National Health (Listing of Pharmaceutical Benefits) Amendment Instrument 2016 (No. 6) (PB 52 of 2016) (Cth)

Case

PB 52 of 2016

National Health (Listing of Pharmaceutical Benefits) Amendment Instrument 2016
(No. 6)

National Health Act 1953

I, JULIANNE QUAINE, First Assistant Secretary (Acting), 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    20th June               2016

JULIANNE QUAINE
First Assistant Secretary (Acting)
Pharmaceutical Benefits Division
Department of Health


1          Name of Instrument

(1)        This Instrument is the National Health (Listing of Pharmaceutical    Benefits) Amendment Instrument 2016 (No. 6).

(2)        This Instrument may also be cited as PB 52 of 2016.

2          Commencement

This Instrument commences on 1 July 2016.

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 Alprazolam in the form Tablet 1 mg

    (a)omit:

Chem mart Alprazolam CH MP NP C5608 50 2 50

(b)omit:

Terry White Chemists Alprazolam TW MP NP C5608 50 2 50

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

    insert:

Amino acid formula with carbohydrate, vitamins, minerals and trace elements without phenylalanine Sachets containing oral powder 20 g, 30 (PKU Go) Oral PKU Go OH MP NP C4295 4 5 1
Amino acid formula with fat, carbohydrate, vitamins, minerals and long chain polyunsaturated fatty acids without phenylalanine and supplemented with docosahexanoic acid Oral liquid 500 mL, 20 (PKU Baby) Oral PKU Baby OH MP NP C4295 2 5 1

  1. Schedule 1, entry for Amlodipine with Atorvastatin in the form Tablet 5 mg amlodipine (as besylate) with 10 mg atorvastatin (as calcium)

    omit:

Cadatin 5/10 FZ MP NP C5619 C5694 C5750 C5751 C5787 C5788 30 5 30

  1. Schedule 1, entry for Amlodipine with Atorvastatin in the form Tablet 5 mg amlodipine (as besylate) with 20 mg atorvastatin (as calcium)

    omit:

Cadatin 5/20 FZ MP NP C5619 C5694 C5750 C5751 C5787 C5788 30 5 30

  1. Schedule 1, entry for Amlodipine with Atorvastatin in the form Tablet 5 mg amlodipine (as besylate) with 40 mg atorvastatin (as calcium)

    omit:

Cadatin 5/40 FZ MP NP C5619 C5694 C5750 C5751 C5787 C5788 30 5 30

  1. Schedule 1, entry for Amlodipine with Atorvastatin in the form Tablet 5 mg amlodipine (as besylate) with 80 mg atorvastatin (as calcium)

    omit:

Cadatin 5/80 FZ MP NP C5619 C5694 C5750 C5751 C5787 C5788 30 5 30

  1. Schedule 1, entry for Amlodipine with Atorvastatin in the form Tablet 10 mg amlodipine (as besylate) with 10 mg atorvastatin (as calcium)

    omit:

Cadatin 10/10 FZ MP NP C5619 C5694 C5750 C5751 C5787 C5788 30 5 30

  1. Schedule 1, entry for Amlodipine with Atorvastatin in the form Tablet 10 mg amlodipine (as besylate) with 20 mg atorvastatin (as calcium)

    omit:

Cadatin 10/20 FZ MP NP C5619 C5694 C5750 C5751 C5787 C5788 30 5 30

  1. Schedule 1, entry for Amlodipine with Atorvastatin in the form Tablet 10 mg amlodipine (as besylate) with 40 mg atorvastatin (as calcium)

    omit:

Cadatin 10/40 FZ MP NP C5619 C5694 C5750 C5751 C5787 C5788 30 5 30

  1. Schedule 1, entry for Amlodipine with Atorvastatin in the form Tablet 10 mg amlodipine (as besylate) with 80 mg atorvastatin (as calcium)

    omit:

Cadatin 10/80 FZ MP NP C5619 C5694 C5750 C5751 C5787 C5788 30 5 30

  1. Schedule 1, entry for Amoxycillin in the form Capsule 250 mg (as trihydrate)

    (a)omit:

Amoxycillin‑GA FM PDP 20 0 20

(b)omit:

Amoxycillin‑GA FM MP NP MW 20 1 20

  1. Schedule 1, entry for Amoxycillin in the form Capsule 500 mg (as trihydrate)

    (a)omit:

Amoxycillin‑GA FM PDP 20 0 20

(b)omit:

Amoxycillin‑GA FM 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)

    (a)omit:

a GA‑Amclav 500/125 FM PDP C5833 C5894 10 0 10

(b)omit:

a GA‑Amclav 500/125 FM MP NP MW C5832 C5893 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)

    (a)omit:

a GA‑Amclav Forte 875/125 FM PDP C5833 C5894 10 0 10

(b)omit:

a GA‑Amclav Forte 875/125 FM MP NP C5832 C5893 10 1 10

  1. Schedule 1, entry for Amoxycillin with Clavulanic Acid in the form Powder for oral suspension containing 125 mg amoxycillin (as trihydrate) with 31.25 mg clavulanic acid (as potassium clavulanate) per 5 mL, 75 mL

    (a)omit:

GA‑Amclav 125/31.25 FM PDP C5833 C5894 1 0 1

(b)omit:

GA‑Amclav 125/31.25 FM MP NP C5832 C5893 1 1 1

  1. Schedule 1, entry for Amoxycillin with Clavulanic Acid in the form Powder for oral suspension containing 400 mg amoxycillin (as trihydrate) with 57 mg clavulanic acid (as potassium clavulanate) per 5 mL, 60 mL

    (a)omit:

GA‑Amclav Forte 400/57 FM PDP C5833 C5894 1 0 1

(b)omit:

GA‑Amclav Forte 400/57 FM MP NP C5832 C5893 1 1 1

  1. Schedule 1, entry for Atomoxetine in each of the forms: Capsule 10 mg (as hydrochloride); Capsule 18 mg (as hydrochloride); Capsule
    25 mg (as hydrochloride); Capsule 40 mg (as hydrochloride); Capsule 60 mg (as hydrochloride); Capsule 80 mg (as hydrochloride); and Capsule 100 mg (as hydrochloride)

    (a)omit from the column headed “Circumstances”:               C4591

    (b)insert in numerical order:       C6279

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

    omit:

GenRx Azathioprine GX MP NP 100 5 100

  1. Schedule 1, entry for Betamethasone

    substitute:

Betamethasone Injection containing betamethasone acetate 3 mg with betamethasone sodium phosphate 3.9 mg in 1 mL Injection Celestone Chronodose MK MP NP C6210 C6211 C6212 C6253 C6254 C6255 C6268 C6269 C6281 5 0 5
PDP C6209 C6237 C6291 5 0 5
Cream 500 micrograms (as dipropionate) per g, 15 g Application a Diprosone MK MP NP C4957 C6218 C6231 C6232 C6246 C6263 P4957 1 1 1
a Eleuphrat FR MP NP C4957 C6218 C6231 C6232 C6246 C6263 P4957 1 1 1
a Diprosone MK MP NP C4957 C6218 C6231 C6232 C6246 C6263 P6232 2 5 1
a Eleuphrat FR MP NP C4957 C6218 C6231 C6232 C6246 C6263 P6232 2 5 1
a Diprosone MK MP NP C4957 C6218 C6231 C6232 C6246 C6263 P6246 4 5 1
a Eleuphrat FR MP NP C4957 C6218 C6231 C6232 C6246 C6263 P6246 4 5 1
a Diprosone MK MP NP C4957 C6218 C6231 C6232 C6246 C6263 P6218 6 5 1
a Eleuphrat FR MP NP C4957 C6218 C6231 C6232 C6246 C6263 P6218 6 5 1
a Diprosone MK MP NP C4957 C6218 C6231 C6232 C6246 C6263 P6263 8 5 1
a Eleuphrat FR MP NP C4957 C6218 C6231 C6232 C6246 C6263 P6263 8 5 1
a Diprosone MK MP NP C4957 C6218 C6231 C6232 C6246 C6263 P6231 10 5 1
a Eleuphrat FR MP NP C4957 C6218 C6231 C6232 C6246 C6263 P6231 10 5 1
Ointment 500 micrograms (as dipropionate) per g, 15 g Application a Diprosone MK MP NP C4957 C6218 C6231 C6232 C6246 C6263 P4957 1 1 1
a Eleuphrat FR MP NP C4957 C6218 C6231 C6232 C6246 C6263 P4957 1 1 1
a Diprosone MK MP NP C4957 C6218 C6231 C6232 C6246 C6263 P6232 2 5 1
a Eleuphrat FR MP NP C4957 C6218 C6231 C6232 C6246 C6263 P6232 2 5 1
a Diprosone MK MP NP C4957 C6218 C6231 C6232 C6246 C6263 P6246 4 5 1
a Eleuphrat FR MP NP C4957 C6218 C6231 C6232 C6246 C6263 P6246 4 5 1
a Diprosone MK MP NP C4957 C6218 C6231 C6232 C6246 C6263 P6218 6 5 1
a Eleuphrat FR MP NP C4957 C6218 C6231 C6232 C6246 C6263 P6218 6 5 1
a Diprosone MK MP NP C4957 C6218 C6231 C6232 C6246 C6263 P6263 8 5 1
a Eleuphrat FR MP NP C4957 C6218 C6231 C6232 C6246 C6263 P6263 8 5 1
a Diprosone MK MP NP C4957 C6218 C6231 C6232 C6246 C6263 P6231 10 5 1
a Eleuphrat FR MP NP C4957 C6218 C6231 C6232 C6246 C6263 P6231 10 5 1
Cream 200 micrograms (as valerate) per g, 100 g Application a Antroquoril FR MP NP C4924 2 0 1
b Betnovate 1/5 QA MP NP C4924 2 0 1
a Celestone-M MK MP NP C4924 2 0 1
b Cortival 1/5 FM MP NP C4924 2 0 1
Cream 500 micrograms (as valerate) per g, 15 g Application a Betnovate 1/2 QA MP NP C4957 C6218 C6231 C6232 C6246 C6263 P4957 1 1 1
a Cortival 1/2 FM MP NP C4957 C6218 C6231 C6232 C6246 C6263 P4957 1 1 1
a Betnovate 1/2 QA MP NP C4957 C6218 C6231 C6232 C6246 C6263 P6232 2 5 1
a Cortival 1/2 FM MP NP C4957 C6218 C6231 C6232 C6246 C6263 P6232 2 5 1
a Betnovate 1/2 QA MP NP C4957 C6218 C6231 C6232 C6246 C6263 P6246 4 5 1
a Cortival 1/2 FM MP NP C4957 C6218 C6231 C6232 C6246 C6263 P6246 4 5 1
a Betnovate 1/2 QA MP NP C4957 C6218 C6231 C6232 C6246 C6263 P6218 6 5 1
a Cortival 1/2 FM MP NP C4957 C6218 C6231 C6232 C6246 C6263 P6218 6 5 1
a Betnovate 1/2 QA MP NP C4957 C6218 C6231 C6232 C6246 C6263 P6263 8 5 1
a Cortival 1/2 FM MP NP C4957 C6218 C6231 C6232 C6246 C6263 P6263 8 5 1
a Betnovate 1/2 QA MP NP C4957 C6218 C6231 C6232 C6246 C6263 P6231 10 5 1
a Cortival 1/2 FM MP NP C4957 C6218 C6231 C6232 C6246 C6263 P6231 10 5 1

