National Health (Listing of Pharmaceutical Benefits) Amendment Instrument 2016 (No. 5) (PB 41 of 2016) (Cth)

Case

PB 41 of 2016

National Health (Listing of Pharmaceutical Benefits) Amendment Instrument 2016
(No. 5)

National Health Act 1953

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

Dated    27th May 2016

PENNY SHAKESPEARE
First Assistant Secretary
Pharmaceutical Benefits Division
Department of Health


1          Name of Instrument

(1)        This Instrument is the National Health (Listing of Pharmaceutical    Benefits) Amendment Instrument 2016 (No. 5).

(2)        This Instrument may also be cited as PB 41 of 2016.

2          Commencement

This Instrument commences on 1 June 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 Acarbose in each of the forms: Tablet 50 mg; and Tablet 100 mg

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

a Acarbose Mylan AF MP NP 90 5 90

(b)insert in the column headed “Schedule Equivalent” for the brands “Glucobay 50” and “Glucobay 100” respectively: a

  1. Schedule 1, entry for Alendronic Acid

    (a)omit:

Chem mart Alendronate 70mg CH MP NP C4882 C4885 C4889 4 5 4

(b)omit:

Terry White Chemists Alendronate 70mg TW MP NP C4882 C4885 C4889 4 5 4
  1. Schedule 1, entry for Ampicillin in the form Powder for injection 500 mg (as sodium)

    (a)omit:

Ibimicyn JU PDP 5 0 5

(b)omit:

Ibimicyn JU MP NP 5 1 5
  1. Schedule 1, entry for Ampicillin in the form Powder for injection 1 g (as sodium)

    (a)omit:

Ibimicyn JU PDP 5 0 5

(b)omit:

Ibimicyn JU MP NP 5 1 5
  1. Schedule 1, entry for Arachidonic acid and docosahexaenoic acid with carbohydrate

    omit from the column headed “Circumstances”:          C4434   substitute:             C6141

  2. Schedule 1, entry for Azacitidine

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

a Azadine RZ MP See Note 3 See Note 3 See Note 3 See
Note 3
1 D(100)

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

  1. Schedule 1, entry for Benzydamine

    substitute:

Benzydamine Mouth and throat rinse containing benzydamine hydrochloride 22.5 mg per 15 mL, 500 mL Oral application Difflam IA PDP C5732 1 0 1
MP NP C5672 C6197 P5672 1 1 1
MP NP C5672 C6197 P6197 1 3 1
  1. Schedule 1, entry for Bisacodyl

    substitute:

Bisacodyl Suppositories 10 mg, 10 Rectal a Dulcolax BY MP NP C5640 C5775 C5819 C5823 C5851 C5866 C5879 C6139 P6139 3 3 1
a Petrus Bisacodyl Suppositories PP MP NP C5640 C5775 C5819 C5823 C5851 C5866 C5879 C6139 P6139 3 3 1
a Dulcolax BY MP NP C5640 C5775 C5819 C5823 C5851 C5866 C5879 C6139 P5640 P5775 P5819 P5823 P5851 P5866 P5879 3 5 1
a Petrus Bisacodyl Suppositories PP MP NP C5640 C5775 C5819 C5823 C5851 C5866 C5879 C6139 P5640 P5775 P5819 P5823 P5851 P5866 P5879 3 5 1
a Dulcolax BY MP See Note 2 See Note 2 See Note 2 See Note 2 1 C(100)
a Petrus Bisacodyl Suppositories PP MP See Note 2 See Note 2 See Note 2 See Note 2 1 C(100)
Suppositories 10 mg, 12 Rectal Petrus Bisacodyl Suppositories PP MP NP C5640 C5775 C5819 C5823 C5851 C5866 C5879 C6139 P6139 3 3 1
MP NP C5640 C5775 C5819 C5823 C5851 C5866 C5879 C6139 P5640 P5775 P5819 P5823 P5851 P5866 P5879 3 4 1
MP See Note 2 See Note 2 See Note 2 See Note 2 1 C(100)
Enemas 10 mg in 5 mL, 25 Rectal Bisalax AS MP NP C5613 C5640 C5685 C5720 C5775 C5776 C5804 C6139 P5613 P5640 P5685 P5720 P5775 P5776 P5804 1 2 1
MP NP C5613 C5640 C5685 C5720 C5775 C5776 C5804 C6139 P6139 1 3 1
MP See Note 2 See Note 2 See Note 2 See Note 2 1 C(100)
Tablet 5 mg Oral Lax-Tab AE MP NP C5613 C5640 C5685 C5720 C5775 C5776 C5804 C6139 P5613 P5640 P5685 P5720 P5775 P5776 P5804 200 2 200
MP NP C5613 C5640 C5685 C5720 C5775 C5776 C5804 C6139 P6139 200 3 200
MP See Note 2 See Note 2 See Note 2 See Note 2 200 C(100)
  1. Schedule 1, entry for Capecitabine in each of the forms: Tablet 150 mg; and Tablet 500 mg

    omit from the column headed “Responsible Person” for the brand “Capecitabine MYX”:   YN        substitute:                OC

  2. Schedule 1, entry for Carbomer

    substitute:

Carbomer Eye gel 2 mg per g, single dose units 0.6 mL, 30 Application to the eye Viscotears Gel PF AQ AO MP NP C6172 3 5 1
Eye gel 2 mg per g, 10 g Application to the eye a Optifresh eye gel PP AO NP C6153 1 5 1
MP C6153 C6185 P6153 1 5 1
a PAA IQ AO NP C6153 1 5 1
MP C6153 C6185 P6153 1 5 1
a Viscotears AQ AO NP C6153 1 5 1
MP C6153 C6185 P6153 1 5 1
a Optifresh eye gel PP MP C6153 C6185 P6185 1 11 1
a PAA IQ MP C6153 C6185 P6185 1 11 1
a Viscotears AQ MP C6153 C6185 P6185 1 11 1
  1. Schedule 1, entry for Carbomer 974

    substitute:

Carbomer 974 Ocular lubricating gel 3 mg per g, single dose units 0.5 g, 30 Application to the eye Poly Gel AQ AO MP NP C6172 3 5 1
  1. Schedule 1, entry for Carmellose

    omit:

Eye drops containing carmellose sodium 2.5 mg per mL, single dose units 0.6 mL, 24 Application to the eye TheraTears CX MP NP C1359 4 5 1
AO C2802 4 5 1
Eye drops containing carmellose sodium 5 mg per mL, single dose units 0.4 mL, 30 Application to the eye Cellufresh AG MP NP C1359 3 5 1
AO C2802 3 5 1
Optifresh Tears PP MP NP C1359 3 5 1
AO C2802 3 5 1
Eye drops containing carmellose sodium 10 mg per mL, single dose units 0.4 mL, 30 Application to the eye Celluvisc AG MP NP C1359 3 5 1
AO C2802 3 5 1
Optifresh Plus PP MP NP C1359 3 5 1
AO C2802 3 5 1
Ocular lubricating gel containing carmellose sodium 10 mg per mL, single dose units 0.6 mL, 28 Application to the eye TheraTears CX MP NP C1359 3 5 1
AO C2802 3 5 1

substitute:

Eye drops containing carmellose sodium 2.5 mg per mL, single dose units 0.6 mL, 24 Application to the eye TheraTears CX AO MP NP C6172 4 5 1
Eye drops containing carmellose sodium 5 mg per mL, single dose units 0.4 mL, 30 Application to the eye a Cellufresh AG MP NP AO C6172 3 5 1
a Optifresh Tears PP MP NP AO C6172 3 5 1
Eye drops containing carmellose sodium 10 mg per mL, single dose units 0.4 mL, 30 Application to the eye a Celluvisc AG MP NP AO C6172 3 5 1
a Optifresh Plus PP MP NP AO C6172 3 5 1
Ocular lubricating gel containing carmellose sodium 10 mg per mL, single dose units 0.6 mL, 28 Application to the eye TheraTears CX AO MP NP C6172 3 5 1
  1. Schedule 1, entry for Cephalexin in the form Capsule 250 mg (anhydrous)

    omit:

APO-Cephalexin TX MP P4243 40 2 20
Cefalexin Sandoz SZ MP P4243 40 2 20
Cephalex 250 CR MP P4243 40 2 20
Cephalexin AN EA MP P4243 40 2 20
Cephalexin generichealth GQ MP P4243 40 2 20
Chem mart Cephalexin CH MP P4243 40 2 20
Cilex ED MP P4243 40 2 20
Ialex LN MP P4243 40 2 20
Ibilex 250 AF MP P4243 40 2 20
Keflex AS MP P4243 40 2 20
Rancef RA MP P4243 40 2 20
Terry White Chemists Cephalexin TW MP P4243 40 2 20

substitute:

a APO-Cephalexin TX MP P4243 40 CN4243 2
CN4243
20
a Cefalexin Sandoz SZ MP P4243 40 CN4243 2
CN4243
20
a Cephalex 250 CR MP P4243 40 CN4243 2
CN4243
20
a Cephalexin AN EA MP P4243 40 CN4243 2
CN4243
20
a Cephalexin generichealth GQ MP P4243 40 CN4243 2
CN4243
20
a Chem mart Cephalexin CH MP P4243 40 CN4243 2
CN4243
20
a Cilex ED MP P4243 40 CN4243 2
CN4243
20
a Ialex LN MP P4243 40 CN4243 2
CN4243
20
a Ibilex 250 AF MP P4243 40 CN4243 2
CN4243
20
a Keflex AS MP P4243 40 CN4243 2
CN4243
20
a Rancef RA MP P4243 40 CN4243 2
CN4243
20
a Terry White Chemists Cephalexin TW MP P4243 40 CN4243 2
CN4243
20
  1. Schedule 1, after entry for Cephalexin in the form Capsule 500 mg (anhydrous) [Brand: Terry White Chemists Cephalexin; Maximum Quantity: 20; Number of Repeats: 1]

    insert in the columns in the order indicated:

a APO-Cephalexin TX MP P6188 40
CN6188
1
CN6188
20
a Cefalexin Sandoz SZ MP P6188 40
CN6188
1
CN6188
20
a Cephalex 500 CR MP P6188 40
CN6188
1
CN6188
20
a Cephalexin AN EA MP P6188 40
CN6188
1
CN6188
20
a Cephalexin generichealth GQ MP P6188 40
CN6188
1
CN6188
20
a Chem mart Cephalexin CH MP P6188 40
CN6188
1
CN6188
20
a Cilex ED MP P6188 40
CN6188
1
CN6188
20
a Ialex LN MP P6188 40
CN6188
1
CN6188
20
a Ibilex 500 AF MP P6188 40
CN6188
1
CN6188
20
a Keflex AS MP P6188 40
CN6188
1
CN6188
20
a Rancef RA MP P6188 40
CN6188
1
CN6188
20
a Terry White Chemists Cephalexin TW MP P6188 40
CN6188
1
CN6188
20
  1. Schedule 1, entry for Clonazepam

    substitute:

Clonazepam Injection 1 mg in 2 mL (set containing solution 1 mg in 1 mL and 1 mL diluent) Injection Rivotril RO MP NP C1093 5 0 5
Oral liquid 2.5 mg per mL, 10 mL Oral Rivotril RO MP NP C1574 C6140 P1574 2 0 1
MP NP C1574 C6140 P6140 2 3 1
Tablet 500 micrograms Oral a Paxam 0.5 AF MP NP C1574 C6140 P6140 100 3 100
a Rivotril RO MP NP C1574 C6140 P6140 100 3 100
a Paxam 0.5 AF MP NP C1574 C6140 P1574 200 2 100
a Rivotril RO MP NP C1574 C6140 P1574 200 2 100
Tablet 2 mg Oral a Paxam 2 AF MP NP C1574 C6140 P6140 100 3 100
a Rivotril RO MP NP C1574 C6140 P6140 100 3 100
a Paxam 2 AF MP NP C1574 C6140 P1574 200 2 100
a Rivotril RO MP NP C1574 C6140 P1574 200 2 100
  1. Schedule 1, entry for Clopidogrel in the form Tablet 75 mg (as hydrogen sulfate)

