National Health (Listing of Pharmaceutical Benefits) Amendment Instrument 2013 (No. 9) (No. PB 40 of 2013) (Cth)

Case

PB 40 of 2013

National Health (Listing of Pharmaceutical Benefits) Amendment Instrument 2013
(No. 9)


National Health Act 1953

I, FELICITY McNEILL, First Assistant Secretary, Pharmaceutical Benefits Division, Department of Health and Ageing, delegate of the Minister for Health, make this Instrument under sections 84AF, 84AK, 85, 85A, 88, 99AEH and 101 of the National Health Act 1953.

Dated   24 July 2013

FELICITY McNEILL

First Assistant Secretary

Pharmaceutical Benefits Division

Department of Health and Ageing

1          Name of Instrument

(1)        This Instrument is the National Health (Listing of Pharmaceutical Benefits) Amendment Instrument 2013 (No. 9).

(2)        This Instrument may also be cited as PB 40 of 2013.

2          Commencement

This Instrument commences on 1 August 2013.

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, after entry for Abciximab

insert:

Abiraterone Tablet containing abiraterone acetate 250 mg Oral Zytiga JC MP C4245 120 2 120

  1. Schedule 1, after entry for Amino acid formula with vitamins and minerals without methionine in the form Oral powder 500 g
    (XMET Maxamum)

insert in the columns in the order indicated:

Oral liquid 87 mL, 30 (HCU cooler 10) Oral HCU cooler 10 VF MP NP C1314 4 5 1

  1. Schedule 1, entry for Amino acid formula with vitamins and minerals without methionine in the form Oral liquid 130 mL, 30 (HCU Cooler)

(a)omit from the column headed “Form”:   (HCU Cooler)    substitute:             (HCU cooler 15)

(b)omit from the column headed “Brand”:               HCU Cooler      substitute:             HCU cooler 15

  1. Schedule 1, after entry for Amino acid formula with vitamins and minerals without methionine in the form Oral liquid 130 mL, 30
    (HCU cooler 15)

insert in the columns in the order indicated:

Oral liquid 174 mL, 30 (HCU cooler 20) Oral HCU cooler 20 VF MP NP C1314 4 5 1

  1. Schedule 1, entry for Amino acid formula with vitamins and minerals without methionine, threonine and valine and low in isoleucine
    in the form Oral liquid 130 mL, 30 (MMA/PA cooler)

(a)omit from the column headed “Form”:   (MMA/PA cooler)          substitute:             (MMA/PA cooler 15)

(b)omit from the column headed “Brand”:               MMA/PA cooler            substitute:             MMA/PA cooler 15

  1. Schedule 1, after entry for Amino acid formula with vitamins and minerals without phenylalanine and tyrosine in the form Oral powder 500 g (XPhen, Tyr Maxamum)

insert in the columns in the order indicated:

Oral liquid 87 mL, 30 (TYR cooler 10) Oral TYR cooler 10 VF MP NP C1453 4 5 1

  1. Schedule 1, entry for Amino acid formula with vitamins and minerals without phenylalanine and tyrosine in the form Oral liquid
    130 mL, 30 (TYR Cooler)

(a)omit from the column headed “Form”:   (TYR Cooler)    substitute:             (TYR cooler 15)

(b)omit from the column headed “Brand”:               TYR Cooler      substitute:             TYR cooler 15

  1. Schedule 1, after entry for Amino acid formula with vitamins and minerals without phenylalanine and tyrosine in the form Oral liquid 130 mL, 30 (TYR cooler 15)

insert in the columns in the order indicated:

Oral liquid 174 mL, 30 (TYR cooler 20) Oral TYR cooler 20 VF MP NP C1453 4 5 1

  1. Schedule 1, after entry for Amino acid formula with vitamins and minerals without valine, leucine and isoleucine in the form Oral powder 500 g (MSUD Maxamum)

insert in the columns in the order indicated:

Oral liquid 87 mL, 30 (MSUD cooler 10) Oral MSUD cooler 10 VF MP NP C1220 4 5 1

  1. Schedule 1, entry for Amino acid formula with vitamins and minerals without valine, leucine and isoleucine in the form Oral liquid
    130 mL, 30 (MSUD Cooler)

(a)omit from the column headed “Form”:   (MSUD Cooler)             substitute:             (MSUD cooler 15)

(b)omit from the column headed “Brand”:               MSUD Cooler   substitute:             MSUD cooler 15

  1. Schedule 1, after entry for Amino acid formula with vitamins and minerals without valine, leucine and isoleucine in the form Oral liquid 130 mL, 30 (MSUD cooler 15)

insert in the columns in the order indicated:

Oral liquid 174 mL, 30 (MSUD cooler 20) Oral MSUD cooler 20 VF MP NP C1220 4 5 1

  1. Schedule 1, entry for Amlodipine in the form Tablet 5 mg (as besylate)

omit:

Pharmacor Amlodipine 5 CR MP NP 30 5 30

  1. Schedule 1, entry for Amlodipine in the form Tablet 10 mg (as besylate)

omit:

Pharmacor Amlodipine 10 CR MP NP 30 5 30

  1. Schedule 1, entry for Anastrozole

omit:

Anastrozole Synthon ZT MP NP C2213 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 SZ HX 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 SZ HX 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 SZ HX 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 SZ HX 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 SZ HX 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 SZ HX 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 SZ HX 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 SZ HX MP C1540 C3047 P3047 30 11 30

  1. Schedule 1, after entry for Azithromycin in the form Powder for oral suspension 200 mg (as dihydrate) per 5 mL, 15 mL

insert:

Bacillus Calmette and Guerin, Connaught strain Powder for intravesical administration containing 6.6 to 19.2 x 10 8  CFU Intravesical ImmuCyst SW MP
See Note 1 		C1419 3 1 1
Bacillus Calmette and Guerin, Tice strain Vial containing powder for intravesical administration approximately
5 x 10 8  CFU 		Intravesical OncoTICE MK MP
See Note 1 		C1290 3 1 3

  1. Schedule 1, omit entry for “BCG Immunotherapeutic” (Bacillus Calmette-Guérin/Connaught strain)

  1. Schedule 1, omit entry for “BCG-Tice” (Bacillus Calmette-Guérin/Tice strain)

  1. Schedule 1, entry for Cabazitaxel

omit from the column headed “Circumstances”:          C4073  C4138    substitute:            C4237  C4262

  1. Schedule 1, entry for Candesartan

substitute:

Candesartan Tablet containing candesartan cilexetil 4 mg Oral Adesan AF MP NP 30 5 30
APO-Candesartan TX MP NP 30 5 30
Atacand AP MP NP 30 5 30
Candesartan Aspen 4 QA MP NP 30 5 30
Candesartan-GA GM MP NP 30 5 30
Candesartan GH GQ MP NP 30 5 30
Candesartan Sandoz SZ MP NP 30 5 30
STADA Candesartan TD MP NP 30 5 30
Tablet containing candesartan cilexetil 8 mg Oral Adesan AF MP NP 30 5 30
APO-Candesartan TX MP NP 30 5 30
Atacand AP MP NP 30 5 30
Candesartan Aspen 8 QA MP NP 30 5 30
Candesartan-GA GM MP NP 30 5 30
Candesartan GH GQ MP NP 30 5 30
Candesartan Sandoz SZ MP NP 30 5 30
STADA Candesartan TD MP NP 30 5 30
Tablet containing candesartan cilexetil 16 mg Oral Adesan AF MP NP 30 5 30
APO-Candesartan TX MP NP 30 5 30
Atacand AP MP NP 30 5 30
Candesartan Aspen 16 QA MP NP 30 5 30
Candesartan-GA GM MP NP 30 5 30
Candesartan GH GQ MP NP 30 5 30
Candesartan Sandoz SZ MP NP 30 5 30
STADA Candesartan TD MP NP 30 5 30
Tablet containing candesartan cilexetil 32 mg Oral Adesan AF MP NP 30 5 30
APO-Candesartan TX MP NP 30 5 30
Atacand AP MP NP 30 5 30
Candesartan Aspen 32 QA MP NP 30 5 30
Candesartan-GA GM MP NP 30 5 30
Candesartan GH GQ MP NP 30 5 30
Candesartan Sandoz SZ MP NP 30 5 30
STADA Candesartan TD MP NP 30 5 30

  1. Schedule 1, entry for Candesartan with Hydrochlorothiazide

substitute:

