C3787

(c)insert in numerical order:     C4609  C4610  C4629  C4642  C4643

(d)omit from the column headed “Purposes”:      P3516

(e)omit:         P3786

(f)insert in numerical order:     P4609 P4610 P4629

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

(a)omit from the column headed “Circumstances”:           C3516  C3518

(b)omit:         C3786  C3787

(c)insert in numerical order:     C4609  C4610  C4629  C4642  C4643

(d)omit from the column headed “Purposes”:      P3518

(e)omit:         P3787

(f)insert in numerical order:     P4642 P4643

  1. Schedule 1, entry for Indapamide in the form Tablet containing indapamide hemihydrate 2.5 mg

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

Indapamide AN EA MP NP 90 1 90

  1. Schedule 1, entry for Irbesartan in the form Tablet 75 mg

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

Irbesartan AN EA MP NP 30 5 30

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

Irbesartan GH GQ MP NP 30 5 30

(c)omit:

Irbesat GH GQ MP NP 30 5 30

  1. Schedule 1, entry for Irbesartan in the form Tablet 150 mg

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

Irbesartan AN EA MP NP 30 5 30

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

Irbesartan GH GQ MP NP 30 5 30

(c)omit:

Irbesat GH GQ MP NP 30 5 30

  1. Schedule 1, entry for Irbesartan in the form Tablet 300 mg

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

Irbesartan AN EA MP NP 30 5 30

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

Irbesartan GH GQ MP NP 30 5 30

(c)omit:

Irbesat GH GQ MP NP 30 5 30

  1. Schedule 1, entry for Irbesartan with Hydrochlorothiazide in the form Tablet 150 mg-12.5 mg

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

Irbesartan HCT GH 150/12.5 GQ MP NP C4374 30 5 30

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

Irbesartan HCTZ AN 150/12.5 EA MP NP C4374 30 5 30

(c)omit:

Irbesatzide GH 150/12.5 GQ MP NP C4374 30 5 30

  1. Schedule 1, entry for Irbesartan with Hydrochlorothiazide in the form Tablet 300 mg-12.5 mg

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

Irbesartan HCT GH 300/12.5 GQ MP NP C4374 30 5 30

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

Irbesartan HCTZ AN 300/12.5 EA MP NP C4374 30 5 30

(c)omit:

Irbesatzide GH 300/12.5 GQ MP NP C4374 30 5 30

  1. Schedule 1, entry for Irbesartan with Hydrochlorothiazide in the form Tablet 300 mg-25 mg

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

Irbesartan HCT GH 300/25 GQ MP NP C4374 30 5 30

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

Irbesartan HCTZ AN 300/25 EA MP NP C4374 30 5 30

(c)omit:

Irbesatzide GH 300/25 GQ MP NP C4374 30 5 30

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

omit:

Irinotecan SZ HX MP See Note 3 See
Note 3 		1 D(100)

  1. Schedule 1, entry for Isosorbide Mononitrate in the form Tablet 60 mg (sustained release)

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

Isosorbide AN EA MP NP 30 5 30

  1. Schedule 1, entry for Isotretinoin in the form Capsule 10 mg

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

Dermatane ER MP C1354 60 3 60

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

Isotretinoin AN EA MP C1354 60 3 60

  1. Schedule 1, entry for Isotretinoin in the form Capsule 20 mg

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

Dermatane ER MP C1354 60 3 60

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

Isotretinoin AN EA MP C1354 60 3 60

  1. Schedule 1, entry for Isotretinoin in the form Capsule 40 mg

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

Dermatane ER MP C1354 30 3 30

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

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

Lercanidipine AN EA MP NP 28 5 28

  1. Schedule 1, entry for Letrozole

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

Letrozole AN EA MP NP C1608 C2691 C2692 30 5 30

  1. Schedule 1, entry for Levetiracetam in each of the forms: Tablet 250 mg; Tablet 500 mg; and Tablet 1 g

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

Levetiracetam AN EA MP NP C2664 60 5 60

  1. Schedule 1, entry for Levodopa with Carbidopa

omit:

Intestinal gel 20 mg‑5 mg per mL, 100 mL Intra-intestinal Duodopa VE MP NP C3703 56 5 7
MP
See Note 1 		C3704 C3705 56 5 7 C(100)

substitute:

Intestinal gel 20 mg‑5 mg per mL, 100 mL Intra-intestinal Duodopa VE MP
See Note 1 		C3703 C3704 C3705 56 5 7
NP C3703 56 5 7

  1. Schedule 1, entry for Levonorgestrel with Ethinyloestradiol in the form Pack containing 21 tablets 150 micrograms-30 micrograms and
    7 inert tablets

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

Evelyn 150/30 ED GQ MP NP 4 2 4

  1. Schedule 1, entry for Lisinopril in each of the forms: Tablet 5 mg; Tablet 10 mg; and Tablet 20 mg

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

Lisinopril AN EA MP NP 30 5 30

  1. Schedule 1, after entry for Losartan in the form Tablet containing losartan potassium 50 mg

insert:

Macitentan Tablet 10 mg Oral Opsumit AT MP
See Note 1 		See Note 3 See Note 3 See Note 3 30 D(100)

  1. Schedule 1, entry for Meloxicam in each of the forms: Tablet 7.5 mg; and Tablet 15 mg

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

Meloxicam AN EA MP NP C1547 C1848 30 3 30

  1. Schedule 1, entry for Metformin in the form Tablet containing metformin hydrochloride 500 mg

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

Metformin AN EA MP NP 100 5 100

  1. Schedule 1, entry for Metformin in the form Tablet containing metformin hydrochloride 850 mg

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

Metformin AN EA MP NP 60 5 60

  1. Schedule 1, entry for Metformin in the form Tablet containing metformin hydrochloride 1 g

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

Metformin AN EA MP NP 90 5 90

  1. Schedule 1, entry for Mirtazapine in the form Tablet 15 mg

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

Mirtazapine AN EA MP NP C1211 30 5 30

  1. Schedule 1, entry for Mirtazapine in the form Tablet 15 mg (orally disintegrating)

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

Mirtazapine AN ODT EA MP NP C1211 30 5 30

  1. Schedule 1, entry for Mirtazapine in the form Tablet 30 mg

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

Mirtazapine AN EA MP NP C1211 30 5 30

  1. Schedule 1, entry for Mirtazapine in the form Tablet 30 mg (orally disintegrating)

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

Mirtazapine AN ODT EA MP NP C1211 30 5 30

  1. Schedule 1, entry for Mirtazapine in the form Tablet 45 mg

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

Mirtazapine AN EA MP NP C1211 30 5 30

  1. Schedule 1, entry for Mirtazapine in the form Tablet 45 mg (orally disintegrating)

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

Mirtazapine AN ODT EA MP NP C1211 30 5 30

  1. Schedule 1, entry for Moclobemide in each of the forms: Tablet 150 mg; and Tablet 300 mg

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

Moclobemide AN EA MP NP C1211 60 5 60

  1. Schedule 1, entry for Montelukast in the form Tablet, chewable, 4 mg (as sodium)

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

Montelukast AN EA MP NP C2617 28 5 28

  1. Schedule 1, entry for Montelukast in the form Tablet, chewable, 5 mg (as sodium)

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

Montelukast AN EA MP NP C2618 C3217 28 5 28

  1. Schedule 1, entry for Norfloxacin

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

Norfloxacin AN EA MP NP C1002 C1070 14 1 14

  1. Schedule 1, entry for Olanzapine in each of the forms: Tablet 2.5 mg; Tablet 5 mg; Tablet 7.5 mg; and Tablet 10 mg

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

Olanzapine AN EA MP NP C1589 C2044 28 5 28

  1. Schedule 1, entry for Olanzapine in each of the forms: Tablet 5 mg (orally disintegrating); Tablet 10 mg (orally disintegrating);
    Tablet 15 mg (orally disintegrating); and Tablet 20 mg (orally disintegrating)

