Commonwealth Coat of Arms of Australia

 

PB 86 of 2024

 

National Health (Pharmaceutical benefits – early supply) Amendment Instrument 2024
(No. 8)

 

National Health Act 1953

 

I, NIKOLAI TSYGANOV, Assistant Secretary, Pricing and PBS Policy Branch, Technology Assessment and Access Division, Department of Health and Aged Care, delegate of the Minister for Health and Aged Care, make this Instrument under subsection 84AAA(2) of the National Health Act 1953.

Dated 29 August 2024

NIKOLAI TSYGANOV

Assistant Secretary

Pricing and PBS Policy Branch

Technology Assessment and Access Division

 

 

Contents

1 Name

2 Commencement

3 Authority

4 Schedules

Schedule 1—Amendments

National Health (Pharmaceutical benefits—early supply) Instrument 2015
(PB 120 of 2015). 2

 

1 Name

  1.            This instrument is the National Health (Pharmaceutical benefits – early supply) Amendment Instrument 2024 (No. 8).
  2.            This instrument may also be cited as PB 86 of 2024.

2 Commencement

  1.            Each provision of this instrument specified in column 1 of the table commences, or is taken to have commenced, in accordance with column 2 of the table. Any other statement in column 2 has effect according to its terms.

 

Commencement information

Column 1

Column 2

Column 3

Provisions

Commencement

Date/Details

1. The whole of this instrument

1 September 2024

1 September 2024

Note: This table relates only to the provisions of this instrument as originally made. It will not be amended to deal with any later amendments of this instrument.

  1.            Any information in column 3 of the table is not part of this instrument. Information may be inserted in this column, or information in it may be edited, in any published version of this instrument.

3 Authority

This instrument is made under subsection 84AAA(2) of the National Health Act 1953.

4 Schedules

Each instrument that is specified in a Schedule to this instrument is amended or repealed as set out in the applicable items in the Schedule concerned, and any other item in a Schedule to this instrument has effect according to its terms.

Schedule 1—Amendments

National Health (Pharmaceutical benefits—early supply) Instrument 2015 (PB 120 of 2015)

  1.            Schedule 1, omit entry for Fosinopril with hydrochlorothiazide
  2.            Schedule 1, after entry for Metoprolol succinate in the form Tablet 190 mg (controlled release)

insert:

Migalastat

Capsule containing 150 mg migalastat hydrochloride (equivalent to 123 mg migalastat)

20

14

5

 

  1.            Schedule 1, after entry for Tiotropium in the form Capsule containing powder for oral inhalation 18 micrograms (as bromide monohydrate) (for use in HandiHaler)

insert:

 

Capsule containing powder for oral inhalation 18 micrograms (as bromide monohydrate) (for use in LupinHaler)

20

30

5

 

  1.            Schedule 2, after entry for Acarbose in the form Tablet 100 mg

insert:

Aclidinium

Powder for oral inhalation in breath actuated device 322 micrograms (as bromide) per dose, 60 doses

50

2

5

 

Aclidinium with formoterol

Powder for oral inhalation in breath actuated device containing aclidinium 340 micrograms (as bromide) with formoterol fumarate dihydrate 12 micrograms per dose, 60 doses

50

2

5

 

  1.            Schedule 2, after entry for Alogliptin with metformin in the form Tablet containing 12.5 mg alogliptin (as benzoate) with 1 g metformin hydrochloride

insert:

Amantadine

Capsule containing amantadine hydrochloride 100 mg

50

200

5

 


  1.            Schedule 2, after entry for Apixaban in the form Tablet 5 mg

insert:

Apomorphine

Injection containing apomorphine hydrochloride hemihydrate 50 mg in 5 mL

50

360

5

 

 

Injection containing apomorphine hydrochloride hemihydrate 100 mg in 20 mL

50

180

5

 

 

Solution for subcutaneous infusion containing apomorphine hydrochloride hemihydrate 50 mg in 10 mL pre-filled syringe

50

360

5

 

 

Solution for subcutaneous injection containing apomorphine hydrochloride 30 mg in 3 mL pre-filled pen

50

200

5

 

  1.            Schedule 2, after entry for Balsalazide

insert:

Beclometasone

Pressurised inhalation containing beclometasone dipropionate 50 micrograms per dose, 200 doses (CFC-free formulation)

50

2

5

 

 

Pressurised inhalation containing beclometasone dipropionate 100 micrograms per dose, 200 doses (CFC-free formulation)