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

Blooms the Chemist Clopidogrel IB MP NP C4165 C4166 C5436 C5459 C5508 C5517 C5524 C5525 28 5 28

(b)insert in numerical order in the column headed “Circumstances” for the brands “Chem mart Clopidogrel” and “Terry White Chemists Clopidogrel”:
C4165  C4166

  1. Schedule 1, entry for Diazepam

    substitute:

Diazepam Tablet 2 mg Oral a Antenex 2 AF MP NP PDP 50 0 50
a APO-Diazepam TX MP NP PDP 50 0 50
a Ranzepam MP NP PDP 50 0 50
a Valpam 2 RW MP NP PDP 50 0 50
a Antenex 2 AF MP NP P6176 50
CN6176
3
C6176
50
a APO-Diazepam TX MP NP P6176 50
CN6176
3
C6176
50
a Ranzepam RA MP NP P6176 50
CN6176
3
C6176
50
a Valpam 2 RW MP NP P6176 50
CN6176
3
C6176
50
Tablet 5 mg Oral a Antenex 5 AF MP NP PDP 50 0 50
a APO-Diazepam TX MP NP PDP 50 0 50
a Ranzepam RA MP NP PDP 50 0 50
a Valium RO MP NP PDP 50 0 50
a Valpam 5 RW MP NP PDP 50 0 50
a Antenex 5 AF MP NP P6176 50
CN6176
3
CN6176
50
a APO-Diazepam TX MP NP P6176 50
CN6176
3
CN6176
50
a Ranzepam RA MP NP P6176 50
CN6176
3
CN6176
50
a Valium RO MP NP P6176 50
CN6176
3
CN6176
50
a Valpam 5 RW MP NP P6176 50
CN6176
3
CN6176
50
Injection 10 mg in 2 mL Injection Hospira Pty Limited HH MP NP PDP 5 0 5
Oral liquid 1 mg in 1 mL, 100 mL Oral Diazepam Elixir ON MP NP C4244 1 0 1
  1. Schedule 1, entry for Diclofenac

    substitute:

Diclofenac Suppository containing diclofenac sodium 100 mg Rectal Voltaren 100 NV PDP 40 0 20
MP NP MW P6149 40 3 20
Tablet (enteric coated) containing diclofenac sodium 25 mg Oral a APO-Diclofenac TX PDP C1036 C1054 100 0 50
a Chem mart Diclofenac CH PDP C1036 C1054 100 0 50
a Clonac 25 RW PDP C1036 C1054 100 0 50
a Diclofenac AN EA PDP C1036 C1054 100 0 50
a Diclofenac Sandoz SZ PDP C1036 C1054 100 0 50
a Diclofenac-GA ED PDP C1036 C1054 100 0 50
a Fenac 25 AF PDP C1036 C1054 100 0 50
a Terry White Chemists Diclofenac TW PDP C1036 C1054 100 0 50
a Voltaren 25 NV PDP C1036 C1054 100 0 50
a APO-Diclofenac TX MP NP C1036 C1054 C6149 100 3 50
a Chem mart Diclofenac CH MP NP C1036 C1054 C6149 100 3 50
a Clonac 25 RW MP NP C1036 C1054 C6149 100 3 50
a Diclofenac AN EA MP NP C1036 C1054 C6149 100 3 50
a Diclofenac Sandoz SZ MP NP C1036 C1054 C6149 100 3 50
a Diclofenac-GA ED MP NP C1036 C1054 C6149 100 3 50
a Fenac 25 AF MP NP C1036 C1054 C6149 100 3 50
a Terry White Chemists Diclofenac TW MP NP C1036 C1054 C6149 100 3 50
a Voltaren 25 NV MP NP C1036 C1054 C6149 100 3 50
Tablet (enteric coated) containing diclofenac sodium 50 mg Oral a APO-Diclofenac TX PDP C1036 C1054 50 0 50
a Chem mart Diclofenac CH PDP C1036 C1054 50 0 50
a Clonac 50 RW PDP C1036 C1054 50 0 50
a Diclofenac AN EA PDP C1036 C1054 50 0 50
a Diclofenac Sandoz SZ PDP C1036 C1054 50 0 50
a Diclofenac-GA ED PDP C1036 C1054 50 0 50
a Fenac AF PDP C1036 C1054 50 0 50
a Terry White Chemists Diclofenac TW PDP C1036 C1054 50 0 50
a Voltaren 50 NV PDP C1036 C1054 50 0 50
a APO-Diclofenac TX MP NP C1036 C1054 C6149 50 3 50
a Chem mart Diclofenac CH MP NP C1036 C1054 C6149 50 3 50
a Clonac 50 RW MP NP C1036 C1054 C6149 50 3 50
a Diclofenac AN EA MP NP C1036 C1054 C6149 50 3 50
a Diclofenac Sandoz SZ MP NP C1036 C1054 C6149 50 3 50
a Diclofenac-GA ED MP NP C1036 C1054 C6149 50 3 50
a Fenac AF MP NP C1036 C1054 C6149 50 3 50
a Terry White Chemists Diclofenac TW MP NP C1036 C1054 C6149 50 3 50
a Voltaren 50 NV MP NP C1036 C1054 C6149 50 3 50
  1. Schedule 1, entry for Dicloxacillin

    omit:

Capsule 500 mg (as sodium) Oral Distaph 500 AF MP NP MW C5415 24 0 24
PDP C5268 24 0 24

substitute:

Capsule 500 mg (as sodium) Oral Distaph 500 AF MP C5415 C6188 P5415 24 0 24
PDP C5268 24 0 24
NP MW C5415 24 0 24
MP C5415 C6188 P6188 48 1 24
  1. Schedule 1, entry for Diltiazem in each of the forms: Capsule (controlled delivery) containing diltiazem hydrochloride 180 mg; and Capsule (controlled delivery) containing diltiazem hydrochloride 240 mg

    (a)omit:

Chem mart Diltiazem CD CH MP NP 30 5 30

(b)omit:

GenRx Diltiazem CD GX MP NP 30 5 30

(c)omit:

Terry White Chemists Diltiazem CD TW MP NP 30 5 30
  1. Schedule 1, entry for Docosahexaenoic acid with carbohydrate

    omit from the column headed “Circumstances”:          C4434   substitute:             C6141

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

    omit from the column headed “Responsible Person” for the brands “Aridon APN 5” and Aridon APN 10” respectively:          FM            substitute:             RF

  3. Schedule 1, entry for Doxorubicin in the form Solution for I.V. injection or intravesical administration containing doxorubicin hydrochloride 200 mg in 100 mL single dose vial

    omit from the column headed “Responsible Person” for the brand “Doxorubicin MYX”:                  YN        substitute:             OC

  4. Schedule 1, after entry for Doxycycline in the form Tablet 100 mg (as monohydrate) [Brand: Terry White Chemists Doxycycline; Maximum Quantity: 28; Number of Repeats: 0; P4514]

    insert in the columns in the order indicated:

a Chem mart Doxycycline CH MP P6200 28 5 7
a Doxycycline Sandoz HX MP P6200 28 5 7
a GenRx Doxycycline GX MP P6200 28 5 7
a Terry White Chemists Doxycycline TW MP P6200 28 5 7
  1. Schedule 1, after entry for Doxycycline in the form Tablet 100 mg (as hydrochloride) [Brand: Doxylin 100; Maximum Quantity: 28; Number of Repeats: 0; P4514]

    insert in the columns in the order indicated:

a Doxsig RW MP P6200 28 5 7
a Doxy-100 ED MP P6200 28 5 7
a Doxycycline AN EA MP P6200 28 5 7
a Doxylin 100 AF MP P6200 28 5 7
  1. Schedule 1, after entry for Doxycycline in the form Capsule 100 mg (as hydrochloride) (containing enteric coated pellets) [Brand: Mayne Pharma Doxycycline; Maximum Quantity: 28; Number of Repeats: 0; P4514]

    insert in the columns in the order indicated:

a Doryx YN MP P6200 28 5 7
a Mayne Pharma Doxycycline YT MP P6200 28 5 7
  1. Schedule 1, entry for Dutasteride

    omit from the column headed “Circumstances”:          C3667   substitute:             C6202

  2. Schedule 1, entry for Dutasteride with tamsulosin

    omit from the column headed “Circumstances”:          C3687   substitute:             C6189

  3. Schedule 1, entry for Enoxaparin

    omit:

Solution for injection containing enoxaparin sodium 40 mg (4,000 I.U. anti‑Xa) in 0.4 mL Injection Clexane SW MP NP 20 0 10
MP NP P4910 20 3 10
  1. Schedule 1, entry for Eplerenone in each of the forms: Tablet 25 mg; and Tablet 50 mg

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

a Inpler AF MP NP C4937 30 5 30

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

  1. Schedule 1, entry for Eribulin

    omit from the column headed “Circumstances”:          C4646  

  2. Schedule 1, after entry for Erythromycin in the form Tablet 400 mg (as ethyl succinate) [Brand: E-Mycin; Maximum Quantity: 25; Number of Repeats: 1]

    insert in the columns in the order indicated:

a E-Mycin AF MP P6160 50
CN6160
5
CN6160
25
a E.E.S. 400 Filmtab ZC MP P6160 50
CN6160
5
CN6160
25
  1. Schedule 1, after entry for Erythromycin in the form Capsule 250 mg (containing enteric coated pellets) [Brand: Mayne Pharma Erythromycin; Maximum Quantity: 25; Number of Repeats: 1]

    insert in the columns in the order indicated:

a Eryc YN MP P6160 50
CN6160
5
CN6160
25
a Mayne Pharma Erythromycin YT MP P6160 50
CN6160
5
CN6160
25
  1. Schedule 1, entry for Esomeprazole in each of the forms: Tablet (enteric coated) 20 mg (as magnesium trihydrate); and Tablet (enteric coated) 40 mg (as magnesium trihydrate)

    omit from the column headed “Responsible Person” for the brand “Nexole” (all instances):           QA       substitute:             RF

  2. Schedule 1, entry for Fentanyl in each of the forms: Tablet (orally disintegrating) 100 microgram (as citrate); Tablet (orally disintegrating) 200 microgram (as citrate); Tablet (orally disintegrating) 400 microgram (as citrate); Tablet (orally disintegrating) 600 microgram (as citrate); and Tablet (orally disintegrating) 800 microgram (as citrate)

    omit from the column headed “Form”:           microgram       substitute:             micrograms

  1. Schedule 1, entry for Flucloxacillin

    omit:

Capsule 500 mg (as sodium) Oral APO-Flucloxacillin TX MP NP MW C5414 24 0 24
PDP C5298 24 0 24
Flopen AS MP NP MW C5414 24 0 24
PDP C5298 24 0 24
Staphylex 250 AF MP NP MW C5414 24 0 24
PDP C5298 24 0 24

substitute:

Capsule 500 mg (as sodium) Oral a APO-Flucloxacillin TX MP C5414 C6169 P5414 24 0 24
NP MW C5414 24 0 24
PDP C5298 24 0 24
a Flopen AS MP C5414 C6169 P5414 24 0 24
NP MW C5414 24 0 24
PDP C5298 24 0 24
a Staphylex 500 AF MP C5414 C6169 P5414 24 0 24
NP MW C5414 24 0 24
PDP C5298 24 0 24
a APO-Flucloxacillin TX MP C5414 C6169 P6169 48 1 24
a Flopen AS MP C5414 C6169 P6169 48 1 24
a Staphylex 500 AF MP C5414 C6169 P6169 48 1 24
  1. Schedule 1, entry for Flucloxacillin in the form Powder for injection 500 mg (as sodium)

    omit:

Flucil AS MP NP PDP 5 0 5
  1. Schedule 1, entry for Fusidic acid

    substitute:

Fusidic acid Tablet containing sodium fusidate 250 mg Oral Fucidin CS MP C4963 C6133 P4963 36 1 36
MP C4963 C6133 P6133 72 1 36
  1. Schedule 1, entry for Gemfibrozil