  1. Schedule 1, entry for Bleomycin

    omit from the column headed “Circumstances” (all instances):               C1139  C1198    substitute:             C6224  C6275

  1. Schedule 1, entry for Calcitriol

    omit:

a GenRx Calcitriol GX MP NP C5089 C5114 C5255 C5401 C5402 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

    (a)insert in the column headed “Schedule Equivalent” for all brands:             a

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

a Blooms the Chemist Candesartan IB 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”:

a Blooms the Chemist Candesartan HCTZ 16/12.5 IB 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”:

a Blooms the Chemist Candesartan HCTZ 32/12.5 IB 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”:

a Blooms the Chemist Candesartan HCTZ 32/25 IB MP NP C4374 30 5 30

  1. Schedule 1, entry for Chorionic Gonadotrophin in the form Injection set containing 3 ampoules powder for injection 1,500 units and 3 ampoules solvent 1 mL [Maximum Quantity: 1; Number of Repeats: 5]

    omit from the column headed “Circumstances”:          C1116  C1117  C1118  C1120  C1878      substitute:             C6257  C6258  C6270  C6271  C6284

  2. Schedule 1, entry for Cladribine in each of the forms: Injection 10 mg in 5 mL; and Solution for I.V. infusion 10 mg in 10 mL single use vial

    omit from the column headed “Circumstances”:          C3180   substitute:             C6265

  3. Schedule 1, entry for Clomiphene

    omit from the column headed “Circumstances” (twice occurring):          C1026  C1267    substitute:             C6221  C6240

  4. Schedule 1, entry for Clomipramine

    omit from the column headed “Circumstances” (all instances):               C1041  C1241  C1287    substitute:             C6250  C6251  C6299

  5. Schedule 1, entry for Clonazepam in the form Injection 1 mg in 2 mL (set containing solution 1 mg in 1 mL and 1 mL diluent)

    omit from the column headed “Circumstances”:          C1093   substitute:             C6295

  6. Schedule 1, entry for Clonazepam in the form Oral liquid 2.5 mg per mL, 10 mL [Maximum Quantity: 2; Number of Repeats: 0]

    (a)omit from the column headed “Circumstances”:               C1574  

    (b)insert in numerical order:       C6296

    (c)omit from the column headed “Purposes”:         P1574   substitute:             P6296

  7. Schedule 1, entry for Clonazepam in the form Oral liquid 2.5 mg per mL, 10 mL [Maximum Quantity: 2; Number of Repeats: 3]

    (a)omit from the column headed “Circumstances”:               C1574  

    (b)insert in numerical order:       C6296

  8. Schedule 1, entry for Clonazepam in the form Tablet 500 micrograms [Maximum Quantity: 100; Number of Repeats: 3]

    (a)omit from the column headed “Circumstances” (twice occurring):               C1574  

    (b)insert in numerical order:       C6296

  9. Schedule 1, entry for Clonazepam in the form Tablet 500 micrograms [Maximum Quantity: 200; Number of Repeats: 2]

    (a)omit from the column headed “Circumstances” (twice occurring):               C1574  

    (b)insert in numerical order:       C6296

    (c)omit from the column headed “Purposes” (twice occurring):         P1574   substitute:             P6296

  10. Schedule 1, entry for Clonazepam in the form Tablet 2 mg [Maximum Quantity: 100; Number of Repeats: 3]

    (a)omit from the column headed “Circumstances” (twice occurring):               C1574  

    (b)insert in numerical order:       C6296

  11. Schedule 1, entry for Clonazepam in the form Tablet 2 mg [Maximum Quantity: 200; Number of Repeats: 2]

    (a)omit from the column headed “Circumstances” (twice occurring):               C1574  

    (b)insert in numerical order:       C6296

    (c)omit from the column headed “Purposes” (twice occurring):         P1574   substitute:             P6296

  12. Schedule 1, entry for Danazol in each of the forms: Capsule 100 mg; and Capsule 200 mg

    omit from the column headed “Circumstances”:          C1090  C1151  C2639  C2640     substitute:             C6242  C6259  C6285  C6293

  13. Schedule 1, entry for Darbepoetin alfa in all forms

    omit from the column headed “Circumstances”:          C1957  C3334    substitute:             C6260  C6294

  14. Schedule 1, entry for Dexamphetamine

    omit from the column headed “Circumstances”:          C1236  C1461    substitute:             C6226  C6227

  15. Schedule 1, entry for Diclofenac in the form Tablet (enteric coated) containing diclofenac sodium 25 mg [Maximum Quantity: 100; Number of Repeats: 0]

    omit from the column headed “Circumstances” (all instances):               C1036  C1054    substitute:             C6256  C6282

  16. Schedule 1, entry for Diclofenac in the form Tablet (enteric coated) containing diclofenac sodium 25 mg [Maximum Quantity: 100; Number of Repeats: 3]

    (a)omit from the column headed “Circumstances” (all instances):     C1036  C1054

    (b)insert in numerical order:       C6214  C6283

  1. Schedule 1, entry for Diclofenac in the form Tablet (enteric coated) containing diclofenac sodium 50 mg [Maximum Quantity: 50; Number of Repeats: 0]

    omit from the column headed “Circumstances” (all instances):               C1036  C1054    substitute:             C6256  C6282

  2. Schedule 1, entry for Diclofenac in the form Tablet (enteric coated) containing diclofenac sodium 50 mg [Maximum Quantity: 50; Number of Repeats: 3]

    (a)omit from the column headed “Circumstances” (all instances):     C1036  C1054

    (b)insert in numerical order:       C6214  C6283

  3. Schedule 1, entry for Doxorubicin – Pegylated Liposomal in the form Suspension for I.V. infusion containing pegylated liposomal doxorubicin hydrochloride 20 mg in 10 mL

    omit from the column headed “Circumstances” (twice occurring):          C1828  C1829  C3348  C3349     substitute:                C6233  C6234  C6264  C6274

  4. Schedule 1, entry for Duloxetine in each of the forms: Capsule 30 mg (as hydrochloride); and Capsule 60 mg (as hydrochloride)

    omit from the column headed “Circumstances” (all instances):               C1211   substitute:             C5650

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

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

Pharmorubicin PF MP See Note 3 See
Note 3 		1 D(100)

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

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

Pharmorubicin PF MP See Note 3 See
Note 3 		1 D(100)

  1. Schedule 1, entry for Epoetin alfa in all forms

    omit from the column headed “Circumstances”:          C1957  C3334    substitute:             C6260  C6294

  2. Schedule 1, entry for Epoetin beta in all forms

    omit from the column headed “Circumstances”:          C1957  C3334    substitute:             C6260  C6294

  3. Schedule 1, entry for Epoetin lambda in all forms

    omit from the column headed “Circumstances”:          C1957  C3334    substitute:             C6245  C6261

  4. Schedule 1, entry for Fluconazole in each of the forms: Solution for I.V. infusion 100 mg in 50 mL; and Solution for I.V. infusion 200 mg in 100 mL

    omit:

Fluconazole Hexal HX MP NP C5978 C5989 C5996 C6002 C6023 C6030 7 0 1

  1. Schedule 1, entry for Fludarabine in each of the forms: Powder for I.V. injection containing fludarabine phosphate 50 mg; and Solution for I.V. injection 50 mg fludarabine phosphate in 2 mL

    omit from the column headed “Circumstances”:          C3887   substitute:             C6248

  2. Schedule 1, entry for Fluorouracil in each of the forms: Injection 500 mg in 10 mL; Injection 1000 mg in 20 mL; Injection 2500 mg in 20 mL; and Injection 5000 mg in 20 mL

    (a)omit from the column headed “Circumstances” (all instances):     See Note 3        substitute:             C6266  C6297

    (b)omit from the column headed “Purposes” (all instances):               See Note 3

  3. Schedule 1, entry for Fluoxetine in each of the forms: Tablet, dispersible, 20 mg (as hydrochloride); and Capsule 20 mg (as hydrochloride)

    omit from the column headed “Circumstances” (all instances):               C1211  C1241    substitute:             C4755  C6277

  1. Schedule 1, entry for Fluvoxamine in each of the forms: Tablet containing fluvoxamine maleate 50 mg; and Tablet containing fluvoxamine maleate 100 mg

    omit from the column headed “Circumstances” (all instances):               C1211  C1241    substitute:             C4755  C6277

  2. Schedule 1, entry for Follitropin Alfa in each of the forms: Injection 300 I.U. in 0.5 mL multi-dose cartridge; Injection 450 I.U. in 0.75 mL
    multi-dose cartridge; and Injection 900 I.U. in 1.5 mL multi-dose cartridge

    omit from the column headed “Circumstances”:          C1119  C1878    substitute:             C6215  C6257

  3. Schedule 1, entry for Follitropin Beta in each of the forms: Solution for injection 300 I.U. in 0.36 mL multi-dose cartridge; Solution for injection 600 I.U. in 0.72 mL multi-dose cartridge; and Solution for injection 900 I.U. in 1.08 mL multi-dose cartridge

    omit from the column headed “Circumstances”:          C1119  C1878    substitute:             C6215  C6257

  4. Schedule 1, entry for Fotemustine

    omit from the column headed “Circumstances”:          C3181   substitute:             C6288

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

    omit:

GenRx Frusemide GX MP NP 100 1 100

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

    omit:

Gemcitabine Actavis GN MP See Note 3 See
Note 3 		1 D(100)

  1. Schedule 1, entry for Gestrinone

    omit from the column headed “Circumstances”:          C3652   substitute:             C6272

  2. Schedule 1, omit entry for Glucose Indicator—Blood

  3. Schedule 1, entry for Hydrocortisone in each of the forms: Injection 100 mg (as sodium succinate) with 2 mL solvent; and Injection 250 mg (as sodium succinate) with 2 mL solvent

    omit from the column headed “Purposes”:    P1128   substitute:             P6252

  4. Schedule 1, entry for Ibuprofen in the form Tablet 400 mg [Maximum Quantity: 90; Number of Repeats: 0]

    omit from the column headed “Purposes”:    P1036 P1054 substitute:             P6256 P6282