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

Olanzapine AN ODT EA MP NP C1589 C2044 28 5 28

  1. Schedule 1, entry for Omeprazole in the form Tablet 20 mg [Maximum Quantity: 30; Number of Repeats: 1]

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

Omeprazole AN EA MP NP C4074 C4075 C4089 C4152 P4074 30 1 30

  1. Schedule 1, entry for Omeprazole in the form Tablet 20 mg [Maximum Quantity: 30; Number of Repeats: 5]

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

Omeprazole AN EA MP NP C4074 C4075 C4089 C4152 P4075 P4089 P4152 30 5 30

  1. Schedule 1, omit entry for Omeprazole and Clarithromycin and Amoxycillin

  1. Schedule 1, entry for Ondansetron in the form Tablet (orally disintegrating) 4 mg [Maximum Quantity: 4; Number of Repeats: 0]

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

Ondansetron AN ODT EA MP NP
See Note 1 		C3050 C3611 See Note 2 P3050
See Note 2 		4
See Note 2 		0
See
Note 2 		4

  1. Schedule 1, entry for Ondansetron in the form Tablet (orally disintegrating) 4 mg [Maximum Quantity: 10; Number of Repeats: 1]

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

Ondansetron AN ODT EA MP NP C3050 C3611 P3611 10 1 10

  1. Schedule 1, entry for Ondansetron in the form Tablet (orally disintegrating) 8 mg [Maximum Quantity: 4; Number of Repeats: 0]

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

Ondansetron AN ODT EA MP NP
See Note 1 		C3050 C3611 See Note 2 P3050
See Note 2 		4
See Note 2 		0
See
Note 2 		4

  1. Schedule 1, entry for Ondansetron in the form Tablet (orally disintegrating) 8 mg [Maximum Quantity: 10; Number of Repeats: 1]

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

Ondansetron AN ODT EA MP NP C3050 C3611 P3611 10 1 10

  1. Schedule 1, entry for Ondansetron in the form Tablet 4 mg (as hydrochloride dihydrate) [Maximum Quantity: 4; Number of Repeats: 0]

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

Ondansetron AN EA MP NP
See Note 1 		C3050 C3611 See Note 2 P3050
See Note 2 		4
See Note 2 		0
See
Note 2 		4

  1. Schedule 1, entry for Ondansetron in the form Tablet 4 mg (as hydrochloride dihydrate) [Maximum Quantity: 10; Number of Repeats: 1]

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

Ondansetron AN EA MP NP C3050 C3611 P3611 10 1 10

  1. Schedule 1, entry for Ondansetron in the form Tablet 8 mg (as hydrochloride dihydrate) [Maximum Quantity: 4; Number of Repeats: 0]

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

Ondansetron AN EA MP NP
See Note 1 		C3050 C3611 See Note 2 P3050
See Note 2 		4
See Note 2 		0
See
Note 2 		4

  1. Schedule 1, entry for Ondansetron in the form Tablet 8 mg (as hydrochloride dihydrate) [Maximum Quantity: 10; Number of Repeats: 1]

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

Ondansetron AN EA MP NP C3050 C3611 P3611 10 1 10

  1. Schedule 1, entry for Oxaliplatin in the form Powder for I.V. infusion 50 mg

omit:

Oxaliplatin Alphapharm AF MP See Note 3 See
Note 3 		1 D(100)

  1. Schedule 1, entry for Oxaliplatin in the form Powder for I.V. infusion 100 mg

omit:

Oxaliplatin Alphapharm AF MP See Note 3 See
Note 3 		1 D(100)

  1. Schedule 1, entry for Oxprenolol

omit:

Tablet containing oxprenolol hydrochloride 20 mg Oral Corbeton 20 AF MP NP 100 5 100

  1. Schedule 1, entry for Pantoprazole in the form Tablet (enteric coated) 40 mg (as sodium sesquihydrate) [Maximum Quantity: 30;
    Number of Repeats: 2]

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

Pantoprazole AN EA MP NP C1177 C1337 C1476 C1533 P1177 30 2 30

  1. Schedule 1, entry for Pantoprazole in the form Tablet (enteric coated) 40 mg (as sodium sesquihydrate) [Maximum Quantity: 30;
    Number of Repeats: 5]

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

Pantoprazole AN EA MP NP C1177 C1337 C1476 C1533 P1337 P1476 P1533 30 5 30

  1. Schedule 1, entry for Pantoprazole in the form Tablet (enteric coated) 20 mg (as sodium sesquihydrate)

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

Pantoprazole AN EA MP NP C1337 C1476 C1533 30 5 30

  1. Schedule 1, entry for Paroxetine in the form Tablet 20 mg (as hydrochloride)

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

Paroxetine AN EA MP NP C1211 C1241 C1862 30 5 30

  1. Schedule 1, entry for Pioglitazone in each of the forms: Tablet 15 mg (as hydrochloride); Tablet 30 mg (as hydrochloride); and
    Tablet 45 mg (as hydrochloride)

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

Pioglitazone AN EA MP NP C4363 C4364 C4388 28 5 28

  1. Schedule 1, entry for Pravastatin in the form Tablet containing pravastatin sodium 10 mg [Maximum Quantity: 30; Number of Repeats: 5]

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

Pravastatin AN EA MP C1540 C3047 P1540 30 5 30
NP C1540 30 5 30

  1. Schedule 1, entry for Pravastatin in the form Tablet containing pravastatin sodium 10 mg [Maximum Quantity: 30;
    Number of Repeats: 11]

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

Pravastatin AN EA MP C1540 C3047 P3047 30 11 30

  1. Schedule 1, entry for Pravastatin in the form Tablet containing pravastatin sodium 20 mg [Maximum Quantity: 30; Number of Repeats: 5]

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

Pravastatin AN EA MP C1540 C3047 P1540 30 5 30
NP C1540 30 5 30

  1. Schedule 1, entry for Pravastatin in the form Tablet containing pravastatin sodium 20 mg [Maximum Quantity: 30;
    Number of Repeats: 11]

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

Pravastatin AN EA MP C1540 C3047 P3047 30 11 30

  1. Schedule 1, entry for Pravastatin in the form Tablet containing pravastatin sodium 40 mg [Maximum Quantity: 30; Number of Repeats: 5]

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

Pravastatin AN EA MP C1540 C3047 P1540 30 5 30
NP C1540 30 5 30

  1. Schedule 1, entry for Pravastatin in the form Tablet containing pravastatin sodium 40 mg [Maximum Quantity: 30;
    Number of Repeats: 11]

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

Pravastatin AN EA MP C1540 C3047 P3047 30 11 30

  1. Schedule 1, entry for Pravastatin in the form Tablet containing pravastatin sodium 80 mg [Maximum Quantity: 30; Number of Repeats: 5]

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

Pravastatin AN EA MP C1540 C3047 P1540 30 5 30
NP C1540 30 5 30

  1. Schedule 1, entry for Pravastatin in the form Tablet containing pravastatin sodium 80 mg [Maximum Quantity: 30;
    Number of Repeats: 11]

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

Pravastatin AN EA MP C1540 C3047 P3047 30 11 30

  1. Schedule 1, entry for Prochlorperazine in the form Tablet containing prochlorperazine maleate 5 mg

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

Prochlorperazine AN EA PDP MP NP 25 0 25

  1. Schedule 1, entry for Quetiapine in the form Tablet 25 mg (as fumarate)

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

Quetiapine AN EA MP NP C4385 C4391 C4396 60 0 60

  1. Schedule 1, entry for Quetiapine in the form Tablet 100 mg (as fumarate)

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

Quetiapine AN EA MP NP C1589 C2044 C2765 90 5 90

  1. Schedule 1, entry for Quetiapine in each of the forms: Tablet 200 mg (as fumarate); and Tablet 300 mg (as fumarate)

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

Quetiapine AN EA MP NP C1589 C2044 C2765 60 5 60

  1. Schedule 1, entry for Rabeprazole in the form Tablet containing rabeprazole sodium 10 mg (enteric coated)

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

Rabeprazole AN EA MP NP C1337 C1533 28 5 28

  1. Schedule 1, entry for Rabeprazole in the form Tablet containing rabeprazole sodium 20 mg (enteric coated) [Maximum Quantity: 30; Number of Repeats: 2]