50

2

5

 

 

Pressurised inhalation in breath actuated device containing beclometasone dipropionate 50 micrograms per dose, 200 doses (CFC-free formulation)

50

2

5

 

 

Pressurised inhalation in breath actuated device containing beclometasone dipropionate 100 micrograms per dose, 200 doses (CFC-free formulation)

50

2

5

 

Beclometasone with formoterol

Pressurised inhalation containing beclometasone dipropionate 100 micrograms and formoterol fumarate dihydrate 6 micrograms per dose,120 dose

50

2

5

 

 

Pressurised inhalation containing beclometasone dipropionate 200 micrograms and formoterol fumarate dihydrate 6 micrograms per dose, 120 doses

50

2

5

 

Beclometasone with formoterol and glycopyrronium

Pressurised inhalation containing beclometasone dipropionate 100 micrograms with formoterol fumarate dihydrate 6 micrograms and glycopyrronium 10 micrograms (as bromide) per dose, 120 doses

50

2

5

 

Betaxolol

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

50

2

5

 

Bimatoprost

Eye drops 300 micrograms per mL, 3 mL

50

2

5

 

 

Eye drops 300 micrograms per mL, single dose units 0.4 mL, 30

50

2

5

 

Bimatoprost with timolol

Eye drops 300 micrograms bimatoprost with timolol 5 mg (as maleate) per mL, 3 mL

50

2

5

 

 

Eye drops 300 micrograms bimatoprost with timolol 5 mg (as maleate) per mL, single dose units 0.4 mL, 30

50

2

5

 

Bisacodyl

Suppositories 10 mg, 10

50

6

5

 

 

Suppositories 10 mg, 12

50

6

4

 

 

Tablet 5 mg

50

400

2

 

  1.            Schedule 2, after entry for Bisoprolol in the form Tablet containing bisoprolol fumarate 10 mg

insert:

Brimonidine

Eye drops containing brimonidine tartrate 1.5 mg per mL, 5 mL

50

2

5

 

 

Eye drops containing brimonidine tartrate 2 mg per mL, 5 mL

50

2

5

 

Brimonidine with timolol

Eye drops containing brimonidine tartrate 2 mg with timolol 5 mg (as maleate) per mL, 5 mL

50

2

5

 

Brinzolamide

Eye drops 10 mg per mL, 5 mL

50

2

5

 

Brinzolamide with brimonidine

Eye drops 10 mg brinzolamide with 2 mg brimonidine tartrate per mL,
5 mL

50

2

5

 

Brinzolamide with timolol

Eye drops 10 mg brinzolamide with timolol 5 mg (as maleate) per mL, 5 mL

50

2

5

 

  1.            Schedule 2, after entry for Bromocriptine

insert:

Budesonide

Nebuliser suspension 1 mg in 2 mL single dose units, 30

50

2

5

 

 

Nebuliser suspension 500 micrograms in 2 mL single dose units, 30

50

2

5

 

 

Powder for oral inhalation in breath actuated device 100 micrograms per dose, 200 doses

50

2

5

 

 

Powder for oral inhalation in breath actuated device 200 micrograms per dose, 200 doses

50

2

5

 

 

Powder for oral inhalation in breath actuated device 400 micrograms per dose, 200 doses

50

2

5

 

Budesonide with formoterol

Powder for oral inhalation in breath actuated device containing budesonide 100 micrograms with formoterol fumarate dihydrate 6 micrograms per dose, 120 doses

50

2

5

 

 

Powder for oral inhalation in breath actuated device containing budesonide 200 micrograms with formoterol fumarate dihydrate 6 micrograms per dose, 120 doses

50

2

5

 

 

Powder for oral inhalation in breath actuated device containing budesonide 400 micrograms with formoterol fumarate dihydrate 12 micrograms per dose, 60 doses

50

4

5

 

 

Pressurised inhalation containing budesonide 100 micrograms with formoterol fumarate dihydrate 3 micrograms per dose, 120 doses

50

4

5

 

 

Pressurised inhalation containing budesonide 200 micrograms with formoterol fumarate dihydrate 6 micrograms per dose, 120 doses

50

4

5

 

Budesonide with glycopyrronium and formoterol

Pressurised inhalation containing budesonide 160 micrograms with glycopyrronium 7.2 micrograms and formoterol fumarate dihydrate 5 micrograms per dose, 120 doses