  5. Schedule 1, entry for Ibuprofen in the form Tablet 400 mg [Maximum Quantity: 90; Number of Repeats: 3]

    (a)omit from the column headed “Purposes”:         P1036 P1054

    (b)insert in numerical order:       P6214 P6283

  6. Schedule 1, entry for Idarubicin in each of the forms: Solution for I.V. injection containing idarubicin hydrochloride 5 mg in 5 mL; and Solution for I.V. injection containing idarubicin hydrochloride 10 mg in 10 mL

    omit from the column headed “Circumstances” (all instances):               C1006   substitute:             C6247

  7. Schedule 1, entry for Indomethacin in the form Capsule 25 mg [Maximum Quantity: 100; Number of Repeats: 0]

    omit from the column headed “Circumstances” (twice occurring):          C1036 P1054 substitute:             C6256  C6282

  8. Schedule 1, entry for Indomethacin in the form Capsule 25 mg [Maximum Quantity: 100; Number of Repeats: 3]

    (a)omit from the column headed “Circumstances” (twice occurring):               C1036  C1054

    (b)insert in numerical order:       C6214  C6283

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

    omit from the column headed “Circumstances”:          C1058  C3385    substitute:             C6222  C6286

  10. Schedule 1, entry for Irbesartan in each of the forms: Tablet 75 mg; Tablet 150 mg; and Tablet 300 mg

    (a)insert in the column headed “Schedule Equivalent” for all brands:             a

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

a Blooms the Chemist Irbesartan IB 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 column headed “Schedule Equivalent” for all brands:             a

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

a Blooms the Chemist Irbesartan HCTZ 150/12.5 IB 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 column headed “Schedule Equivalent” for all brands:             a

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

a Blooms the Chemist Irbesartan HCTZ 300/12.5 IB 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 column headed “Schedule Equivalent” for all brands:             a

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

a Blooms the Chemist Irbesartan HCTZ 300/25 IB MP NP C4374 30 5 30

  1. Schedule 1, entry for Ketoprofen

    omit from the column headed “Circumstances” (all instances”):             C1054   substitute:             C6214

  1. Schedule 1, entry for Lamotrigine in each of the forms: Tablet 25 mg; Tablet 50 mg; Tablet 100 mg; and Tablet 200 mg

    omit:

GenRx Lamotrigine GX MP NP C5138 56 5 56

  1. Schedule 1, entry for Medroxyprogesterone in the form Tablet containing medroxyprogesterone acetate 10 mg

    omit from the column headed “Purposes” (twice occurring):    P1089   substitute:             P6244

  2. Schedule 1, entry for Mefenamic Acid

    omit from the column headed “Circumstances”:          C1087  C1222    substitute:             C6213  C6229

  3. Schedule 1, entry for Meloxicam in the form Tablet 7.5 mg

    (a)omit:

GenRx Meloxicam GX MP NP C1547 C1848 30 3 30

(b)omit from the column headed “Circumstances” (all instances):     C1547  C1848    substitute:             C6220  C6239

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

    (a)omit:

GenRx Meloxicam GX MP NP C1547 C1848 30 3 30

(b)omit from the column headed “Circumstances” (all instances):     C1547  C1848    substitute:             C6220  C6239

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

    omit from the column headed “Circumstances” (all instances):               C1547  C1848     substitute:             C6220  C6239

  2. Schedule 1, entry for Methotrexate

    substitute:

Methotrexate Injection 5 mg in 2 mL vial Injection Hospira Pty Limited HH MP 5

 0 5
MP P6276

 See Note 2 See Note 2 5 C(100)
Injection 50 mg in 2 mL vial Injection a Methaccord EA MP 5 5 1
a Methotrexate MYX YN MP 5 5 1
a Hospira Pty Limited HH MP 5

 5 5
Methaccord EA MP See Note 2 See Note 2 1 C(100)
Methotrexate MYX YN MP See Note 2 See Note 2 1 C(100)
Hospira Pty Limited HH MP See Note 2 See Note 2 5 C(100)
Methaccord EA MP P6276 See Note 2 See Note 2 1 C(100)
Methotrexate MYX YN MP P6276 See Note 2 See Note 2 1 C(100)
Hospira Pty Limited HH MP P6276 See Note 2 See Note 2 5 C(100)
Solution concentrate for I.V. infusion 500 mg in 20 mL vial Injection Hospira Pty Limited HH MP See Note 3 See Note 3 1 PB(100)
MP P6276 See Note 3 See Note 3 1 PB(100)
Solution concentrate for I.V. infusion 1000 mg in 10 mL vial Injection Hospira Pty Limited HH MP See Note 3 See Note 3 1 PB(100)
Methaccord EA MP See Note 3 See Note 3 1 PB(100)
Methotrexate MYX YN MP See Note 3 See Note 3 1 PB(100)
Pfizer Australia Pty Ltd PF MP See Note 3 See Note 3 1 PB(100)
Hospira Pty Limited HH MP P6276 See Note 3 See Note 3 1 PB(100)
Methaccord EA MP P6276 See Note 3 See Note 3 1 PB(100)
Methotrexate MYX YN MP P6276 See Note 3 See Note 3 1 PB(100)
Pfizer Australia Pty Ltd PF MP P6276 See Note 3 See Note 3 1 PB(100)
Solution concentrate for I.V. infusion 5000 mg in 50 mL vial Injection Methotrexate Ebewe SZ MP See Note 3 See Note 3 1 PB(100)
MP P6276 See Note 3 See Note 3 1 PB(100)
Tablet 2.5 mg Oral Methoblastin PF MP 30 5 30
Tablet 10 mg Oral Methoblastin PF MP 15 3 15
MP P5648 50 2 50

  1. Schedule 1, entry for Methoxy polyethylene glycol‑epoetin beta in all forms

    omit from the column headed “Circumstances”:          C1957  C3334    substitute:             C6260  C6294

  2. Schedule 1, entry for Methylphenidate in the form Tablet containing methylphenidate hydrochloride 10 mg

    omit from the column headed “Circumstances”:          C1461substitute:             C6226

  3. Schedule 1, entry for Methylphenidate in each of the forms: Tablet containing methylphenidate hydrochloride 18 mg (extended release); Tablet containing methylphenidate hydrochloride 27 mg (extended release); Tablet containing methylphenidate hydrochloride 36 mg (extended release); and Tablet containing methylphenidate hydrochloride 54 mg (extended release)

    omit from the column headed “Circumstances”:          C3188substitute:             C6249

  4. Schedule 1, entry for Methylphenidate in each of the forms: Capsule containing methylphenidate hydrochloride 10 mg (modified release); Capsule containing methylphenidate hydrochloride 20 mg (modified release); Capsule containing methylphenidate hydrochloride 30 mg (modified release); and Capsule containing methylphenidate hydrochloride 40 mg (modified release)

    omit from the column headed “Circumstances”:          C3189substitute:             C6298

  5. Schedule 1, entry for Methylprednisolone

    (a)omit:

Injection containing methylprednisolone acetate 40 mg in 1 mL Injection Depo‑Medrol PF MP NP PDP C1102 5 0 5
Depo‑Nisolone FZ MP NP PDP C1102 5 0 5

substitute:

Cream containing methylprednisolone aceponate 1 mg per g, 15 g Application Advantan BN MP NP C4957 C6218 C6231 C6232 C6246 C6263 P4957 1 0 1
MP NP C4957 C6218 C6231 C6232 C6246 C6263 P6232 2 5 1
MP NP C4957 C6218 C6231 C6232 C6246 C6263 P6246 4 5 1
MP NP C4957 C6218 C6231 C6232 C6246 C6263 P6218 6 5 1
MP NP C4957 C6218 C6231 C6232 C6246 C6263 P6263 8 5 1
MP NP C4957 C6218 C6231 C6232 C6246 C6263 P6231 10 5 1
Injection containing methylprednisolone acetate 40 mg in 1 mL Injection Depo‑Medrol PF MP NP C6273 5 0 5
PDP C6209
Depo‑Nisolone FZ MP NP C6273 5 0 5
PDP C6209
Lotion containing methylprednisolone aceponate 1 mg per g, 20 g Application Advantan BN MP NP C6218 C6231 C6232 C6246 C6263 C6302 P6302 1 0 1
MP NP C6218 C6231 C6232 C6246 C6263 C6302 P6232 2 5 1
MP NP C6218 C6231 C6232 C6246 C6263 C6302 P6246 3 5 1
MP NP C6218 C6231 C6232 C6246 C6263 C6302 P6218 P6263 4 5 1
MP NP C6218 C6231 C6232 C6246 C6263 C6302 P6231 5 5 1
Fatty ointment containing methylprednisolone aceponate 1 mg per g, 15 g Application Advantan BN MP NP C4957 C6218 C6231 C6232 C6246 C6263 P4957 1 0 1
MP NP C4957 C6218 C6231 C6232 C6246 C6263 P6232 2 5 1
MP NP C4957 C6218 C6231 C6232 C6246 C6263 P6246 4 5 1
MP NP C4957 C6218 C6231 C6232 C6246 C6263 P6218 6 5 1
MP NP C4957 C6218 C6231 C6232 C6246 C6263 P6263 8 5 1
MP NP C4957 C6218 C6231 C6232 C6246 C6263 P6231 10 5 1
Ointment containing methylprednisolone aceponate 1 mg per g, 15 g Application Advantan BN MP NP C4957 C6218 C6231 C6232 C6246 C6263 P4957 1 0 1
MP NP C4957 C6218 C6231 C6232 C6246 C6263 P6232 2 5 1
MP NP C4957 C6218 C6231 C6232 C6246 C6263 P6246 4 5 1
MP NP C4957 C6218 C6231 C6232 C6246 C6263 P6218 6 5 1
MP NP C4957 C6218 C6231 C6232 C6246 C6263 P6263 8 5 1
MP NP C4957 C6218 C6231 C6232 C6246 C6263 P6231 10 5 1

(b)omit:

Cream containing methylprednisolone aceponate 1 mg per g, 15 g Application Advantan BN MP NP C1422 1 0 1
Ointment containing methylprednisolone aceponate 1 mg per g, 15 g Application Advantan BN MP NP C1422 1 0 1
Fatty ointment containing methylprednisolone aceponate 1 mg per g, 15 g Application Advantan BN MP NP C1422 1 0 1
Lotion containing methylprednisolone aceponate 1 mg per g, 20 g Application Advantan BN MP NP C1622 1 0 1

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

    omit:

GenRx Metoprolol GX MP NP 100 5 100

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

    omit:

GenRx Metoprolol GX MP NP 60 5 60

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

    omit from the column headed “Circumstances”:          C1355substitute:             C6278

  2. Schedule 1, entry for Mirtazapine in each of the forms: Tablet 15 mg; Tablet 15 mg (orally disintegrating); Tablet 30 mg; Tablet 30 mg (orally disintegrating); Tablet 45 mg; and Tablet 45 mg (orally disintegrating)

    omit from the column headed “Circumstances” (all instances):               C1211substitute:             C5650