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

Rabeprazole AN EA MP NP C1177 C1337 C1533 P1177 30 2 30

  1. Schedule 1, entry for Rabeprazole in the form Tablet containing rabeprazole sodium 20 mg (enteric coated) [Maximum Quantity: 30; Number of Repeats: 5]

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

Rabeprazole AN EA MP NP C1177 C1337 C1533 P1337 P1533 30 5 30

  1. Schedule 1, entry for Ramipril in the form Tablet 1.25 mg

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

Ramipril AN EA MP NP 30 5 30

  1. Schedule 1, entry for Ramipril in the form Tablet 2.5 mg

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

Ramipril AN EA MP NP 30 5 30

  1. Schedule 1, entry for Ramipril in the form Tablet 5 mg

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

Ramipril AN EA MP NP 30 5 30

  1. Schedule 1, entry for Ramipril in the form Tablet 10 mg

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

Ramipril AN EA MP NP 30 5 30

  1. Schedule 1, entry for Ramipril in the form Capsule 10 mg

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

Ramipril CH EA MP NP 30 5 30

  1. Schedule 1, entry for Ranibizumab

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

Solution for intravitreal injection 1.65 mg in 0.165 mL Injection Lucentis NV MP C4607 C4640 1 2 1

  1. Schedule 1, entry for Ranibizumab in the form Solution for intravitreal injection 2.3 mg in 0.23 mL

omit from the column headed “Circumstances”:           C2677  C3859    substitute:             C4607  C4640

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

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

Risedronate AN EA MP NP C4122 C4123 C4133 4 5 4

  1. Schedule 1, entry for Risperidone in the form Tablet 0.5 mg [Maximum Quantity: 60; Number of Repeats: 2]

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

Risperidone AN EA MP NP C1589 C2061 C3083 P2061 P3083 60 2 60

  1. Schedule 1, entry for Risperidone in the form Tablet 0.5 mg [Maximum Quantity: 60; Number of Repeats: 5]

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

Risperidone AN EA MP NP C1589 C2061 C3083 P1589 60 5 60

  1. Schedule 1, entry for Risperidone in the form Tablet 1 mg [Maximum Quantity: 60; Number of Repeats: 2]

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

Risperidone AN EA MP NP C1589 C2061 C2272 C3083 P2061 P3083 60 2 60

  1. Schedule 1, entry for Risperidone in the form Tablet 1 mg [Maximum Quantity: 60; Number of Repeats: 5]

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

Risperidone AN EA MP NP C1589 C2061 C2272 C3083 P1589 P2272 60 5 60

  1. Schedule 1, entry for Risperidone in the form Tablet 2 mg [Maximum Quantity: 60; Number of Repeats: 2]

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

Risperidone AN EA MP NP C1589 C2272 C3083 P3083 60 2 60

  1. Schedule 1, entry for Risperidone in the form Tablet 2 mg [Maximum Quantity: 60; Number of Repeats: 5]

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

Risperidone AN EA MP NP C1589 C2272 C3083 P1589 P2272 60 5 60

  1. Schedule 1, entry for Risperidone in the form Tablet 3 mg

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

Risperidone AN EA MP NP C1589 C2272 60 5 60

  1. Schedule 1, entry for Risperidone in the form Tablet 4 mg

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

Risperidone AN EA MP NP C1589 C2272 60 5 60

  1. Schedule 1, entry for Rosuvastatin in the form Tablet 5 mg (as calcium) [Maximum Quantity: 30; Number of Repeats: 5]

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

Rosuvastatin AN EA MP C4225 C4228 P4228 30 5 30
NP C4228 30 5 30

  1. Schedule 1, entry for Rosuvastatin in the form Tablet 5 mg (as calcium) [Maximum Quantity: 30; Number of Repeats: 11]

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

Rosuvastatin AN EA MP C4225 C4228 P4225 30 11 30

  1. Schedule 1, entry for Rosuvastatin in the form Tablet 10 mg (as calcium) [Maximum Quantity: 30; Number of Repeats: 5]

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

Rosuvastatin AN EA MP C4225 C4228 P4228 30 5 30
NP C4228 30 5 30

  1. Schedule 1, entry for Rosuvastatin in the form Tablet 10 mg (as calcium) [Maximum Quantity: 30; Number of Repeats: 11]

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

Rosuvastatin AN EA MP C4225 C4228 P4225 30 11 30

  1. Schedule 1, entry for Rosuvastatin in the form Tablet 20 mg (as calcium) [Maximum Quantity: 30; Number of Repeats: 5]

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

Rosuvastatin AN EA MP C4225 C4227 P4227 30 5 30
NP C4227 30 5 30

  1. Schedule 1, entry for Rosuvastatin in the form Tablet 20 mg (as calcium) [Maximum Quantity: 30; Number of Repeats: 11]

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

Rosuvastatin AN EA MP C4225 C4227 P4225 30 11 30

  1. Schedule 1, entry for Rosuvastatin in the form Tablet 40 mg (as calcium) [Maximum Quantity: 30; Number of Repeats: 5]

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

Rosuvastatin AN EA MP C4225 C4226 P4226 30 5 30
NP C4226 30 5 30

  1. Schedule 1, entry for Rosuvastatin in the form Tablet 40 mg (as calcium) [Maximum Quantity: 30; Number of Repeats: 11]

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

Rosuvastatin AN EA MP C4225 C4226 P4225 30 11 30

  1. Schedule 1, entry for Simvastatin in the form Tablet 10 mg [Maximum Quantity: 30; Number of Repeats: 5]

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

Simvastatin AN EA MP C1540 C3047 P1540 30 5 30
NP C1540 30 5 30

  1. Schedule 1, entry for Simvastatin in the form Tablet 10 mg [Maximum Quantity: 30; Number of Repeats: 11]

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

Simvastatin AN EA MP C1540 C3047 P3047 30 11 30

  1. Schedule 1, entry for Simvastatin in the form Tablet 20 mg [Maximum Quantity: 30; Number of Repeats: 5]

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

Simvastatin AN EA MP C1540 C3047 P1540 30 5 30
NP C1540 30 5 30

  1. Schedule 1, entry for Simvastatin in the form Tablet 20 mg [Maximum Quantity: 30; Number of Repeats: 11]

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

Simvastatin AN EA MP C1540 C3047 P3047 30 11 30

  1. Schedule 1, entry for Simvastatin in the form Tablet 40 mg [Maximum Quantity: 30; Number of Repeats: 5]

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

Simvastatin AN EA MP C1540 C3047 P1540 30 5 30
NP C1540 30 5 30

  1. Schedule 1, entry for Simvastatin in the form Tablet 40 mg [Maximum Quantity: 30; Number of Repeats: 11]

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

Simvastatin AN EA MP C1540 C3047 P3047 30 11 30

  1. Schedule 1, entry for Simvastatin in the form Tablet 80 mg [Maximum Quantity: 30; Number of Repeats: 5]

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

Simvastatin AN EA MP C1540 C3047 P1540 30 5 30
NP C1540 30 5 30

  1. Schedule 1, entry for Simvastatin in the form Tablet 80 mg [Maximum Quantity: 30; Number of Repeats: 11]

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

Simvastatin AN EA MP C1540 C3047 P3047 30 11 30

  1. Schedule 1, entry for Sodium Chloride

omit:

I.V. infusion 38.5 mmol per 250 mL, 250 mL Injection Sodium Chloride 0.9% Freeflex PK MP NP 5 1 1
I.V. infusion 77 mmol per 500 mL, 500 mL Injection Fresenius Kabi Australia Pty Limited PK PDP 5 0 1
Fresenius Kabi Australia Pty Limited PK MP NP 5 1 1

  1. Schedule 1, entry for Sodium Lactate Compound

omit:

I.V. infusion containing approximately 65 mmol sodium (as lactate and chloride), 2.7 mmol potassium (as chloride), 0.9 mmol calcium (as chloride), 14 mmol bicarbonate (as lactate) and 56 mmol chloride per 500 mL, 500 mL Injection Fresenius Kabi Australia Pty Limited PK MP NP 5 1 1