Candesartan with Hydrochlorothiazide Tablet containing candesartan cilexetil 16 mg with hydrochlorothiazide 12.5 mg Oral Adesan HCT 16/12.5 AF MP NP C3307 30 5 30
APO-Candesartan HCTZ 16/12.5 TX MP NP C3307 30 5 30
Atacand Plus 16/12.5 AP MP NP C3307 30 5 30
Candesartan Combi Aspen 16/12.5 QA MP NP C3307 30 5 30
Candesartan HCT GH 16/12.5 GQ MP NP C3307 30 5 30
Candesartan HCTZ-GA 16/12.5 GM MP NP C3307 30 5 30
STADA Candesartan HCT 16/12.5 TD MP NP C3307 30 5 30
Tablet containing candesartan cilexetil 32 mg with hydrochlorothiazide 12.5 mg Oral APO-Candesartan HCTZ 32/12.5 TX MP NP C3307 30 5 30
Atacand Plus 32/12.5 AP MP NP C3307 30 5 30
Candesartan Combi Aspen 32/12.5 QA MP NP C3307 30 5 30
Candesartan HCT GH 32/12.5 GQ MP NP C3307 30 5 30
Candesartan HCTZ-GA 32/12.5 GM MP NP C3307 30 5 30
STADA Candesartan HCT 32/12.5 TD MP NP C3307 30 5 30
Tablet containing candesartan cilexetil 32 mg with hydrochlorothiazide 25 mg Oral APO-Candesartan HCTZ 32/25 TX MP NP C3307 30 5 30
Atacand Plus 32/25 AP MP NP C3307 30 5 30
Candesartan Combi Aspen 32/25 QA MP NP C3307 30 5 30
Candesartan HCT GH 32/25 GQ MP NP C3307 30 5 30
Candesartan HCTZ-GA 32/25 GM MP NP C3307 30 5 30
STADA Candesartan HCT 32/25 TD MP NP C3307 30 5 30

  1. Schedule 1, entry for Carvedilol in the form Tablet 25 mg

omit:

GenRx Carvedilol GX MP NP C1735 C3234 60 5 60

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

omit from the column headed “Pack Quantity” for the brand “Max Pharma Ceftriaxone”:              1              substitute:             5

  1. Schedule 1, entry for Cephalexin in the form Capsule 250 mg (anhydrous)

(a)omit:

Cephatrust 250 MI PDP 20 0 20

(b)omit:

Cephatrust 250 MI MP NP MW 20 1 20

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

insert in the columns in the order indicated:

Cefalexin Sandoz SZ MP C4243 40 2 20
Cephalexin generichealth GQ MP C4243 40 2 20
Chem mart Cephalexin CH MP C4243 40 2 20
Cilex GM MP C4243 40 2 20
GenRx Cephalexin GX MP C4243 40 2 20
Ialex LN MP C4243 40 2 20
Ibilex 250 AF MP C4243 40 2 20
Keflex AS MP C4243 40 2 20
Pharmacor Cephalexin 250 CR MP C4243 40 2 20
Rancef RA MP C4243 40 2 20
Terry White Chemists Cephalexin TW MP C4243 40 2 20

  1. Schedule 1, entry for Cephalexin in the form Capsule 500 mg (anhydrous)

(a)omit:

Cephatrust 500 MI PDP 20 0 20

(b)omit:

Cephatrust 500 MI MP NP MW 20 1 20

  1. Schedule 1, entry for Citalopram in the form Tablet 20 mg (as hydrobromide)

(a)omit:

Citalopram 20 CR MP NP C1211 28 5 28

(b)omit from the column headed “Responsible Person” for the brand “Pharmacor Citalo 20”:                 MI           substitute:      CR

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

omit from the column headed “Responsible Person” for the brand “Plavicor 75”:             MI           substitute:             CR

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

insert in numerical order after existing codes in the column headed “Circumstances” for the brand “Clopidogrel-GA”:

C4165  C4166

  1. Schedule 1, after entry for Diazepam in the form Injection 10 mg in 2 mL

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

Oral liquid 1 mg in 1 mL, 100 mL Oral Diazepam Elixir ON MP NP 4244 1 0 1

  1. Schedule 1, entry for Docetaxel in all forms

omit from the column headed “Circumstances” (all instances):               C4155

insert in numerical order:                  C4239

  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 DR GH GQ 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 DR GH GQ MP NP C1211 28 5 28

  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”:

Famlo RA MP NP C3622 C3623 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”:

Famlo RA MP NP C3622 C3623 P3623 56 5 56

  1. Schedule 1, entry for Felodipine in the form Tablet 2.5 mg (extended release)

omit from the column headed “Responsible Person” for the brand “Felodur ER 2.5 mg”:                                ZA          substitute:                TX

  1. Schedule 1, entry for Felodipine in the form Tablet 5 mg (extended release)

omit from the column headed “Responsible Person” for the brand “Felodur ER 5 mg”:                    ZA          substitute:             TX

  1. Schedule 1, entry for Felodipine in the form Tablet 10 mg (extended release)

omit from the column headed “Responsible Person” for the brand “Felodur ER 10 mg”:                 ZA          substitute:             TX

  1. Schedule 1, entry for Fentanyl in the form Lozenge 200 micrograms (as citrate) [Maximum Quantity 9; Number of Repeats 0]

(a)omit from the column headed “Circumstances”:               C3663  C3664    substitute:             C4250  C4267

(b)omit from the column headed “Purposes”:         P3663   substitute:             P4250

  1. Schedule 1, entry for Fentanyl in the form Lozenge 200 micrograms (as citrate) [Maximum Quantity 60; Number of Repeats 0]

(a)omit from the column headed “Circumstances”:               C3663  C3664    substitute:             C4250  C4267

(b)omit from the column headed “Purposes”:         P3664   substitute:             P4267

  1. Schedule 1, entry for Fentanyl in the form Lozenge 400 micrograms (as citrate) [Maximum Quantity 9; Number of Repeats 0]

(a)omit from the column headed “Circumstances”:               C3663  C3664    substitute:             C4250  C4267

(b)omit from the column headed “Purposes”:         P3663   substitute:             P4250

  1. Schedule 1, entry for Fentanyl in the form Lozenge 400 micrograms (as citrate) [Maximum Quantity 60; Number of Repeats 0]

(a)omit from the column headed “Circumstances”:               C3663  C3664    substitute:             C4250  C4267

(b)omit from the column headed “Purposes”:         P3664   substitute:             P4267

  1. Schedule 1, entry for Fentanyl in the form Lozenge 600 micrograms (as citrate) [Maximum Quantity 9; Number of Repeats 0]

(a)omit from the column headed “Circumstances”:               C3663  C3664    substitute:             C4250  C4267

(b)omit from the column headed “Purposes”:         P3663   substitute:             P4250

  1. Schedule 1, entry for Fentanyl in the form Lozenge 600 micrograms (as citrate) [Maximum Quantity 60; Number of Repeats 0]

(a)omit from the column headed “Circumstances”:               C3663  C3664    substitute:             C4250  C4267

(b)omit from the column headed “Purposes”:         P3664   substitute:             P4267

  1. Schedule 1, entry for Fentanyl in the form Lozenge 800 micrograms (as citrate) [Maximum Quantity 9; Number of Repeats 0]

(a)omit from the column headed “Circumstances”:               C3663  C3664    substitute:             C4250  C4267

(b)omit from the column headed “Purposes”:         P3663   substitute:             P4250

  1. Schedule 1, entry for Fentanyl in the form Lozenge 800 micrograms (as citrate) [Maximum Quantity 60; Number of Repeats 0]

(a)omit from the column headed “Circumstances”:               C3663  C3664    substitute:             C4250  C4267

(b)omit from the column headed “Purposes”:         P3664   substitute:             P4267

  1. Schedule 1, entry for Fentanyl in the form Lozenge 1200 micrograms (as citrate) [Maximum Quantity 9; Number of Repeats 0]

(a)omit from the column headed “Circumstances”:               C3663  C3664    substitute:             C4250  C4267

(b)omit from the column headed “Purposes”:         P3663   substitute:             P4250

  1. Schedule 1, entry for Fentanyl in the form Lozenge 1200 micrograms (as citrate) [Maximum Quantity 60; Number of Repeats 0]

(a)omit from the column headed “Circumstances”:               C3663  C3664    substitute:             C4250  C4267

(b)omit from the column headed “Purposes”:         P3664   substitute:             P4267

  1. Schedule 1, entry for Fentanyl in the form Lozenge 1600 micrograms (as citrate) [Maximum Quantity 9; Number of Repeats 0]

(a)omit from the column headed “Circumstances”:               C3663  C3664    substitute:             C4250  C4267