    (a)omit:

a Chem mart Gemfibrozil CH MP C6028 C6048 P6048 60 5 60
NP C6048 60 5 60

(b)omit:

a GenRx Gemfibrozil GX MP C6028 C6048 P6048 60 5 60
NP C6048 60 5 60

(c)omit:

a Terry White Chemists Gemfibrozil TW MP C6028 C6048 P6048 60 5 60
NP C6048 60 5 60

(d)omit:

a Chem mart Gemfibrozil CH MP C6028 C6048 P6028 60 11 60

(e)omit:

a GenRx Gemfibrozil GX MP C6028 C6048 P6028 60 11 60

(f)omit:

a Terry White Chemists Gemfibrozil TW MP C6028 C6048 P6028 60 11 60
  1. Schedule 1, entry for Glucose Indicator—Blood in each of the forms: Test strips, 50 (Accu-Chek Aviva); and Test strips, 50 (Accu-Chek Go)

    omit from the column headed “Responsible Person”:                 RD        substitute:             RP

  2. Schedule 1, entry for Glucose Indicator—Blood in each of the forms: Test strips, 100 (Accu-Chek Active); Test strips, 100 (Accu-Chek Mobile); and Test strips, 100 (Accu-Chek Performa)

    omit from the column headed “Responsible Person”:                 RD        substitute:             RP

  3. Schedule 1, entry for Hyaluronic Acid

    substitute:

Hyaluronic acid Eye drops containing sodium hyaluronate 1 mg per mL, 10 mL Application to the eye Hylo-Fresh AE AO MP NP C4105 1 5 1
Eye drops containing sodium hyaluronate 2 mg per mL, 10 mL Application to the eye Hylo-Forte AE AO MP NP C4105 1 5 1
  1. Schedule 1, entry for Hyoscine

    substitute:

Hyoscine Injection containing hyoscine butylbromide 20 mg in 1 mL Injection Buscopan BY MP NP P6207 30
CN6207
3
CN6207
5
  1. Schedule 1, entry for Hypromellose with Dextran

    omit:

Eye drops containing 3 mg hypromellose 2900 with 1 mg dextran 70 per mL, single dose units 0.4 mL, 28 Application to the eye Bion Tears AQ AO C2802 3 5 1
MP NP C1359 3 5 1

substitute:

Eye drops containing 3 mg hypromellose 2900 with 1 mg dextran 70 per mL, single dose units 0.4 mL, 28 Application to the eye Bion Tears AQ AO MP NP C6172 3 5 1
  1. Schedule 1, entry for Ibuprofen

    substitute:

Ibuprofen Tablet 400 mg Oral Brufen GO MP NP MW PDP 30 0 30
PDP P1036 P1054 90 0 30
MP NP P1036 P1054 P6149 90 3 30
  1. Schedule 1, entry for Imatinib in the form Tablet 100 mg (as mesylate) [Maximum Quantity: 60; Number of Repeats: 2]

    (a)omit from the column headed “Circumstances”:               C4007  C4008

    (b)insert in numerical order:       C6183  C6184  C6198 

  2. Schedule 1, entry for Imatinib in the form Tablet 100 mg (as mesylate) [Maximum Quantity: 60; Number of Repeats: 5]

    (a)omit from the column headed “Circumstances”:               C4007  C4008

    (b)insert in numerical order:       C6183  C6184  C6198 

    (c)omit from the column headed “Purposes”:         P4007 P4008

    (d)insert in numerical order:       P6183 P6184 P6198

  1. Schedule 1, entry for Imatinib in the form Tablet 400 mg (as mesylate) [Maximum Quantity: 30; Number of Repeats: 2]

    (a)omit from the column headed “Circumstances”:               C4007  C4008

    (b)insert in numerical order:       C6183  C6184  C6198 

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

    (a)omit from the column headed “Circumstances”:               C4007  C4008

    (b)insert in numerical order:       C6183  C6184  C6198 

    (c)omit from the column headed “Purposes”:         P4007 P4008

    (d)insert in numerical order:       P6183 P6184 P6198

  3. Schedule 1, entry for Indomethacin

    substitute:

Indomethacin Capsule 25 mg Oral a Arthrexin AF PDP C1036 C1054 100 0 50
a Indocid AS PDP C1036 C1054 100 0 50
a Arthrexin AF MP NP C1036 C1054 C6149 100 3 50
a Indocid AS MP NP C1036 C1054 C6149 100 3 50
Suppository 100 mg Rectal Indocid AS PDP 40 0 20
MP NP P6149 40 3 20
  1. Schedule 1, entry for Irinotecan in the form I.V. injection containing irinotecan hydrochloride trihydrate 100 mg in 5 mL

    omit from the column headed “Responsible Person” for the brand “Irinotecan MYX”:      YN        substitute:             OC

  2. Schedule 1, entry for Isosorbide Dinitrate

    omit from the column headed “Responsible Person”:                 QA       substitute:             RW

  3. Schedule 1, entry for Ketoprofen

    omit:

Suppository 100 mg Rectal Orudis SW PDP 40 0 20
MP NP 40 3 20
  1. Schedule 1, entry for Levodopa with Carbidopa

    omit:

Intestinal gel 20 mg‑5 mg per mL, 100 mL Intra-intestinal Duodopa VE MP C3704 C3705 C5473 56 5 7
NP C5473 56 5 7

substitute:

Intestinal gel 20 mg-5 mg per mL, 100 mL Intra-intestinal Duodopa VE MP NP C5473 56 5 7
MP C6154 C6179 56 5 7 C(100)
  1. Schedule 1, entry for Macrogol 3350

    substitute:

Macrogol 3350 Powder for oral solution 510 g Oral a OsmoLax KY MP NP C4171 C4173 C4177 C4179 C4180 C6170 P4171 P4173 P4177 P4179 P4180 1 5 1
MP NP C4171 C4173 C4177 C4179 C4180 C6170 P6170 2 3 1
Sachets containing powder for oral solution 17 g, 30 Oral a Herron ClearLax ON MP NP C4171 C4173 C4177 C4179 C4180 C6170 P4171 P4173 P4177 P4179 P4180 1 5 1
MP NP C4171 C4173 C4177 C4179 C4180 C6170 P6170 2 3 1
Oral liquid 13.125 g in 25 mL with electrolytes, 500 mL Oral Movicol Liquid NE MP NP C4576 C4577 C4580 C4596 C4601 C6171 P6171 2 3 1
MP NP C4576 C4577 C4580 C4596 C4601 C6171 P4576 P4577 P4580 P4596 P4601 2 5 1
Sachets containing powder for oral solution 13.125 g with electrolytes, 30 Oral a APO-MACROGOL plus ELECTROLYTES TX MP NP C4576 C4577 C4580 C4596 C4601 C6171 P4576 P4577 P4580 P4596 P4601 1 5 1
a Chemists' Own Macrogol with Electrolytes RW MP NP C4576 C4577 C4580 C4596 C4601 C6171 P4576 P4577 P4580 P4596 P4601 1 5 1
a LaxaCon EA MP NP C4576 C4577 C4580 C4596 C4601 C6171 P4576 P4577 P4580 P4596 P4601 1 5 1
a Macrovic RF MP NP C4576 C4577 C4580 C4596 C4601 C6171 P4576 P4577 P4580 P4596 P4601 1 5 1
a Molaxole HM MP NP C4576 C4577 C4580 C4596 C4601 C6171 P4576 P4577 P4580 P4596 P4601 1 5 1
a Movicol NE MP NP C4576 C4577 C4580 C4596 C4601 C6171 P4576 P4577 P4580 P4596 P4601 1 5 1
a lax-sachets AE MP NP C4576 C4577 C4580 C4596 C4601 C6171 P4576 P4577 P4580 P4596 P4601 1 5 1
a APO-MACROGOL plus ELECTROLYTES TX MP NP C4576 C4577 C4580 C4596 C4601 C6171 P6171 2 3 1
a Chemists' Own Macrogol with Electrolytes RW MP NP C4576 C4577 C4580 C4596 C4601 C6171 P6171 2 3 1
a LaxaCon EA MP NP C4576 C4577 C4580 C4596 C4601 C6171 P6171 2 3 1
a Macrovic RF MP NP C4576 C4577 C4580 C4596 C4601 C6171 P6171 2 3 1
a Molaxole HM MP NP C4576 C4577 C4580 C4596 C4601 C6171 P6171 2 3 1
a Movicol NE MP NP C4576 C4577 C4580 C4596 C4601 C6171 P6171 2 3 1
a lax-sachets AE MP NP C4576 C4577 C4580 C4596 C4601 C6171 P6171 2 3 1
a APO-MACROGOL plus ELECTROLYTES TX MP See Note 2 See Note 2 See Note 2 See Note 2 1 C(100)
a Chemists' Own Macrogol with Electrolytes RW MP See Note 2 See Note 2 See Note 2 See Note 2 1 C(100)
a LaxaCon EA MP See Note 2 See Note 2 See Note 2 See Note 2 1 C(100)
a Macrovic RF MP See Note 2 See Note 2 See Note 2 See Note 2 1 C(100)
a Molaxole HM MP See Note 2 See Note 2 See Note 2 See Note 2 1 C(100)
a Movicol NE MP See Note 2 See Note 2 See Note 2 See Note 2 1 C(100)
a lax-sachets AE MP See Note 2 See Note 2 See Note 2 See Note 2 1 C(100)
  1. Schedule 1, entry for Methotrexate in each of the forms: Injection 50 mg in 2 mL vial; and Solution concentrate for I.V. infusion 1000 mg in 10 mL vial

    omit from the column headed “Responsible Person” for the brand “Methotrexate MYX” (all instances):      YN        substitute:                OC

  2. Schedule 1, after entry for Methylnaltrexone

    substitute:

Methylnaltrexone Solution for injection containing methylnaltrexone bromide 12 mg in 0.6 mL Injection Relistor LM MP NP C6180 7 0 1
MP NP C6180 7 0 7
  1. Schedule 1, entry for Milk powder—synthetic

    omit from the column headed “Circumstances”:          C1158   substitute:             C6208

  1. Schedule 1, entry for Morphine

    (a)omit:

Tablet containing morphine sulfate 10 mg Oral Sevredol MF MP NP C4935 C4948 C4960 P4935 P4960 20 0 20
MP NP C4935 C4948 C4960 P4948 20 2 20
Tablet containing morphine sulfate 20 mg Oral Sevredol MF MP NP C4935 C4948 C4960 P4935 P4960 20 0 20
MP NP C4935 C4948 C4960 P4948 20 2 20

substitute:

Tablet containing morphine sulfate 10 mg Oral Sevredol MF MP NP C4960 C6168 P4960 20 0 20
MP NP C4960 C6168 P6168 20 2 20
Tablet containing morphine sulfate 20 mg Oral Sevredol MF MP NP C4960 C6168 P4960 20 0 20
MP NP C4960 C6168 P6168 20 2 20

(b)omit:

Tablet containing morphine sulfate 200 mg (controlled release) Oral MS Contin MF MP NP C4900 C4911 C4927 P4900 P4927 28 0 28
MP NP C4900 C4911 C4927 P4911 28 2 28

substitute:

Tablet containing morphine sulfate 200 mg (controlled release) Oral MS Contin MF MP NP C4900 C6151 P4900 28 0 28
MP NP C4900 C6151 P6151 28 2 28
  1. Schedule 1, entry for Naloxone

    substitute:

Naloxone Injection containing naloxone hydrochloride 400 micrograms in 1 mL ampoule Injection Naloxone Hydrochloride (DBL) HH MP NP PDP 5 0 5
  1. Schedule 1, entry for Naproxen

    substitute:

Naproxen Oral suspension 125 mg per 5 mL, 474 mL Oral Phebra Naproxen Suspension PL MP NP C4124 C4159 C6150 1 3 1
Tablet 250 mg Oral a Inza 250 AF PDP C1036 C1054 100 0 50
a Naprosyn IX PDP C1036 C1054 100 0 50
a Inza 250 AF MP NP C1036 C1054 C6149 100 3 50
a Naprosyn IX MP NP C1036 C1054 C6149 100 3 50
Tablet 500 mg Oral a Inza 500 AF PDP C1036 C1054 50 0 50
a Naprosyn IX PDP C1036 C1054 50 0 50
a Inza 500 AF MP NP C1036 C1054 C6149 50 3 50
a Naprosyn IX MP NP C1036 C1054 C6149 50 3 50
Tablet containing naproxen sodium 550 mg Oral a Anaprox 550 IX PDP C1036 C1054 50 0 50
a Crysanal IY PDP C1036 C1054 50 0 50
a Anaprox 550 IX MP NP C1036 C1054 C6196 50 3 50
a Crysanal IY MP NP C1036 C1054 C6196 50 3 50
Tablet 750 mg (sustained release) Oral a Naprosyn SR750 IX PDP C1036 C1054 28 0 28
a Proxen SR 750 IY PDP C1036 C1054 28 0 28
a Naprosyn SR750 IX MP NP C1036 C1054 C6149 28 3 28
a Proxen SR 750 IY MP NP C1036 C1054 C6149 28 3 28
Tablet 1 g (sustained release) Oral a Naprosyn SR1000 IX PDP C1036 C1054 28 0 28
a Proxen SR 1000 IY PDP C1036 C1054 28 0 28
a Naprosyn SR1000 IX MP NP C1036 C1054 C6149 28 3 28
a Proxen SR 1000 IY MP NP C1036 C1054 C6149 28 3 28
  1. Schedule 1, entry for Nitrazepam in the form Tablet 5 mg

    omit:

Alodorm AF MP NP P5610 50
CN5610
0 25
Mogadon IA MP NP P5610 50
CN5610
0 25
  1. Schedule 1, entry for Nitrazepam in the form Tablet 5 mg [Maximum Quantity: 50; Number of Repeats: 3]

    (a)omit from the column headed “Purposes” (twice occurring):         P5662    substitute:             P6175

    (b)omit from the column headed “Maximum Quantity” (twice occurring):       CN5662 substitute:             CN6175

    (c)omit from the column headed “Number of Repeats” (twice occurring):       CN5662 substitute:             CN6175

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

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

Ondansetron ODT GH GQ MP NP C5618 C5777 P5618 4 0 4
MP C5743 4 0 4 C(100)
  1. Schedule 1, entry for Ondansetron in the form Tablet (orally disintegrating) 4 mg [Maximum Quantity: 10; Number of Repeats: 1]

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

Ondansetron ODT GH GQ MP NP C5618 C5777 P5777 10 1 10
  1. Schedule 1, entry for Ondansetron in the form Tablet (orally disintegrating) 8 mg [Maximum Quantity: 4; Number of Repeats: 0]

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

Ondansetron ODT GH GQ MP NP C5618 C5777 P5618 4 0 4
MP C5743 4 0 4 C(100)
  1. Schedule 1, entry for Ondansetron in the form Tablet (orally disintegrating) 8 mg [Maximum Quantity: 10; Number of Repeats: 1]

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

Ondansetron ODT GH GQ MP NP C5618 C5777 P5777 10 1 10
  1. Schedule 1, entry for Oxazepam in the form Tablet 15 mg

    omit:

Alepam 15 AF MP NP P3656 50
CN3656
0 25
Serepax QA MP NP P3656 50
CN3656
0 25
  1. Schedule 1, entry for Oxazepam in the form Tablet 15 mg [Maximum Quantity: 50; Number of Repeats: 3]

    (a)omit from the column headed “Purposes” (twice occurring):         P3655    substitute:             P6176

    (b)omit from the column headed “Maximum Quantity” (twice occurring):       CN3655 substitute:             CN6176

    (c)omit from the column headed “Number of Repeats” (twice occurring):       CN3655 substitute:             CN6176

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

    omit:

Alepam 30 AF MP NP P3656 50
CN3656
0 25
APO‑Oxazepam TX MP NP P3656 50
CN3656
0 25
Murelax RW MP NP P3656 50
CN3656
0 25
Serepax QA MP NP P3656 50
CN3656
0 25
  1. Schedule 1, entry for Oxazepam in the form Tablet 30 mg [Maximum Quantity: 50; Number of Repeats: 3]

    (a)omit from the column headed “Purposes” (all instances):               P3655    substitute:             P6176

    (b)omit from the column headed “Maximum Quantity” (all instances):             CN3655 substitute:             CN6176

    (c)omit from the column headed “Number of Repeats” (all instances):             CN3655 substitute:             CN6176

  2. Schedule 1, entry for Paracetamol

    (a)omit:

Suppositories 500 mg, 24 Rectal Panadol GC MP NP C4940 C4950 P4950 4 0 1
MP NP C4940 C4950 P4940 4 3 1

substitute:

Suppositories 500 mg, 24 Rectal Panadol GC MP NP C6167 4 3 1

(b)omit:

Tablet 665 mg (modified release) Oral Osteomol 665 Paracetamol CR MP NP C4940 C4950 C5847 P4950 192 0 96
MP NP C4940 C4950 C5847 P4940 192 3 96
MP NP C4940 C4950 C5847 P5847 192 5 96

substitute:

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
  1. Schedule 1, entry for Pemetrexed in each of the forms: Powder for I.V. infusion 100 mg (as disodium); and Powder for I.V. infusion 500 mg (as disodium)

    omit from the column headed “Responsible Person” for the brand “Pemetrexed MYX”:                    YN        substitute:             OC

  2. Schedule 1, entry for Phenoxybenzamine in each of the forms: Capsule containing phenoxybenzamine hydrochloride 10 mg; Capsule containing 10 mg phenoxybenzamine hydrochloride; and Capsules containing phenoxybenzamine hydrochloride 10 mg, 30

    omit from the column headed “Circumstances”:          C4772  C4781    substitute:             C6145  C6178

  3. Schedule 1, entry for Polyethylene Glycol 400 with Propylene Glycol

    omit:

Eye drops 4 mg‑3 mg per mL, single dose units 0.8 mL, 28 Application to the eye Systane AQ MP NP C1359 2 5 1
AO C2802 2 5 1

substitute:

Eye drops 4 mg-3 mg per mL, single dose units 0.8 mL, 28 Application to the eye Systane AQ AO MP NP C6172 2 5 1
  1. Schedule 1, entry for Protein hydrolysate formula with medium chain triglycerides

    substitute:

Protein hydrolysate formula with medium chain triglycerides Oral powder 400 g (Alfaré) Oral Alfaré NT MP NP C6137 C6138 C6148 C6157 C6158 C6166 C6174 C6182 C6193 C6194 C6195 C6204 C6205 C6206 8 5 1
Oral powder 450 g (Aptamil Gold+ Pepti-Junior) Oral Aptamil Gold+ Pepti-Junior NU MP NP C6137 C6138 C6148 C6157 C6158 C6166 C6174 C6182 C6193 C6194 C6195 C6204 C6205 8 5 1
  1. Schedule 1, entry for Quetiapine in each of the forms: Tablet (modified release) 200 mg (as fumarate); Tablet (modified release) 300 mg (as fumarate); and Tablet (modified release) 400 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 Risedronic Acid in the form Tablet containing risedronate sodium 150 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 ATELVIA ONCE-A-MONTH GN MP NP C4882 C4885 C4889 1 5 1
  1. Schedule 1, entry for Rituximab in each of the forms: Solution for I.V. infusion 100 mg in 10 mL; and Solution for I.V. infusion 500 mg
    in 50 mL

    (a)omit from the column headed “Circumstances”:               C5980

    (b)omit from the column headed “Circumstances”:               C6001

    (c)omit from the column headed “Circumstances”:               C6040  C6058

    (d)insert in numerical order:       C6161  C6162  C6187

  2. Schedule 1, entry for Rituximab

    omit:

Solution for subcutaneous injection containing rituximab 1400 mg in 11.7 mL Injection Mabthera SC RO MP C5980 C5992 C5998 C6011 P5998 1 2 1
MP C6004 C6008 C6039 C6040 P6039 1 2 1 C(100)
MP C5980 C5992 C5998 C6011 P5980 1 6 1
MP C6004 C6008 C6039 C6040 P6040 1 6 1 C(100)
MP C5980 C5992 C5998 C6011 P6011 1 7 1
MP C6004 C6008 C6039 C6040 P6008 1 7 1 C(100)
MP C5980 C5992 C5998 C6011 P5992 1 11 1
MP C6004 C6008 C6039 C6040 P6004 1 11 1 C(100)

substitute:

Solution for subcutaneous injection containing rituximab 1400 mg in 11.7 mL Injection Mabthera SC RO MP C5998 C6011 C6039 C6161 C6162 C6187 P5998 P6039 1 2 1
MP C5998 C6011 C6039 C6161 C6162 C6187 P6162 P6187 1 6 1
MP C5998 C6011 C6039 C6161 C6162 C6187 P6011 1 7 1
MP C5998 C6008 C6039 C6161 C6162 C6187 P6008 1 7 1 C(100)
MP C5998 C6011 C6039 C6161 C6162 C6187 P6161 1 11 1
  1. Schedule 1, entry for Salbutamol in the form Pressurised inhalation 100 micrograms (as sulfate) per dose, 200 doses (CFC-free formulation)

    omit:

APO‑Salbutamol Inhaler TX MP NP 2 5 1
  1. Schedule 1, entry for Sorbitol with sodium citrate and sodium lauryl sulfoacetate in the form Enemas 3.125 g-450 mg-45 mg in 5 mL, 12

    omit:

a Micolette AE MP NP C5613 C5640 C5641 C5685 C5720 C5774 C5775 C5776 C5804 P5641 2 0 1
a Microlax JT MP NP C5613 C5640 C5641 C5685 C5720 C5774 C5775 C5776 C5804 P5641 2 0 1
  1. Schedule 1, entry for Sorbitol with sodium citrate and sodium lauryl sulfoacetate in the form Enemas 3.125 g-450 mg-45 mg in 5 mL, 12 [Maximum Quantity: 2; Number of Repeats: 2]

    (a)omit from the column headed “Circumstances” (twice occurring):               C5641

    (b)omit from the column headed “Circumstances” (twice occurring):               C5774

    (c)insert in numerical order:       C6139

  2. Schedule 1, entry for Sorbitol with sodium citrate and sodium lauryl sulfoacetate in the form Enemas 3.125 g-450 mg-45 mg in 5 mL, 12 [Maximum Quantity: 2; Number of Repeats: 3]

    (a)omit from the column headed “Circumstances” (twice occurring):               C5641

    (b)omit from the column headed “Circumstances” (twice occurring :               C5774

    (c)insert in numerical order:       C6139

    (d)omit from the column headed “Purposes” (twice occurring):         P5774   substitute:             P6139

  3. Schedule 1, entry for Soy lethicin

    substitute:

Soy lecithin Eye spray 10 mg per mL, 10 mL Application tearsagain RB AO MP NP C6172 2 5 1
  1. Schedule 1, entry for Sterculia with frangula bark in the form Granules 620 mg-80 mg per g, 500 g

    omit:

MP NP C5613 C5640 C5641 C5685 C5720 C5774 C5775 C5776 C5804 P5641 1 0 1
  1. Schedule 1, entry for Sterculia with frangula bark in the form Granules 620 mg-80 mg per g, 500 g [Maximum Quantity: 1; Number of Repeats: 1]

    (a)omit from the column headed “Circumstances”:               C5641

    (b)omit from the column headed “Circumstances”:               C5774

    (c)insert in numerical order:       C6139

  2. Schedule 1, entry for Sterculia with frangula bark in the form Granules 620 mg-80 mg per g, 500 g [Maximum Quantity: 1; Number of Repeats: 3]

    (a)omit from the column headed “Circumstances”:               C5641

    (b)omit from the column headed “Circumstances”:               C5774

    (c)insert in numerical order:       C6139

    (d)omit from the column headed “Purposes”:         P5774   substitute:             P6139

  3. Schedule 1, entry for Temazepam

    omit:

APO‑Temazepam TX MP NP P5610 50
CN5610
0 25
Normison QA MP NP P5610 50
CN5610
0 25
Temaze AF MP NP P5610 50
CN5610
0 25
Temtabs FM MP NP P5610 50
CN5610
0 25
  1. Schedule 1, entry for Temazepam in the form Tablet 10 mg [Maximum Quantity: 50; Number of Repeats: 3]

    (a)omit from the column headed “Purposes” (all instances):               P5662    substitute:             P6175

    (b)omit from the column headed “Maximum Quantity” (all instances):             CN5662 substitute:             CN6175

    (c)omit from the column headed “Number of Repeats” (all instances):             CN5662 substitute:             CN6175

  2. Schedule 1, entry for Tiotropium in the form Solution for oral inhalation 2.5 micrograms (as bromide monohydrate) per actuation (60 doses)

    omit from the column headed “Authorised Prescriber”:             MP       substitute:             MP  NP

  3. Schedule 1, entry for Tramadol in the form Capsule containing tramadol hydrochloride 50 mg

    omit from the column headed “Responsible Person” for the brand “Zydol” (twice occurring):        QA       substitute:             RW

  1. Schedule 1, entry for Tramadol in each of the forms: Tablet (sustained release) containing tramadol hydrochloride 100 mg; Tablet (sustained release) containing tramadol hydrochloride 150 mg; and Tablet (sustained release) containing tramadol hydrochloride 200 mg

    omit from the column headed “Responsible Person” for the brands “Zydol SR 100”, “Zydol SR 150” and “Zydol SR 200” respectively:         QA
    substitute:             RW

  2. Schedule 1, entry for Triglycerides, medium chain in each of the forms: Oil 500 mL (MCT Oil); and Oral emulsion 250 mL (Liquigen)

    omit from the column headed “Circumstances”:          C4379  C4393  C5690  C5723  C5807  C5853  C5888
    substitute:             C6134  C6135  C6146  C6155  C6164  C6181  C6203

  3. Schedule 1, entry for Triglycerides, medium chain in the form Oral liquid 250 mL, 18 (betaquik)

    omit from the column headed “Circumstances”:          C4443  C4447    substitute:             C6147  C6191

  4. Schedule 1, entry for Triglycerides—medium chain, formula in the Sachets containing oral powder 16 g, 30 (MCT Pro-Cal)

    omit from the column headed “Circumstances”:          C5644  C5645  C5693  C5726  C5784 substitute:                    C6136  C6156  C6165  C6173  C6192

  5. Schedule 1, entry for Trimethoprim

    substitute:

Trimethoprim Tablet 300 mg Oral a Alprim AF MP NP 7 1 7
a Triprim RW MP NP 7 1 7
a Alprim AF MP P4243 14
CN4243
2
CN4243
7
a Triprim RW MP P4243 14
CN4243
2
CN4243
7
a Alprim AF MP P6163 28 0 7
a Triprim RW MP P6163 28 0 7
  1. Schedule 1, entry for Trimethoprim with sulfamethoxazole

    omit:

Tablet 160 mg‑800 mg Oral Bactrim DS RO PDP 10 0 10
Resprim Forte AF PDP 10 0 10
Septrin Forte RW PDP 10 0 10
Bactrim DS RO MP NP 10 1 10
Resprim Forte AF MP NP 10 1 10
Septrin Forte RW MP NP 10 1 10

substitute:

Tablet 160 mg-800 mg Oral a Bactrim DS RO PDP 10 0 10
a Resprim Forte AF PDP 10 0 10
a Septrin Forte RW PDP 10 0 10
a Bactrim DS RO MP NP 10 1 10
a Resprim Forte AF MP NP 10 1 10
a Septrin Forte RW MP NP 10 1 10
a Bactrim DS RO MP P6201 30
CN6201
2
CN6201
10
a Resprim Forte AF MP P6201 30
CN6201
2
CN6201
10
a Septrin Forte RW MP P6201 30
CN6201
2
CN6201
10
  1. Schedule 1, entry for Vitamins, minerals and trace elements with carbohydrate in the form Oral powder 200 g (Paediatric Seravit)

    omit from the column headed “Circumstances”:          C4916   substitute:             C6152

  2. Schedule 1, entry for Vitamins, minerals and trace elements with carbohydrate in the form Sachets containing oral powder 6 g, 30 (FruitiVits)

    omit from the column headed “Circumstances”:          C4663   substitute:             C6159

  3. Schedule 1, entry for Whey protein formula supplemented with amino acids, long chain polyunsaturated fatty acids, vitamins and minerals, and low in protein, phosphate, potassium and lactose in each of the forms: Sachets containing oral powder 100 g, 10 (RenaStart); and Oral powder 400 g, 6 (Renastart)

    omit from the column headed “Circumstances”:          C4322   substitute:             C6190

  4. Schedule 1, entry for Whey protein formula supplemented with amino acids, vitamins and minerals, and low in protein, phosphate, potassium and lactose

    omit from the column headed “Circumstances”:          C4322   substitute:             C6190

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

    insert:

OC Accord Healthcare Pty Ltd  49 110 502 513
  1. Schedule 3, after details relevant to Responsible Person code RO

    insert:

RP Roche Diabetes Care Australia Pty Ltd  69 602 140 278
  1. Schedule 4, Part 1, entry for Arachidonic acid and docosahexaenoic acid with carbohydrate

    substitute:

Arachidonic acid and docosahexaenoic acid with carbohydrate C6141 Peroxisomal biogenesis disorders
  1. Schedule 4, Part 1, entry for Benzydamine

    (a)omit:

C5622 P5622

Painful mouth

Initial treatment

Patient must be receiving palliative care; AND
Patient must not receive more than 4 months treatment under this restriction.

Compliance with Authority Required procedures - Streamlined Authority Code 5622
C5651 P5651

Painful mouth

Continuing treatment

Patient must be receiving palliative care.

Compliance with Authority Required procedures - Streamlined Authority Code 5651

(b)insert in numerical order after existing text:

C6197 P6197

Painful mouth

Patient must be receiving palliative care.

Compliance with Authority Required procedures - Streamlined Authority Code 6197
  1. Schedule 4, Part 1, entry for Bisacodyl

    (a)omit:

C5641 P5641

Constipation

Continuing treatment

Patient must be receiving palliative care.

Compliance with Authority Required procedures - Streamlined Authority Code 5641

(b)omit:

C5774 P5774

Constipation

Initial treatment, for up to 4 months

Patient must be receiving palliative care.

Compliance with Authority Required procedures - Streamlined Authority Code 5774

(c)insert in numerical order after existing text:

C6139 P6139

Constipation

Patient must be receiving palliative care.

  1. Schedule 4, Part 1, entry for Carbomer

    substitute:

Carbomer C6153 P6153 Severe dry eye syndrome, including Sjogren's syndrome
C6172 Severe dry eye syndrome
Patient must be sensitive to preservatives in multi-dose eye drops.
Compliance with Authority Required procedures - Streamlined Authority Code 6172
C6185 P6185

Severe dry eye syndrome, including Sjogren's syndrome

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, entry for Carbomer 974

    substitute:

Carbomer 974 C6172 Severe dry eye syndrome
Patient must be sensitive to preservatives in multi-dose eye drops.
Compliance with Authority Required procedures - Streamlined Authority Code 6172
  1. Schedule 4, Part 1, entry for Carmellose

    (a)omit:

C1359 Severe dry eye syndrome in patients who are sensitive to preservatives in multi‑dose eye drops Compliance with Authority Required procedures – Streamlined Authority Code 1359

(b)omit:

C2802 Severe dry eye syndrome in patients who are sensitive to preservatives in multi‑dose eye drops Compliance with Authority Required procedures

(c)insert in numerical order after existing text

C6172

Severe dry eye syndrome

Patient must be sensitive to preservatives in multi-dose eye drops.

Compliance with Authority Required procedures - Streamlined Authority Code 6172
  1. Schedule 4, Part 1, entry for Cephalexin

    (a)insert in the column headed “Conditions Code” for Purposes Code P4243:              CN4243

    (b)insert in numerical order after existing text:

P6188 CN6188 Osteomyelitis

Compliance with Authority Required procedures - Streamlined Authority Code 6188
  1. Schedule 4, Part 1, entry for Clonazepam

    (a)omit:

C3657 P3657 Initial supply, for up to 4 months, for a palliative care patient for the prevention of epilepsy Compliance with Authority Required procedures
C3658 P3658 Continuing supply for a palliative care patient for the prevention of epilepsy Compliance with Authority Required procedures

(b)insert in numerical order after existing text:

C6140 P6140

Myoclonus

The treatment must be for prophylaxis or prevention of the indication; AND
Patient must be receiving palliative care.

Compliance with Authority Required procedures
  1. Schedule 4, Part 1, entry for Diazepam

    (a)omit:

P3655 CN3655 Initial supply, for up to 4 months, for a palliative care patient where anxiety is a problem Compliance with Authority Required procedures
P3656 CN3656 Continuing supply for a palliative care patient where anxiety is a problem Compliance with Authority Required procedures

(b)insert in numerical order after existing text:

P6176 CN6176

Anxiety

Patient must be receiving palliative care.

Compliance with Authority Required procedures
  1. Schedule 4, Part 1, entry for Diclofenac

    (a)omit from the column headed “Purposes Code” for Circumstances Code C1036:     P1036

    (b)omit from the column headed “Purposes Code” for Circumstances Code C1054:     P1054

    (c)omit:

C3645 P3645 Initial supply, for up to 4 months, for a palliative care patient where severe pain is a problem Compliance with Authority Required procedures – Streamlined Authority Code 3645
C3646 P3646 Continuing supply for a palliative care patient where severe pain is a problem Compliance with Authority Required procedures – Streamlined Authority Code 3646
P3665 CN3665 Initial supply, for up to 4 months, for a palliative care patient where severe pain is a problem Compliance with Authority Required procedures
P3666 CN3666 Continuing supply for a palliative care patient where severe pain is a problem Compliance with Authority Required procedures

(d)insert in numerical order after existing text:

C6149 P6149

Severe pain

Patient must be receiving palliative care.

  1. Schedule 4, Part 1, entry for Dicloxacillin

    (a)insert in the column headed “Purposes Code” for Circumstances Code C5415:       P5415

    (b)insert in numerical order after existing text:

C6188 P6188 Osteomyelitis

Compliance with Authority Required procedures - Streamlined Authority Code 6188
  1. Schedule 4, Part 1, entry for Docosahexaenoic acid with carbohydrate

    substitute:

Docosahexaenoic acid with carbohydrate C6141 Peroxisomal biogenesis disorders
  1. Schedule 4, Part 1, entry for Doxycycline

    insert in numerical order after existing text:

P6200 Severe acne
  1. Schedule 4, Part 1, entry for Dutasteride

    substitute:

Dutasteride C6202

Benign prostatic hyperplasia

Patient must have lower urinary tract symptoms; AND
Patient must have moderate to severe benign prostatic hyperplasia; AND
The treatment must be in combination with an alpha-antagonist.

Compliance with Authority Required procedures - Streamlined Authority Code 6202
  1. Schedule 4, Part 1, entry for Dutasteride with tamsulosin

    substitute:

Dutasteride with tamsulosin C6189

Benign prostatic hyperplasia

Patient must have lower urinary tract symptoms; AND
Patient must have moderate to severe benign prostatic hyperplasia.

Compliance with Authority Required procedures - Streamlined Authority Code 6189
  1. Schedule 4, Part 1, entry for Eribulin

    (a)omit:

C4646

Where the patient is receiving treatment in the community setting or at/from a Private Hospital

Locally advanced or metastatic breast cancer

Patient must have progressive disease; AND
Patient must have failed at least two prior chemotherapeutic regimens for this condition; AND
The treatment must be the sole PBS-subsidised therapy for this condition

Compliance with Authority Required procedures

(b)omit from the column headed “Circumstances and Purposes” for Circumstances Code C4649:

Where the patient is receiving treatment at/from a Public Hospital

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

    insert:

Erythromycin P6160 CN6160

Severe acne

The condition must be one in which tetracycline therapy is inappropriate.