  1. Schedule 1, entry for Sumatriptan in the form Tablet 50 mg (as succinate) [Maximum Quantity: 4; Number of Repeats: 5; Pack Quantity: 4]

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

Sumatriptan AN EA MP NP C4558 4 5 4

  1. Schedule 1, entry for Telmisartan

substitute:

Telmisartan Tablet 40 mg Oral APO-Telmisartan TX MP NP 28 5 28
Chem mart Telmisartan CH MP NP 28 5 28
Micardis BY MP NP 28 5 28
Mizart AF MP NP 28 5 28
Pharmacor Telmisartan 40 CR MP NP 28 5 28
Telmigen GN MP NP 28 5 28
Telmisartan AN EA MP NP 28 5 28
Telmisartan-DRLA RZ MP NP 28 5 28
Telmisartan GH GQ MP NP 28 5 28
Telmisartan Sandoz SZ MP NP 28 5 28
Teltartan QA MP NP 28 5 28
Terry White Chemists Telmisartan TW MP NP 28 5 28
Tablet 80 mg Oral APO-Telmisartan TX MP NP 28 5 28
Chem mart Telmisartan CH MP NP 28 5 28
Micardis BY MP NP 28 5 28
Mizart AF MP NP 28 5 28
Pharmacor Telmisartan 80 CR MP NP 28 5 28
Telmigen GN MP NP 28 5 28
Telmisartan AN EA MP NP 28 5 28
Telmisartan-DRLA RZ MP NP 28 5 28
Telmisartan GH GQ MP NP 28 5 28
Telmisartan Sandoz SZ MP NP 28 5 28
Teltartan QA MP NP 28 5 28
Terry White Chemists Telmisartan TW MP NP 28 5 28

  1. Schedule 1, entry for Telmisartan with Hydrochlorothiazide

substitute:

Telmisartan with Hydrochlorothiazide Tablet 40 mg-12.5 mg Oral APO-Telmisartan HCTZ 40/12.5 TX MP NP C4374 28 5 28
Chem mart Telmisartan HCTZ 40/12.5 CH MP NP C4374 28 5 28
Micardis Plus 40/12.5 mg BY MP NP C4374 28 5 28
Mizart HCT 40/12.5 AF MP NP C4374 28 5 28
Pritor Plus 40/12.5 mg FI MP NP C4374 28 5 28
Telmigen HCT 40/12.5 GN MP NP C4374 28 5 28
Telmisartan/HCT Sandoz SZ MP NP C4374 28 5 28
Telmisartan HCTZ AN 40/12.5 EA MP NP C4374 28 5 28
Teltartan HCT 40/12.5 QA MP NP C4374 28 5 28
Terry White Chemists Telmisartan HCTZ 40/12.5 TW MP NP C4374 28 5 28
Tablet 80 mg-12.5 mg Oral APO-Telmisartan HCTZ 80/12.5 TX MP NP C4374 28 5 28
Chem mart Telmisartan HCTZ 80/12.5 CH MP NP C4374 28 5 28
Micardis Plus 80/12.5 mg BY MP NP C4374 28 5 28
Mizart HCT 80/12.5 AF MP NP C4374 28 5 28
Pritor Plus 80/12.5 mg FI MP NP C4374 28 5 28
Telmigen HCT 80/12.5 GN MP NP C4374 28 5 28
Telmisartan/HCT Sandoz SZ MP NP C4374 28 5 28
Telmisartan HCTZ AN 80/12.5 EA MP NP C4374 28 5 28
Teltartan HCT 80/12.5 QA MP NP C4374 28 5 28
Terry White Chemists Telmisartan HCTZ 80/12.5 TW MP NP C4374 28 5 28
Tablet 80 mg-25 mg Oral APO-Telmisartan HCTZ 80/25 TX MP NP C4374 28 5 28
Chem mart Telmisartan HCTZ 80/25 CH MP NP C4374 28 5 28
Micardis Plus 80/25 mg BY MP NP C4374 28 5 28
Mizart HCT 80/25 AF MP NP C4374 28 5 28
Pritor Plus 80/25 mg FI MP NP C4374 28 5 28
Telmigen HCT 80/25 GN MP NP C4374 28 5 28
Telmisartan/HCT Sandoz SZ MP NP C4374 28 5 28
Telmisartan HCTZ AN 80/25 EA MP NP C4374 28 5 28
Teltartan HCT 80/25 QA MP NP C4374 28 5 28
Terry White Chemists Telmisartan HCTZ 80/25 TW MP NP C4374 28 5 28

  1. Schedule 1, entry for Temozolomide in the form Capsule 5 mg [Maximum Quantity: 5; Number of Repeats: 5]

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

Temozolomide AN EA MP C1736 C1737 C2101 C4496 P1736 P1737 P2101 5 5 5

  1. Schedule 1, entry for Temozolomide in the form Capsule 5 mg [Maximum Quantity: 15; Number of Repeats: 2]

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

Temozolomide AN EA MP C1736 C1737 C2101 C4496 P4496 15 2 5

  1. Schedule 1, entry for Temozolomide in the form Capsule 20 mg [Maximum Quantity: 5; Number of Repeats: 5]

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

Temozolomide AN EA MP C1736 C1737 C2101 C4496 P1736 P1737 P2101 5 5 5

  1. Schedule 1, entry for Temozolomide in the form Capsule 20 mg [Maximum Quantity: 15; Number of Repeats: 2]

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

Temozolomide AN EA MP C1736 C1737 C2101 C4496 P4496 15 2 5

  1. Schedule 1, entry for Temozolomide in the form Capsule 100 mg [Maximum Quantity: 5; Number of Repeats: 5]

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

Temozolomide AN EA MP C1736 C1737 C2101 C4496 P1736 P1737 P2101 5 5 5

  1. Schedule 1, entry for Temozolomide in the form Capsule 100 mg [Maximum Quantity: 15; Number of Repeats: 2]

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

Temozolomide AN EA MP C1736 C1737 C2101 C4496 P4496 15 2 5

  1. Schedule 1, entry for Temozolomide in the form Capsule 140 mg [Maximum Quantity: 5; Number of Repeats: 5]

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

Temozolomide AN EA MP C1736 C1737 C2101 C4496 P1736 P1737 P2101 5 5 5

  1. Schedule 1, entry for Temozolomide in the form Capsule 140 mg [Maximum Quantity: 15; Number of Repeats: 2]

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

Temozolomide AN EA MP C1736 C1737 C2101 C4496 P4496 15 2 5

  1. Schedule 1, entry for Temozolomide in the form Capsule 250 mg

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

Temozolomide AN EA MP C1736 C1737 C2101 5 5 5

  1. Schedule 1, entry for Terbinafine in the form Tablet 250 mg (as hydrochloride) [Maximum Quantity: 42; Number of Repeats: 0]

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

Terbinafine Actavis VN MP NP C2191 C2865 C3244 P2865 P3244 42 0 42

  1. Schedule 1, entry for Terbinafine in the form Tablet 250 mg (as hydrochloride) [Maximum Quantity: 42; Number of Repeats: 1]

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

Terbinafine Actavis VN MP NP C2191 C2865 C3244 P2191 42 1 42

  1. Schedule 1, entry for Testosterone

(a)omit:

Subcutaneous implant 100 mg Implantation Merck Sharp & Dohme (Australia) Pty Ltd MK MP C1021 C1022 C1226 6 0 1

(b)omit:

Subcutaneous implant 200 mg Implantation Merck Sharp & Dohme (Australia) Pty Ltd MK MP C1021 C1022 C1226 3 0 1

  1. Schedule 1, entry for Topiramate in each of the forms: Tablet 25 mg; and Tablet 50 mg

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

Topiramate GH GQ MP NP C2797 C2799 60 5 60

  1. Schedule 1, entry for Topiramate in each of the forms: Tablet 100 mg; and Tablet 200 mg

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

Topiramate GH GQ MP NP C2797 60 5 60

  1. Schedule 1, entry for Tramadol in the form Capsule containing tramadol hydrochloride 50 mg [Maximum Quantity: 20;
    Number of Repeats: 0]