(b)omit from the column headed “Purposes”:         P3663   substitute:             P4250

  1. Schedule 1, entry for Fentanyl in the form Lozenge 1600 micrograms (as citrate) [Maximum Quantity 60; Number of Repeats 0]

(a)omit from the column headed “Circumstances”:               C3663  C3664    substitute:             C4250  C4267

(b)omit from the column headed “Purposes”:         P3664   substitute:             P4267

  1. Schedule 1, entry for Gemcitabine in the form Powder for I.V. infusion 2 g (as hydrochloride)

omit:

Gemcitabine Actavis 2000 WQ MP See Note 3 See Note 3 1 D(100)

  1. Schedule 1, entry for Gemfibrozil in the form Tablet 600 mg

(a)omit:

Pharmacor Gemfibrozil 600 CR MP C1540 C3047 P1540 60 5 60
NP C1540 60 5 60

(b)omit:

Pharmacor Gemfibrozil 600 CR MP C1540 C3047 P3047 60 11 60

  1. Schedule 1, entry for Glimepiride in the form Tablet 1 mg

omit:

Pharmacor Glimepiride 1 CR MP NP 30 5 30

  1. Schedule 1, entry for Glimepiride in the form Tablet 2 mg

omit:

Pharmacor Glimepiride 2 CR MP NP 30 5 30

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

omit:

Pharmacor Glimepiride 3 CR MP NP 30 5 30

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

omit:

Pharmacor Glimepiride 4 CR MP NP 30 5 30

  1. Schedule 1, entry for Glucose Indicator―Blood in all forms of Test strips [Number of Repeats 11]

omit from the column headed “Purposes” (all instances):         P3035    substitute:             P4241

  1. Schedule 1, after entry for Glucose Indicator―Blood in the form Test strips, 50 (Omnitest EZ)

insert in the columns in the order indicated:

Test strips, 50 (OneTouch Select) For external use OneTouch Select JJ MP NP 2 5 1
MP P4241 2 11 1

  1. Schedule 1, after entry for Glyceryl Trinitrate

insert:

Glycomacropeptide and essential amino acids Oral liquid 500 mL, 12 (Camino Pro Restore) Oral Camino Pro Restore QH MP NP C1286 12 5 1
Glycomacropeptide and essential amino acids with vitamins and minerals Bars 54 g, 7 (Camino Pro Complete) Oral Camino Pro Complete QH MP NP C1286 14 5 1
Bars 81 g, 7 (Camino Pro Complete) Oral Camino Pro Complete QH MP NP C1286 14 5 1
Sachets containing oral powder 49 g, 28 (Camino Pro Bettermilk) Oral Camino Pro Bettermilk QH MP NP C1286 4 5 1

  1. Schedule 1, after entry for High fat formula with vitamins, minerals and trace elements and low in protein and carbohydrate in the form Oral powder 300 g (KetoCal)

insert in the columns in the order indicated:

Oral powder 300 g (KetoCal 3:1) Oral KetoCal 3:1 SB MP NP C4253 24 5 1

  1. Schedule 1, after entry for Interferon Gamma-1b

insert:

Ipilimumab Injection concentrate for I.V. infusion 50 mg in 10 mL Injection Yervoy BQ MP C4235 C4236 C4251 C4252 C4254 C4256 C4261 C4265 See Note 3 See Note 3 See Note 3 1 D(100)
Injection concentrate for I.V. infusion 200 mg in 40 mL Injection Yervoy BQ MP C4235 C4236 C4251 C4252 C4254 C4256 C4261 C4265 See Note 3 See Note 3 See Note 3 1 D(100)

  1. Schedule 1, entry for Lacosamide

substitute:

Lacosamide Tablet 50 mg Oral Vimpat UC MP NP C4271 14 1 14
Tablet 100 mg Oral Vimpat UC MP NP C4249 C4264 C4271 P4271 14 1 14
MP NP C4249 C4264 C4271 P4249 P4264 56 5 56
Tablet 150 mg Oral Vimpat UC MP NP C4240 C4257 C4271 P4271 14 1 14
MP NP C4240 C4257 C4271 P4240 P4257 56 5 56
Tablet 200 mg Oral Vimpat UC MP NP C4240 C4257 56 5 56

  1. Schedule 1, entry for Lamivudine with Zidovudine

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

Lamivudine 150mg + Zidovudine 300mg Alphapharm AF MP
See Note 1 		C3586 C3587 C3588 C3589 120 5 60 D(100)

  1. Schedule 1, entry for Lamotrigine in the form Tablet 25 mg

omit from the column headed “Responsible Person” for the brand “Lamotrust 25”:          MI           substitute:             CR

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

omit from the column headed “Responsible Person” for the brand “Lamotrust 50”:          MI           substitute:             CR

  1. Schedule 1, entry for Lamotrigine in the form Tablet 100 mg

omit from the column headed “Responsible Person” for the brand “Lamotrust 100”:        MI           substitute:             CR

  1. Schedule 1, entry for Lamotrigine in the form Tablet 200 mg

omit from the column headed “Responsible Person” for the brand “Lamotrust 200”:        MI           substitute:             CR

  1. Schedule 1, entry for Letrozole

omit:

Letrozole-Synthon ZT MP NP C1608 C2691 C2692 30 5 30

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

omit:

Lisinopril 5 CR MP NP 30 5 30

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

omit:

Lisinopril 10 CR MP NP 30 5 30

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

omit:

Lisinopril 20 CR MP NP 30 5 30

  1. Schedule 1, entry for Macrogol 3350

omit:

Macrogol 3350 Sachets containing powder for oral solution 13.125 g with electrolytes, 30 Oral Movicol NE MP NP
See Note 1 		C1263 C1613 C2693 C2823 C3642 C3643
See Note 2 		P3643
See Note 2 		2
See Note 2 		0
See Note 2 		1
MP NP
See Note 1 		C1263 C1613 C2693 C2823 C3642 C3643
See Note 2 		P3642
See Note 2 		2
See Note 2 		3
See Note 2 		1
MP NP
See Note 1 		C1263 C1613 C2693 C2823 C3642 C3643
See Note 2 		P1263 P1613 P2693 P2823
See Note 2 		1
See Note 2 		5
See Note 2 		1

substitute:

Macrogol 3350 Sachets containing powder for oral solution 13.125 g with electrolytes, 30 Oral LaxaCon GM MP NP
See Note 1 		C1263 C1613 C2693 C2823 C3642 C3643
See Note 2 		P3643
See Note 2 		2
See Note 2 		0
See Note 2 		1
MP NP
See Note 1 		C1263 C1613 C2693 C2823 C3642 C3643
See Note 2 		P3642
See Note 2 		2
See Note 2 		3
See Note 2 		1
MP NP
See Note 1 		C1263 C1613 C2693 C2823 C3642 C3643
See Note 2 		P1263 P1613 P2693 P2823
See Note 2 		1
See Note 2 		5
See Note 2 		1
Movicol NE MP NP
See Note 1 		C1263 C1613 C2693 C2823 C3642 C3643
See Note 2 		P3643
See Note 2 		2
See Note 2 		0
See Note 2 		1
MP NP
See Note 1 		C1263 C1613 C2693 C2823 C3642 C3643
See Note 2 		P3642
See Note 2 		2
See Note 2 		3
See Note 2 		1
MP NP
See Note 1 		C1263 C1613 C2693 C2823 C3642 C3643
See Note 2 		P1263 P1613 P2693 P2823
See Note 2 		1
See Note 2 		5
See Note 2 		1

  1. Schedule 1, entry for Macrogol 3350

omit:

Powder for oral solution 510 g Oral MediHealth ClearLax ON MP NP C4170 C4171 C4173 C4176 C4177 C4179 C4180 P4171 P4173 P4177 P4179 P4180 1 5 1
OsmoLax KY MP NP C4170 C4171 C4173 C4176 C4177 C4179 C4180 P4171 P4173 P4177 P4179 P4180 1 5 1
MediHealth ClearLax ON MP NP C4170 C4171 C4173 C4176 C4177 C4179 C4180 P4170 2 0 1
OsmoLax KY MP NP C4170 C4171 C4173 C4176 C4177 C4179 C4180 P4170 2 0 1
MediHealth ClearLax ON MP NP C4170 C4171 C4173 C4176 C4177 C4179 C4180 P4176 2 3 1
OsmoLax KY MP NP C4170 C4171 C4173 C4176 C4177 C4179 C4180 P4176 2 3 1

substitute:

Powder for oral solution 510 g Oral OsmoLax KY MP NP C4170 C4171 C4173 C4176 C4177 C4179 C4180 P4171 P4173 P4177 P4179 P4180 1 5 1
MP NP C4170 C4171 C4173 C4176 C4177 C4179 C4180 P4170 2 0 1
MP NP C4170 C4171 C4173 C4176 C4177 C4179 C4180 P4176 2 3 1

  1. Schedule 1, entry for Metoprolol in the form Tablet containing metoprolol tartrate 50 mg

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

APO-Metoprolol TX MP NP 100 5 100

  1. Schedule 1, entry for Metoprolol in the form Tablet containing metoprolol tartrate 100 mg

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

APO-Metoprolol TX MP NP 60 5 60

  1. Schedule 1, after entry for Miconazole in the form Lotion containing miconazole nitrate 20 mg per mL, 30 g

insert:

Mifepristone Tablet 200 mg Oral Mifepristone Linepharma XH MP C4247 1 0 1

  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-GA GN 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-GA GM MP NP C1211 30 5 30

  1. Schedule 1, entry for Misoprostol

substitute:

Misoprostol Tablet 200 micrograms Oral GyMiso XH MP C4266 4 1 4
Cytotec PF MP C2630 C2631 C2632 120 2 120

  1. Schedule 1, entry for Montelukast

substitute:

Montelukast Tablet, chewable, 4 mg (as sodium) Oral APO-Montelukast TX MP NP C2617 28 5 28
Chem mart Montelukast CH MP NP C2617 28 5 28
Lukair FR MP NP C2617 28 5 28
Montair 4 GM MP NP C2617 28 5 28
Montelukast GH GQ MP NP C2617 28 5 28
Montelukast RBX RA MP NP C2617 28 5 28
Montelukast Sandoz 4 SZ MP NP C2617 28 5 28
Respikast 4 QA MP NP C2617 28 5 28
Singulair MK MP NP C2617 28 5 28
Terry White Chemists Montelukast TW MP NP C2617 28 5 28
Tablet, chewable, 5 mg (as sodium) Oral APO-Montelukast TX MP NP C2618 C3217 28 5 28
Chem mart Montelukast CH MP NP C2618 C3217 28 5 28
Lukair FR MP NP C2618 C3217 28 5 28
Montair 5 GM MP NP C2618 C3217 28 5 28
Montelukast GH GQ MP NP C2618 C3217 28 5 28
Montelukast RBX RA MP NP C2618 C3217 28 5 28
Montelukast Sandoz 5 SZ MP NP C2618 C3217 28 5 28
Respikast 5 QA MP NP C2618 C3217 28 5 28
Singulair MK MP NP C2618 C3217 28 5 28
Terry White Chemists Montelukast TW MP NP C2618 C3217 28 5 28

  1. Schedule 1, entry for Norfloxacin

(a)omit:

Chem mart Norfloxacin CH MP NP C1002 C1070 14 1 14

(b)omit:

Terry White Chemists Norfloxacin TW MP NP C1002 C1070 14 1 14

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

omit:

Olanzapine-Synthon ZT MP NP C1589 C2044 28 5 28

  1. Schedule 1, entry for Omeprazole in the form Tablet 20 mg (as magnesium)

omit from the column headed “Responsible Person” for the brand “Omepral” (twice occurring):                  PM         substitute:                TX

  1. Schedule 1, entry for Paliperidone

omit from the column headed “Circumstances” (all instances):               C1589   substitute:             C4246

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

omit:

Paroxetine 20 MI MP NP C1211 C1241 C1862 30 5 30

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

omit:

Paroxetine Synthon ZT MP NP C1211 C1241 C1862 30 5 30
Pharmacor Paroxo 20 MI MP NP C1211 C1241 C1862 30 5 30

  1. Schedule 1, entry for Perindopril in the form Tablet containing perindopril erbumine 2 mg

omit:

Perindopril 2 CR MP NP 30 5 30

  1. Schedule 1, entry for Perindopril in the form Tablet containing perindopril erbumine 4 mg

omit:

Perindopril 4 CR MP NP 30 5 30

  1. Schedule 1, entry for Perindopril in the form Tablet containing perindopril erbumine 8 mg

omit:

Perindopril 8 CR MP NP 30 5 30

  1. Schedule 1, entry for Pramipexole in the form Tablet containing pramipexole hydrochloride 125 micrograms

(a)omit from the column headed “Circumstances” for the brand “Simipex 0.125”:
C3088

(b)omit from the column headed “Purposes” for the brand “Simipex 0.125”:
P3216

  1. Schedule 1, entry for Pramipexole in the form Tablet containing pramipexole hydrochloride 250 micrograms

(a)omit from the column headed “Circumstances” for the brand “Simipex 0.25”:
C3088

(b)omit from the column headed “Purposes” for the brand “Simipex 0.25”:
P3216

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

omit from the column headed “Brand”:         Orion Laboratories Pty Ltd         substitute:             Oripro

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

omit:

Quetiapine-Synthon ZT MP NP C1589 C2044 C2765 60 5 60

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

omit:

Quetiapine-Synthon ZT 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)

omit:

Quetiapine-Synthon ZT MP NP C1589 C2044 C2765 60 5 60

  1. Schedule 1, entry for Quinapril in the form Tablet 5 mg (as hydrochloride)

omit:

Pharmacor Quinapril 5 CR MP NP 30 5 30

  1. Schedule 1, entry for Quinapril in the form Tablet 10 mg (as hydrochloride)

omit:

Pharmacor Quinapril 10 CR MP NP 30 5 30

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

omit:

Pharmacor Quinapril 20 CR MP NP 30 5 30

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

omit:

Pharmacor Ramipril 1.25 CR MP NP 30 5 30

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

omit:

Pharmacor Ramipril 2.5 CR MP NP 30 5 30

  1. Schedule 1, entry for Risedronic Acid in each of the forms: Tablet containing risedronate sodium 5 mg; Tablet containing
    risedronate sodium 35 mg; Tablet (enteric coated) containing risedronate sodium 35 mg; and Tablet containing risedronate sodium 150 mg

omit from the column headed “Circumstances” (all instances):               C4117

insert in numerical order:                 C4133

  1. Schedule 1, entry for Risedronic Acid and Calcium in each of the forms: Pack containing 4 tablets risedronate sodium 35 mg and 24 tablets calcium 500 mg (as carbonate); and Pack containing 4 enteric coated tablets risedronate sodium 35 mg and 24 tablets
    calcium 500 mg (as carbonate)

omit from the column headed “Circumstances” (all instances):               C4117

insert in numerical order:                 C4133

  1. Schedule 1, entry for Risedronic acid and calcium with colecalciferol

omit from the column headed “Circumstances” (all instances):               C4117

insert in numerical order:                 C4133

  1. Schedule 1, entry for Rivaroxaban

omit:

Tablet 15 mg Oral Xarelto BN MP NP C4098 42 0 42
Tablet 20 mg Oral Xarelto BN MP NP C4099 C4132 28 5 28

substitute:

Tablet 15 mg Oral Xarelto BN MP NP C4098 C4260 C4269 P4269 28 5 28
MP NP C4098 C4260 C4269 P4098 P4260 42 0 42
Tablet 20 mg Oral Xarelto BN MP NP C4099 C4132 C4268 C4269 28 5 28

  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”:

Cavstat AF MP C4225 C4228 C4238 C4248 P4228 P4248 30 5 30
NP C4228 C4248 30 5 30

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

(a)omit from the column headed “Circumstances” for the brand “Crestor” with Authorised Prescriber “MP”:
C1540  C3047  C4225  C4228            substitute:             C4225  C4228  C4238  C4248

(b)omit from the column headed “Purposes” for the brand “Crestor” with Authorised Prescriber “MP”:
P1540 P4228          substitute:             P4228 P4248

(c)omit from the column headed “Circumstances” for the brand “Crestor” with Authorised Prescriber “NP”:
C1540  C4228          substitute:             C4228  C4248

  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”:

Rostor 5 DO 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 5]

(a)omit from the column headed “Circumstances” for the brand “Rosuvastatin Actavis 5” with Authorised Prescriber “MP”:
C1540  C3047  C4225  C4228            substitute:             C4225  C4228  C4238  C4248

(b)omit from the column headed “Purposes” for the brand “Rosuvastatin Actavis 5” with Authorised Prescriber “MP”:
P1540 P4228          substitute:             P4228 P4248

(c)omit from the column headed “Circumstances” for the brand “Rosuvastatin Actavis 5” with Authorised Prescriber “NP”:
C1540  C4228          substitute:             C4228  C4248