50

2

5

 

  1.        Schedule 2, after entry for Cabergoline

insert:

 

Tablet 1 mg

50

60

5

 

 

Tablet 2 mg

50

60

5

 


  1.        Schedule 2, after entry for Carbamazepine in the form Oral suspension 100 mg per 5 mL, 300 mL

insert:

 

Tablet 100 mg

50

400

2

 

 

Tablet 200 mg

50

400

2

 

  1.        Schedule 2, after entry for Carbimazole

insert:

Carbomer

Eye gel 2 mg per g, 10 g

50

2

5

 

 

Eye gel 2 mg per g, single dose units 0.6 mL, 30

50

6

5

 

Carmellose

Eye drops containing carmellose sodium 10 mg per mL, single dose units 0.4 mL, 30

50

6

5

 

 

Eye drops containing carmellose sodium 5 mg per mL, 10 mL

50

2

5

 

 

Eye drops containing carmellose sodium 5 mg per mL, single dose units 0.4 mL, 30

50

6

5

 

  1.        Schedule 2, after entry for Chlortalidone

insert:

Ciclesonide

Pressurised inhalation 80 micrograms per dose, 120 doses (CFC-free formulation)

50

2

5

 

 

Pressurised inhalation 160 micrograms per dose, 120 doses (CFC-free formulation)

50

2

5

 

  1.        Schedule 2, after entry for Ciclosporin in the form Oral liquid 100 mg per mL, 50 mL

insert:

Citalopram

Tablet 10 mg (as hydrobromide)

50

56

2

 

 

Tablet 20 mg (as hydrobromide)

50

56

2

 

 

Tablet 40 mg (as hydrobromide)

50

56

2

 

  1.        Schedule 2, after entry for Clopidogrel with aspirin

insert:

Colestyramine

Sachets containing 4.7 g oral powder (equivalent to 4 g colestyramine), 50

50

4

5

 

  1.        Schedule 2, after entry for Desmopressin in the form Wafer 240 micrograms (as acetate)

insert:

Desvenlafaxine

Tablet (extended release) 100 mg (as succinate)

50

56

2

 

 

Tablet (extended release) 50 mg (as succinate)

50

56

2

 

 

Tablet (modified release) 100 mg

50

56

2

 

 

Tablet (modified release) 100 mg (as benzoate)

50

56

2

 

 

Tablet (modified release) 50 mg

50

56

2

 

 

Tablet (modified release) 50 mg (as benzoate)

50

56

2

 

  1.        Schedule 2, after entry for Dexamethasone

insert:

Diltiazem

Capsule (controlled delivery) containing diltiazem hydrochloride 180 mg

50

60

5

 

 

Capsule (controlled delivery) containing diltiazem hydrochloride 240 mg

50

60

5

 

 

Capsule (controlled delivery) containing diltiazem hydrochloride 360 mg

50

60

5

 

 

Tablet containing diltiazem hydrochloride 60 mg

50

180

5

 

Dorzolamide

Eye drops 20 mg (as hydrochloride) per mL, 5 mL

50

2

5

 

Dorzolamide with timolol

Eye drops containing dorzolamide 20 mg (as hydrochloride) with timolol 5 mg (as maleate) per mL, 5 mL

50

2

5

 

Doxycycline

Capsule 100 mg (as hyclate) (containing enteric coated pellets)

50

56

2

 

 

Capsule 50 mg (as hyclate) (containing enteric coated pellets)

50

50

2

 

 

Tablet 100 mg (as hyclate)

50

56

2

 

 

Tablet 100 mg (as monohydrate)

50

56

2

 

 

Tablet 50 mg (as hyclate)

50

50

2

 

 

Tablet 50 mg (as monohydrate)

50

50

2

 

  1.        Schedule 2, after entry for Enalapril with hydrochlorothiazide

insert:

Entacapone

Tablet 200 mg

50

400

4

 

  1.        Schedule 2, after entry for Eprosartan

insert:

Eprosartan with hydrochlorothiazide

Tablet 600 mg eprosartan (as mesilate) with 12.5 mg hydrochlorothiazide

50

56

5

 

Erythromycin

Capsule 250 mg (containing enteric coated pellets)

50

100

2

 

Escitalopram

Oral solution 20 mg (as oxalate) per mL, 15 mL

50

2

2

 

 

Tablet 10 mg (as oxalate)

50

56

2

 