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

Tramadol AN EA MP NP C1497 C1615 P1497 20 0 20
PDP C1497 C1615 20 0 20

  1. Schedule 1, entry for Tramadol in the form Capsule containing tramadol hydrochloride 50 mg [Maximum Quantity: 20;
    Number of Repeats: 2]

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

Tramadol AN EA MP NP C1497 C1615 P1615 20 2 20

  1. Schedule 1, entry for Valaciclovir in the form Tablet 500 mg (as hydrochloride) [Maximum Quantity: 20; Number of Repeats: 0]

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

Valaciclovir Actavis VN MP NP C3622 C3623 C3624 C3631 C3632 P3632 20 0 10

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

Valaciclovir AN EA MP NP C3622 C3623 C3624 C3631 C3632 P3632 20 0 10

  1. Schedule 1, entry for Valaciclovir in the form Tablet 500 mg (as hydrochloride) [Maximum Quantity: 30; Number of Repeats: 5]

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

Valaciclovir Actavis VN MP NP C3622 C3623 C3624 C3631 C3632 P3623 P3624 30 5 30

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

Valaciclovir AN EA MP NP C3622 C3623 C3624 C3631 C3632 P3623 P3624 30 5 30

  1. Schedule 1, entry for Valaciclovir in the form Tablet 500 mg (as hydrochloride) [Maximum Quantity: 42; Number of Repeats: 0]

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

Valaciclovir Actavis VN MP NP C3622 C3623 C3624 C3631 C3632 P3622 P3631 42 0 42

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

Valaciclovir AN EA MP NP C3622 C3623 C3624 C3631 C3632 P3622 P3631 42 0 42

  1. Schedule 1, entry for Valsartan in the form Tablet 40 mg

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

APO-Valsartan TX MP NP 28 0 28

  1. Schedule 1, entry for Valsartan in each of the forms: Tablet 80 mg; Tablet 160 mg; and Tablet 320 mg

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

APO-Valsartan TX MP NP 28 5 28

  1. Schedule 1, entry for Venlafaxine in the form Capsule (modified release) 37.5 mg (as hydrochloride)

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

Venlafaxine AN SR EA MP NP C1211 28 0 28

  1. Schedule 1, entry for Venlafaxine in each of the forms: Capsule (modified release) 75 mg (as hydrochloride); and Capsule (modified release) 150 mg (as hydrochloride)

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

Venlafaxine AN SR EA MP NP C1211 28 5 28

  1. Schedule 3, after details relevant to Responsible Person code DV

insert:

EA Amneal Pharmaceuticals Pty Ltd  11 163 167 851

  1. Schedule 4, Part 1, entry for Adalimumab

(a)omit:

C3502 P3502 Ankylosing spondylitis — initial treatment 1
Initial treatment with adalimumab commencing a treatment cycle, by a rheumatologist, of an adult with active ankylosing spondylitis who has radiographically (plain X‑ray) confirmed Grade II bilateral sacroiliitis or Grade III unilateral sacroiliitis, and:
(a) who has not received any PBS‑subsidised treatment with a tumour necrosis factor (TNF)‑alfa antagonist, or, where the patient has previously received PBS‑subsidised TNF‑alfa antagonist treatment for this condition, has received no such treatment for a period of 5 years or more starting from the date the last course of PBS‑subsidised treatment was approved; and
(b) who has at least 2 of the following:
(i) low back pain and stiffness for 3 or more months that is relieved by exercise but not by rest; or
(ii) limitation of motion of the lumbar spine in the sagittal and the frontal planes as determined by a score of at least 1 on each of the lumbar flexion and lumbar side flexion measurements of the Bath Ankylosing Spondylitis Metrology Index (BASMI); or
(iii) limitation of chest expansion relative to normal values for age and gender; and
(c) who has failed to achieve an adequate response following treatment with at least 2 non‑steroidal anti‑inflammatory drugs (NSAIDs), whilst completing an appropriate exercise program, for a total period of at least 3 months, unless the patient has had a break in PBS‑subsidised TNF‑alfa antagonist therapy of at least 5 years duration, in which case the patient is required to demonstrate failure to achieve an adequate response to treatment with at least 1 NSAID, at an adequate dose, for a minimum of 3 consecutive months; and
where TNF‑alfa antagonist means adalimumab, etanercept, golimumab or infliximab; and
where a treatment cycle is a period of treatment with successive TNF‑alfa antagonists which commences when an eligible patient (one who has not received PBS‑subsidised treatment with a TNF‑alfa antagonist for ankylosing spondylitis in at least the previous 5 years) receives an initial course of PBS‑subsidised therapy with 1 TNF‑alfa antagonist, and which continues until the patient has tried and either failed, or ceased to respond to, PBS‑subsidised treatment with 3 TNF‑alfa antagonists, at which point the patient is no longer eligible for treatment and the period of treatment ceases; and
where the following conditions apply:
failure to achieve an adequate response is demonstrated by:
(a) a Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) score of at least 4 on a 0‑10 scale, where the BASDAI score is determined at the completion of the 3 month NSAID and exercise trial, but prior to ceasing NSAID treatment, and is no more than 1 month old at the time of application; and
(b) an elevated erythrocyte sedimentation rate (ESR) greater than 25 mm per hour or a C‑reactive protein (CRP) level greater than 10 mg per L;
both ESR and CRP measurements are included in the authority application and are no more than 1 month old;
if the requirement to demonstrate an elevated ESR or CRP cannot be met, the authority application includes the reason why this criterion cannot be satisfied;
the authority application includes details of the NSAIDs trialled, their doses and duration of treatment;
if the NSAID dose is less than the maximum recommended dose in the relevant Therapeutic Goods Administration (TGA)‑approved Product Information, the authority application includes the reason why a higher dose cannot be used;
if treatment with NSAIDs is contraindicated according to the relevant TGA‑approved Product Information, the authority application includes details of the contraindication;
if intolerance to NSAID treatment develops during the relevant period of use and is of a severity necessitating permanent treatment withdrawal, the authority application includes details of the nature and severity of this intolerance;
an appropriate minimum exercise program includes stretch and range of motion exercises at least 5 times per week, and either aerobic exercise of at least 20 minutes duration at least 3 times per week or a group exercise class at least once per week;
if a patient is unable to complete the minimum exercise program, the authority application includes the clinical reasons for this and details what, if any, exercise program has been followed;
the authority application is made in writing and includes a completed copy of the appropriate Ankylosing Spondylitis PBS Authority Application ‑ Supporting Information Form which includes the following:
(i) a copy of the radiological report confirming Grade II bilateral sacroiliitis or Grade III unilateral sacroiliitis; and
(ii) a completed BASDAI Assessment Form; and
(iii) a signed patient acknowledgment form; and
(iv) a completed Exercise Program Self Certification Form detailing the program followed and the dates over which it was followed, and including confirmation by the prescribing doctor that, to the best of their knowledge, the patient has followed the exercise program detailed;
a course of initial treatment commencing a treatment cycle is limited to a maximum of 16 weeks of treatment 		Compliance with Written Authority Required procedures
Continuation of a course of initial treatment with adalimumab in a treatment cycle, by a rheumatologist, of an adult with active ankylosing spondylitis who has radiographically (plain X‑ray) confirmed Grade II bilateral sacroiliitis or Grade III unilateral sacroiliitis, and who, qualifying under the criteria specified above, has previously been issued with an authority prescription for initial treatment with this drug for a period of less than 16 weeks, and where approval of the application would enable the patient to complete a course of 16 weeks of treatment in total Compliance with Written or Telephone Authority Required procedures

  1. Schedule 4, Part 1, entry for Everolimus [Circumstances Code: C4334; C4351 and C4557]

insert in  the column headed “Purposes Code”respectively:

P4334

P4351

P4557

  1. Schedule 4, Part 1, entry for Everolimus

insert in numerical order following existing text:

C4604 P4604

Stage IV clear cell variant renal cell carcinoma (RCC)

Initial treatment

Patient must have progressive disease according to the Response Evaluation Criteria In Solid Tumours (RECIST) following first-line treatment with a tyrosine kinase inhibitor; AND
Patient must have a WHO performance status of 2 or less; AND
The treatment must be the sole PBS-subsidised therapy for this condition

Patients who have developed intolerance to a tyrosine kinase inhibitor of a severity necessitating permanent treatment withdrawal are eligible to receive PBS-subsidised everolimus

Patients who have progressive disease with everolimus are no longer eligible for PBS-subsidised everolimus

 Compliance with Authority Required procedures
C4632 P4632

Stage IV clear cell variant renal cell carcinoma (RCC)

Continuing treatment beyond 3 months

Patient must have previously been issued with an authority prescription for this drug for this condition; AND
Patient must have stable or responding disease according to the Response Evaluation Criteria In Solid Tumours (RECIST); AND
The treatment must be the sole PBS-subsidised therapy for this condition

Patients who have progressive disease with everolimus are no longer eligible for PBS-subsidised everolimus

 Compliance with Authority Required procedures

  1. Schedule 4, Part 1, entry for Golimumab

(a)omit:

C3516 P3516 Ankylosing spondylitis — initial treatment 1
Initial treatment with golimumab commencing a treatment cycle, by a rheumatologist, of an adult with active ankylosing spondylitis who has radiographically (plain X‑ray) confirmed Grade II bilateral sacroiliitis or Grade III unilateral sacroiliitis, and:
(a) who has not received any PBS‑subsidised treatment with a tumour necrosis factor (TNF)‑alfa antagonist, or, where the patient has previously received PBS‑subsidised TNF‑alfa antagonist treatment for this condition, has received no such treatment for a period of 5 years or more starting from the date the last course of PBS‑subsidised treatment was approved; and
(b) who has at least 2 of the following:
(i) low back pain and stiffness for 3 or more months that is relieved by exercise but not by rest; or
(ii) limitation of motion of the lumbar spine in the sagittal and the frontal planes as determined by a score of at least 1 on each of the lumbar flexion and lumbar side flexion measurements of the Bath Ankylosing Spondylitis Metrology Index (BASMI); or
(iii) limitation of chest expansion relative to normal values for age and gender; and
(c) who has failed to achieve an adequate response following treatment with at least 2 non‑steroidal anti‑inflammatory drugs (NSAIDs), whilst completing an appropriate exercise program, for a total period of at least 3 months, unless the patient has had a break in PBS‑subsidised TNF‑alfa antagonist therapy of at least 5 years duration, in which case the patient is required to demonstrate failure to achieve an adequate response to treatment with at least 1 NSAID, at an adequate dose, for a minimum of 3 consecutive months; and
where TNF‑alfa antagonist means adalimumab, etanercept, golimumab or infliximab; and
where a treatment cycle is a period of treatment with successive TNF‑alfa antagonists which commences when an eligible patient (one who has not received PBS‑subsidised treatment with a TNF‑alfa antagonist for ankylosing spondylitis in at least the previous 5 years) receives an initial course of PBS‑subsidised therapy with 1 TNF‑alfa antagonist, and which continues until the patient has tried and either failed, or ceased to respond to, PBS‑subsidised treatment with 3 TNF‑alfa antagonists, at which point the patient is no longer eligible for treatment and the period of treatment ceases; and
where the following conditions apply:
failure to achieve an adequate response is demonstrated by:
(a) a Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) score of at least 4 on a 0‑10 scale, where the BASDAI score is determined at the completion of the 3 month NSAID and exercise trial, but prior to ceasing NSAID treatment, and is no more than 1 month old at the time of application; and
(b) an elevated erythrocyte sedimentation rate (ESR) greater than 25 mm per hour or a C‑reactive protein (CRP) level greater than 10 mg per L;
both ESR and CRP measurements are included in the authority application and are no more than 1 month old;
if the requirement to demonstrate an elevated ESR or CRP cannot be met, the authority application includes the reason why this criterion cannot be satisfied;
the authority application includes details of the NSAIDs trialled, their doses and duration of treatment;
if the NSAID dose is less than the maximum recommended dose in the relevant Therapeutic Goods Administration (TGA)‑approved Product Information, the authority application includes the reason why a higher dose cannot be used;
if treatment with NSAIDs is contraindicated according to the relevant TGA‑approved Product Information, the authority application includes details of the contraindication;
if intolerance to NSAID treatment develops during the relevant period of use and is of a severity necessitating permanent treatment withdrawal, the authority application includes details of the nature and severity of this intolerance;
an appropriate minimum exercise program includes stretch and range of motion exercises at least 5 times per week, and either aerobic exercise of at least 20 minutes duration at least 3 times per week or a group exercise class at least once per week;
if a patient is unable to complete the minimum exercise program, the authority application includes the clinical reasons for this and details what, if any, exercise program has been followed;
the authority application is made in writing and includes a completed copy of the appropriate Ankylosing Spondylitis PBS Authority Application ‑ Supporting Information Form which includes the following:
(i) a copy of the radiological report confirming Grade II bilateral sacroiliitis or Grade III unilateral sacroiliitis; and
(ii) a completed BASDAI Assessment Form; and
(iii) a signed patient acknowledgment form; and
(iv) a completed Exercise Program Self Certification Form detailing the program followed and the dates over which it was followed, and including confirmation by the prescribing doctor that, to the best of their knowledge, the patient has followed the exercise program detailed;
a course of initial treatment commencing a treatment cycle is limited to a maximum of 16 weeks of treatment 		Compliance with Written Authority Required procedures
Continuation of a course of initial treatment with golimumab in a treatment cycle, by a rheumatologist, of an adult with active ankylosing spondylitis who has radiographically (plain X‑ray) confirmed Grade II bilateral sacroiliitis or Grade III unilateral sacroiliitis, and who, qualifying under the criteria specified above, has previously been issued with an authority prescription for initial treatment with this drug for a period of less than 16 weeks, and where approval of the application would enable the patient to complete a course of 16 weeks of treatment in total Compliance with Written or Telephone Authority Required procedures
C3518 P3518 Ankylosing spondylitis — initial treatment 3
Commencement of a treatment cycle with an initial PBS‑subsidised course of golimumab for continuing treatment, by a rheumatologist, of an adult with a documented history of active ankylosing spondylitis who has radiographically (plain X‑ray) confirmed Grade II bilateral sacroiliitis or Grade III unilateral sacroiliitis, who was receiving treatment with golimumab prior to 1 March 2010; and
(a) who has demonstrated a response as specified in the criteria for continuing PBS‑subsidised treatment with golimumab; and
(b) who is receiving treatment with golimumab at the time of application; and
where TNF‑alfa antagonist means adalimumab, etanercept, golimumab or infliximab; and
where a treatment cycle is a period of treatment with successive TNF‑alfa antagonists which commences when an eligible patient (one who has not received PBS‑subsidised treatment with a TNF‑alfa antagonist for ankylosing spondylitis in at least the previous 5 years) receives an initial course of PBS‑subsidised therapy with 1 TNF‑alfa antagonist, and which continues until the patient has tried and either failed, or ceased to respond to, PBS‑subsidised treatment with 3 TNF‑alfa antagonists, at which point the patient is no longer eligible for treatment and the period of treatment ceases; and
where the following conditions apply:
the authority application is made in writing and includes a completed copy of the appropriate Ankylosing Spondylitis PBS Authority Application ‑ Supporting Information Form which includes the following:
(i) a copy of the radiological report confirming Grade II bilateral sacroiliitis or Grade III unilateral sacroiliitis; and
(ii) a completed BASDAI Assessment Form; and
(iii) a signed patient acknowledgment form;
the BASDAI assessment and the ESR and/or CRP measurements provided are no more than 1 month old at the time of application;
the course of treatment is limited to a maximum of 24 weeks of treatment;
patients are eligible for PBS‑subsidised treatment under the above criteria once only 		Compliance with Written Authority Required procedures
Continuation of a course of initial PBS‑subsidised treatment with golimumab commencing a treatment cycle, by a rheumatologist, of an adult with a documented history of active ankylosing spondylitis who was receiving non‑PBS‑subsidised treatment with golimumab prior to 1 March 2010 and at the time of the initial application for PBS‑subsidised therapy and who, qualifying under the criteria specified above, has previously been issued with an authority prescription for initial PBS‑subsidised treatment with this drug for a period of less than 24 weeks, and where approval of the application would enable the patient to complete a course of 24 weeks of treatment in total Compliance with Written or Telephone Authority Required procedures