  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 GH GQ MP C4225 C4228 C4238 C4248 P4228 P4248 30 5 30
NP C4228 C4248 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”:

Cavstat AF MP C4225 C4228 C4238 C4248 P4225 P4238 30 11 30

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

(a)omit from the column headed “Circumstances” for the brand “Crestor”:
C1540  C3047  C4225  C4228            substitute:             C4225  C4228  C4238  C4248

(b)omit from the column headed “Purposes” for the brand “Crestor”:

P3047 P4225          substitute:             P4225 P4238

  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”:

Rostor 5 DO MP C4225 C4228 P4225 30 11 30

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

(a)omit from the column headed “Circumstances” for the brand “Rosuvastatin Actavis 5”:
C1540  C3047  C4225  C4228            substitute:             C4225  C4228  C4238  C4248

(b)omit from the column headed “Purposes” for the brand “Rosuvastatin Actavis 5”:
P3047 P4225          substitute:             P4225 P4238

  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 GH GQ MP C4225 C4228 C4238 C4248 P4225 P4238 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”:

Cavstat AF MP C4225 C4228 C4238 C4248 P4228 P4248 30 5 30
NP C4228 C4248 30 5 30

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

(a)omit from the column headed “Circumstances” for the brand “Crestor” with Authorised Prescriber “MP”:
C1540  C3047  C4225  C4228            substitute:             C4225  C4228  C4238  C4248

(b)omit from the column headed “Purposes” for the brand “Crestor” with Authorised Prescriber “MP”:
P1540 P4228          substitute:             P4228 P4248

(c)omit from the column headed “Circumstances” for the brand “Crestor” with Authorised Prescriber “NP”:
C1540  C4228          substitute:             C4228  C4248

  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”:

Rostor 10 DO 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 5]

(a)omit from the column headed “Circumstances” for the brand “Rosuvastatin Actavis 10” with Authorised Prescriber “MP”:
C1540  C3047  C4225  C4228            substitute:             C4225  C4228  C4238  C4248

(b)omit from the column headed “Purposes” for the brand “Rosuvastatin Actavis 10” with Authorised Prescriber “MP”:
P1540 P4228          substitute:             P4228 P4248

(c)omit from the column headed “Circumstances” for the brand “Rosuvastatin Actavis 10” with Authorised Prescriber “NP”:
C1540  C4228          substitute:             C4228  C4248

  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 GH GQ MP C4225 C4228 C4238 C4248 P4228 P4248 30 5 30
NP C4228 C4248 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”:

Cavstat AF MP C4225 C4228 C4238 C4248 P4225 P4238 30 11 30

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

(a)omit from the column headed “Circumstances” for the brand “Crestor”:
C1540  C3047  C4225  C4228            substitute:             C4225  C4228  C4238  C4248

(b)omit from the column headed “Purposes” for the brand “Crestor”:
P3047 P4225          substitute:             P4225 P4238

  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”:

Rostor 10 DO 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 11]

(a)omit from the column headed “Circumstances” for the brand “Rosuvastatin Actavis 10”:
C1540  C3047  C4225  C4228            substitute:             C4225  C4228  C4238  C4248

(b)omit from the column headed “Purposes” for the brand “Rosuvastatin Actavis 10”:
P3047 P4225          substitute:             P4225 P4238

  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 GH GQ MP C4225 C4228 C4238 C4248 P4225 P4238 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”:

Cavstat AF MP C4225 C4227 C4238 C4259 P4227 P4259 30 5 30
NP C4227 C4259 30 5 30

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

(a)omit from the column headed “Circumstances” for the brand “Crestor” with Authorised Prescriber “MP”:
C1540  C3047  C4225  C4227            substitute:             C4225  C4227  C4238  C4259

(b)omit from the column headed “Purposes” for the brand “Crestor” with Authorised Prescriber “MP”:
P1540 P4227          substitute:             P4227 P4259

(c)omit from the column headed “Circumstances” for the brand “Crestor” with Authorised Prescriber “NP”:
C1540  C4227          substitute:             C4227  C4259

  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”:

Rostor 20 DO 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 5]

(a)omit from the column headed “Circumstances” for the brand “Rosuvastatin Actavis 20” with Authorised Prescriber “MP”:
C1540  C3047  C4225  C4227            substitute:             C4225  C4227  C4238  C4259

(b)omit from the column headed “Purposes” for the brand “Rosuvastatin Actavis 20” with Authorised Prescriber “MP”:
P1540 P4227          substitute:             P4227 P4259

(c)omit from the column headed “Circumstances” for the brand “Rosuvastatin Actavis 20” with Authorised Prescriber “NP”:
C1540  C4227          substitute:             C4227  C4259

  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 GH GQ MP C4225 C4227 C4238 C4259 P4227 P4259 30 5 30
NP C4227 C4259 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”:

Cavstat AF MP C4225 C4227 C4238 C4259 P4225 P4238 30 11 30

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

(a)omit from the column headed “Circumstances” for the brand “Crestor”:
C1540  C3047  C4225  C4227            substitute:             C4225  C4227  C4238  C4259

(b)omit from the column headed “Purposes” for the brand “Crestor”:
P3047 P4225          substitute:             P4225 P4238

  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”:

Rostor 20 DO MP C4225 C4227 P4225 30 11 30

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

(a)omit from the column headed “Circumstances” for the brand “Rosuvastatin Actavis 20”:
C1540  C3047  C4225  C4227            substitute:             C4225  C4227  C4238  C4259

(b)omit from the column headed “Purposes” for the brand “Rosuvastatin Actavis 20”:
P3047 P4225          substitute:             P4225 P4238

  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 GH GQ MP C4225 C4227 C4238 C4259 P4225 P4238 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”:

Cavstat AF MP C4225 C4226 C4238 C4263 P4226 P4263 30 5 30
NP C4226 C4263 30 5 30

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

(a)omit from the column headed “Circumstances” for the brand “Crestor” with Authorised Prescriber “MP”:
C1540  C3047  C4225  C4226            substitute:             C4225  C4226  C4238  C4263

(b)omit from the column headed “Purposes” for the brand “Crestor” with Authorised Prescriber “MP”:
P1540 P4226          substitute:             P4226 P4263

(c)omit from the column headed “Circumstances” for the brand “Crestor” with Authorised Prescriber “NP”:
C1540  C4226          substitute:             C4226  C4263

  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”:

Rostor 40 DO 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 5]

(a)omit from the column headed “Circumstances” for the brand “Rosuvastatin Actavis 40” with Authorised Prescriber “MP”:
C1540  C3047  C4225  C4226            substitute:             C4225  C4226  C4238  C4263

(b)omit from the column headed “Purposes” for the brand “Rosuvastatin Actavis 40” with Authorised Prescriber “MP”:
P1540 P4226          substitute:             P4226 P4263

(c)omit from the column headed “Circumstances” for the brand “Rosuvastatin Actavis 40” with Authorised Prescriber “NP”:
C1540  C4226          substitute:             C4226  C4263

  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 GH GQ MP C4225 C4226 C4238 C4263 P4226 P4263 30 5 30
NP C4226 C4263 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”:

Cavstat AF MP C4225 C4226 C4238 C4263 P4225 P4238 30 11 30

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

(a)omit from the column headed “Circumstances” for the brand “Crestor”:
C1540  C3047  C4225  C4226            substitute:             C4225  C4226  C4238  C4263

(b)omit from the column headed “Purposes” for the brand “Crestor”:
P3047 P4225          substitute:             P4225 P4238

  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”:

Rostor 40 DO MP C4225 C4226 P4225 30 11 30

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

(a)omit from the column headed “Circumstances” for the brand “Rosuvastatin Actavis 40”:
C1540  C3047  C4225  C4226            substitute:             C4225  C4226  C4238  C4263

(b)omit from the column headed “Purposes” for the brand “Rosuvastatin Actavis 40”:
P3047 P4225          substitute:             P4225 P4238

  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 GH GQ MP C4225 C4226 C4238 C4263 P4225 P4238 30 11 30

  1. Schedule 1, entry for Sertraline in the form Tablet 50 mg (as hydrochloride)

(a)omit from the column headed “Responsible Person” for the brand “Sertracor 50”:                 MI           substitute:             CR

(b)omit:

Sertraline 50 CR MP NP C1211 30 5 30

  1. Schedule 1, entry for Sertraline in the form Tablet 100 mg (as hydrochloride)

(a)omit from the column headed “Responsible Person” for the brand “Sertracor 100”:                              MI           substitute:      CR

(b)omit:

Sertraline 100 CR MP NP C1211 30 5 30

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

(a)omit:

Pharmacor Simvastatin 10 MI MP C1540 C3047 P1540 30 5 30
NP C1540 30 5 30

(b)omit:

Synthon Simvastatin ZT MP C1540 C3047 P1540 30 5 30
NP C1540 30 5 30

(c)omit:

Pharmacor Simvastatin 10 MI MP C1540 C3047 P3047 30 11 30

(d)omit:

Synthon Simvastatin ZT MP C1540 C3047 P3047 30 11 30

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

(a)omit:

Pharmacor Simvastatin 20 MI MP C1540 C3047 P1540 30 5 30
NP C1540 30 5 30

(b)omit:

Synthon Simvastatin ZT MP C1540 C3047 P1540 30 5 30
NP C1540 30 5 30

(c)omit:

Pharmacor Simvastatin 20 MI MP C1540 C3047 P3047 30 11 30

(d)omit:

Synthon Simvastatin ZT MP C1540 C3047 P3047 30 11 30

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

(a)omit:

Pharmacor Simvastatin 40 MI MP C1540 C3047 P1540 30 5 30
NP C1540 30 5 30

(b)omit:

Synthon Simvastatin ZT MP C1540 C3047 P1540 30 5 30
NP C1540 30 5 30

(c)omit:

Pharmacor Simvastatin 40 MI MP C1540 C3047 P3047 30 11 30

(d)omit:

Synthon Simvastatin ZT MP C1540 C3047 P3047 30 11 30

  1. Schedule 1, entry for Simvastatin in the form Tablet 80 mg

(a)omit:

Pharmacor Simvastatin 80 MI MP C1540 C3047 P1540 30 5 30
NP C1540 30 5 30

(b)omit:

Synthon Simvastatin ZT MP C1540 C3047 P1540 30 5 30
NP C1540 30 5 30

(c)omit:

Pharmacor Simvastatin 80 MI MP C1540 C3047 P3047 30 11 30

(d)omit:

Synthon Simvastatin ZT MP C1540 C3047 P3047 30 11 30

  1. Schedule 1, entry for Strontium

omit from the column headed “Circumstances”:

C4117

  1. Schedule 1, entry for Telmisartan with Hydrochlorothiazide in the form Tablet 40 mg-12.5 mg

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

Pritor Plus 40/12.5 mg FI MP NP C3307 28 5 28

  1. Schedule 1, entry for Telmisartan with Hydrochlorothiazide in the form Tablet 80 mg-12.5 mg

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

Pritor Plus 80/12.5 mg FI MP NP C3307 28 5 28

  1. Schedule 1, entry for Telmisartan with Hydrochlorothiazide in the form Tablet 80 mg-25 mg

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

Pritor Plus 80/25 mg FI MP NP C3307 28 5 28

  1. Schedule 1, entry for Terbinafine in the form Tablet 250 mg (as hydrochloride)

(a)omit:

Terbinafine 250 CR MP NP C2191 C2865 C3244 P2865 P3244 42 0 42

(b)omit:

Terbinafine 250 CR MP NP C2191 C2865 C3244 P2191 42 1 42

  1. Schedule 1, after entry for Trimethoprim in the form Tablet 300 mg [Triprim]

insert in the columns in the order indicated:

Alprim AF MP C4243 14 2 7
Triprim QA MP C4243 14 2 7

  1. Schedule 1, entry for Vinorelbine in each of the forms: Capsule 20 mg (as tartrate); and Capsule 30 mg (as tartrate)

omit from the column headed “Circumstances”:          C1194   substitute:             C4242  C4272

  1. Schedule 3, after details relevant to Responsible Person Code FB

insert:

FI Boehringer Ingelheim Pty Ltd  52 000 452 308

  1. Schedule 3, after details relevant to Responsible Person Code QB

insert:

QH Cortex Health Pty Ltd  17 144 062 386

  1. Schedule 3, after details relevant to Responsible Person Code XA

insert:

XH MS Health Pty Ltd  33 155 182 586

  1. Schedule 3

omit:

ZA AstraZeneca Pty Ltd  54 009 682 311

  1. Schedule 3

omit:

ZT Synthon A.U. Pty Ltd  58 080 948 698

  1. Schedule 4, Part 1, after entry for Abciximab

insert:

Abiraterone C4245

Castration resistant metastatic carcinoma of the prostate

The treatment must be in combination with prednisone or prednisolone;
The treatment must not be used in combination with chemotherapy;
Patient must have failed treatment with docetaxel due to resistance or intolerance;
Patient must have a WHO performance status of 2 or less;
Patient must not receive PBS-subsidised abiraterone if progressive disease develops while on abiraterone

 Compliance with Authority Required procedures

  1. Schedule 4, Part 1, after entry for Azithromycin

insert:

Bacillus Calmette and Guerin, Connaught strain C1419 Treatment of carcinoma in situ of the urinary bladder
Bacillus Calmette and Guerin, Tice strain C1290 Primary and relapsing superficial urothelial carcinoma of the bladder

  1. Schedule 4, Part 1, omit entry for “BCG Immunotherapeutic” (Bacillus Calmette-Guérin/Connaught strain)

  1. Schedule 4, Part 1, omit entry for “BCG-Tice” (Bacillus Calmette-Guérin/Tice strain)

  1. Schedule 4, Part 1, entry for Cabazitaxel

substitute:

Cabazitaxel C4237

Castration resistant metastatic carcinoma of the prostate

The treatment must be in combination with prednisone or prednisolone;
The treatment must not be used in combination with abiraterone;
Patient must have failed treatment with docetaxel due to resistance or intolerance;
Patient must have a WHO performance status of 2 or less;
Patient must not receive PBS-subsidised cabazitaxel if progressive disease develops while on cabazitaxel

 Compliance with Authority Required procedures
C4262

Castration resistant metastatic carcinoma of the prostate

The treatment must be in combination with prednisone or prednisolone;
The treatment must not be used in combination with abiraterone;
Patient must have failed treatment with docetaxel due to resistance or intolerance;
Patient must have a WHO performance status of 2 or less;
Patient must not receive PBS-subsidised cabazitaxel if progressive disease develops while on cabazitaxel

 Compliance with Authority Required procedures - Streamlined Authority Code 4262

  1. Schedule 4, Part 1, after entry for Celecoxib

insert:

Cephalexin C4243 Prophylaxis of urinary tract infection Compliance with Authority Required procedures - Streamlined Authority Code 4243

  1. Schedule 4, Part 1, entry for Diazepam

insert in numerical order after existing text:

C4244

Chronic spasticity

Patient must be under 18 years of age

 Compliance with Authority Required procedures

  1. Schedule 4, Part 1, entry for Docetaxel

(a)omit:

C4155

Androgen independent (castration resistant) metastatic carcinoma of the prostate

Patient must have a Karnofsky performance status score of at least 60%;

The treatment must be used as first-line chemotherapy;
The treatment must be administered in three weekly cycles;
Patient must not receive more than 10 cycles of treatment with docetaxel under this restriction

 Compliance with Authority Required procedures - Streamlined Authority Code 4155

(b)insert in numerical order following existing text:

C4239

Androgen independent (castration resistant) metastatic carcinoma of the prostate

Patient must have a Karnofsky performance status score of at least 60%;
The treatment must be used as first-line chemotherapy;
The treatment must be administered in three weekly cycles;
Patient must not receive more than 10 cycles of treatment with docetaxel under this restriction

 Compliance with Authority Required procedures - Streamlined Authority Code 4239

  1. Schedule 4, Part 1, entry for Fentanyl

(a)omit:

C3663 P3663 Initial supply for dose titration for breakthrough pain in a palliative care patient with cancer who is receiving opioids for their persistent pain and where further escalation in the dose of morphine for breakthrough pain results in intolerable adverse effects Compliance with Authority Required procedures
C3664 P3664 Continuing supply for breakthrough pain in a palliative care patient with cancer who is receiving opioids for their persistent pain and where further escalation in the dose of morphine for breakthrough pain results in intolerable adverse effects Compliance with Authority Required procedures

(b)insert in numerical order following existing text:

C4250 P4250

Breakthrough pain

Initial treatment for dose titration

Patient must be undergoing palliative care;
Patient must have cancer;
Patient must be receiving opioids for their persistent pain;
Patient must be unable to tolerate further escalation in the dose of morphine for breakthrough pain due to adverse effects

 Compliance with Authority Required procedures
C4267 P4267

Breakthrough pain

Continuing treatment

Patient must be undergoing palliative care;
Patient must have cancer;
Patient must be receiving opioids for their persistent pain;
Patient must be unable to tolerate further escalation in the dose of morphine for breakthrough pain due to adverse effects