 

Tablet 20 mg (as oxalate)

50

56

2

 

Esomeprazole

Capsule (enteric) 20 mg (as magnesium)

50

60

5

 

 

 

50

120

5

 

 

Capsule (enteric) 40 mg (as magnesium)

50

60

5

 

 

 

50

120

5

 

 

Tablet (enteric coated) 20 mg (as magnesium trihydrate)

50

60

5

 

 

 

50

120

5

 

 

Tablet (enteric coated) 40 mg (as magnesium trihydrate)

50

60

5

 

 

 

50

120

5

 

  1.        Schedule 2, entry for Estradiol with norethisterone

substitute:

Estradiol with norethisterone

Transdermal patches containing 510 micrograms estradiol (as hemihydrate) with 4.8 mg norethisterone acetate, 8

50

2

5

 

 

Transdermal patches containing 620 micrograms estradiol (as hemihydrate) with 2.7 mg norethisterone acetate, 8

50

2

5

 

  1.        Schedule 2, after entry for Fenofibrate in the form Tablet 145 mg

insert:

Fluoxetine

Capsule 20 mg (as hydrochloride)

50

56

2

 

Fluticasone furoate

Powder for oral inhalation in breath actuated device containing fluticasone furoate 100 micrograms per dose, 30 doses

50

2

5

 

 

Powder for oral inhalation in breath actuated device containing fluticasone furoate 200 micrograms per dose, 30 doses

50

2

5

 

Fluticasone furoate with umeclidinium and vilanterol

Powder for oral inhalation in breath actuated device containing fluticasone furoate 100 micrograms with umeclidinium 62.5 micrograms (as bromide) and vilanterol 25 micrograms (as trifenatate) per dose, 30 doses

50

2

5

 

 

Powder for oral inhalation in breath actuated device containing fluticasone furoate 200 micrograms with umeclidinium 62.5 micrograms (as bromide) and vilanterol 25 micrograms (as trifenatate) per dose, 30 doses

50

2

5

 

Fluticasone furoate with vilanterol

Powder for oral inhalation in breath actuated device containing fluticasone furoate 100 micrograms with vilanterol 25 micrograms (as trifenatate) per dose, 30 doses

50

2

5

 

 

Powder for oral inhalation in breath actuated device containing fluticasone furoate 200 micrograms with vilanterol 25 micrograms (as trifenatate) per dose, 30 doses

50

2

5

 

Fluticasone propionate

Powder for oral inhalation in breath actuated device containing fluticasone propionate 100 micrograms per dose, 60 doses

50

2

5

 

 

Powder for oral inhalation in breath actuated device containing fluticasone propionate 250 micrograms per dose, 60 doses

50

2

5

 

 

Pressurised inhalation containing fluticasone propionate 125 micrograms per dose, 120 doses (CFC-free formulation)

50

2

5

 

 

Pressurised inhalation containing fluticasone propionate 50 micrograms per dose, 120 doses (CFC-free formulation)

50

2

5

 

Fluticasone propionate with formoterol

Pressurised inhalation containing fluticasone propionate 125 micrograms with formoterol fumarate dihydrate 5 micrograms per dose, 120 doses

50

2

5

 

 

Pressurised inhalation containing fluticasone propionate 250 micrograms with formoterol fumarate dihydrate 10 micrograms per dose, 120 doses

50

2

5

 

 

Pressurised inhalation containing fluticasone propionate 50 micrograms with formoterol fumarate dihydrate 5 micrograms per dose, 120 doses

50

2

5

 

Fluticasone propionate with salmeterol

Powder for oral inhalation in breath actuated device containing fluticasone propionate 100 micrograms with salmeterol 50 micrograms (as xinafoate) per dose, 60 doses

50

2

5

 

 

Powder for oral inhalation in breath actuated device containing fluticasone propionate 250 micrograms with salmeterol 50 micrograms (as xinafoate) per dose, 60 doses

50

2

5

 

 

Powder for oral inhalation in breath actuated device containing fluticasone propionate 500 micrograms with salmeterol 50 micrograms (as xinafoate) per dose, 60 doses

50

2

5

 

 

Pressurised inhalation containing fluticasone propionate 125 micrograms with salmeterol 25 micrograms (as xinafoate) per dose, 120 doses (CFC-free formulation)

50

2

5

 

 