Compliance with Authority Required procedures - Streamlined Authority Code 6160
  1. Schedule 4, Part 1, entry for Flucloxacillin

    insert in numerical order after existing text:

C6169 P6169 Osteomyelitis

Compliance with Authority Required procedures - Streamlined Authority Code 6169
  1. Schedule 4, Part 1, entry for Fusidic acid

    substitute:

Fusidic acid C4963 P4963 Serious staphylococcal infections
The treatment must be used in combination with another antibiotic; AND
The condition must be proven to be due to a staphylococcus.
C6133 P6133 Osteomyelitis
The condition must be methicillin-resistant staphylococcal aureus (MRSA); AND
The treatment must be used in combination with other anti-staphylococcal antibiotics.
Compliance with Authority Required procedures - Streamlined Authority Code 6133
  1. Schedule 4, Part 1, entry for Hyaluronic acid

    omit:

C4130

Severe dry eye syndrome

Patient must be sensitive to preservatives in multi‑dose eye drops.

Compliance with Authority Required procedures
  1. Schedule 4, Part 1, entry for Hyoscine

    substitute:

Hyoscine P6207 CN6207 For use in patients receiving palliative care

Compliance with Authority Required procedures - Streamlined Authority Code 6207
  1. Schedule 4, Part 1, entry for Hypromellose with Dextran

    (a)omit:

C1359 Severe dry eye syndrome in patients who are sensitive to preservatives in multi‑dose eye drops Compliance with Authority Required procedures – Streamlined Authority Code 1359
C2802 Severe dry eye syndrome in patients who are sensitive to preservatives in multi‑dose eye drops Compliance with Authority Required procedures

(b)insert in numerical order after existing text:

C6172

Severe dry eye syndrome

Patient must be sensitive to preservatives in multi-dose eye drops.

Compliance with Authority Required procedures - Streamlined Authority Code 6172
  1. Schedule 4, Part 1, entry for Ibuprofen

    (a)omit:

P3665 Initial supply, for up to 4 months, for a palliative care patient where severe pain is a problem Compliance with Authority Required procedures
P3666 Continuing supply for a palliative care patient where severe pain is a problem Compliance with Authority Required procedures

(b)insert in numerical order after existing text:

P6149

Severe pain

Patient must be receiving palliative care.

  1. Schedule 4, Part 1, entry for Imatinib

    (a)omit:

C4007 P4007

Chronic myeloid leukaemia (chronic phase)
Initial treatment, as the sole PBS‑subsidised therapy, of a patient in the chronic phase of chronic myeloid leukaemia expressing the Philadelphia chromosome or the transcript, BCR‑ABL tyrosine kinase, and who has a primary diagnosis of chronic myeloid leukaemia

Applications under this restriction will be limited to provide patients with a maximum of 18 months of therapy with dasatinib, imatinib or nilotinib from the date the first application for initial treatment was approved

Patients should be commenced on a dose of imatinib mesylate of 400 mg (base) daily. Continuing therapy is dependent on patients demonstrating a response to imatinib mesylate therapy following the initial 18 months of treatment and at 12 monthly intervals thereafter

Applications for authorisation must be in writing and must include:
(1) a completed authority prescription form; and
(2) a completed Chronic Myeloid Leukaemia ‑ Chronic Phase, First Line ‑ Supporting Information form; and
(3) a pathology cytogenetic report conducted on peripheral blood or bone marrow supporting the diagnosis of chronic myeloid leukaemia to confirm eligibility for treatment, or a qualitative PCR report documenting the presence of the BCR‑ABL transcript in either peripheral blood or bone marrow; and
(4) a signed patient acknowledgement form

Compliance with Written Authority Required procedures
C4008 P4008

Chronic myeloid leukaemia (chronic phase)
Continuing treatment, as the sole PBS‑subsidised therapy, of a patient who has received initial PBS‑subsidised treatment with imatinib mesylate for the chronic phase of chronic myeloid leukaemia and who has demonstrated either a major cytogenetic response or less than 1% BCR‑ABL level in the blood

First continuing applications for authorisation must be in writing and must include:

(1) a completed authority prescription form; and
(2) demonstration of a response to treatment as evidenced by either:
(a) major cytogenetic response; or
(b) a peripheral blood level of BCR‑ABL of less than 1% on the international scale

Definitions of response
A major cytogenetic response is defined as less than 35% Philadelphia positive bone marrow cells
A peripheral blood BCR‑ABL level of less than 1% on the international scale (Blood 108: 28‑37, 2006) also indicates a response, at least the biological equivalent of a major cytogenetic response

Compliance with Written Authority Required procedures
Continuing treatment, as the sole PBS‑subsidised therapy, of a patient who has previously been issued with an authority prescription for continuing treatment with imatinib mesylate for the chronic phase of chronic myeloid leukaemia. Patients must maintain a major cytogenetic response or have a peripheral blood BCR‑ABL of less than 1% to receive continuing therapy Compliance with Written or Telephone Authority Required procedures

(b)insert in numerical order after existing text:

C6183 P6183

Chronic Myeloid Leukaemia (CML)

Initial

Patient must have a primary diagnosis of chronic myeloid leukaemia; AND
The condition must be in the chronic phase of chronic myeloid leukaemia; AND
The condition must be expressing the Philadelphia chromosome; OR
The condition must have the transcript BCR-ABL tyrosine kinase; AND
The treatment must be for first line therapy for this condition; AND
Patient must not have previously experienced a failure of response to the PBS-subsidised treatment with this drug for this condition; OR
Patient must have experienced intolerance, not a failure of response, to PBS-subsidised treatment with dasatinib as a first line therapy for this condition; OR
Patient must have experienced intolerance, not a failure of response, to PBS-subsidised treatment with nilotinib as a first line therapy for this condition; AND
The treatment must not exceed a total maximum of 18 months of therapy with a PBS-subsidised treatment with a tyrosine kinase inhibitor for this condition; AND
The treatment must be the sole PBS-subsidised therapy for this condition.
Applications for authorisation must be in writing and must include:(1) a completed authority prescription form; and(2) a completed Chronic Myeloid Leukaemia - Chronic Phase, First Line - Supporting Information form; and(3) a pathology cytogenetic report conducted on peripheral blood or bone marrow supporting the diagnosis of chronic myeloid leukaemia to confirm eligibility for treatment, or a qualitative PCR report documenting the presence of the BCR-ABL transcript in either peripheral blood or bone marrow; and(4) a signed patient acknowledgement form
Applications under this restriction will be limited to provide patients with a maximum of 18 months of therapy with dasatinib, imatinib or nilotinib from the date the first application for initial treatment was approved.
Patients should be commenced on a dose of imatinib mesylate of 400 mg (base) daily. Continuing therapy is dependent on patients demonstrating a response to imatinib mesylate therapy following the initial 18 months of treatment and at 12 monthly intervals thereafter.

Compliance with Written Authority Required procedures
C6184 P6184

Chronic Myeloid Leukaemia (CML)

First Continuing

The condition must be in the chronic phase of chronic myeloid leukaemia; AND
Patient must have received initial PBS-subsidised treatment with this drug as a first line therapy for this condition; OR
Patient must have experienced intolerance, not a failure of response, to PBS-subsidised treatment with dasatinib as a first line therapy for this condition; OR
Patient must have experienced intolerance, not a failure of response, to PBS-subsidised treatment with nilotinib as a first line therapy for this condition; AND
Patient must have demonstrated a major cytogenic response; OR
Patient must have demonstrated a peripheral blood level of BCR-ABL of less than 1%; AND
The treatment must not exceed a total maximum of 24 weeks of therapy with a PBS-subsidised treatment with a tyrosine kinase inhibitor for this condition under this restriction; AND
The treatment must be the sole PBS-subsidised therapy for this condition.
First continuing applications for authorisation must be in writing and must include:
(1) a completed authority prescription form; and
(2) a response to treatment as evidenced by either:
(a) a major cytogenetic response [see Note explaining requirements]; or
(b) a peripheral blood level of BCR-ABL of less than 1% on the international scale [see Note explaining requirements].

Compliance with Written Authority Required procedures
C6198 P6198

Chronic Myeloid Leukaemia (CML)

Subsequent continuing

The condition must be in the chronic phase of chronic myeloid leukaemia; AND
Patient must have received initial continuing PBS-subsidised treatment with this drug as a first line therapy for this condition; OR
Patient must have experienced intolerance, not a failure of response, to PBS-subsidised treatment with dasatinib as a first line therapy for this condition; OR
Patient must have experienced intolerance, not a failure of response, to PBS-subsidised treatment with nilotinib as a first line therapy for this condition; AND
Patient must have maintained a major cytogenic response; OR
Patient must have maintained a peripheral blood level of BCR-ABL of less than 1%; AND
The treatment must not exceed a total maximum of 24 weeks of therapy with a PBS-subsidised treatment with a tyrosine kinase inhibitor for this condition under this restriction; AND
The treatment must be the sole PBS-subsidised therapy for this condition.
Second and subsequent authority applications for continuing therapy with imatinib mesylate may be made on the telephone by contacting the Department of Human Services on 1800 700 270 (hours of operation 8 a.m. to 5 p.m. EST Monday to Friday).

Compliance with Authority Required procedures
  1. Schedule 4, Part 1, entry for Indomethacin

    (a)omit:

C3645 P3645 Initial supply, for up to 4 months, for a palliative care patient where severe pain is a problem Compliance with Authority Required procedures – Streamlined Authority Code 3645
C3646 P3646 Continuing supply for a palliative care patient where severe pain is a problem Compliance with Authority Required procedures – Streamlined Authority Code 3646
P3665 CN3665 Initial supply, for up to 4 months, for a palliative care patient where severe pain is a problem Compliance with Authority Required procedures
P3666 CN3666 Continuing supply for a palliative care patient where severe pain is a problem Compliance with Authority Required procedures

(b)insert in numerical order after existing text:

C6149 P6149

Severe pain

Patient must be receiving palliative care.

  1. Schedule 4, Part 1, entry for Levodopa with Carbidopa

    (a)omit:

C3704

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

Management of advanced Parkinson disease in a patient with severe disabling motor fluctuations not adequately controlled by oral therapy.
Treatment must be commenced in a hospital‑based movement disorder clinic

Compliance with Written or Telephone Authority Required procedures – Streamlined Authority Code 3704
C3705

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

Management of advanced Parkinson disease in a patient with severe disabling motor fluctuations not adequately controlled by oral therapy.
Treatment must be commenced in a hospital‑based movement disorder clinic

Compliance with Written or Telephone Authority Required procedures

(b)insert in numerical order after existing text:

C6154

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

Advanced Parkinson disease

Patient must have severe disabling motor fluctuations not adequately controlled by oral therapy; AND
The treatment must be commenced in a hospital-based movement disorder clinic.

Compliance with Authority Required procedures
C6179

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

Advanced Parkinson disease

Patient must have severe disabling motor fluctuations not adequately controlled by oral therapy; AND
The treatment must be commenced in a hospital-based movement disorder clinic.

Compliance with Authority Required procedures - Streamlined Authority Code 6179
  1. Schedule 4, Part 1, entry for Macrogol 3350

    (a)omit:

C4170 P4170

Constipation
Continuing treatment

Patient must be receiving palliative care

Compliance with Authority Required procedures – Streamlined Authority Code 4170

(b)omit:

C4176 P4176

Constipation
Initial treatment

Patient must be receiving palliative care;

Patient must not receive more than 4 months treatment under this restriction

Compliance with Authority Required procedures – Streamlined Authority Code 4176

(c)omit:

C4590 P4590 Constipation
Continuing treatment
Patient must be receiving palliative care
Compliance with Authority Required procedures - Streamlined Authority Code 4590
C4595 P4595

Constipation

Initial treatment

Patient must be receiving palliative care; AND
Patient must not receive more than 4 months treatment under this restriction

Compliance with Authority Required procedures - Streamlined Authority Code 4595

(d)insert in numerical order after existing text:

C6170 P6170

Constipation

Patient must be receiving palliative care.

Compliance with Authority Required procedures - Streamlined Authority Code 6170
C6171 P6171

Constipation

Patient must be receiving palliative care.