 Compliance with Authority Required procedures

  1. Schedule 4, Part 1, entry for Glucose Indicator―Blood

(a)omit:

P3035 For use in patients who are receiving treatment under a GP Management Plan or Team Care Arrangements where Medicare benefits were or are payable for the preparation of the Plan or coordination of the Arrangements

(b)insert in numerical order following existing text:

P4241

Blood glucose monitoring

Patient must be receiving treatment under a GP Management Plan or Team Care Arrangements where Medicare benefits were or are payable for the preparation of the Plan or coordination of the Arrangements

  1. Schedule 4, Part 1, after entry for Glycerol

insert:

Glycomacropeptide and essential amino acids C1286 Phenylketonuria
Glycomacropeptide and essential amino acids with vitamins and minerals C1286 Phenylketonuria

  1. Schedule 4, Part 1, entry for High fat formula with vitamins, minerals and trace elements and low in protein and carbohydrate

insert in numerical order following existing text:

C4253

Ketogenic diet

Patient must have intractable seizures requiring treatment with a ketogenic diet; OR
Patient must have a glucose transport protein defect; OR
Patient must have pyruvate dehydrogenase deficiency

KetoCal 3:1 should only be used under strict supervision of a dietician, together with a metabolic physician and/or neurologist

  1. Schedule 4, Part 1, after entry for Interferon Gamma-1b

insert:

Ipilimumab C4235

Unresectable Stage III or Stage IV malignant melanoma

Induction treatment

The treatment must be as monotherapy;
Patient must not have received prior treatment with ipilimumab;
The treatment must not exceed a total of 4 doses at a maximum dose of 3 mg per kg every 3 weeks

The patient's body weight must be documented in the patient's medical records at the time treatment is initiated

 Compliance with Authority Required procedures
C4236

Unresectable Stage III or Stage IV malignant melanoma

Re-induction treatment

The treatment must be as monotherapy;
Patient must have progressive disease after achieving an initial objective response to the most recent course of ipilimumab treatment (induction or re-induction);
The treatment must not exceed a total of 4 doses at a maximum dose of 3 mg per kg every 3 weeks

An initial objective response to treatment is defined as either:

(i) sustained stable disease of greater than or equal to 3 months duration measured from at least 2 weeks after the date of completion of the most recent course of ipilimumab; or

(ii) a partial or complete response

The patient's body weight must be documented in the patient's medical records at the time treatment with ipilimumab is initiated

 Compliance with Authority Required procedures
C4251

Unresectable Stage III or Stage IV malignant melanoma

Completion of induction treatment

The treatment must be as monotherapy;
The treatment must be for completion of induction treatment in a patient who commenced induction treatment with ipilimumab prior to 1 August 2013;
The treatment must not exceed a total of 4 doses (combined PBS-subsidised and non-PBS-subsidised) at a maximum dose of 3 mg per kg every 3 weeks

The patient's body weight must be documented in the patient's medical records at the time treatment is initiated

For patients who commenced induction treatment with ipilimumab prior to 1 August 2013 prescribers should request the appropriate number of repeats to provide a total of 4 doses of ipilimumab (combined PBS-subsidised and non-PBS subsidised)

 Compliance with Authority Required procedures - Streamlined Authority Code 4251
C4252

Unresectable Stage III or Stage IV malignant melanoma

Completion of re-induction treatment

The treatment must be as monotherapy;

Patient must have progressive disease after achieving an initial objective response to the most recent course of ipilimumab treatment (induction or re-induction) received prior to 1 August 2013;
The treatment must be for completion of re-induction treatment in a patient who commenced re-induction treatment with ipilimumab prior to 1 August 2013;
The treatment must not exceed a total of 4 doses (combined PBS-subsidised and non-PBS-subsidised) at a maximum dose of 3 mg per kg every 3 weeks

An initial objective response to treatment is defined as either:

(i) sustained stable disease of greater than or equal to 3 months duration measured from at least 2 weeks after the date of completion of the most recent course of ipilimumab; or

(ii) a partial or complete response

The patient's body weight must be documented in the patient's medical records at the time treatment with ipilimumab is initiated

For patients who commenced re-induction treatment with ipilimumab prior to 1 August 2013 prescribers should request the appropriate number of repeats to provide a maximum of 4 doses of ipilimumab (combined PBS-subsidised and non-PBS-subsidised)

 Compliance with Authority Required procedures - Streamlined Authority Code 4252
C4254

Unresectable Stage III or Stage IV malignant melanoma

Induction treatment

The treatment must be as monotherapy;
Patient must not have received prior treatment with ipilimumab;
The treatment must not exceed a total of 4 doses at a maximum dose of 3 mg per kg every 3 weeks

The patient's body weight must be documented in the patient's medical records at the time treatment is initiated

 Compliance with Authority Required procedures - Streamlined Authority Code 4254
C4256

Unresectable Stage III or Stage IV malignant melanoma

Completion of re-induction treatment

The treatment must be as monotherapy;
Patient must have progressive disease after achieving an initial objective response to the most recent course of ipilimumab treatment (induction or re-induction) received prior to 1 August 2013;
The treatment must be for completion of re-induction treatment in a patient who commenced re-induction treatment with ipilimumab prior to 1 August 2013;
The treatment must not exceed a total of 4 doses (combined PBS-subsidised and non-PBS-subsidised) at a maximum dose of 3 mg per kg every 3 weeks

An initial objective response to treatment is defined as either:

(i) sustained stable disease of greater than or equal to 3 months duration measured from at least 2 weeks after the date of completion of the most recent course of ipilimumab; or

(ii) a partial or complete response

The patient's body weight must be documented in the patient's medical records at the time treatment with ipilimumab is initiated

For patients who commenced re-induction treatment with ipilimumab prior to 1 August 2013 prescribers should request the appropriate number of repeats to provide a maximum of 4 doses of ipilimumab (combined PBS-subsidised and non-PBS-subsidised)

 Compliance with Authority Required procedures
C4261

Unresectable Stage III or Stage IV malignant melanoma

Re-induction treatment

The treatment must be as monotherapy;
Patient must have progressive disease after achieving an initial objective response to the most recent course of ipilimumab treatment (induction or re-induction);
The treatment must not exceed a total of 4 doses at a maximum dose of 3 mg per kg every 3 weeks

An initial objective response to treatment is defined as either:

(i) sustained stable disease of greater than or equal to 3 months duration measured from at least 2 weeks after the date of completion of the most recent course of ipilimumab; or

(ii) a partial or complete response

The patient's body weight must be documented in the patient's medical records at the time treatment with ipilimumab is initiated

 Compliance with Authority Required procedures - Streamlined Authority Code 4261
C4265

Unresectable Stage III or Stage IV malignant melanoma

Completion of induction treatment

The treatment must be as monotherapy;
The treatment must be for completion of induction treatment in a patient who commenced induction treatment with ipilimumab prior to 1 August 2013;
The treatment must not exceed a total of 4 doses (combined PBS-subsidised and non-PBS-subsidised) at a maximum dose of 3 mg per kg every 3 weeks

The patient's body weight must be documented in the patient's medical records at the time treatment is initiated

For patients who commenced induction treatment with ipilimumab prior to 1 August 2013 prescribers should request the appropriate number of repeats to provide a total of 4 doses of ipilimumab (combined PBS-subsidised and non-PBS subsidised)

 Compliance with Authority Required procedures

  1. Schedule 4, Part 1, entry for Lacosamide

substitute:

Lacosamide C4240

Intractable partial epileptic seizures

Initial treatment

Must be treated by a neurologist;
The treatment must be in combination with two or more anti-epileptic drugs which includes one second-line adjunctive agent;
The condition must have failed to be controlled satisfactorily by other anti-epileptic drugs, which includes at least one first-line anti-epileptic agent and at least two second-line adjunctive anti-epileptic agents

Patient must be aged 16 years or older

 Compliance with Authority Required procedures - Streamlined Authority Code 4240
C4249

Intractable partial epileptic seizures

Continuing treatment

Patient must have previously been treated with PBS-subsidised lacosamide

Patient must be aged 16 years or older

 Compliance with Authority Required procedures - Streamlined Authority Code 4249
C4257

Intractable partial epileptic seizures

Continuing treatment

Patient must have previously been treated with PBS-subsidised lacosamide

Patient must be aged 16 years or older

 Compliance with Authority Required procedures - Streamlined Authority Code 4257
C4264