Pressurised inhalation containing fluticasone propionate 250 micrograms with salmeterol 25 micrograms (as xinafoate) per dose, 120 doses (CFC-free formulation)

50

2

5

 

 

Pressurised inhalation containing fluticasone propionate 50 micrograms with salmeterol 25 micrograms (as xinafoate) per dose, 120 doses (CFC-free formulation)

50

2

5

 

  1.        Schedule 2, after entry for Fluvastatin

insert:

Fluvoxamine

Tablet containing fluvoxamine maleate 100 mg

50

60

2

 

 

Tablet containing fluvoxamine maleate 50 mg

50

60

2

 

Formoterol

Capsule containing powder for oral inhalation containing formoterol fumarate dihydrate 12 micrograms (for use in Foradile Aerolizer)

50

120

5

 

 

Powder for oral inhalation in breath actuated device containing formoterol fumarate dihydrate 12 micrograms per dose, 60 doses

50

2

5

 

 

Powder for oral inhalation in breath actuated device containing formoterol fumarate dihydrate 6 micrograms per dose, 60 doses

50

2

5

 

  1.        Schedule 2, entry for Glyceryl trinitrate

substitute:

Glyceryl trinitrate

Sublingual spray (pump pack) 400 micrograms per dose, 200 doses

50

2

5

 

 

Transdermal patch 18 mg

50

60

5

 

 

Transdermal patch 25 mg

50

60

5

 

 

Transdermal patch 36 mg

50

60

5

 

 

Transdermal patch 50 mg

50

60

5

 

 

Transdermal patch 54 mg

50

60

5

 

  1.        Schedule 2, after entry for Glyceryl trinitrate in the form Transdermal patch 54 mg

insert:

Glycopyrronium

Capsule containing powder for oral inhalation 50 micrograms (as bromide) (for use in Breezhaler)

50

60

5

 

Hyaluronic acid

Eye drops containing sodium hyaluronate 1 mg per mL, 10 mL

50

2

5

 

 

Eye drops containing sodium hyaluronate 2 mg per mL, 10 mL

50

2

5

 

  1.        Schedule 2, after entry for Hydrocortisone

insert:

 

Tablet 20 mg

50

120

4

 

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

insert:

Hypromellose

0.3% w/v eye drops, 10 mL (preservative free)

50

2

5

 

 

Eye drops 3 mg per mL, 10 mL

50

2

5

 

 

Eye drops 5 mg per mL, 15 mL

50

2

5

 

Hypromellose with dextran

Eye drops containing 3 mg hypromellose 4500 with 1 mg dextran 70 per mL, 15 mL

50

2

5

 

Indacaterol

Capsule containing powder for oral inhalation 150 micrograms (as maleate) (for use in Breezhaler)

50

60

5

 

 

Capsule containing powder for oral inhalation 300 micrograms (as maleate) (for use in Breezhaler)

50

60

5

 

Indacaterol with glycopyrronium

Capsule containing powder for oral inhalation indacaterol 110 micrograms (as maleate) with glycopyrronium 50 micrograms (as bromide) (for use in Breezhaler)

50

60

5

 

Indacaterol with glycopyrronium and mometasone

Capsule containing powder for oral inhalation indacaterol 114 micrograms (as maleate) with glycopyrronium 46 micrograms (as bromide) and mometasone furoate 136 micrograms (for use in Breezhaler)

50

60

5

 

 

Capsule containing powder for oral inhalation indacaterol 114 micrograms (as maleate) with glycopyrronium 46 micrograms (as bromide) and mometasone furoate 68 micrograms (for use in Breezhaler)

50

60

5

 

Indacaterol with mometasone

Capsule containing powder for oral inhalation indacaterol 125 micrograms (as acetate) with mometasone furoate 127.5 micrograms (for use in Breezhaler)

50

60

5

 

 

Capsule containing powder for oral inhalation indacaterol 125 micrograms (as acetate) with mometasone furoate 260 micrograms (for use in Breezhaler)

50

60

5

 

 

Capsule containing powder for oral inhalation indacaterol 125 micrograms (as acetate) with mometasone furoate 62.5 micrograms (for use in Breezhaler)

50

60

5

 

  1.        Schedule 2, after entry for Lamotrigine in the form Tablet 200 mg

insert:

Lansoprazole

Capsule 15 mg

50

60

5

 

 

Capsule 30 mg

50

56

5

 

 

 

50

112

5

 

 

Tablet 15 mg (orally disintegrating)

