National Health Determination under paragraph 98C(1)(b) Amendment 2018 (No. 5) (PB 64 of 2018) (Cth)
PB 64 of 2018
National Health Determination under paragraph 98C(1)(b) Amendment 2018 (No. 5)
National Health Act 1953
___________________________________________________________________________
I, LISA LA RANCE, Assistant Secretary, Pricing and PBS Policy Branch, Technology Assessment and Access Division, Department of Health, delegate of the Minister for Health, make this Instrument under paragraph 98C(1)(b) of the National Health Act 1953.
Dated 27 JULY 2018
LISA LA RANCE
Assistant Secretary
Pricing and PBS Policy Branch
Technology Assessment and Access Division
Department of Health
___________________________________________________________________________
Name of Instrument
(1)This Instrument is the National Health Determination under paragraph 98C(1)(b) Amendment 2018 (No. 5).
(2)This Instrument may also be cited as PB 64 of 2018.
Commencement
This Instrument commences on 1 August 2018.
Amendments to Determination under paragraph 98C(1)(b) of the National Health Act 1953 (PB 119 of 2008)
Schedule 1 amends the Determination under paragraph 98C(1)(b) of the National Health Act 1953 (PB 119 of 2008).
Schedule 1 Amendments
Schedule 1, entry for Amoxycillin with Water – Purified BP
omit from the column headed "Listed Drug": Amoxycillin substitute: Amoxicillin
Schedule 1, entry for Amoxycillin with Clavulanic Acid and Water – Purified BP
(a)omit from the column headed "Listed Drug": Amoxycillin with Clavulanic Acid and Water
substitute: Amoxicillin with clavulanic acid and water – purified BP
(b) omit from the column headed "Form": Powder for oral suspension containing 125 mg amoxycillin (as trihydrate) with 31.25 mg clavulanic acid (as potassium clavulanate) per 5 mL, 75 mL substitute: Powder for oral suspension containing 125 mg amoxicillin (as trihydrate) with 31.25 mg clavulanic acid (as potassium clavulanate) per 5 mL, 75 mL (c) omit from the column headed "Form": Powder for oral suspension containing 400 mg amoxycillin (as trihydrate) with 57 mg clavulanic acid (as potassium clavulanate) per 5 mL, 60 mL substitute: Powder for oral suspension containing 400 mg amoxicillin (as trihydrate) with 57 mg clavulanic acid (as potassium clavulanate) per 5 mL, 60 mL
Schedule 1, after entry for Cefaclor with Water – Purified BP
insert:
Cefalexin with water – purified BP Granules for oral suspension 125 mg (as monohydrate) per 5 mL, 100 mL Granules for oral suspension 250 mg (as monohydrate) per 5 mL, 100 mL
Schedule 1, omit entry for Cephalexin with Water – Purified BP
Schedule 1, entry for Flucloxacillin with Water – Purified BP
(a)omit from the column headed "Form": Powder for oral liquid 125 mg (as sodium) per 5 mL, 100 mL
substitute: Powder for oral liquid 125 mg (as sodium monohydrate) per 5 mL, 100 mL
(b)omit from the column headed "Form": Powder for oral liquid 250 mg (as sodium) per 5 mL, 100 mL
substitute: Powder for oral liquid 250 mg (as sodium monohydrate) per 5 mL, 100 mL
Schedule 1, entry for Valganciclovir
omit from the column headed "Listed Drug": Valganciclovir substitute: Valganciclovir with water — purified BP
Schedule 3, entry for Codeine
omit from the column headed "Form": Tablet containing codeine phosphate 30 mg
substitute: Tablet containing codeine phosphate hemihydrate 30 mg
Schedule 3, entry for Dexamphetamine
(a)omit from the column headed "Listed Drug": Dexamphetamine substitute: Dexamfetamine
(b)omit from the column headed "Form": Tablet containing dexamphetamine sulfate 5 mg
substitute: Tablet containing dexamfetamine sulfate 5 mg
Schedule 3, entry for Morphine
substitute:
Morphine Capsule containing morphine sulfate pentahydrate 10 mg (containing sustained release pellets) Capsule containing morphine sulfate pentahydrate 20 mg (containing sustained release pellets) Capsule containing morphine sulfate pentahydrate 50 mg (containing sustained release pellets) Capsule containing morphine sulfate pentahydrate 100 mg (containing sustained release pellets) Capsule containing morphine sulfate pentahydrate 30 mg (controlled release) Capsule containing morphine sulfate pentahydrate 60 mg (controlled release) Capsule containing morphine sulfate pentahydrate 90 mg (controlled release) Capsule containing morphine sulfate pentahydrate 120 