Compliance with Authority Required procedures - Streamlined Authority Code 6171
  1. Schedule 4, Part 1, entry for Methylnaltrexone

    substitute:

Methylnaltrexone C6180

Opioid-induced constipation

The treatment must be in combination with oral laxatives; AND
Patient must be receiving palliative care; AND
Patient must have failed to respond to laxatives.

Compliance with Authority Required procedures - Streamlined Authority Code 6180
  1. Schedule 4, Part 1, entry for Milk powder — synthetic

    substitute:

Milk powder -- synthetic C6208

Hypercalcaemia

Patient must be under the age of 4 years.

  1. Schedule 4, Part 1, entry for Morphine

    (a)omit:

C4911 P4911

Chronic severe disabling pain

Initial treatment, for up to 3 months

Patient must be receiving palliative care; AND
The condition must be unresponsive to non-opioid analgesics

Compliance with Authority Required procedures

(b)omit:

C4927 P4927

Chronic severe disabling pain

Continuing treatment

Patient must be receiving palliative care; AND
The condition must be unresponsive to non-opioid analgesics

Compliance with Authority Required procedures
C4935 P4935

Severe disabling pain

Continuing treatment

Patient must be receiving palliative care; AND
The condition must be unresponsive to non-opioid analgesics

Compliance with Authority Required procedures

C4948 P4948

Severe disabling pain

Initial treatment, for up to 3 months

Patient must be receiving palliative care; AND
The condition must be unresponsive to non-opioid analgesics

Compliance with Authority Required procedures

(c)insert in numerical order after existing text:

C6151 P6151

Chronic severe disabling pain

Patient must be receiving palliative care; AND
The condition must be unresponsive to non-opioid analgesics.

Compliance with Authority Required procedures
C6168 P6168

Severe disabling pain

Patient must be receiving palliative care; AND
The condition must be unresponsive to non-opioid analgesics.

Compliance with Authority Required procedures
  1. Schedule 4, Part 1, entry for Naproxen

    (a)omit from the column headed “Purposes Code” for Circumstances Code C1036:     P1036

    (b)omit from the column headed “Purposes Code” for Circumstances Code C1054:     P1054

    (c)omit:

C3645 P3645 Initial supply, for up to 4 months, for a palliative care patient where severe pain is a problem Compliance with Authority Required procedures – Streamlined Authority Code 3645
C3646 P3646 Continuing supply for a palliative care patient where severe pain is a problem Compliance with Authority Required procedures – Streamlined Authority Code 3646

(d)omit from the column headed “Purposes Code” for Circumstances Code C4124:     P4124

(e)omit:

C4128 P4128

Severe pain

Initial treatment

Patient must be undergoing palliative care;

Patient must be unable to take a solid dose form of a non‑steroidal anti‑inflammatory agent;

Patient must not receive more than 4 months treatment under this restriction

Compliance with Authority Required procedures – Streamlined Authority Code 4128
C4129 P4129

Severe pain

Continuing treatment

Patient must be undergoing palliative care;

Patient must be unable to take a solid dose form of a non‑steroidal anti‑inflammatory agent

Compliance with Authority Required procedures – Streamlined Authority Code 4129

(f)omit from the column headed “Purposes Code” for Circumstances Code C4159:     P4159

(g)insert in numerical order after existing text:

C6149

Severe pain

Patient must be receiving palliative care.

C6150

Severe pain

Patient must be unable to take a solid dose form of a non-steroidal anti-inflammatory agent.

Patient must be undergoing palliative care.

C6196

Severe pain

Patient must be receiving palliative care.

  1. Schedule 4, Part 1, entry for Nitrazepam

    (a)omit:

P5610 CN5610

Insomnia

Continuing treatment

Patient must be receiving palliative care.

Compliance with Authority Required procedures

(b)omit:

P5662 CN5662

Insomnia

Initial treatment, for up to 4 months

Patient must be receiving palliative care.

Compliance with Authority Required procedures

(c)insert in numerical order after existing text:

P6175 CN6175

Insomnia

Patient must be receiving palliative care.

Compliance with Authority Required procedures
  1. Schedule 4, Part 1, entry for Oxazepam

    (a)omit:

P3655 CN3655 Initial supply, for up to 4 months, for a palliative care patient where anxiety is a problem Compliance with Authority Required procedures
P3656 CN3656 Continuing supply for a palliative care patient where anxiety is a problem Compliance with Authority Required procedures

(b)insert in numerical order after existing text:

P6176 CN6176

Anxiety

Patient must be receiving palliative care.

Compliance with Authority Required procedures
  1. Schedule 4, Part 1, entry for Paracetamol

    (a)omit:

C4940 P4940

Analgesia or fever

Initial treatment, for up to 4 months

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

Compliance with Authority Required procedures - Streamlined Authority Code 4940
C4950 P4950

Analgesia or fever

Continuing treatment

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

Compliance with Authority Required procedures - Streamlined Authority Code 4950

(b)insert in numerical order after existing text:

C6167 P6167

Analgesia or fever

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

  1. Schedule 4, Part 1, entry for Phenoxybenzamine

    substitute:

Phenoxybenzamine C6145 Phaeochromocytoma
C6178 Neurogenic urinary retention
  1. Schedule 4, Part 1, entry for Polyethylene Glycol 400 with Propylene Glycol

    (a)omit:

C1359 Severe dry eye syndrome in patients who are sensitive to preservatives in multi‑dose eye drops Compliance with Authority Required procedures – Streamlined Authority Code 1359
C2802 Severe dry eye syndrome in patients who are sensitive to preservatives in multi‑dose eye drops Compliance with Authority Required procedures

(b)insert in numerical order after existing text:

C6172

Severe dry eye syndrome

Patient must be sensitive to preservatives in multi-dose eye drops.

Compliance with Authority Required procedures - Streamlined Authority Code 6172
  1. Schedule 4, Part 1, entry for Protein hydrolysate formula with medium chain triglycerides

    substitute:

Protein hydrolysate formula with medium chain triglycerides C6137

Proven combined immunoglobulin E (IgE) mediated allergy to cows' milk protein and soy protein

Initial treatment for up to 6 months

Patient must be up to the age of 24 months.
Must be treated by a specialist allergist, clinical immunologist or specialist paediatric gastroenterologist and hepatologist, or in consultation with a specialist allergist, clinical immunologist or specialist paediatric gastroenterologist and hepatologist.
The name of the specialist must be documented in the patient's medical records

Compliance with Authority Required procedures - Streamlined Authority Code 6137
C6138 Severe intestinal malabsorption including short bowel syndrome Compliance with Authority Required procedures - Streamlined Authority Code 6138
C6148

Severe diarrhoea of greater than 2 weeks duration

Patient must be aged less than 4 months.

Compliance with Authority Required procedures - Streamlined Authority Code 6148
C6157 Chronic liver failure with fat malabsorption Compliance with Authority Required procedures - Streamlined Authority Code 6157
C6158 Enterokinase deficiency Compliance with Authority Required procedures - Streamlined Authority Code 6158
C6166 Proven fat malabsorption Compliance with Authority Required procedures - Streamlined Authority Code 6166
C6174

Cows' milk protein enteropathy and intolerance to soy protein

Initial treatment

The condition must not be isolated infant colic or reflux; AND
Patient must have failed to respond to a strict soy-based cows' milk protein free diet.
Patient must be up to the age of 24 months.
Must be treated by a specialist allergist, clinical immunologist, specialist paediatrician or specialist paediatric gastroenterologist and hepatologist, or in consultation with a specialist allergist, clinical immunologist, specialist paediatrician or specialist paediatric gastroenterologist and hepatologist.

Compliance with Authority Required procedures - Streamlined Authority Code 6174
C6182

Proven combined immunoglobulin E (IgE) mediated allergy to cows' milk protein and soy protein

Continuing treatment

Patient must be up to the age of 24 months.
Must be treated by a specialist allergist, clinical immunologist or specialist paediatric gastroenterologist and hepatologist.
The name of the specialist must be documented in the patient's medical records

Compliance with Authority Required procedures - Streamlined Authority Code 6182
C6193

Cows' milk protein enteropathy and intolerance to soy protein

Continuing treatment

The condition must not be isolated infant colic or reflux; AND
Patient must have demonstrated a clinical improvement with the protein hydrolysate formula with medium chain triglycerides.
Patient must be up to the age of 24 months.
Must be treated by a specialist allergist, clinical immunologist, specialist paediatrician or specialist paediatric gastroenterologist and hepatologist, or in consultation with a specialist allergist, clinical immunologist, specialist paediatrician or specialist paediatric gastroenterologist and hepatologist.

Compliance with Authority Required procedures - Streamlined Authority Code 6193
C6194 Biliary atresia Compliance with Authority Required procedures - Streamlined Authority Code 6194
C6195 Cystic fibrosis Compliance with Authority Required procedures - Streamlined Authority Code 6195
C6204

Cows' milk protein enteropathy and intolerance to soy protein

The condition must not be isolated infant colic or reflux; AND
Patient must have failed to respond to a strict soy-based cows' milk protein free diet.
Patient must be older than 24 months of age.
Must be treated by a specialist allergist, clinical immunologist, specialist paediatrician or specialist paediatric gastroenterologist and hepatologist.
The name of the specialist must be documented in the patient's medical records

Compliance with Authority Required procedures - Streamlined Authority Code 6204
C6205 Chylous ascites Compliance with Authority Required procedures - Streamlined Authority Code 6205
C6206 Chylothorax Compliance with Authority Required procedures - Streamlined Authority Code 6206
  1. Schedule 4, Part 1, entry for Rituximab

    (a)omit:

C5980

Previously untreated CD20 positive diffuse large B-cell non-Hodgkin's lymphoma

Induction treatment

The treatment must be in combination with chemotherapy; AND
The condition must be previously untreated; AND
The condition must be symptomatic; AND
The treatment must be for induction treatment purposes only; AND
Patient must not receive more than 8 doses of rituximab in total, including intravenous and subcutaneous injections, and no more than 7 doses of subcutaneous rituximab under this restriction.
An initial dose of rituximab must be administered with rituximab intravenous injection. Subsequent doses may be administered with either intravenous or subcutaneous rituximab with no more than 8 doses in total.

Compliance with Authority Required procedures - Streamlined Authority Code 5980
C5992

Stage III or IV CD20 positive follicular B-cell non-Hodgkin's lymphoma

Maintenance therapy

Patient must have demonstrated a partial or complete response to the induction phase of treatment for previously untreated follicular B-cell Non-Hodgkin's lymphoma, received immediately prior to this current Authority application; AND
The treatment must be maintenance therapy; AND
Patient must not receive more than 12 doses or 2 years duration of treatment, whichever comes first, under this restriction.

Compliance with Authority Required procedures - Streamlined Authority Code 5992

(b)insert in the column headed “Purposes Code” for Circumstances Code C5998:       P5998

(c)omit:

C6001

Stage III or IV CD20 positive follicular B-cell non-Hodgkin's lymphoma

Maintenance therapy

Patient must have demonstrated a partial or complete response to the induction phase of treatment for previously untreated follicular B-cell Non-Hodgkin's lymphoma, received immediately prior to this current Authority application; AND
The treatment must be maintenance therapy; AND
Patient must not receive more than 12 doses or 2 years duration of treatment, whichever comes first, under this restriction.

Compliance with Authority Required procedures - Streamlined Authority Code 6001
C6004

Stage III or IV CD20 positive follicular B-cell non-Hodgkin's lymphoma

Maintenance therapy

Patient must have demonstrated a partial or complete response to the induction phase of treatment for previously untreated follicular B-cell Non-Hodgkin's lymphoma, received immediately prior to this current Authority application; AND
The treatment must be maintenance therapy; AND
Patient must not receive more than 12 doses or 2 years duration of treatment, whichever comes first, under this restriction.