50

56

5

 

 

Tablet 30 mg (orally disintegrating)

50

56

5

 

 

 

50

112

5

 

  1.        Schedule 2, after entry for Lanthanum in the form Tablet, chewable, 1000 mg (as carbonate hydrate)

insert:

Latanoprost

Eye drops 50 micrograms per mL, 2.5 mL

50

2

5

 

Latanoprost with timolol

Eye drops 50 micrograms latanoprost with timolol 5 mg (as maleate) per mL, 2.5 mL

50

2

5

 

  1.        Schedule 2, after entry for Levetiracetam in the form Tablet 1 g

insert:

Levodopa with benserazide

Capsule containing levodopa 100 mg with 25 mg benserazide (as hydrochloride)

50

200

5

 

 

Capsule containing levodopa 100 mg with 25 mg benserazide (as hydrochloride) (sustained release)

50

200

5

 

 

Capsule containing levodopa 50 mg with 12.5 mg benserazide (as hydrochloride)

50

200

5

 

 

Capsule containing levodopa 200 mg with 50 mg benserazide (as hydrochloride)

50

200

5

 

 

Dispersible tablet containing levodopa 50 mg with 12.5 mg benserazide (as hydrochloride)

50

200

5

 

 

Dispersible tablet containing levodopa 100 mg with 25 mg benserazide (as hydrochloride)

50

200

5

 

 

Tablet containing levodopa 100 mg with 25 mg benserazide (as hydrochloride)

50

200

5

 

 

Tablet containing levodopa 200 mg with 50 mg benserazide (as hydrochloride)

50

200

5

 

Levodopa with carbidopa

Tablet (modified release) 200 mg-50 mg (as monohydrate)

50

200

5

 

 

Tablet 100 mg-25 mg (as monohydrate)

50

200

5

 

 

Tablet 250 mg-25 mg (as monohydrate)

50

200

5

 

Levodopa with carbidopa and entacapone

Tablet 50 mg-12.5 mg (as monohydrate)-200 mg

50

400

4

 

 

Tablet 75 mg-18.75 mg (as monohydrate)-200 mg

50

400

4

 

 

Tablet 100 mg-25 mg (as monohydrate)-200 mg

50

400

4

 

 

Tablet 125 mg-31.25 mg (as monohydrate)-200 mg

50

400

4

 

 

Tablet 150 mg-37.5 mg (as monohydrate)-200 mg

50

400

4

 

 

Tablet 200 mg-50 mg (as monohydrate)-200 mg

50

400

4

 

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

insert:

Macrogol 3350

Powder for oral solution 510 g

50

2

5

 

 

Sachets containing powder for oral solution 13.125 g with electrolytes, 30

50

2

5

 

  1.        Schedule 2, after entry for Metoprolol succinate in the form Tablet 190 mg (controlled release)

insert:

Mianserin

Tablet containing mianserin hydrochloride 10 mg

50

100

2

 

 

Tablet containing mianserin hydrochloride 20 mg

50

100

2

 

Minocycline

Tablet 50 mg (as hydrochloride)

50

120

2

 

  1.        Schedule 2, after entry for Minoxidil

insert:

Mirtazapine

Tablet 15 mg

50

60

2

 

 

Tablet 15 mg (orally disintegrating)

50

60

2

 

 

Tablet 30 mg

50

60

2

 

 

Tablet 30 mg (orally disintegrating)

50

60

2

 

 

Tablet 45 mg

50

60

2

 

 

Tablet 45 mg (orally disintegrating)

50

60

2

 

Moclobemide

Tablet 150 mg

50

120

2

 

 

Tablet 300 mg

50

120

2

 

Montelukast

Tablet, chewable, 4 mg (as sodium)

50

56

5

 

 

Tablet, chewable, 5 mg (as sodium)

50

56

5

 

  1.        Schedule 2, after entry for Nifedipine in the form Tablet 60 mg (controlled release)

insert:

Nizatidine

Capsule 150 mg

50

120

5

 

 

Capsule 300 mg

50

60

5

 

  1.        Schedule 2, after entry for Olmesartan with hydrochlorothiazide in the form Tablet containing olmesartan medoxomil 40 mg with hydrochlorothiazide 25 mg

insert:

Omeprazole

Capsule 20 mg

50

60

5

 

 

 

50

120

5

 

 

Tablet 10 mg (as magnesium)

50

60

5

 

 