mg (controlled release) Injection containing morphine hydrochloride trihydrate 10 mg in 1 mL Injection containing morphine hydrochloride trihydrate 20 mg in 1 mL Injection containing morphine hydrochloride trihydrate 50 mg in 5 mL Injection containing morphine hydrochloride trihydrate 100 mg in 5 mL Injection containing morphine sulfate pentahydrate 10 mg in 1 mL Injection containing morphine sulfate pentahydrate 15 mg in 1 mL Injection containing morphine sulfate pentahydrate 30 mg in 1 mL Injection containing morphine tartrate 120 mg in 1.5 mL Oral solution containing morphine hydrochloride trihydrate 2 mg per mL, 200 mL Oral solution containing morphine hydrochloride trihydrate 5 mg per mL, 200 mL Oral solution containing morphine hydrochloride trihydrate 10 mg per mL, 200 mL Sachet containing controlled release granules for oral suspension, containing morphine sulfate pentahydrate 20 mg per sachet Sachet containing controlled release granules for oral suspension, containing morphine sulfate pentahydrate 30 mg per sachet Sachet containing controlled release granules for oral suspension, containing morphine sulfate pentahydrate 60 mg per sachet Sachet containing controlled release granules for oral suspension, containing morphine sulfate pentahydrate 100 mg per sachet Sachet containing controlled release granules for oral suspension, containing morphine sulfate pentahydrate 200 mg per sachet Tablet containing morphine sulfate pentahydrate 10 mg Tablet containing morphine sulfate pentahydrate 20 mg Tablet containing morphine sulfate pentahydrate 30 mg Tablet containing morphine sulfate pentahydrate 5 mg (controlled release) Tablet containing morphine sulfate pentahydrate 10 mg (controlled release) Tablet containing morphine sulfate pentahydrate 15 mg (controlled release) Tablet containing morphine sulfate pentahydrate 30 mg (controlled release) Tablet containing morphine sulfate pentahydrate 60 mg (controlled release) Tablet containing morphine sulfate pentahydrate 100 mg (controlled release) Tablet containing morphine sulfate pentahydrate 200 mg (controlled release)
Schedule 4, entry for Aclidinium with eformoterol
(a)omit from the column headed "Listed Drug": Aclidinium with eformoterol substitute: Aclidinium with formoterol
(b) omit from the column headed "Form": Powder for oral inhalation in breath actuated device containing aclidinium 340 micrograms (as bromide) with eformoterol fumarate dihydrate 12 micrograms per dose, 60 doses substitute: Powder for oral inhalation in breath actuated device containing aclidinium 340 micrograms (as bromide) with formoterol fumarate dihydrate 12 micrograms per dose, 60 doses
Schedule 4, entry for Amoxycillin
omit from the column headed "Listed Drug": Amoxycillin substitute: Amoxicillin
Schedule 4, entry for Amoxycillin with Clavulanic Acid
(a)omit from the column headed "Listed Drug": Amoxycillin with Clavulanic Acid substitute: Amoxicillin with clavulanic acid
(b) omit from the column headed "Form": Powder for oral suspension containing 125 mg amoxycillin (as trihydrate) with 31.25 mg clavulanic acid (as potassium clavulanate) per 5 mL, 75 mL substitute: Powder for oral suspension containing 125 mg amoxicillin (as trihydrate) with 31.25 mg clavulanic acid (as potassium clavulanate) per 5 mL, 75 mL (c) omit from the column headed "Form": Powder for oral suspension containing 400 mg amoxycillin (as trihydrate) with 57 mg clavulanic acid (as potassium clavulanate) per 5 mL, 60 mL substitute: Powder for oral suspension containing 125 mg amoxicillin (as trihydrate) with 31.25 mg clavulanic acid (as potassium clavulanate) per 5 mL, 75 mL
Schedule 4, entry for Atropine
omit from the column headed "Form": Eye drops containing atropine sulfate 10 mg per mL, 15 mL
substitute: Eye drops containing atropine sulfate monohydrate 10 mg per mL, 15 mL
Schedule 4, entry for Beclomethasone
(a)omit from the column headed "Listed Drug": Beclomethasone substitute: Beclometasone