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

    omit from the column headed “Circumstances” (all instances):               C1211substitute:             C5650

  2. Schedule 1, entry for Mometasone

    substitute:

Mometasone Cream containing mometasone furoate 1 mg per g, 15 g Application a Elocon MK MP NP C4957 C6218 C6231 C6232 C6246 C6263 P4957 1 0 1
a Momasone QA MP NP C4957 C6218 C6231 C6232 C6246 C6263 P4957 1 0 1
a Novasone AF MP NP C4957 C6218 C6231 C6232 C6246 C6263 P4957 1 0 1
a Elocon MK MP NP C4957 C6218 C6231 C6232 C6246 C6263 P6232 2 5 1
a Momasone QA MP NP C4957 C6218 C6231 C6232 C6246 C6263 P6232 2 5 1
a Novasone AF MP NP C4957 C6218 C6231 C6232 C6246 C6263 P6232 2 5 1
a Elocon MK MP NP C4957 C6218 C6231 C6232 C6246 C6263 P6246 4 5 1
a Momasone QA MP NP C4957 C6218 C6231 C6232 C6246 C6263 P6246 4 5 1
a Novasone AF MP NP C4957 C6218 C6231 C6232 C6246 C6263 P6246 4 5 1
a Elocon MK MP NP C4957 C6218 C6231 C6232 C6246 C6263 P6218 6 5 1
a Momasone QA MP NP C4957 C6218 C6231 C6232 C6246 C6263 P6218 6 5 1
a Novasone AF MP NP C4957 C6218 C6231 C6232 C6246 C6263 P6218 6 5 1
a Elocon MK MP NP C4957 C6218 C6231 C6232 C6246 C6263 P6263 8 5 1
a Momasone QA MP NP C4957 C6218 C6231 C6232 C6246 C6263 P6263 8 5 1
a Novasone AF MP NP C4957 C6218 C6231 C6232 C6246 C6263 P6263 8 5 1
a Elocon MK MP NP C4957 C6218 C6231 C6232 C6246 C6263 P6231 10 5 1
a Momasone QA MP NP C4957 C6218 C6231 C6232 C6246 C6263 P6231 10 5 1
a Novasone AF MP NP C4957 C6218 C6231 C6232 C6246 C6263 P6231 10 5 1
Lotion containing mometasone furoate 1 mg per g, 30 mL Application a Elocon MK MP NP C4957 C6218 C6231 C6232 C6246 C6263 P4957 1 0 1
a Momasone QA MP NP C4957 C6218 C6231 C6232 C6246 C6263 P4957 1 0 1
a Novasone AF MP NP C4957 C6218 C6231 C6232 C6246 C6263 P4957 1 0 1
a Zatamil EO MP NP C4957 C6218 C6231 C6232 C6246 C6263 P4957 1 0 1
a Elocon MK MP NP C4957 C6218 C6231 C6232 C6246 C6263 P6232 2 5 1
a Momasone QA MP NP C4957 C6218 C6231 C6232 C6246 C6263 P6232 2 5 1
a Novasone AF MP NP C4957 C6218 C6231 C6232 C6246 C6263 P6232 2 5 1
a Zatamil EO MP NP C4957 C6218 C6231 C6232 C6246 C6263 P6232 2 5 1
a Elocon MK MP NP C4957 C6218 C6231 C6232 C6246 C6263 P6246 3 5 1
a Momasone QA MP NP C4957 C6218 C6231 C6232 C6246 C6263 P6246 3 5 1
a Novasone AF MP NP C4957 C6218 C6231 C6232 C6246 C6263 P6246 3 5 1
a Zatamil EO MP NP C4957 C6218 C6231 C6232 C6246 C6263 P6246 3 5 1
a Elocon MK MP NP C4957 C6218 C6231 C6232 C6246 C6263 P6218 P6263 4 5 1
a Momasone QA MP NP C4957 C6218 C6231 C6232 C6246 C6263 P6218 P6263 4 5 1
a Novasone AF MP NP C4957 C6218 C6231 C6232 C6246 C6263 P6218 P6263 4 5 1
a Zatamil EO MP NP C4957 C6218 C6231 C6232 C6246 C6263 P6218 P6263 4 5 1
a Elocon MK MP NP C4957 C6218 C6231 C6232 C6246 C6263 P6231 5 5 1
a Momasone QA MP NP C4957 C6218 C6231 C6232 C6246 C6263 P6231 5 5 1
a Novasone AF MP NP C4957 C6218 C6231 C6232 C6246 C6263 P6231 5 5 1
a Zatamil EO MP NP C4957 C6218 C6231 C6232 C6246 C6263 P6231 5 5 1
Ointment containing mometasone furoate 1 mg per g, 15 g Application a Elocon MK MP NP C4957 C6218 C6231 C6232 C6246 C6263 P4957 1 0 1
a Novasone AF MP NP C4957 C6218 C6231 C6232 C6246 C6263 P4957 1 0 1
a Zatamil EO MP NP C4957 C6218 C6231 C6232 C6246 C6263 P4957 1 0 1
a Elocon MK MP NP C4957 C6218 C6231 C6232 C6246 C6263 P6232 2 5 1
a Novasone AF MP NP C4957 C6218 C6231 C6232 C6246 C6263 P6232 2 5 1
a Zatamil EO MP NP C4957 C6218 C6231 C6232 C6246 C6263 P6232 2 5 1
a Elocon MK MP NP C4957 C6218 C6231 C6232 C6246 C6263 P6246 4 5 1
a Novasone AF MP NP C4957 C6218 C6231 C6232 C6246 C6263 P6246 4 5 1
a Zatamil EO MP NP C4957 C6218 C6231 C6232 C6246 C6263 P6246 4 5 1
a Elocon MK MP NP C4957 C6218 C6231 C6232 C6246 C6263 P6218 6 5 1
a Novasone AF MP NP C4957 C6218 C6231 C6232 C6246 C6263 P6218 6 5 1
a Zatamil EO MP NP C4957 C6218 C6231 C6232 C6246 C6263 P6218 6 5 1
a Elocon MK MP NP C4957 C6218 C6231 C6232 C6246 C6263 P6263 8 5 1
a Novasone AF MP NP C4957 C6218 C6231 C6232 C6246 C6263 P6263 8 5 1
a Zatamil EO MP NP C4957 C6218 C6231 C6232 C6246 C6263 P6263 8 5 1
a Elocon MK MP NP C4957 C6218 C6231 C6232 C6246 C6263 P6231 10 5 1
a Novasone AF MP NP C4957 C6218 C6231 C6232 C6246 C6263 P6231 10 5 1
a Zatamil EO MP NP C4957 C6218 C6231 C6232 C6246 C6263 P6231 10 5 1

  1. Schedule 1, entry for Netupitant with Palonosetron

    omit from the column headed “Responsible Person”:                 ZD        substitute:             MF

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

    omit:

GenRx Nifedipine GX MP NP 60 5 60

  1. Schedule 1, entry for Nortriptyline in each of the forms: Tablet 10 mg (as hydrochloride); and Tablet 25 mg (as hydrochloride)

    omit from the column headed “Circumstances”:          C1860  C1861substitute:             C6235  C6300

  2. Schedule 1, entry for Olanzapine in the form Tablet 5 mg (orally disintegrating)

    (a)omit:

Chem mart Olanzapine ODT CH MP NP C5856 C5869 28 5 28

(b)omit:

Terry White Chemists Olanzapine ODT TW MP NP C5856 C5869 28 5 28

  1. Schedule 1, entry for Olanzapine in the form Tablet 10 mg (orally disintegrating)

    (a)omit:

Chem mart Olanzapine ODT CH MP NP C5856 C5869 28 5 28

(b)omit:

Terry White Chemists Olanzapine ODT TW MP NP C5856 C5869 28 5 28

  1. Schedule 1, entry for Oxazepam in the form Tablet 15 mg [Maximum Quantity: 50; Number of Repeats: 5]

    (a)omit from the column headed “Purposes” (twice occurring):         P1123 P1126 P1216      substitute:             P6217 P6230 P6262

    (b)omit from the column headed “Maximum Quantity” (twice occurring):       CN1123  CN1126  CN1216             substitute:      CN6217  CN6230  CN6262

    (c)omit from the column headed “Number of Repeats” (twice occurring):       CN1123  CN1126  CN1216             substitute:      CN6217  CN6230  CN6262

  2. Schedule 1, entry for Oxazepam in the form Tablet 30 mg [Maximum Quantity: 50; Number of Repeats: 5]

    (a)omit from the column headed “Purposes” (all instances):               P1123 P1126 P1216      substitute:             P6217 P6230 P6262

    (b)omit from the column headed “Maximum Quantity” (all instances):             CN1123  CN1126  CN1216             substitute:      CN6217  CN6230  CN6262

    (c)omit from the column headed “Number of Repeats” (all instances):             CN1123  CN1126  CN1216             substitute:      CN6217  CN6230  CN6262

  3. Schedule 1, entry for Oxybutynin in the form Tablet containing oxybutynin hydrochloride 5 mg

    (a)omit:

Oxybutynin Winthrop WA MP NP C1081 100 5 100

(b)omit from the column headed “Circumstances” (twice occurring):               C1081    substitute:             C6241

  1. Schedule 1, entry for Oxybutynin in the form Transdermal patches 36 mg, 8

    omit from the column headed “Circumstances”:          C3152    substitute:             C6243

  2. Schedule 1, entry for Palonosetron

    omit from the column headed “Responsible Person”:                 ZD        substitute:             MF

  3. Schedule 1, entry for Paracetamol

    omit:

Tablet 665 mg (modified release) Oral Osteomol 665 Paracetamol CR MP NP C5847 C6167 P6167 192 3 96
MP NP C5847 C6167 P5847 192 5 96

substitute:

Tablet 665 mg (modified release) Oral Osteomol 665 Paracetamol CR MP NP C6225 C6280 P6225 192 3 96
MP NP C6225 C6280 P6225 192 3 192
MP NP C6225 C6280 P6280 192 5 96
MP NP C6225 C6280 P6280 192 5 192

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

    (a)omit:

Paroxetine‑GA FM MP NP C1211 C1241 C1862 30 5 30

(b)omit from the column headed “Circumstances” (all instances):     C1211  C1241  C1862      substitute:             C6219  C6267  C6290

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

    omit from the column headed “Circumstances”:          C1211  C1241  C1862      substitute:             C6219  C6267  C6290

  2. Schedule 1, after entry for Pemetrexed in the form Powder for I.V. infusion 500 mg (as disodium) [Brand: Reladdin]

    insert in the columns in the order indicated:

Powder for I.V. infusion 1 g (as disodium) Injection DBL Pemetrexed HH MP C4789 C4792 See Note 3 See
Note 3 		1 D(100)
Pemetrexed MYX YN MP C4789 C4792 See Note 3 See
Note 3 		1 D(100)

  1. Schedule 1, entry for Perindopril

    (a)omit:

Tablet containing perindopril arginine 2.5 mg Oral Coversyl 2.5mg SE MP NP 30 5 30
PREXUM 2.5 RX MP NP 30 5 30

substitute:

Tablet containing perindopril arginine 2.5 mg Oral APO-Perindopril Arginine TX MP NP 30 5 30
Chem mart Perindopril Arginine CH MP NP 30 5 30
Coversyl 2.5mg SE MP NP 30 5 30
PREXUM 2.5 RX MP NP 30 5 30
Terry White Chemists Perindopril Arginine TW MP NP 30 5 30

(b)omit:

Tablet containing perindopril arginine 5 mg Oral Coversyl 5mg SE MP NP 30 5 30
PREXUM 5 RX MP NP 30 5 30

substitute:

Tablet containing perindopril arginine 5 mg Oral APO-Perindopril Arginine TX MP NP 30 5 30
Chem mart Perindopril Arginine CH MP NP 30 5 30
Coversyl 5mg SE MP NP 30 5 30
PREXUM 5 RX MP NP 30 5 30
Terry White Chemists Perindopril Arginine TW MP NP 30 5 30

(c)omit:

Tablet containing perindopril arginine 10 mg Oral Coversyl 10mg SE MP NP 30 5 30
PREXUM 10 RX MP NP 30 5 30

substitute:

Tablet containing perindopril arginine 10 mg Oral APO-Perindopril Arginine TX MP NP 30 5 30
Chem mart Perindopril Arginine CH MP NP 30 5 30
Coversyl 10mg SE MP NP 30 5 30
PREXUM 10 RX MP NP 30 5 30
Terry White Chemists Perindopril Arginine TW MP NP 30 5 30

  1. Schedule 1, entry for Perindopril with amlodipine

    substitute:

Perindopril with amlodipine Tablet containing 5 mg perindopril arginine with 5 mg amlodipine (as besylate) Oral a APO-Perindopril Arginine/ Amlodipine 5/5 TX MP NP C4398 C4418 30 5 30
a Blooms the Chemist Perindopril Arginine/ Amlodipine 5/5 IB MP NP C4398 C4418 30 5 30
a Chem mart Perindopril Arginine/ Amlodipine 5/5 CH MP NP C4398 C4418 30 5 30
a Coveram 5/5 SE MP NP C4398 C4418 30 5 30
a Reaptan 5/5 RX MP NP C4398 C4418 30 5 30
a Terry White Chemists Perindopril Arginine/ Amlodipine 5/5 TW MP NP C4398 C4418 30 5 30
Tablet containing 5 mg perindopril arginine with 10 mg amlodipine (as besylate) Oral a APO-Perindopril Arginine/ Amlodipine 5/10 TX MP NP C4398 C4418 30 5 30
a Blooms the Chemist Perindopril Arginine/ Amlodipine 5/10 IB MP NP C4398 C4418 30 5 30
a Chem mart Perindopril Arginine/ Amlodipine 5/10 CH MP NP C4398 C4418 30 5 30
a Coveram 5/10 SE MP NP C4398 C4418 30 5 30
a Reaptan 5/10 RX MP NP C4398 C4418 30 5 30
a Terry White Chemists Perindopril Arginine/ Amlodipine 5/10 TW MP NP C4398 C4418 30 5 30
Tablet containing 10 mg perindopril arginine with 5 mg amlodipine (as besylate) Oral a APO-Perindopril Arginine/ Amlodipine 10/5 TX MP NP C4398 C4418 30 5 30
a Blooms the Chemist Perindopril Arginine/ Amlodipine 10/5 IB MP NP C4398 C4418 30 5 30
a Chem mart Perindopril Arginine/ Amlodipine 10/5 CH MP NP C4398 C4418 30 5 30
a Coveram 10/5 SE MP NP C4398 C4418 30 5 30
a Reaptan 10/5 RX MP NP C4398 C4418 30 5 30
a Terry White Chemists Perindopril Arginine/ Amlodipine 10/5 TW MP NP C4398 C4418 30 5 30
Tablet containing 10 mg perindopril arginine with 10 mg amlodipine (as besylate) Oral a APO-Perindopril Arginine/ Amlodipine 10/10 TX MP NP C4398 C4418 30 5 30
a Blooms the Chemist Perindopril Arginine/ Amlodipine 10/10 IB MP NP C4398 C4418 30 5 30
a Chem mart Perindopril Arginine/ Amlodipine 10/10 CH MP NP C4398 C4418 30 5 30
a Coveram 10/10 SE MP NP C4398 C4418 30 5 30
a Reaptan 10/10 RX MP NP C4398 C4418 30 5 30
a Terry White Chemists Perindopril Arginine/ Amlodipine 10/10 TW MP NP C4398 C4418 30 5 30

  1. Schedule 1, entry for Phenelzine

    omit from the column headed “Circumstances”:          C1609    substitute:             C6236

  2. Schedule 1, entry for Phenobarbitone in each of the forms: Tablet 30 mg; and Injection 200 mg (as sodium) in 1 mL

    omit from the column headed “Circumstances”:          C1093    substitute:             C6295

  3. Schedule 1, entry for Piroxicam in all forms

    omit from the column headed “Circumstances”:          C1054   substitute:             C6214

  4. Schedule 1, entry for Pizotifen

    omit from the column headed “Responsible Person”:                 NV        substitute:             AE

  5. Schedule 1, entry for Pramipexole in each of the forms: Tablet (extended release) containing pramipexole hydrochloride 375 micrograms; Tablet (extended release) containing pramipexole hydrochloride 750 micrograms; Tablet (extended release) containing pramipexole hydrochloride 1.5 mg; Tablet (extended release) containing pramipexole hydrochloride 2.25 mg; Tablet (extended release) containing pramipexole hydrochloride 3 mg; Tablet (extended release) containing pramipexole hydrochloride 3.75 mg; and Tablet (extended release) containing pramipexole hydrochloride 4.5 mg

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

a Pramipexole XR GP AF MP NP C5131 30 5 30

  1. Schedule 1, entry for Propantheline

    omit from the column headed “Circumstances”:          C1081   substitute:             C6241

  2. Schedule 1, entry for Quetiapine in the form Tablet (modified release) 50 mg (as fumarate)

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

a Quetiapine-AS XR RW MP NP C4246 C5611 C5639 60 5 60

(b)insert in the column headed “Schedule Equivalent” for the brand “Seroquel XR”: a

  1. Schedule 1, entry for Raltitrexed

    omit from the column headed “Circumstances”:          C3185   substitute:             C6228

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

    omit:

GenRx Ramipril GX MP NP 30 5 30

  1. Schedule 1, entry for Reboxetine

    omit from the column headed “Circumstances”:          C1211    substitute:             C5650

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

    (a)omit from the column headed “Circumstances” for the brand “APO-Sertraline”:     C1211    substitute:             C4755

    (b)omit from the column headed “Circumstances” for the brand “Auro‑Sertraline 50”:              C1211  C1241  C1975     
    substitute:       C4755  C6277  C6289

    (c)omit from the column headed “Circumstances” for the brand “Chem mart Sertraline”:          C1211    substitute:      C4755

    (d)omit from the column headed “Circumstances” for the brand “Eleva 50”: C1211  C1241  C1975      substitute:      C4755  C6277  C6289

    (e)omit from the column headed “Circumstances” for the brands “GenRx Sertraline”, “Sertra 50” and “Sertracor 50”:      C1211    substitute:             C4755

    (f)omit from the column headed “Circumstances” for the brands “Sertraline Actavis” and “Sertraline AN”:        C1211  C1241  C1975         
    substitute:       C4755  C6277  C6289

    (g)omit from the column headed “Circumstances” for the brands “Sertraline generichealth”, “Sertraline Sandoz”, “Setrona” and “Terry White Chemists Sertraline”:              C1211    substitute:             C4755

    (h)omit from the column headed “Circumstances” for the brands “Xydep 50” and “Zoloft”:     C1211  C1241  C1975     
    substitute:       C4755  C6277  C6289

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

    (a)omit from the column headed “Circumstances” for the brand “APO-Sertraline”:     C1211    substitute:             C4755

    (b)omit from the column headed “Circumstances” for the brand “Auro‑Sertraline 100”:            C1211  C1241  C1975     
    substitute:       C4755  C6277  C6289

    (c)omit from the column headed “Circumstances” for the brand “Chem mart Sertraline”:          C1211    substitute:      C4755

    (d)omit from the column headed “Circumstances” for the brand “Eleva 100”:              C1211  C1241  C1975      substitute:      C4755  C6277  C6289

    (e)omit from the column headed “Circumstances” for the brands “GenRx Sertraline”, “Sertra 100” and “Sertracor 100”:     C1211     substitute: C4755

    (f)omit from the column headed “Circumstances” for the brands “Sertraline Actavis” and “Sertraline AN”:        C1211  C1241  C1975         
    substitute:       C4755  C6277  C6289

    (g)omit from the column headed “Circumstances” for the brands “Sertraline generichealth”, “Sertraline Sandoz”, “Setrona” and “Terry White Chemists Sertraline”:                              C1211    substitute:             C4755

    (h)omit from the column headed “Circumstances” for the brands “Xydep 100” and “Zoloft”:   C1211  C1241  C1975     
    substitute:       C4755  C6277  C6289

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

    (a)   omit:

GenRx Simvastatin GX MP C4238 C4263 P4263 30 5 30
NP C4263 30 5 30

(b)   omit:

GenRx Simvastatin GX MP C4238 C4263 P4238 30 11 30

  1. Schedule 1, entry for Sotalol in the form Tablet containing sotalol hydrochloride 80 mg

    omit:

GenRx Sotalol GX MP NP C5664 60 5 60

  1. Schedule 1, entry for Topotecan

    omit from the column headed “Circumstances” (all instances):               C3186   substitute:             C6238

  2. Schedule 1, entry for Triamcinolone in the form Injection containing triamcinolone acetonide 10 mg in 1 mL

    (a)omit from the column headed “Circumstances” (Authorised Prescriber MP NP):
    C1020  C1102  C1146  C1189  C1191  C1192  C1197  C1237  C1313
    substitute:   C6210  C6211  C6253  C6254  C6255  C6268  C6269  C6281  C6287

    (b)omit from the column headed “Circumstances” (Authorised Prescriber PDP):          C1102  C1189  C1191    substitute:      C6209  C6237  C6291

  3. Schedule 1, entry for Triamcinolone in each of the forms: Cream containing triamcinolone acetonide 200 micrograms per g, 100 g; and Ointment containing triamcinolone acetonide 200 micrograms per g, 100 g

    omit from the column headed “Circumstances” (all instances):               C1422   substitute:             C4924