(b)omit:

C3786 P3786 Ankylosing spondylitis — initial treatment 2
Initial treatment, or recommencement of treatment, with golimumab within an ongoing treatment cycle, by a rheumatologist, of an adult with a documented history of active ankylosing spondylitis who, in this treatment cycle, has received prior PBS‑subsidised tumour necrosis factor (TNF)‑alfa antagonist treatment for this condition and is eligible to receive further TNF‑alfa antagonist therapy, and has not failed PBS‑subsidised therapy with golimumab in the current treatment cycle; and
where TNF‑alfa antagonist means adalimumab, etanercept, golimumab or infliximab; and
where a treatment cycle is a period of treatment with successive TNF‑alfa antagonists which commences when an eligible patient (one who has not received PBS‑subsidised treatment with a TNF‑alfa antagonist for ankylosing spondylitis in at least the previous 5 years) receives an initial course of PBS‑subsidised therapy with 1 TNF‑alfa antagonist, and which continues until the patient has tried and either failed, or ceased to respond to, PBS‑subsidised treatment with 3 TNF‑alfa antagonists, at which point the patient is no longer eligible for treatment and the period of treatment ceases; and
where the following conditions apply:
a patient is eligible to receive further therapy with a TNF‑alfa antagonist within this treatment cycle provided they have not already failed, or ceased to respond to, PBS‑subsidised treatment with 3 TNF‑alfa antagonists within this treatment cycle;
the authority application is made in writing and includes a completed copy of the appropriate Ankylosing Spondylitis PBS Authority Application ‑ Supporting Information Form;
an assessment of response to the patient’s most recent course of PBS‑subsidised TNF‑alfa antagonist treatment is provided to the Chief Executive Medicare no later than 4 weeks from the date that course was ceased;
where the most recent course of TNF‑antagonist treatment is an initial treatment course, the assessment of response is made following a minimum of 12 weeks of treatment;
if the response assessment to the previous course of TNF‑alfa antagonist treatment is not submitted to the Chief Executive Medicare within the timeframes specified above, the patient will be deemed to have failed that course of treatment;
a course of initial treatment within an ongoing treatment cycle is limited to a maximum of 16 weeks of treatment 		Compliance with Written Authority Required procedures
Continuation of a course of initial treatment, or of a course which recommences treatment, with golimumab within an ongoing treatment cycle, by a rheumatologist, of an adult with a documented history of active ankylosing spondylitis who, qualifying under the criteria specified above, has previously been issued with an authority prescription for initial treatment or recommencement of treatment with this drug for a period of less than 16 weeks, and where approval of the application would enable the patient to complete a course of 16 weeks of treatment in total Compliance with Written or Telephone Authority Required procedures
C3787 P3787 Ankylosing spondylitis — continuing treatment
Continuing treatment with golimumab within an ongoing treatment cycle, by a rheumatologist, of an adult with a documented history of active ankylosing spondylitis who has demonstrated an adequate response to treatment with golimumab, and whose most recent course of PBS‑subsidised therapy in this treatment cycle was with golimumab; and
where TNF‑alfa antagonist means adalimumab, etanercept, golimumab or infliximab; and
where a treatment cycle is a period of treatment with successive TNF‑alfa antagonists which commences when an eligible patient (one who has not received PBS‑subsidised treatment with a TNF‑alfa antagonist for ankylosing spondylitis in at least the previous 5 years) receives an initial course of PBS‑subsidised therapy with 1 TNF‑alfa antagonist, and which continues until the patient has tried and either failed, or ceased to respond to, PBS‑subsidised treatment with 3 TNF‑alfa antagonists, at which point the patient is no longer eligible for treatment and the period of treatment ceases; and
where the following conditions apply:
an adequate response is defined as an improvement from baseline of at least 2 in the patient’s Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) score and 1 of the following:
(a) an erythrocyte sedimentation rate (ESR) measurement no greater than 25 mm per hour; or
(b) a C‑reactive protein (CRP) measurement no greater than 10 mg per L; or
(c) an ESR or CRP measurement reduced by at least 20% from baseline;
all measurements provided are no more than 1 month old at the time of application;
where only 1 acute phase reactant measurement is supplied to establish baseline in the first application for PBS‑subsidised treatment, that same marker is measured and supplied in all subsequent continuing treatment applications;
the authority application is made in writing and includes a completed copy of the appropriate Ankylosing Spondylitis PBS Authority Application ‑ Supporting Information Form, and a measurement of response to the most recent prior course of therapy with golimumab;
the response assessment included in the application is provided to the Chief Executive Medicare no later than 4 weeks from the cessation of the treatment course;
if the most recent course of golimumab therapy is a 16‑week initial treatment course, the application for continuing treatment is accompanied by an assessment of response to a minimum of 12 weeks of treatment with that course;
if the response assessment to a course of treatment is not submitted to the Chief Executive Medicare within the timeframes specified above, the patient will be deemed to have failed that course of treatment;
a course of continuing treatment within an ongoing treatment cycle is limited to a maximum of 24 weeks of treatment 		Compliance with Written Authority Required procedures
Continuation of a course of continuing treatment with golimumab within an ongoing treatment cycle, by a rheumatologist, of an adult with a documented history of active ankylosing spondylitis who, qualifying under the criteria specified above, has previously been issued with an authority prescription for continuing treatment with this drug for a period of less than 24 weeks, and where approval of the application would enable the patient to complete a course of 24 weeks of treatment in total Compliance with Written or Telephone Authority Required procedures

(c)insert in numerical order following existing text:

C4609 P4609

Active ankylosing spondylitis

Initial treatment – Initial 1 (new patients)

The condition must be radiographically (plain X-ray) confirmed Grade II bilateral sacroiliitis or Grade III unilateral sacroiliitis; AND
Patient must not have received any PBS-subsidised treatment with either adalimumab, certolizumab pegol, etanercept, golimumab or infliximab in this treatment cycle; AND
Patient must have at least 2 of the following: (i) low back pain and stiffness for 3 or more months that is relieved by exercise but not by rest; or (ii) limitation of motion of the lumbar spine in the sagittal and the frontal planes as determined by a score of at least 1 on each of the lumbar flexion and lumbar side flexion measurements of the Bath Ankylosing Spondylitis Metrology Index (BASMI); or (iii) limitation of chest expansion relative to normal values for age and gender; AND
Patient must have failed to achieve an adequate response following treatment with at least 2 non-steroidal anti-inflammatory drugs (NSAIDs), whilst completing an appropriate exercise program, for a total period of 3 months

Patient must be an adult

Must be treated by a rheumatologist

The application must include details of the NSAIDs trialled, their doses and duration of treatment

If the NSAID dose is less than the maximum recommended dose in the relevant TGA-approved Product Information, the application must include the reason a higher dose cannot be used

If treatment with NSAIDs is contraindicated according to the relevant TGA-approved Product Information, the application must provide details of the contraindication

If intolerance to NSAID treatment develops during the relevant period of use which is of a severity to necessitate permanent treatment withdrawal, the application must provide details of the nature and severity of this intolerance

The following criteria indicate failure to achieve an adequate response and must be demonstrated at the time of the initial application:
(a) a Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) of at least 4 on a 0-10 scale; AND
(b) an elevated erythrocyte sedimentation rate (ESR) greater than 25 mm per hour or a C-reactive protein (CRP) level greater than 10 mg per L

The BASDAI must be determined at the completion of the 3 month NSAID and exercise trial, but prior to ceasing NSAID treatment