(b) omit from the column headed "Form": Pressurised inhalation containing beclomethasone dipropionate 50 micrograms per dose, 200 doses (CFC free formulation) substitute: Pressurised inhalation containing beclometasone dipropionate 50 micrograms per dose, 200 doses (CFC free formulation) (c) omit from the column headed "Form": Pressurised inhalation containing beclomethasone dipropionate 100 micrograms per dose, 200 doses (CFC free formulation) substitute: Pressurised inhalation containing beclometasone dipropionate 100 micrograms per dose, 200 doses (CFC free formulation) (d) omit from the column headed "Form": Pressurised inhalation in breath actuated device containing beclomethasone dipropionate 50 micrograms per dose, 200 doses (CFC free formulation) substitute: Pressurised inhalation in breath actuated device containing beclometasone dipropionate 50 micrograms per dose, 200 doses (CFC free formulation) (e) omit from the column headed "Form": Pressurised inhalation in breath actuated device containing beclomethasone dipropionate 100 micrograms per dose, 200 doses (CFC free formulation) substitute: Pressurised inhalation in breath actuated device containing beclometasone dipropionate 100 micrograms per dose, 200 doses (CFC free formulation)
Schedule 4, entry for Budesonide with Eformoterol
(a)omit from the column headed "Listed Drug": Budesonide with Eformoterol substitute: Budesonide with formoterol
(b) omit from the column headed "Form": Powder for oral inhalation in breath actuated device containing budesonide 100 micrograms with eformoterol fumarate dihydrate 6 micrograms per dose, 120 doses substitute: Powder for oral inhalation in breath actuated device containing budesonide 100 micrograms with formoterol fumarate dihydrate 6 micrograms per dose, 120 doses (c) omit from the column headed "Form": Powder for oral inhalation in breath actuated device containing budesonide 200 micrograms with eformoterol fumarate dihydrate 6 micrograms per dose, 120 doses substitute: Powder for oral inhalation in breath actuated device containing budesonide 200 micrograms with formoterol fumarate dihydrate 6 micrograms per dose, 120 doses (d) omit from the column headed "Form": Powder for oral inhalation in breath actuated device containing budesonide 400 micrograms with eformoterol fumarate dihydrate 12 micrograms per dose, 60 doses, 2 substitute: Powder for oral inhalation in breath actuated device containing budesonide 400 micrograms with formoterol fumarate dihydrate 12 micrograms per dose, 60 doses, 2
Schedule 4, after entry for Cefaclor
insert:
Cefalexin Granules for oral suspension 125 mg (as monohydrate) per 5 mL, 100 mL Granules for oral suspension 250 mg (as monohydrate) per 5 mL, 100 mL
Schedule 4, omit entry for Cephalexin
Schedule 4, after entry for Clonazepam
insert:
Clozapine Oral liquid 50 mg per mL, 100 mL
Schedule 4, omit entry for Eformoterol
Schedule 4, entry for Electrolyte Replacement, Oral
omit from the column headed "Form": Oral rehydration salts containing glucose 3.56 g, sodium chloride 470 mg, potassium chloride 300 mg and sodium acid citrate 530 mg per sachet, 10 substitute: Oral rehydration salts containing glucose monohydrate 3.56 g, sodium chloride 470 mg, potassium chloride 300 mg and sodium acid citrate 530 mg per sachet, 10
Schedule 4, entry for Esomeprazole and Clarithromycin and Amoxycillin
(a)omit from the column headed "Listed Drug": Esomeprazole and Clarithromycin and Amoxycillin
substitute: Esomeprazole and clarithromycin and amoxicillin
(b) omit from the column headed "Form": Pack containing 14 tablets (enteric coated) containing esomeprazole 20 mg (as magnesium), 14 tablets clarithromycin 500 mg and 28 capsules amoxycillin 500 mg (as trihydrate) substitute: Pack containing 14 tablets (enteric coated) containing esomeprazole 20 mg (as magnesium), 14 tablets clarithromycin 500 mg and 28 capsules amoxicillin 500 mg (as trihydrate) (c) omit from the column headed "Form": Pack containing 14 tablets (enteric coated) containing esomeprazole 20 mg (as magnesium trihydrate), 14 tablets clarithromycin 500 mg and 28 capsules amoxycillin 500 mg (as trihydrate) substitute: Pack containing 14 tablets (enteric coated) containing esomeprazole 20 mg (as magnesium trihydrate), 14 tablets clarithromycin 500 mg and 28 capsules amoxicillin 500 mg (as trihydrate)
Schedule 4, after entry for Esomeprazole and clarithromycin and amoxicillin
insert:
Estradiol Transdermal gel 1 mg (as hemihydrate) in 1 g sachet, 28 Transdermal patches 390 micrograms, 8 Transdermal patches 585 micrograms, 8 Transdermal patches 750 micrograms (as hemihydrate), 8 Transdermal patches 780 micrograms, 8 Transdermal patches 1.17 mg, 8 Transdermal patches 1.5 mg (as hemihydrate), 8 Transdermal patches 1.56 mg, 8 Transdermal patches 2 mg, 4 Transdermal patches 3 mg (as hemihydrate), 8 Transdermal patches 3.8 mg, 4 Transdermal patches 5.7 mg, 4 Transdermal patches 7.6 mg, 4
Schedule 4, after entry for Estradiol
insert:
Estradiol and estradiol with dydrogesterone Pack containing 14 tablets estradiol 1 mg and 14 tablets estradiol 1 mg with dydrogesterone 10 mg Pack containing 14 tablets estradiol 2 mg and 14 tablets estradiol 2 mg with dydrogesterone 10 mg
Schedule 4, after entry for Estradiol and estradiol with dydrogesterone
insert:
Estradiol and estradiol with norethisterone Pack containing 4 transdermal patches 780 micrograms estradiol (as hemihydrate) and 4 transdermal patches 510 micrograms estradiol (as hemihydrate) with 4.8 mg norethisterone acetate Pack containing 4 transdermal patches 780 micrograms estradiol (as hemihydrate) and 4 transdermal patches 620 micrograms estradiol (as hemihydrate) with 2.7 mg norethisterone acetate
Schedule 4, after entry for Estradiol and estradiol with norethisterone
insert:
Estradiol with norethisterone Transdermal patches containing 510 micrograms estradiol (as hemihydrate) with 4.8 mg norethisterone acetate, 8 Transdermal patches containing 620 micrograms estradiol (as hemihydrate) with 2.7 mg norethisterone acetate, 8
Schedule 4, after entry for Estradiol with norethisterone
insert:
Estriol Pessaries 500 micrograms, 15 Vaginal cream 1 mg per g, 15 g
Schedule 4, entry for Ferrous Sulfate
omit from the column headed "Form": Oral liquid 30 mg per mL, 250 mL
substitute: Oral liquid containing 30 mg ferrous sulfate heptahydrate per mL, 250 mL
Schedule 4, entry for Flucloxacillin
(a)omit from the column headed "Form": Powder for oral liquid 125 mg (as sodium) per 5 mL, 100 mL
substitute: Powder for oral liquid 125 mg (as sodium monohydrate) per 5 mL, 100 mL
(b)omit from the column headed "Form": Powder for oral liquid 250 mg (as sodium) per 5 mL, 100 mL
substitute: Powder for oral liquid 250 mg (as sodium monohydrate) per 5 mL, 100 mL
Schedule 4, entry for Fluticasone with eformoterol
(a)omit from the column headed "Listed Drug": Fluticasone with eformoterol substitute: Fluticasone with formoterol
(b) omit from the column headed "Form": Pressurised inhalation containing fluticasone propionate 50 micrograms with eformoterol fumarate dihydrate 5 micrograms per dose, 120 doses substitute: Pressurised inhalation containing fluticasone propionate 50 micrograms with formoterol fumarate dihydrate 5 micrograms per dose, 120 doses (c) omit from the column headed "Form": Pressurised inhalation containing fluticasone propionate 125 micrograms with eformoterol fumarate dihydrate 5 micrograms per dose, 120 doses substitute: Pressurised inhalation containing fluticasone propionate 125 micrograms with formoterol fumarate dihydrate 5 micrograms per dose, 120 doses (d) omit from the column headed "Form": Pressurised inhalation containing fluticasone propionate 250 micrograms with eformoterol fumarate dihydrate 10 micrograms per dose, 120 doses substitute: Pressurised inhalation containing fluticasone propionate 250 micrograms with formoterol fumarate dihydrate 10 micrograms per dose, 120 doses
Schedule 4, after entry for Fluticasone with Salmeterol
insert:
Formoterol Powder for oral inhalation in breath actuated device containing formoterol fumarate dihydrate 6 micrograms per dose, 60 doses Powder for oral inhalation in breath actuated device containing formoterol fumarate dihydrate 12 micrograms per dose, 60 doses
Schedule 4, entry for Frusemide
omit from the column headed "Listed Drug": Frusemide substitute: Furosemide
Schedule 4, entry for Mercaptopurine
omit from the column headed "Form": Oral suspension 20 mg per mL, 100 mL
substitute: Oral suspension containing mercaptopurine monohydrate 20 mg per mL, 100 mL
Schedule 4, omit entry for Oestradiol
Schedule 4, omit entry for Oestradiol and Oestradiol with Dydrogesterone
Schedule 4, omit entry for Oestradiol and Oestradiol with Norethisterone
Schedule 4, omit entry for Oestradiol with Norethisterone
Schedule 4, omit entry for Oestriol
Schedule 4, entry for Tiotropium
reorder in the table alphabetically for the column headed “Listed Drug”
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