  1. Schedule 3

    omit:

EH Entra Health Systems Pty Ltd  14 135 973 303

  1. Schedule 3

    omit:

IF Infopia Australia Pty Ltd  65 166 458 751

  1. Schedule 3

    omit:

IK Medtronic Australasia Pty Ltd  47 001 162 661

  1. Schedule 3

    omit:

MS Abbott Australasia Pty Ltd  95 000 180 389

  1. Schedule 3

    omit:

NA National Diagnostic Products (Australia) Pty Limited  61 003 512 598

  1. Schedule 3

    omit:

NX Nipro Australia Pty Ltd  81 140 554 169

  1. Schedule 3

    omit:

OZ Medical Specialties Australia Unit Trust  75 880 043 044

  1. Schedule 3

    omit:

PB Pharmaco (Australia) Limited  89 113 383 501

  1. Schedule 3

    omit:

PX Point of Care Diagnostics Australia Pty Ltd  93 067 939 824

  1. Schedule 3

    omit:

QB Bionime Australia Pty Ltd  84 142 133 677

  1. Schedule 3

    omit:

RP Roche Diabetes Care Australia Pty Ltd  69 602 140 278

  1. Schedule 3

    omit:

UB Merchantshub Networks (AustPacific) Pty Ltd  89 164 346 794

  1. Schedule 3

    omit:

UH uHealth Australia Pty Limited  86 159 107 258

  1. Schedule 3

    omit:

WI Wincot Pty. Limited  14 003 526 930

  1. Schedule 3

    omit:

ZD Specialized Therapeutics Pty Ltd  89 601 114 087

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

    insert:

Amino acid formula with carbohydrate, vitamins, minerals and trace elements without phenylalanine C4295 Phenylketonuria
Amino acid formula with fat, carbohydrate, vitamins, minerals and long chain polyunsaturated fatty acids without phenylalanine and supplemented with docosahexanoic acid C4295 Phenylketonuria

  1. Schedule 4, Part 1, entry for Atomoxetine

    (a)omit:

C4591

Attention deficit hyperactivity disorder

Initial treatment

The condition must be or have been diagnosed by a paediatrician or psychiatrist according to the DSM-5 criteria; AND
Patient must have a contraindication to dexamphetamine or methylphenidate as specified in TGA-approved product information; OR
Patient must have a comorbid mood disorder that has developed or worsened as a result of dexamphetamine or methylphenidate treatment and is of a severity necessitating treatment withdrawal; OR
Patient must be at an unacceptable medical risk of a severity necessitating permanent stimulant treatment withdrawal if given a stimulant treatment with another agent; OR
Patient must have experienced adverse reactions of a severity necessitating permanent treatment withdrawal following treatment with dexamphetamine and treatment with methylphenidate (not simultaneously)

Patient must be or have been diagnosed between the ages of 6 and 18 years inclusive

 Compliance with Authority Required procedures - Streamlined Authority Code 4591

(b)insert in numerical order after existing text:

C6279

Attention deficit hyperactivity disorder

Initial treatment

The condition must be or have been diagnosed by a paediatrician or psychiatrist according to the DSM-5 criteria; AND
Patient must have a contraindication to dexamphetamine, methylphenidate or lisdexamfetamine as specified in TGA-approved product information; OR
Patient must have a comorbid mood disorder that has developed or worsened as a result of dexamphetamine, methylphenidate or lisdexamfetamine treatment and is of a severity necessitating treatment withdrawal; OR
Patient must be at an unacceptable medical risk of a severity necessitating permanent stimulant treatment withdrawal if given a stimulant treatment with another agent; OR
Patient must have experienced adverse reactions of a severity necessitating permanent treatment withdrawal following treatment with dexamphetamine, methylphenidate and lisdexamfetamine (not simultaneously).
Patient must be or have been diagnosed between the ages of 6 and 18 years inclusive.

 Compliance with Authority Required procedures - Streamlined Authority Code 6279

  1. Schedule 4, Part 1, entry for Betamethasone

    (a)omit:

C1020 Alopecia areata
C1102 For local intra‑articular or peri‑articular infiltration
C1146 Granulomata, dermal
C1189 Keloid
C1191 Lichen planus hypertrophic
C1192 Lichen simplex chronicus
C1197 Lupus erythematosus, chronic discoid
C1237 Necrobiosis lipoidica
C1465 Uveitis

(b)insert in numerical order after existing text:

C6209 Local intra-articular or peri-articular infiltration
C6210 Keloid
C6211 Chronic discoid lupus erythematosus
C6212 Uveitis
C6218 P6218

Corticosteroid-responsive dermatoses

The condition must cover 40-60% of the patient's body surface area.

 Compliance with Authority Required procedures - Streamlined Authority Code 6218
C6231 P6231

Corticosteroid-responsive dermatoses

The condition must cover >80% of the patient's body surface area.

 Compliance with Authority Required procedures - Streamlined Authority Code 6231
C6232 P6232

Corticosteroid-responsive dermatoses

The condition must cover 10-20% of the patient's body surface area.

 Compliance with Authority Required procedures - Streamlined Authority Code 6232
C6237 Keloid
C6246 P6246

Corticosteroid-responsive dermatoses

The condition must cover 20-40% of the patient's body surface area.

 Compliance with Authority Required procedures - Streamlined Authority Code 6246
C6253 Alopecia areata
C6254

Granulomata

The condition must be dermal.
C6255 Lichen simplex chronicus
C6263 P6263 Corticosteroid-responsive dermatoses
The condition must cover 60-80% of the patient's body surface area.

 Compliance with Authority Required procedures - Streamlined Authority Code 6263
C6268 Local intra-articular or peri-articular infiltration
C6269 Necrobiosis lipoidica
C6281 Lichen planus hypertrophic
C6291 Lichen planus hypertrophic

  1. Schedule 4, Part 1, entry for Bleomycin

    substitute:

Bleomycin C6224 Lymphoma
C6275 Germ cell neoplasms

  1. Schedule 4, Part 1, entry for Chorionic Gonadotrophin

    (a)omit:

C1116 For the treatment, for a period not exceeding 6 months, of males over the age of 16 years who show clinical evidence of hypogonadism or delayed puberty
C1117 For the treatment of infertility in males associated with isolated luteinising hormone deficiency
C1118 For the treatment of infertility in males due to hypogonadotrophic hypogonadism
C1120 For the treatment of males who have combined deficiency of human growth hormone and gonadotrophins and in whom the absence of secondary sexual characteristics indicates a lag in maturation
C1878 Anovulatory infertility

(b)insert in numerical order after existing text:

C6257 Anovulatory infertility
C6258

Infertility

The condition must be due to hypogonadotrophic hypogonadism.
Patient must be male.
C6270 Infertility
The condition must be associated with isolated luteinising hormone deficiency.
Patient must be male.
C6271

Combined deficiency of human growth hormone and gonadotrophins

Patient must be one in whom the absence of secondary sexual characteristics indicates a lag in maturation.
Patient must be male.
C6284

Hypogonadism or delayed puberty

Patient must show clinical evidence of the condition; AND
The treatment must not extend beyond 6 months.
Patient must be male; AND
Patient must be aged 16 years or older.

  1. Schedule 4, Part 1, entry for Cladribine

    substitute:

Cladribine C6265 Hairy cell leukaemia Compliance with Authority Required procedures - Streamlined Authority Code 6265

  1. Schedule 4, Part 1, entry for Clomiphene

    substitute:

Clomiphene C6221 Anovulatory infertility
C6240 Patients undergoing in-vitro fertilisation

  1. Schedule 4, Part 1, entry for Clomipramine

    substitute:

Clomipramine C6250

Cataplexy

The condition must be associated with narcolepsy.
C6251 Obsessive-compulsive disorder
C6299

Phobic disorders

Patient must be an adult.

  1. Schedule 4, Part 1, entry for Clonazepam

    (a)omit:

C1093 Epilepsy.
C1574 P1574 Neurologically proven epilepsy Compliance with Authority Required procedures

(b)insert in numerical order after existing text:

C6295 Epilepsy
C6296 P6296

Epilepsy

The condition must be neurologically proven.

 Compliance with Authority Required procedures

  1. Schedule 4, Part 1, entry for Danazol

    substitute:

Danazol C6242

Breast disease

The treatment must be for the short-term (up to 6 months); AND
The condition must be severe benign (fibrocystic) breast disease; OR
The condition must be mastalgia associated with severe symptomatic benign breast disease; AND
The condition must be refractory to treatment with other drugs.

 Compliance with Authority Required procedures - Streamlined Authority Code 6242
C6259

Intractable primary menorrhagia

The treatment must be for the short-term (up to 6 months).

 Compliance with Authority Required procedures - Streamlined Authority Code 6259
C6285 Hereditary angio-oedema Compliance with Authority Required procedures - Streamlined Authority Code 6285
C6293

Endometriosis

The condition must be visually proven.

 Compliance with Authority Required procedures - Streamlined Authority Code 6293

  1. Schedule 4, Part 1, entry for Darbepoetin alfa

    substitute:

Darbepoetin alfa C6260

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

Anaemia associated with intrinsic renal disease

Patient must require transfusion; AND
Patient must have a haemoglobin level of less than 100 g per L; AND
Patient must have intrinsic renal disease, as assessed by a nephrologist.

 Compliance with Authority Required procedures
C6294

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

Anaemia associated with intrinsic renal disease

Patient must require transfusion; AND
Patient must have a haemoglobin level of less than 100 g per L; AND
Patient must have intrinsic renal disease, as assessed by a nephrologist.

 Compliance with Authority Required procedures - Streamlined Authority Code 6294

  1. Schedule 4, Part 1, entry for Dexamphetamine

    substitute:

Dexamphetamine C6226

Attention deficit hyperactivity disorder

Treatment must be in accordance with the law of the relevant State or Territory.

 Compliance with Authority Required procedures
C6227 Narcolepsy Compliance with Authority Required procedures

  1. Schedule 4, Part 1, entry for Diclofenac

    (a)omit:

C1036 Bone pain due to malignant disease
C1054 Chronic arthropathies (including osteoarthritis) with an inflammatory component

(b)insert in numerical order after existing text:

C6214 Chronic arthropathies (including osteoarthritis)
The condition must have an inflammatory component.
C6256 Bone pain
The condition must be due to malignant disease.
C6282 Chronic arthropathies (including osteoarthritis)
The condition must have an inflammatory component.
C6283 Bone pain
The condition must be due to malignant disease.