Tablet 20 mg

50

60

5

 

 

 

50

120

5

 

 

Tablet 20 mg (as magnesium)

50

60

5

 

 

 

50

120

5

 

  1.        Schedule 2, after entry for Oxcarbazepine in the form Oral suspension 60 mg per mL, 250 mL

insert:

 

Tablet 150 mg

50

200

5

 

  1.        Schedule 2, after entry for Pancreatic extract in the form Granules (enteric coated) providing not less than 5,000 BP units of lipase activity per 100 mg, 20 g

insert:

Pantoprazole

Sachet containing granules 40 mg (as sodium sesquihydrate)

50

60

5

 

 

 

50

120

5

 

 

Tablet (enteric coated) 20 mg (as sodium sesquihydrate)

50

60

5

 

 

Tablet (enteric coated) 40 mg (as sodium sesquihydrate)

50

60

5

 

 

 

50

120

5

 

Paraffin

Eye drops containing liquid paraffin, glycerol, tyloxapol, poloxamer-188, trometamol hydrochloride, trometamol, cetalkonium chloride, 10 mL (preservative free)

50

2

5

 

 

Eye ointment, compound, containing white soft paraffin with liquid paraffin, 3.5 g

50

4

5

 

 

Pack containing 2 tubes eye ointment, compound, containing white soft paraffin with liquid paraffin, 3.5 g

50

2

5

 

Paroxetine

Tablet 20 mg (as hydrochloride)

50

60

2

 

  1.        Schedule 2, after entry for Perampanel in the form Tablet 12 mg (as hemisesquihydrate)

insert:

Perfluorohexyloctane

Eye drops, 3 mL

50

2

5

 

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

insert:

Pilocarpine

Eye drops containing pilocarpine hydrochloride 10 mg per mL, 15 mL

50

2

5

 

 

Eye drops containing pilocarpine hydrochloride 20 mg per mL, 15 mL

50

2

5

 

 

Eye drops containing pilocarpine hydrochloride 40 mg per mL, 15 mL

50

2

5

 

  1.        Schedule 2, after entry for Pizotifen

insert:

Polyethylene glycol 400 with propylene glycol

Eye drops 4 mg-3 mg per mL, 15 mL

50

2

5

 

 

Eye drops 4 mg-3 mg per mL, single dose units 0.8 mL, 30

50

4

5

 

  1.        Schedule 2, after entry for Potassium chloride with potassium bicarbonate

insert:

Pramipexole

Tablet (extended release) containing pramipexole dihydrochloride monohydrate 1.5 mg

50

60

5

 

 

Tablet (extended release) containing pramipexole dihydrochloride monohydrate 2.25 mg

50

60

5

 

 

Tablet (extended release) containing pramipexole dihydrochloride monohydrate 3 mg

50

60

5

 

 

Tablet (extended release) containing pramipexole dihydrochloride monohydrate 3.75 mg

50

60

5

 

 

Tablet (extended release) containing pramipexole dihydrochloride monohydrate 375 micrograms

50

60

5

 

 

Tablet (extended release) containing pramipexole dihydrochloride monohydrate 4.5 mg

50

60

5

 

 

Tablet (extended release) containing pramipexole dihydrochloride monohydrate 750 micrograms

50

60

5

 

 

Tablet containing pramipexole dihydrochloride monohydrate 1 mg

50

200

5

 

 

Tablet containing pramipexole dihydrochloride monohydrate 250 micrograms

50

200

5

 

  1.        Schedule 2, after entry for Propylthiouracil

insert:

Pyridostigmine

Tablet containing pyridostigmine bromide 10 mg

50

200

5

 

 

Tablet containing pyridostigmine bromide 180 mg (modified release)

50

200

5

 

 

Tablet containing pyridostigmine bromide 60 mg

50

300

5

 

  1.        Schedule 2, after entry for Quinagolide

insert:

Rabeprazole

Tablet containing rabeprazole sodium 10 mg (enteric coated)

50

56

5

 

 

Tablet containing rabeprazole sodium 20 mg (enteric coated)

50

60

5

 

 

 

50

120

5

 

  1.        Schedule 2, after entry for Ramipril with felodipine in the form Tablet 5 mg-5 mg (modified release)

insert:

Rasagiline

Tablet 1 mg (as mesilate)

50

60

5

 

Reboxetine

Tablet 4 mg (as mesilate)

50

120

2

 

