National Health Act 1953 Amendment declaration under subsections 85(2) and 85(2AA) Amendment determination under subsection 85(2A) drugs and medicinal preparations (No. PB 44 of 2010) (Cth)

Case

COMMONWEALTH OF AUSTRALIA

Instrument number PB 44 of 2010

Amendment declaration under subsections 85(2) and 85(2AA) of the National Health Act 1953

Amendment determination under subsection 85(2A) of the National Health Act 1953

I, FELICITY McNEILL, Assistant Secretary, Pharmaceutical Evaluation Branch, Department of Health and Ageing, delegate of the Minister for Health and Ageing, make this instrument under subsections 85(2), 85(2A) and 85(2AA) of the National Health Act 1953.

Dated                        12 May 2010

FELICITY McNEILL

Assistant Secretary

Pharmaceutical Evaluation Branch

Department of Health and Ageing

Amendment declaration and determination — drugs and medicinal preparations

1              Commencement

This instrument commences on 1 June 2010.

2              Amendment of PB 14 of 2010

Schedule 1 amends PB 14 of 2010.


Schedule 1        Amendments

  1. Schedule 1, after item dealing with Alendronic acid with colecalciferol

insert in the columns in the order indicated:

Alendronic acid with colecalciferol and calcium

2645

In compliance with authority procedures set out in subparagraph 14 (d):

 Treatment as the sole PBS-subsidised anti-resorptive agent for osteoporosis in a patient aged 70 years of age or older with a bone mineral density T-score of -3.0 or less, and where the date, site (femoral neck or lumbar spine) and score of the qualifying bone mineral density measurement are documented in the patient's medical records when treatment is initiated
2646  Treatment as the sole PBS-subsidised anti-resorptive agent for established osteoporosis in patients with fracture due to minimal trauma, where the fracture has been demonstrated radiologically and the year of plain x-ray or computed tomography scan or magnetic resonance imaging scan is documented in the patient's medical records when treatment is initiated, provided that if the fracture is a vertebral fracture, there is a 20% or greater reduction in height of the anterior or mid portion of the affected vertebral body relative to the posterior height of that body, or, a 20% or greater reduction in any of these heights compared to the vertebral body above or below the affected vertebral body

  1. Schedule 1, omit item dealing with Amino acid formula without methionine, threonine and valine and low in isoleucine

  1. Schedule 1, omit item dealing with Amino acid formula without phenylalanine, tyrosine and methionine

  1. Schedule 1, omit item dealing with Amlodipine with valsartan

and substitute:

Amlodipine with valsartan Hypertension in a patient who is not adequately controlled with either of the drugs in the combination

  1. Schedule 1, omit item dealing with Candesartan with Hydrochlorothiazide

and substitute:

Candesartan with Hydrochlorothiazide Hypertension in a patient who is not adequately controlled with either of the drugs in the combination

  1. Schedule 1, omit item dealing with Ciprofloxacin

and substitute:

Ciprofloxacin

In respect of the tablet 250 mg (as hydrochloride):

In compliance with authority procedures set out in subparagraph 14 (d):
Respiratory tract infection proven or suspected to be caused by Pseudomonas aeruginosa in severely immunocompromised patients
Bacterial gastroenteritis in severely immunocompromised patients
Treatment of infections proven to be due to Pseudomonas aeruginosa or other gram-negative bacteria resistant to all other oral antimicrobials
Treatment of joint and bone infections, epididymo-orchitis, prostatitis or perichondritis of the pinna, suspected or proven to be caused by gram-negative bacteria or gram-positive bacteria resistant to all other appropriate antimicrobials
Gonorrhoea

In respect of the tablet 500 mg (as hydrochloride) and tablet 750 mg (as hydrochloride):

In compliance with authority procedures set out in subparagraph 14 (d):
Respiratory tract infection proven or suspected to be caused by Pseudomonas aeruginosa in severely immunocompromised patients
Bacterial gastroenteritis in severely immunocompromised patients
Treatment of infections proven to be due to Pseudomonas aeruginosa or other gram-negative bacteria resistant to all other oral antimicrobials
Treatment of joint and bone infections, epididymo-orchitis, prostatitis or perichondritis of the pinna, suspected or proven to be caused by gram-negative bacteria or gram-positive bacteria resistant to all other appropriate antimicrobials

In respect of the ear drops 3 mg (as hydrochloride) per mL, 5 mL:

In compliance with authority procedures set out in subparagraph 14 (d):
Treatment of chronic suppurative otitis media in an Aboriginal or a Torres Strait Islander person aged 1 month or older
Treatment of chronic suppurative otitis media in a patient less than 18 years of age with perforation of the tympanic membrane
Treatment of chronic suppurative otitis media in a patient less than 18 years of age with a grommet in situ