  1. Schedule 4, Part 1, entry for Doxorubicin ‑ Pegylated Liposomal

    (a)omit:

C1828

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

Treatment of acquired immunodeficiency syndrome‑related Kaposi’s sarcoma in patients with CD4 cell counts of less than 200 per cubic millimetre and extensive mucocutaneous involvement

 Compliance with Written or Telephone Authority Required procedures
C1829

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

Treatment of acquired immunodeficiency syndrome‑related Kaposi’s sarcoma in patients with CD4 cell counts of less than 200 per cubic millimetre and extensive visceral involvement

 Compliance with Written or Telephone Authority Required procedures
C3348

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

Treatment of acquired immunodeficiency syndrome‑related Kaposi’s sarcoma in patients with CD4 cell counts of less than 200 per cubic millimetre and extensive mucocutaneous involvement

 Compliance with Written or Telephone Authority Required procedures – Streamlined Authority Code 3348
C3349

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

Treatment of acquired immunodeficiency syndrome‑related Kaposi’s sarcoma in patients with CD4 cell counts of less than 200 per cubic millimetre and extensive visceral involvement

 Compliance with Written or Telephone Authority Required procedures – Streamlined Authority Code 3349

(b)insert in numerical order after existing text:

C6233

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

Kaposi sarcoma

The condition must be AIDS-related; AND
Patient must have a CD4 cell count of less than 200 per cubic millimetre; AND
The condition must include extensive visceral involvement.

 Compliance with Authority Required procedures
C6234

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

Kaposi sarcoma

The condition must be AIDS-related; AND
Patient must have a CD4 cell count of less than 200 per cubic millimetre; AND
The condition must include extensive mucocutaneous involvement.

 Compliance with Authority Required procedures - Streamlined Authority Code 6234
C6264

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

Kaposi sarcoma

The condition must be AIDS-related; AND
Patient must have a CD4 cell count of less than 200 per cubic millimetre; AND
The condition must include extensive mucocutaneous involvement.

 Compliance with Authority Required procedures
C6274

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

Kaposi sarcoma

The condition must be AIDS-related; AND
Patient must have a CD4 cell count of less than 200 per cubic millimetre; AND
The condition must include extensive visceral involvement.

 Compliance with Authority Required procedures - Streamlined Authority Code 6274

  1. Schedule 4, Part 1, entry for Duloxetine

    substitute:

Duloxetine C5650 Major depressive disorders

  1. Schedule 4, Part 1, entry for Epoetin alfa

    substitute:

Epoetin alfa C6260

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

Anaemia associated with intrinsic renal disease

Patient must require transfusion; AND
Patient must have a haemoglobin level of less than 100 g per L; AND
Patient must have intrinsic renal disease, as assessed by a nephrologist.

 Compliance with Authority Required procedures
C6294

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

Anaemia associated with intrinsic renal disease

Patient must require transfusion; AND
Patient must have a haemoglobin level of less than 100 g per L; AND
Patient must have intrinsic renal disease, as assessed by a nephrologist.

 Compliance with Authority Required procedures - Streamlined Authority Code 6294

  1. Schedule 4, Part 1, entry for Epoetin beta

    substitute:

Epoetin beta C6260

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

Anaemia associated with intrinsic renal disease

Patient must require transfusion; AND
Patient must have a haemoglobin level of less than 100 g per L; AND
Patient must have intrinsic renal disease, as assessed by a nephrologist.

 Compliance with Authority Required procedures
C6294

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

Anaemia associated with intrinsic renal disease

Patient must require transfusion; AND
Patient must have a haemoglobin level of less than 100 g per L; AND
Patient must have intrinsic renal disease, as assessed by a nephrologist.

 Compliance with Authority Required procedures - Streamlined Authority Code 6294

  1. Schedule 4, Part 1, entry for Epoetin lambda

    substitute:

Epoetin lambda C6245

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

Anaemia associated with intrinsic renal disease

Patient must require transfusion; AND
Patient must have a haemoglobin level of less than 100 g per L; AND
Patient must have intrinsic renal disease, as assessed by a nephrologist.

 Compliance with Authority Required procedures - Streamlined Authority Code 6245
C6261

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

Anaemia associated with intrinsic renal disease

Patient must require transfusion; AND
Patient must have a haemoglobin level of less than 100 g per L; AND
Patient must have intrinsic renal disease, as assessed by a nephrologist.

 Compliance with Authority Required procedures

  1. Schedule 4, Part 1, entry for Fludarabine

    substitute:

Fludarabine C6248 B-cell chronic lymphocytic leukaemia
Patient must have advanced disease (Binet Stage B or C); OR
Patient must have evidence of progressive Stage A disease; AND
The treatment must be in combination with cyclophosphamide.
Stage A progressive disease is defined by at least one of the following: persistent rise in lymphocyte count with doubling time less than 12 months; a downward trend in haemoglobin or platelets, or both; more than 50% increase in the size of liver, spleen, or lymph nodes, or appearance of these signs if not previously present; constitutional symptoms attributable to disease.
The diagnosis of chronic lymphocytic leukaemia (CLL) must have been established based on:
(a) a lymphocytosis, with more than 5,000 million lymphocytes per L in the peripheral blood; and
(b) a clonal population of B-cells (CD5/CD19) documented by flow cytometry. 		Compliance with Authority Required procedures - Streamlined Authority Code 6248

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

    insert:

Fluorouracil C6266 Patients requiring administration of fluorouracil by intravenous infusion
C6297 Patients requiring administration of fluorouracil by intravenous injection

  1. Schedule 4, Part 1, entry for Fluoxetine

    substitute:

Fluoxetine C4755 Major depressive disorders
C6277 Obsessive-compulsive disorder

  1. Schedule 4, Part 1, entry for Fluvoxamine

    substitute:

Fluvoxamine C4755 Major depressive disorders
C6277 Obsessive-compulsive disorder

  1. Schedule 4, Part 1, entry for Follitropin Alfa

    (a)omit:

C1119 In combination with chorionic gonadotrophin, for the treatment of infertility in males due to hypogonadotrophic hypogonadism, following failure of 6 months’ treatment with chorionic gonadotrophin to achieve adequate spermatogenesis
C1878 Anovulatory infertility

(b)insert in numerical order after existing text:

C6215

Infertility

The condition must be due to hypogonadotrophic hypogonadism; AND
The treatment must be following failure of 6 months' treatment with human chorionic gonadotrophin to achieve adequate spermatogenesis; AND
The treatment must be administered with human chorionic gonadotrophin.
Patient must be male.
C6257 Anovulatory infertility

  1. Schedule 4, Part 1, entry for Follitropin Beta

    (a)omit:

C1119 In combination with chorionic gonadotrophin, for the treatment of infertility in males due to hypogonadotrophic hypogonadism, following failure of 6 months’ treatment with chorionic gonadotrophin to achieve adequate spermatogenesis
C1878 Anovulatory infertility

(b)insert in numerical order after existing text:

C6215

Infertility

The condition must be due to hypogonadotrophic hypogonadism; AND
The treatment must be following failure of 6 months' treatment with human chorionic gonadotrophin to achieve adequate spermatogenesis; AND
The treatment must be administered with human chorionic gonadotrophin.
Patient must be male.
C6257 Anovulatory infertility

  1. Schedule 4, Part 1, entry for Fotemustine

    substitute:

Fotemustine C6288 Metastatic malignant melanoma Compliance with Authority Required procedures - Streamlined Authority Code 6288

  1. Schedule 4, Part 1, entry for Gestrinone

    substitute:

Gestrinone C6272

Endometriosis

The condition must be visually proven; AND
The treatment must be for the short-term (up to 6 months).
Only 1 course of not more than 6 months' therapy may be prescribed

 Compliance with Authority Required procedures - Streamlined Authority Code 6272

  1. Schedule 4, Part 1, omit entry for Glucose Indicator—Blood

  2. Schedule 4, Part 1, entry for Hydrocortisone

    (a)omit:

P1128 For use in a hospital

(b)insert in numerical order after existing text:

P6252 For use in a hospital

  1. Schedule 4, Part 1, entry for Ibuprofen

    (a)omit:

P1036 Bone pain due to malignant disease
P1054 Chronic arthropathies (including osteoarthritis) with an inflammatory component

(b)insert in numerical order after existing text:

P6214

Chronic arthropathies (including osteoarthritis)

The condition must have an inflammatory component.
P6256

Bone pain

The condition must be due to malignant disease.
P6282

Chronic arthropathies (including osteoarthritis)

The condition must have an inflammatory component.
P6283

Bone pain

The condition must be due to malignant disease.

  1. Schedule 4, Part 1, entry for Idarubicin

    (a)omit:

C1006 Acute myelogenous leukaemia

(b)insert in numerical order after existing text:

C6247 Acute myelogenous leukaemia (AML)

  1. Schedule 4, Part 1, entry for Indomethacin

    (a)omit:

C1036 P1036 Bone pain due to malignant disease
C1054 P1054 Chronic arthropathies (including osteoarthritis) with an inflammatory component

(b)insert in numerical order after existing text:

C6214

Chronic arthropathies (including osteoarthritis)

The condition must have an inflammatory component.
C6256

Bone pain

The condition must be due to malignant disease.
C6282

Chronic arthropathies (including osteoarthritis)

The condition must have an inflammatory component.
C6283

Bone pain

The condition must be due to malignant disease.

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

    substitute:

Interferon gamma-1b C6222

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

Chronic granulomatous disease

Patient must have frequent and severe infections despite adequate prophylaxis with antimicrobial agents.

 Compliance with Authority Required procedures - Streamlined Authority Code 6222
C6286

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

Chronic granulomatous disease

Patient must have frequent and severe infections despite adequate prophylaxis with antimicrobial agents.

 Compliance with Authority Required procedures

  1. Schedule 4, Part 1, entry for Ketoprofen

    substitute:

Ketoprofen C6214

Chronic arthropathies (including osteoarthritis)

The condition must have an inflammatory component.

  1. Schedule 4, Part 1, entry for Medroxyprogesterone

    (a)omit:

P1089 Endometriosis

(b)insert in numerical order after existing text:

P6244 Endometriosis

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

    substitute:

Mefenamic acid C6213 Menorrhagia
C6229 Dysmenorrhoea

  1. Schedule 4, Part 1, entry for Meloxicam

    substitute:

Meloxicam C6220

Osteoarthritis

Patient must be symptomatic.
C6239

Rheumatoid arthritis

Patient must be symptomatic.

  1. Schedule 4, Part 1, entry for Methotrexate

    (a)omit:

C3925 P3925 Patients receiving treatment with a high dose regimen.

(b)insert in numerical order after existing text:

C6276 P6276 Patients receiving treatment with a high dose regimen

  1. Schedule 4, Part 1, entry for Methoxy polyethylene glycol‑epoetin beta

    substitute:

Methoxy polyethylene glycol-epoetin beta C6260

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

Anaemia associated with intrinsic renal disease

Patient must require transfusion; AND
Patient must have a haemoglobin level of less than 100 g per L; AND
Patient must have intrinsic renal disease, as assessed by a nephrologist.