Riluzole

Oral suspension 50 mg per 10 mL, 300 mL

50

4

5

 

 

Tablet 50 mg

50

112

5

 

  1.        Schedule 2, after entry for Rosuvastatin in the form Tablet 40 mg (as calcium)

insert:

Rotigotine

Transdermal patch 4.5 mg

50

56

5

 

 

Transdermal patch 9 mg

50

56

5

 

 

Transdermal patch 13.5 mg

50

56

5

 

 

Transdermal patch 18 mg

50

56

5

 

  1.        Schedule 2, after entry for Sacubitril with valsartan in the form Tablet containing sacubitril 97.2 mg with valsartan 102.8 mg

insert:

Safinamide

Tablet 50 mg

50

60

5

 

 

Tablet 100 mg

50

60

5

 

Salmeterol

Powder for oral inhalation in breath actuated device 50 micrograms (as xinafoate) per dose, 60 doses

50

2

5

 

  1.        Schedule 2, after entry for Saxagliptin with metformin in the form Tablet (modified release) containing 5 mg saxagliptin (as hydrochloride) with 1000 mg metformin hydrochloride

insert:

Selegiline

Tablet containing selegiline hydrochloride 5 mg

50

200

5

 

Sertraline

Tablet 50 mg (as hydrochloride)

50

60

2

 

 

Tablet 100 mg (as hydrochloride)

50

60

2

 

  1.        Schedule 2, after entry for Sodium bicarbonate

insert:

Sorbitol with sodium citrate dihydrate and sodium lauryl sulfoacetate

Enemas 3.125 g-450 mg-45 mg in 5 mL, 12

50

4

2

 

Soy lecithin

Eye spray 10 mg per mL, 10 mL

50

4

5

 

  1.        Schedule 2, after entry for Telmisartan with hydrochlorothiazide in the form Tablet 80 mg-25 mg

insert:

Teriparatide

Injection 250 micrograms per mL, 2.4 mL in multi‑dose pre‑filled pen

50

2

2

 

  1.        Schedule 2, entry for Testosterone

insert as first entry:

 

Transdermal cream 50 mg per mL, 50 mL

50

2

1

 

  1.        Schedule 2, after entry for Testosterone in the form Transdermal gel (pump pack) 23 mg per 1.15 g dose, 56 doses

insert:

Tetrabenazine

Tablet 25 mg

50

224

5

 

  1.        Schedule 2, after entry for Ticagrelor

insert:

Tiotropium

Capsule containing powder for oral inhalation 13 micrograms (as bromide) (for use in Zonda device)

50

60

5

 

 

Capsule containing powder for oral inhalation 18 micrograms (as bromide monohydrate) (for use in HandiHaler)

50

60

5

 

 

Capsule containing powder for oral inhalation 18 micrograms (as bromide monohydrate) (for use in LupinHaler)

50

60

5

 

 

Solution for oral inhalation 2.5 micrograms (as bromide monohydrate) per actuation (60 actuations)

50

2

5

 

Tiotropium with olodaterol

Solution for oral inhalation containing tiotropium 2.5 micrograms (as bromide monohydrate) with olodaterol 2.5 micrograms (as hydrochloride) per dose, 60 doses

50

2

5

 

  1.        Schedule 2, after entry for Trandolapril with verapamil in the form Tablet containing trandolapril 4 mg with verapamil hydrochloride 240 mg (sustained release)

insert:

Tranylcypromine

Tablet 10 mg (as sulfate)

50

100

1

 

Travoprost

Eye drops 40 micrograms per mL, 2.5 mL

50

2

5

 

Travoprost with timolol

Eye drops 40 micrograms travoprost with timolol 5 mg (as maleate) per mL, 2.5 mL

50

2

5

 

Umeclidinium

Powder for oral inhalation in breath actuated device 62.5 micrograms (as bromide) per dose, 30 doses

50

2

5

 

Umeclidinium with vilanterol

Powder for oral inhalation in breath actuated device containing umeclidinium 62.5 micrograms (as bromide) with vilanterol 25 micrograms (as trifenatate) per dose, 30 doses

50

2

5

 

  1.        Schedule 2, after entry for Valsartan with hydrochlorothiazide in the form Tablet 320 mg-25 mg

insert:

Venlafaxine

Capsule (modified release) 75 mg (as hydrochloride)

50

56

2

 

 

Capsule (modified release) 150 mg (as hydrochloride)

50

56

2