Compliance with Authority Required procedures - Streamlined Authority Code 6004

(d)insert in the column headed “Purposes Code” for Circumstances Code C6008:       P6008

(e)insert in the column headed “Purposes Code” for Circumstances Code C6011:       P6011

(f)insert in the column headed “Purposes Code” for Circumstances Code C6039:       P6039

(g)omit:

C6040

Previously untreated Stage III or IV CD20 positive follicular B-cell non-Hodgkin's lymphoma

Induction treatment

The treatment must be in combination with chemotherapy; AND
The condition must be previously untreated; AND
The condition must be symptomatic; AND
The treatment must be for induction treatment purposes only; AND
Patient must not receive more than 8 doses of rituximab in total, including intravenous and subcutaneous injections, and no more than 7 doses of subcutaneous rituximab under this restriction.
An initial dose of rituximab must be administered with rituximab intravenous injection. Subsequent doses may be administered with either intravenous or subcutaneous rituximab with no more than 8 doses in total.

Compliance with Authority Required procedures - Streamlined Authority Code 6040
C6058

Stage III or IV CD20 positive follicular B-cell non-Hodgkin's lymphoma

Maintenance therapy

Patient must have demonstrated a partial or complete response to the induction phase of treatment for previously untreated follicular B-cell Non-Hodgkin's lymphoma, received immediately prior to this current Authority application; AND
The treatment must be maintenance therapy; AND
Patient must not receive more than 12 doses or 2 years duration of treatment, whichever comes first, under this restriction.

Compliance with Authority Required procedures - Streamlined Authority Code 6058

(h)insert in numerical order after existing text:

C6161 P6161 Stage III or IV CD20 positive follicular B-cell non-Hodgkin's lymphoma
Maintenance therapy
Patient must have demonstrated a partial or complete response to induction treatment with either R-CHOP or R-CVP regimens for previously untreated follicular B-cell Non-Hodgkin's lymphoma, received immediately prior to this current Authority application; AND
Patient must not have received bendamustine induction therapy; AND
The treatment must be maintenance therapy; AND
Patient must not receive more than 12 doses or 2 years duration of treatment, whichever comes first, under this restriction.
Compliance with Authority Required procedures - Streamlined Authority Code 6161
C6162 P6162 Previously untreated symptomatic indolent CD20 positive non-Hodgkin's lymphoma in combination with chemotherapy
Induction treatment
The treatment must be in combination with PBS-subsidised chemotherapy; AND
The condition must be previously untreated; AND
The condition must be symptomatic; AND
The treatment must be for induction treatment purposes only; AND
Patient must not receive more than the number of cycles of treatment recommended by standard guidelines for the partner chemotherapy under this restriction.
An initial dose of rituximab must be administered with rituximab intravenous injection. Subsequent doses may be administered with either intravenous or subcutaneous rituximab with no more than 8 doses in total.
Compliance with Authority Required procedures - Streamlined Authority Code 6162
C6187 P6187 Previously untreated aggressive CD20 positive non-Hodgkin's lymphoma
Induction treatment
The treatment must be in combination with PBS-subsidised chemotherapy; AND
The condition must be previously untreated; AND
The treatment must be for induction treatment purposes only; AND
Patient must not be eligible for stem cell transplantation if they have mantle cell lymphoma.
An initial dose of rituximab must be administered with rituximab intravenous injection. Subsequent doses may be administered with either intravenous or subcutaneous rituximab with no more than 8 doses in total.
Compliance with Authority Required procedures - Streamlined Authority Code 6187
  1. Schedule 4, Part 1, entry for Sorbitol with sodium citrate and sodium lauryl sulfoacetate

    (a)omit:

C5641 P5641

Constipation

Continuing treatment

Patient must be receiving palliative care.

Compliance with Authority Required procedures - Streamlined Authority Code 5641

(b)omit:

C5774 P5774

Constipation

Initial treatment, for up to 4 months

Patient must be receiving palliative care.

Compliance with Authority Required procedures - Streamlined Authority Code 5774

(c)insert in numerical order after existing text:

C6139 P6139

Constipation

Patient must be receiving palliative care.

  1. Schedule 4, Part 1, entry for Soy lethicin

    substitute:

Soy lecithin C6172

Severe dry eye syndrome

Patient must be sensitive to preservatives in multi-dose eye drops.

Compliance with Authority Required procedures - Streamlined Authority Code 6172
  1. Schedule 4, Part 1, entry for Sterculia with frangula bark

    (a)omit:

C5641 P5641

Constipation

Continuing treatment

Patient must be receiving palliative care.

Compliance with Authority Required procedures - Streamlined Authority Code 5641

(b)omit:

C5774 P5774

Constipation

Initial treatment, for up to 4 months

Patient must be receiving palliative care.

Compliance with Authority Required procedures - Streamlined Authority Code 5774

(c)insert in numerical order after existing text:

C6139 P6139

Constipation

Patient must be receiving palliative care.

  1. Schedule 4, Part 1, entry for Temazepam

    (a)omit:

P5610 CN5610

Insomnia

Continuing treatment

Patient must be receiving palliative care.

Compliance with Authority Required procedures

(b)omit:

P5662 CN5662

Insomnia

Initial treatment, for up to 4 months

Patient must be receiving palliative care.

Compliance with Authority Required procedures

(c)insert in numerical order after existing text:

P6175 CN6175

Insomnia

Patient must be receiving palliative care.

Compliance with Authority Required procedures
  1. Schedule 4, Part 1, entry for Triglycerides, medium chain

    substitute:

Triglycerides, medium chain C6134 Chylothorax Compliance with Authority Required procedures - Streamlined Authority Code 6134
C6135

Cerebrospinal fluid glucose transporter defect

Patient must require a ketogenic diet.

Compliance with Authority Required procedures - Streamlined Authority Code 6135
C6146 Long chain fatty acid oxidation disorders Compliance with Authority Required procedures - Streamlined Authority Code 6146
C6147

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.

Compliance with Authority Required procedures - Streamlined Authority Code 6147
C6155

Intractable childhood epilepsy

Patient must require a ketogenic diet.

Compliance with Authority Required procedures - Streamlined Authority Code 6155
C6164

Fat malabsorption

The condition must be due to liver disease; OR
The condition must be due to short gut syndrome; OR
The condition must be due to cystic fibrosis; OR
The condition must be due to gastrointestinal disorders.

Compliance with Authority Required procedures - Streamlined Authority Code 6164
C6181 Chylous ascites Compliance with Authority Required procedures - Streamlined Authority Code 6181
C6191

Dietary management of conditions requiring a source of medium chain triglycerides

Patient must have chylous ascites; OR
Patient must have chylothorax; OR
Patient must have hyperlipoproteinaemia type 1; OR
Patient must have long chain fatty acid oxidation disorders; OR
Patient must have fat malabsorption due to liver disease; OR
Patient must have fat malabsorption due to short gut syndrome; OR
Patient must have fat malabsorption due to cystic fibrosis; OR
Patient must have fat malabsorption due to gastrointestinal disorders.

Compliance with Authority Required procedures - Streamlined Authority Code 6191
C6203 Hyperlipoproteinaemia type 1 Compliance with Authority Required procedures - Streamlined Authority Code 6203
  1. Schedule 4, Part 1, entry for Triglycerides — medium chain, formula

    omit:

C5644

Chylothorax

Compliance with Authority Required procedures
C5645 Long chain fatty acid oxidation disorders Compliance with Authority Required procedures
C5693

Fat malabsorption

The condition must be due to liver disease; OR
The condition must be due to short gut syndrome; OR
The condition must be due to cystic fibrosis; OR
The condition must be due to gastrointestinal disorders.

Compliance with Authority Required procedures
C5726 Chylous ascites Compliance with Authority Required procedures
C5784 Hyperlipoproteinaemia type 1 Compliance with Authority Required procedures

substitute:

C6136 Long chain fatty acid oxidation disorders Compliance with Authority Required procedures - Streamlined Authority Code 6136
C6156 Hyperlipoproteinaemia type 1 Compliance with Authority Required procedures - Streamlined Authority Code 6156
C6165 Chylous ascites Compliance with Authority Required procedures - Streamlined Authority Code 6165
C6173

Fat malabsorption

The condition must be due to liver disease; OR
The condition must be due to short gut syndrome; OR
The condition must be due to cystic fibrosis; OR
The condition must be due to gastrointestinal disorders.

Compliance with Authority Required procedures - Streamlined Authority Code 6173
C6192 Chylothorax Compliance with Authority Required procedures - Streamlined Authority Code 6192
  1. Schedule 4, Part 1, entry for Trimethoprim

    substitute:

Trimethoprim P4243 CN4243 Prophylaxis of urinary tract infection Compliance with Authority Required procedures – Streamlined Authority Code 4243
P6163 Prostatitis
  1. Schedule 4, Part 1, after entry for Trimethoprim

    insert:

Trimethoprim with sulfamethoxazole P6201 CN6201 Prophylaxis of Pneumocystis jiroveci pneumonia

Compliance with Authority Required procedures - Streamlined Authority Code 6201
  1. Schedule 4, Part 1, entry for Vitamins, minerals and trace elements with carbohydrate

    substitute:

Vitamins, minerals and trace elements with carbohydrate C6152

Dietary management of conditions requiring a highly restrictive therapeutic diet

Patient must have insufficient vitamin and mineral intake due to a specific diagnosis requiring a highly restrictive therapeutic diet; AND
Patient must be unable to adequately meet vitamin, mineral and trace element needs with other proprietary vitamin and mineral preparations.
Patient must be an infant or a child.

C6159

Dietary management of conditions requiring a highly restrictive therapeutic diet

Patient must have insufficient vitamin and mineral intake due to a specific diagnosis requiring a highly restrictive therapeutic diet; AND
Patient must be unable to adequately meet vitamin, mineral and trace element needs with other proprietary vitamin and mineral preparations.
Patient must be aged 3 years or older.

  1. Schedule 4, Part 1, entry for Whey protein formula supplemented with amino acids, long chain polyunsaturated fatty acids, vitamins and minerals, and low in protein, phosphate, potassium and lactose

    substitute:

Whey protein formula supplemented with amino acids, long chain polyunsaturated fatty acids, vitamins and minerals, and low in protein, phosphate, potassium and lactose C6190

Chronic renal failure

Patient must require treatment with a low protein and a low phosphorus diet; OR
Patient must require treatment with a low protein, low phosphorus and low potassium diet.
Patient must be an infant or a young child.

Compliance with Authority Required procedures - Streamlined Authority Code 6190
  1. Schedule 4, Part 1, entry for Whey protein formula supplemented with amino acids, vitamins and minerals, and low in protein, phosphate, potassium and lactose

    substitute:

Whey protein formula supplemented with amino acids, vitamins and minerals, and low in protein, phosphate, potassium and lactose C6190

Chronic renal failure

Patient must require treatment with a low protein and a low phosphorus diet; OR
Patient must require treatment with a low protein, low phosphorus and low potassium diet.
Patient must be an infant or a young child.

Compliance with Authority Required procedures - Streamlined Authority Code 6190
  1. Schedule 5

    insert as first entry:

Clopidogrel

GRP-15475 Tablet 75 mg (as besilate) Oral

Clopidogrel-GA

Clovix 75

Plidogrel

Tablet 75 mg (as hydrogen sulfate) Oral

APO-Clopidogrel

Blooms the Chemist Clopidogrel

Chem mart Clopidogrel

Clopidogrel AN

Clopidogrel Winthrop

Iscover

Piax

Plavix

Terry White Chemists Clopidogrel

GRP-17110 Tablet 75 mg Oral Clopidogrel-DRLA
Tablet 75 mg (as besilate) Oral

Clopidogrel GH

Clopidogrel-GA

Clovix 75

Plidogrel

Tablet 75 mg (as hydrogen sulfate) Oral

APO-Clopidogrel

Blooms the Chemist Clopidogrel

Chem mart Clopidogrel

Clopidogrel AN

Clopidogrel RBX

Clopidogrel Sandoz

Clopidogrel Winthrop

Iscover

Piax

Plavicor 75

Plavix

Terry White Chemists Clopidogrel

  1. Schedule 5, entry for Ondansetron in each of the forms: Tablet (orally disintegrating) 4 mg; and Tablet (orally disintegrating) 8 mg

    insert in alphabetical order in the column headed “Brand”:   Ondansetron ODT GH

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