 Compliance with Authority Required procedures
C6294

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

Anaemia associated with intrinsic renal disease

Patient must require transfusion; AND
Patient must have a haemoglobin level of less than 100 g per L; AND
Patient must have intrinsic renal disease, as assessed by a nephrologist.

 Compliance with Authority Required procedures - Streamlined Authority Code 6294

  1. Schedule 4, Part 1, entry for Methylphenidate

    substitute:

Methylphenidate C6226

Attention deficit hyperactivity disorder

Treatment must be in accordance with the law of the relevant State or Territory.

 Compliance with Authority Required procedures
C6249

Attention deficit hyperactivity disorder

Patient must have demonstrated a response to immediate-release methylphenidate hydrochloride with no emergence of serious adverse events; AND
Patient must require continuous coverage over 12 hours.
Patient must be or have been diagnosed between the ages of 6 and 18 years inclusive.

 Compliance with Authority Required procedures
C6298

Attention deficit hyperactivity disorder

Patient must have demonstrated a response to immediate-release methylphenidate hydrochloride with no emergence of serious adverse events; AND
Patient must require continuous coverage over 8 hours.
Patient must be or have been diagnosed between the ages of 6 and 18 years inclusive.

 Compliance with Authority Required procedures

  1. Schedule 4, Part 1, entry for Methylprednisolone

    substitute:

Methylprednisolone C4957 P4957 Corticosteroid-responsive dermatoses
C6209 Local intra-articular or peri-articular infiltration
C6218 P6218 Corticosteroid-responsive dermatoses
The condition must cover 40-60% of the patient's body surface area. 		Compliance with Authority Required procedures - Streamlined Authority Code 6218
C6231 P6231

Corticosteroid-responsive dermatoses

The condition must cover >80% of the patient's body surface area.

 Compliance with Authority Required procedures - Streamlined Authority Code 6231
C6232 P6232

Corticosteroid-responsive dermatoses

The condition must cover 10-20% of the patient's body surface area.

 Compliance with Authority Required procedures - Streamlined Authority Code 6232
C6246 P6246

Corticosteroid-responsive dermatoses

The condition must cover 20-40% of the patient's body surface area.

 Compliance with Authority Required procedures - Streamlined Authority Code 6246
C6263 P6263

Corticosteroid-responsive dermatoses

The condition must cover 60-80% of the patient's body surface area.

 Compliance with Authority Required procedures - Streamlined Authority Code 6263
C6273 Local intra-articular or peri-articular infiltration
C6302 P6302 Eczema

  1. Schedule 4, Part 1, entry for Mianserin

    substitute:

Mianserin C6278 Severe depression

  1. Schedule 4, Part 1, entry for Mirtazapine

    substitute:

Mirtazapine C5650 Major depressive disorders

  1. Schedule 4, Part 1, entry for Moclobemide

    substitute:

Moclobemide C5650 Major depressive disorders

  1. Schedule 4, Part 1, entry for Mometasone

    substitute:

Mometasone C4957 P4957 Corticosteroid-responsive dermatoses
C6218 P6218

Corticosteroid-responsive dermatoses

The condition must cover 40-60% of the patient's body surface area.

 Compliance with Authority Required procedures - Streamlined Authority Code 6218
C6231 P6231

Corticosteroid-responsive dermatoses

The condition must cover >80% of the patient's body surface area.

 Compliance with Authority Required procedures - Streamlined Authority Code 6231
C6232 P6232

Corticosteroid-responsive dermatoses

The condition must cover 10-20% of the patient's body surface area.

 Compliance with Authority Required procedures - Streamlined Authority Code 6232
C6246 P6246

Corticosteroid-responsive dermatoses

The condition must cover 20-40% of the patient's body surface area.

 Compliance with Authority Required procedures - Streamlined Authority Code 6246
C6263 P6263

Corticosteroid-responsive dermatoses

The condition must cover 60-80% of the patient's body surface area.

 Compliance with Authority Required procedures - Streamlined Authority Code 6263

  1. Schedule 4, Part 1, entry for Nortriptyline

    substitute:

Nortriptyline C6235

Major depression

The treatment must be for use when other anti-depressant therapy has failed.
C6300

Major depression

The treatment must be for use when other anti-depressant therapy is contraindicated.

  1. Schedule 4, Part 1, entry for Oxazepam

    (a)omit:

P1123 CN1123 For use by a patient who is receiving long‑term nursing care and in respect of whom a Carer Allowance is payable as a disabled adult and who has been demonstrated, within the past 6 months, to be benzodiazepine dependent by an unsuccessful attempt at gradual withdrawal Compliance with Authority Required procedures
P1126 CN1126 For use by patients who are receiving long‑term nursing care on account of age, infirmity or other condition in hospitals, nursing homes or residential facilities and who have been demonstrated, within the past 6 months, to be benzodiazepine dependent by an unsuccessful attempt at gradual Compliance with Authority Required procedures
P1216 CN1216 Malignant neoplasia (late stage) Compliance with Authority Required procedures

(b)insert in numerical order after existing text:

P6217 CN6217 Malignant neoplasia (late stage) Compliance with Authority Required procedures
P6230 CN6230

Anxiety

Patient must be receiving this drug for the management of anxiety; AND
Patient must be receiving long-term nursing care on account of age, infirmity or other condition in a hospital, nursing home or residential facility; AND
Patient must have demonstrated, within the past 6 months, benzodiazepine dependence by an unsuccessful attempt at gradual withdrawal.

 Compliance with Authority Required procedures
P6262 CN6262

Anxiety

Patient must be receiving this drug for the management of anxiety; AND
Patient must be receiving long-term nursing care; AND
Patient must be one in respect of whom a Carer Allowance is payable as a disabled adult; AND
Patient must have demonstrated, within the past 6 months, benzodiazepine dependence by an unsuccessful attempt at gradual withdrawal.

 Compliance with Authority Required procedures

  1. Schedule 4, Part 1, entry for Oxybutynin

    substitute:

Oxybutynin C6241 Detrusor overactivity
C6243

Detrusor overactivity

Patient must be unable to tolerate oral oxybutynin; OR
Patient must be unable to swallow oral oxybutynin.

  1. Schedule 4, Part 1, entry for Paracetamol

    (a)omit:

C5847 P5847

Persistent pain

The condition must be associated with osteoarthritis.
Patient must identify as Aboriginal or Torres Strait Islander.

(b)insert in numerical order after existing text:

C6225 P6225

Analgesia or fever

Patient must be receiving palliative care; AND
Patient must be intolerant to alternative therapy.
C6280 P6280

Persistent pain

The condition must be associated with osteoarthritis.
Patient must identify as Aboriginal or Torres Strait Islander.

  1. Schedule 4, Part 1, entry for Paroxetine

    substitute:

Paroxetine C6219 Obsessive-compulsive disorder
C6267 Major depressive disorders
C6290 Panic disorder

  1. Schedule 4, Part 1, entry for Phenelzine

    substitute:

Phenelzine C6236

Depression

The treatment must be for when all other anti-depressant therapy has failed; OR
The treatment must be for when all other anti-depressant therapy is inappropriate.

  1. Schedule 4, Part 1, entry for Phenobarbitone

    substitute:

Phenobarbitone C6295 Epilepsy

  1. Schedule 4, Part 1, entry for Piroxicam

    substitute:

Piroxicam C6214

Chronic arthropathies (including osteoarthritis)

The condition must have an inflammatory component.

  1. Schedule 4, Part 1, entry for Propantheline

    substitute:

Propantheline C6241 Detrusor overactivity

  1. Schedule 4, Part 1, entry for Raltitrexed

    substitute:

Raltitrexed C6228

Advanced colorectal cancer

The treatment must only be used as a single agent in the treatment of this condition.

 Compliance with Authority Required procedures - Streamlined Authority Code 6228

  1. Schedule 4, Part 1, entry for Reboxetine

    substitute:

Reboxetine C5650 Major depressive disorders

  1. Schedule 4, Part 1, entry for Sertraline

    substitute:

Sertraline C4755 Major depressive disorders
C6277 Obsessive-compulsive disorder
C6289 Panic disorder
The treatment must be for use when other treatments have failed; OR
The treatment must be for use when other treatments are inappropriate.

  1. Schedule 4, Part 1, entry for Topotecan

    substitute:

Topotecan C6238 Advanced metastatic ovarian cancer
Patient must have failed prior therapy which included a platinum compound.

 Compliance with Authority Required procedures - Streamlined Authority Code 6238

  1. Schedule 4, Part 1, entry for Triamcinolone

    substitute:

Triamcinolone C4924 Corticosteroid-responsive dermatoses
C6209 Local intra-articular or peri-articular infiltration
C6210 Keloid
C6211 Chronic discoid lupus erythematosus
C6237 Keloid
C6253 Alopecia areata
C6254

Granulomata

The condition must be dermal.
C6255 Lichen simplex chronicus
C6268 Local intra-articular or peri-articular infiltration
C6269 Necrobiosis lipoidica
C6281 Lichen planus hypertrophic
C6287 Psoriasis
C6291 Lichen planus hypertrophic

  1. Schedule 5, after entry for Ondansetron [GRP-15402]

    insert in the columns in the order indicated:

Perindopril GRP-15442 Tablet containing perindopril erbumine 4 mg Oral

APO-Perindopril

Blooms the Chemist Perindopril

Chem mart Perindopril

Idaprex 4

Indosyl Mono 4

Ozapace

Perindo

Perindopril Actavis 4

Perindopril CH

Perindopril generichealth

Terry White Chemists Perindopril

Tablet containing perindopril arginine 5 mg Oral

APO-Perindopril Arginine

Chem mart Perindopril Arginine

Coversyl 5mg

PREXUM 5

Terry White Chemists Perindopril Arginine

GRP-15525 Tablet containing perindopril erbumine 8 mg Oral

APO-Perindopril

Blooms the Chemist Perindopril

Chem mart Perindopril

Idaprex 8

Indosyl Mono 8

Ozapace

Perindo

Perindopril Actavis 8

Perindopril CH

Perindopril generichealth

Terry White Chemists Perindopril

Tablet containing perindopril arginine 10 mg Oral

APO-Perindopril Arginine

Chem mart Perindopril Arginine

Coversyl 10mg

PREXUM 10

Terry White Chemists Perindopril Arginine

GRP-15965 Tablet containing perindopril erbumine 2 mg Oral

APO-Perindopril

Blooms the Chemist Perindopril

Chem mart Perindopril

Idaprex 2

Indosyl Mono 2

Ozapace

Perindo

Perindopril Actavis 2

Terry White Chemists Perindopril

Tablet containing perindopril arginine 2.5 mg Oral

APO-Perindopril Arginine

Chem mart Perindopril Arginine

Coversyl 2.5mg

PREXUM 2.5

Terry White Chemists Perindopril Arginine

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