The BASDAI must be no more than 1 month old at the time of initial application

Both ESR and CRP measures should be provided with the initial treatment application and both must be no more than 1 month old. If the above requirement to demonstrate an elevated ESR or CRP cannot be met, the application must state the reason this criterion cannot be satisfied

The authority application must be made in writing and must include:
(a) a completed authority prescription form; and
(b) a completed Ankylosing Spondylitis PBS Authority Application - Supporting Information Form which must include the following:
(i) a copy of the radiological report confirming Grade II bilateral sacroiliitis or Grade III unilateral sacroiliitis; and
(ii) a completed BASDAI Assessment Form; and
(iii) a completed Exercise Program Self Certification Form included in the supporting information form; and
(iv) a signed patient acknowledgment

The assessment of the patient's response to the initial course of treatment must be made following a minimum of 12 weeks of treatment and submitted no later than 4 weeks from the cessation of that treatment course. If the response assessment is not submitted within these timeframes, the patient will be deemed to have failed this course of treatment

A maximum of 16 weeks of treatment with this drug will be approved under this criterion

Patients who fail to demonstrate a response to treatment with this drug under this restriction will not be eligible to receive further PBS-subsidised treatment with this drug in this treatment cycle. Patients may re-trial this drug after a minimum of 5 years have elapsed between the date the last prescription for a PBS-subsidised biological disease modifying anti-rheumatic drug (bDMARD) was approved in this cycle and the date of the first application under a new cycle

 Compliance with Written Authority Required procedures
C4610 P4610

Ankylosing spondylitis

Initial treatment – Initial 1 (new patients) or Initial 2 (change or recommencement for all patients) – balance of supply

Patient must have active, or a documented history of active, ankylosing spondylitis; AND
Patient must have received insufficient therapy with this drug under the Initial 1 (new patients) restriction to complete 16 weeks treatment; OR
Patient must have received insufficient therapy with this drug under the Initial 2 (change or recommencement for all patients) restriction to complete 16 weeks treatment; AND
The treatment must provide no more than the balance of up to 16 weeks treatment available under the above restrictions

Patient must be an adult

Must be treated by a rheumatologist

 Compliance with Written or Telephone Authority Required procedures
C4629 P4629

Ankylosing spondylitis

Initial treatment – Initial 2 (change or recommencement for all patients)

Patient must have a documented history of active ankylosing spondylitis; AND
Patient must have received prior PBS-subsidised biological disease modifying anti-rheumatic drug (bDMARD) treatment for this condition in this treatment cycle; AND
Patient must not have failed PBS-subsidised therapy with this drug for this condition in the current treatment cycle; AND
Patient must be eligible to receive further bDMARD therapy

Patient must be an adult

Must be treated by a rheumatologist

Where the most recent course of PBS-subsidised bDMARD treatment was approved under either of the initial treatment restrictions (i.e. for patients with no prior PBS-subsidised bDMARD therapy or, under this restriction, for patients who have received previous PBS-subsidised bDMARD therapy) the patient must have been assessed for response to that course following a minimum of 12 weeks of treatment. These assessments must be provided to the Department of Human Services no later than 4 weeks from the date the course was ceased. If the response assessment is not submitted within these timeframes, the patient will be deemed to have failed this course of treatment

Where the most recent course of PBS-subsidised treatment with this drug was approved under the continuing treatment criteria, patients must have been assessed for response, and the assessment must be submitted to the Department of Human Services no later than 4 weeks from the date that course was ceased

The authority application must be made in writing and must include:
(a) a completed authority prescription form; and
(b) a completed Ankylosing Spondylitis PBS Authority Application - Supporting Information Form

A maximum of 16 weeks of treatment with this drug will be approved under this criterion

Patients who fail to demonstrate a response to treatment with this drug under this restriction will not be eligible to receive further PBS-subsidised treatment with this drug in this treatment cycle. Patients may re-trial this drug after a minimum of 5 years have elapsed between the date the last prescription for a PBS-subsidised bDMARD was approved in this cycle and the date of the first application under a new cycle

 Compliance with Written Authority Required procedures
C4642 P4642

Ankylosing spondylitis

Continuing treatment

Patient must have a documented history of active ankylosing spondylitis; AND
Patient must have received this drug as their most recent course of PBS-subsidised biological disease modifying anti-rheumatic drug (bDMARD) treatment in this treatment cycle; AND
Patient must have demonstrated an adequate response to treatment with this drug

Patient must be an adult

Must be treated by a rheumatologist

An adequate response is defined as an improvement from baseline of at least 2 of the BASDAI and 1 of the following:
(a) an ESR measurement no greater than 25 mm per hour; or
(b) a CRP measurement no greater than 10 mg per L; or
(c) an ESR or CRP measurement reduced by at least 20% from baseline

Where only 1 acute phase reactant measurement is supplied in the first application for PBS-subsidised treatment, that same marker must be measured and supplied in all subsequent continuing treatment applications

The authority application must be made in writing and must include:
(a) a completed authority prescription form; and
(b) a completed Ankylosing Spondylitis PBS Authority Application - Supporting Information Form

All measurements provided must be no more than 1 month old at the time of application

A maximum of 24 weeks of treatment with this drug will be authorised under this criterion

All applications for continuing treatment with this drug must include a measurement of response to the prior course of therapy. This assessment must be submitted no later than 4 weeks from the cessation of that treatment course. If the application is the first application for continuing treatment following an initial treatment course it must be made following a minimum of 12 weeks of treatment with this drug. If the response assessment is not submitted within these timeframes, the patient will be deemed to have failed this course of treatment

Patients who fail to demonstrate a response to treatment with this drug under this restriction will not be eligible to receive further PBS-subsidised treatment with this drug in this treatment cycle. Patients may re-trial this drug after a minimum of 5 years have elapsed between the date the last prescription for a PBS-subsidised bDMARD was approved in this cycle and the date of the first application under a new cycle

 Compliance with Written Authority Required procedures
C4643 P4643

Ankylosing spondylitis

Continuing treatment – balance of supply

Patient must have a documented history of active ankylosing spondylitis; AND
Patient must have received insufficient therapy with this drug under the Continuing treatment restriction to complete 24 weeks treatment; AND
The treatment must provide no more than the balance of up to 24 weeks treatment available under the above restriction

Patient must be an adult

Must be treated by a rheumatologist

 Compliance with Written or Telephone Authority Required procedures

  1. Schedule 4, Part 1, omit entry for Omeprazole and Clarithromycin and Amoxycillin

  1. Schedule 4, Part 1, entry for Ranibizumab

substitute:

Ranibizumab C4607

Subfoveal choroidal neovascularisation (CNV)

Continuing treatment

The condition must be due to age-related macular degeneration (AMD); AND
The treatment must be the sole PBS-subsidised therapy for this condition; AND
Patient must have previously been granted an authority prescription for the same eye

Must be treated by an ophthalmologist

 Compliance with Written or Telephone Authority Required procedures
C4640

Subfoveal choroidal neovascularisation (CNV)

Initial treatment

The condition must be due to age-related macular degeneration (AMD); AND
The condition must be diagnosed by fluorescein angiography; AND
The treatment must be the sole PBS-subsidised therapy for this condition

Must be treated by an ophthalmologist

Authority approval for initial treatment of each eye must be sought

The first authority application for each eye must be made in writing or by telephone

A written application must include:
a) a completed authority prescription form;
b) a completed Subfoveal Choroidal Neovascularisation (CNV) - PBS Supporting Information Form; and
c) a copy of the fluorescein angiogram

A telephone application must be made following submission by facsimile of a copy of a completed Subfoveal Choroidal Neovascularisation (CNV) - PBS Supporting Information Form and a copy of the fluorescein angiogram. The original documentation must be submitted to the Chief Executive Medicare by post after the application has been authorised

Where a fluorescein angiogram cannot be performed due to a contraindication as listed in the TGA-approved product information, details of the contraindication must be provided. A copy of the report of an alternative method of diagnosis must be included in the application, for example, optical coherence tomography (OCT) or red free photography

 Compliance with Written or Telephone Authority Required procedures
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