Intractable partial epileptic seizures

Initial treatment

Must be treated by a neurologist;
The treatment must be in combination with two or more anti-epileptic drugs which includes one second-line adjunctive agent;
The condition must have failed to be controlled satisfactorily by other anti-epileptic drugs, which includes at least one first-line anti-epileptic agent and at least two second-line adjunctive anti-epileptic agents

Patient must be aged 16 years or older

 Compliance with Authority Required procedures - Streamlined Authority Code 4264
C4271

Intractable partial epileptic seizures

Initial treatment

Must be treated by a neurologist;
The treatment must be in combination with two or more anti-epileptic drugs which includes one second-line adjunctive agent;
The condition must have failed to be controlled satisfactorily by other anti-epileptic drugs, which includes at least one first-line anti-epileptic agent and at least two second-line adjunctive anti-epileptic agents;
The treatment must be for dose titration purposes

Patient must be aged 16 years or older

 Compliance with Authority Required procedures - Streamlined Authority Code 4271

  1. Schedule 4, Part 1, after entry for Miconazole

insert:

Mifepristone C4247

Termination of an intra-uterine pregnancy

Must be treated by a prescriber who is registered with the MS 2 Step Prescribing Program;
The condition must be an intra-uterine pregnancy of up to 49 days of gestation;
The treatment must be in sequential combination with misoprostol 800 micrograms

An authority prescription for misoprostol 200 microgram tablets must be sought at the time of authority application

 Compliance with Authority Required procedures

  1. Schedule 4, Part 1, entry for Misoprostol

insert in numerical order following existing text:

C4266

Termination of an intra-uterine pregnancy

Must be treated by a prescriber who is registered with the MS 2 Step Prescribing Program;
The condition must be an intra-uterine pregnancy of up to 49 days of gestation;
The treatment must be in sequential combination with mifepristone 200 mg

An authority prescription for mifepristone 200 mg tablet must be sought at the time of authority application

 Compliance with Authority Required procedures

  1. Schedule 4, Part 1, entry for Paliperidone

substitute:

Paliperidone C4246 Schizophrenia Compliance with Authority Required procedures - Streamlined Authority Code 4246

  1. Schedule 4, Part 1, entry for Risedronic Acid

(a)omit:

C4117

Osteoporosis

Patient must be aged 70 years or older;

Patient must have a Bone Mineral Density (BMD) T-score of -3.0 or less;
Patient must not receive concomitant treatment with any other PBS-subsidised anti-resorptive agent for this condition

The date, site (femoral neck or lumbar spine) and score of the qualifying BMD measurement must be documented in the patient's medical records when treatment is initiated

 Compliance with Authority Required procedures - Streamlined Authority Code 4117

(b)insert in numerical order following existing text:

C4133

Osteoporosis

Patient must be aged 70 years or older;

Patient must have a Bone Mineral Density (BMD) T-score of -2.5 or less;
Patient must not receive concomitant treatment with any other PBS-subsidised anti-resorptive agent for this condition

The date, site (femoral neck or lumbar spine) and score of the qualifying BMD measurement must be documented in the patient's medical records when treatment is initiated

Compliance with Authority Required procedures - Streamlined Authority Code 4133

  1. Schedule 4, Part 1, entry for Risedronic Acid and Calcium

(a)omit:

C4117

Osteoporosis

Patient must be aged 70 years or older;

Patient must have a Bone Mineral Density (BMD) T-score of -3.0 or less;
Patient must not receive concomitant treatment with any other PBS-subsidised anti-resorptive agent for this condition

The date, site (femoral neck or lumbar spine) and score of the qualifying BMD measurement must be documented in the patient's medical records when treatment is initiated

 Compliance with Authority Required procedures - Streamlined Authority Code 4117

(b)insert in numerical order following existing text:

C4133

Osteoporosis

Patient must be aged 70 years or older;

Patient must have a Bone Mineral Density (BMD) T-score of -2.5 or less;
Patient must not receive concomitant treatment with any other PBS-subsidised anti-resorptive agent for this condition

The date, site (femoral neck or lumbar spine) and score of the qualifying BMD measurement must be documented in the patient's medical records when treatment is initiated

Compliance with Authority Required procedures - Streamlined Authority Code 4133

  1. Schedule 4, Part 1, entry for Risedronic acid and calcium with colecalciferol

(a)omit:

C4117

Osteoporosis

Patient must be aged 70 years or older;

Patient must have a Bone Mineral Density (BMD) T-score of -3.0 or less;
Patient must not receive concomitant treatment with any other PBS-subsidised anti-resorptive agent for this condition

The date, site (femoral neck or lumbar spine) and score of the qualifying BMD measurement must be documented in the patient's medical records when treatment is initiated

 Compliance with Authority Required procedures - Streamlined Authority Code 4117

(b)insert in numerical order following existing text:

C4133

Osteoporosis

Patient must be aged 70 years or older;

Patient must have a Bone Mineral Density (BMD) T-score of -2.5 or less;
Patient must not receive concomitant treatment with any other PBS-subsidised anti-resorptive agent for this condition

The date, site (femoral neck or lumbar spine) and score of the qualifying BMD measurement must be documented in the patient's medical records when treatment is initiated

Compliance with Authority Required procedures - Streamlined Authority Code 4133

  1. Schedule 4, Part 1, entry for Rivaroxaban

insert in numerical order following existing text:

C4260 P4260

Pulmonary embolism

Initial treatment

Patient must have confirmed acute symptomatic pulmonary embolism

 Compliance with Authority Required procedures - Streamlined Authority Code 4260
C4268

Pulmonary embolism

Continuing treatment

Patient must have confirmed acute symptomatic pulmonary embolism

 Compliance with Authority Required procedures - Streamlined Authority Code 4268
C4269 P4269

Prevention of stroke or systemic embolism

Patient must have non-valvular atrial fibrillation;
Patient must have one or more risk factors for developing stroke or systemic embolism

Risk factors for developing stroke or systemic ischaemic embolism are:

(i) Prior stroke (ischaemic or unknown type), transient ischaemic attack or non-central nervous system (CNS) systemic embolism;

(ii) age 75 years or older;

(iii) hypertension;

(iv) diabetes mellitus;

(v) heart failure and/or left ventricular ejection fraction 35% or less

 Compliance with Authority Required procedures - Streamlined Authority Code 4269

  1. Schedule 4, Part 1, entry for Rosuvastatin

(a)omit:

C1540 P1540 For use in patients that meet the criteria set out in the General Statement for Lipid-Lowering Drugs
C3047 P3047 For use in patients who meet the criteria set out in the General Statement for Lipid-Lowering Drugs, and who are receiving treatment under a GP Management Plan or Team Care Arrangements where Medicare benefits were or are payable for the preparation of the Plan or coordination of the Arrangements

(b)insert in numerical order following existing text:

C4238 P4238

For use in patients who meet the criteria set out in the General Statement for Lipid-Lowering Drugs

Patient must be receiving treatment under a GP Management Plan or Team Care Arrangements where Medicare benefits were or are payable for the preparation of the Plan or coordination of the Arrangements
C4248 P4248 For use in patients who meet the criteria set out in the General Statement for Lipid-Lowering Drugs
C4259 P4259 For use in patients who meet the criteria set out in the General Statement for Lipid-Lowering Drugs
C4263 P4263 For use in patients who meet the criteria set out in the General Statement for Lipid-Lowering Drugs

  1. Schedule 4, Part 1, entry for Strontium

omit:

C4117

Osteoporosis

Patient must be aged 70 years or older;

Patient must have a Bone Mineral Density (BMD) T-score of -3.0 or less;
Patient must not receive concomitant treatment with any other PBS-subsidised anti-resorptive agent for this condition

The date, site (femoral neck or lumbar spine) and score of the qualifying BMD measurement must be documented in the patient's medical records when treatment is initiated

 Compliance with Authority Required procedures - Streamlined Authority Code 4117

  1. Schedule 4, Part 1, after entry for Triglycerides, medium chain and long chain with glucose polymer

insert:

Trimethoprim C4243 Prophylaxis of urinary tract infection Compliance with Authority Required procedures - Streamlined Authority Code 4243

  1. Schedule 4, Part 1, entry for Vinorelbine

(a)omit:

C1194 Locally advanced or metastatic non-small cell lung cancer Compliance with Authority Required procedures

(b)insert in numerical order following existing text:

C4242 Locally advanced or metastatic non-small cell lung cancer Compliance with Authority Required procedures
C4272

Advanced breast cancer

Patient must have failed standard prior therapy, which includes an anthracycline

 Compliance with Authority Required procedures
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