In respect of the eye drops 3 mg (as hydrochloride) per mL, 5 mL:

In compliance with authority procedures set out in subparagraph 14 (d):
Bacterial keratitis

  1. Schedule 1, omit item dealing with Clopidogrel

and substitute:

Clopidogrel

In respect of the tablet 75 mg (as hydrogen sulfate):

In compliance with authority procedures set out in subparagraph 14 (d):
1719  Prevention of recurrence of ischaemic stroke or transient cerebral ischaemic events in patients with a history of symptomatic cerebrovascular ischaemic episodes while on therapy with low-dose aspirin
1720  Prevention of recurrence of ischaemic stroke or transient cerebral ischaemic events in patients where low-dose aspirin poses an unacceptable risk of gastrointestinal bleeding
1721  Prevention of recurrence of ischaemic stroke or transient cerebral ischaemic events in patients where there is a history of anaphylaxis, urticaria or asthma within 4 hours of ingestion of aspirin, other salicylates, or non-steroidal anti-inflammatory drugs
1722  Prevention of recurrence of myocardial infarction or unstable angina in patients with a history of symptomatic cardiac ischaemic events while on therapy with low-dose aspirin
1723  Prevention of recurrence of myocardial infarction or unstable angina in patients where low-dose aspirin poses an unacceptable risk of gastrointestinal bleeding
1724  Prevention of recurrence of myocardial infarction or unstable angina in patients where there is a history of anaphylaxis, urticaria or asthma within 4 hours of ingestion of aspirin, other salicylates, or non-steroidal anti-inflammatory drugs
3245  Treatment of acute coronary syndromes (myocardial infarction or unstable angina) in combination with aspirin
3146  Treatment in combination with aspirin following cardiac stent insertion

In respect of the tablet 75 mg (as besilate):

In compliance with authority procedures set out in subparagraph 14 (d):
1719  Prevention of recurrence of ischaemic stroke or transient cerebral ischaemic events in patients with a history of symptomatic cerebrovascular ischaemic episodes while on therapy with low-dose aspirin
1720  Prevention of recurrence of ischaemic stroke or transient cerebral ischaemic events in patients where low-dose aspirin poses an unacceptable risk of gastrointestinal bleeding
1721  Prevention of recurrence of ischaemic stroke or transient cerebral ischaemic events in patients where there is a history of anaphylaxis, urticaria or asthma within 4 hours of ingestion of aspirin, other salicylates, or non-steroidal anti-inflammatory drugs
1722  Prevention of recurrence of myocardial infarction or unstable angina in patients with a history of symptomatic cardiac ischaemic events while on therapy with low-dose aspirin
1723  Prevention of recurrence of myocardial infarction or unstable angina in patients where low-dose aspirin poses an unacceptable risk of gastrointestinal bleeding
1724  Prevention of recurrence of myocardial infarction or unstable angina in patients where there is a history of anaphylaxis, urticaria or asthma within 4 hours of ingestion of aspirin, other salicylates, or non-steroidal anti-inflammatory drugs

  1. Schedule 1, omit item dealing with Cromoglycic Acid

and substitute:

Cromoglycic Acid

In respect of the capsule containing powder for oral inhalation containing sodium cromoglycate 20 mg (for use in Intal Spinhaler or Intal Halermatic), pressurised inhalation containing sodium cromoglycate 1 mg per dose, 200 doses (CFC-free formulation) and pressurised inhalation containing sodium cromoglycate 5 mg per dose, 112 doses (CFC-free formulation):

—

In respect of the eye drops containing sodium cromoglycate 20 mg per mL, 10 mL:

Vernal kerato-conjunctivitis

  1. Schedule 1, omit item dealing with Enalapril with Hydrochlorothiazide

and substitute:

Enalapril with Hydrochlorothiazide Hypertension in a patient who is not adequately controlled with either of the drugs in the combination

  1. Schedule 1, omit item dealing with Eprosartan with Hydrochlorothiazide

and substitute:

Eprosartan with Hydrochlorothiazide Hypertension in a patient who is not adequately controlled with either of the drugs in the combination

  1. Schedule 1, omit item dealing with Follitropin Alfa

and substitute:

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

  1. Schedule 1, omit item dealing with Fosinopril with Hydrochlorothiazide

and substitute:

Fosinopril with Hydrochlorothiazide Hypertension in a patient who is not adequately controlled with either of the drugs in the combination

  1. Schedule 1, omit item dealing with Glucose Indicator—Blood

and substitute:

Glucose Indicator—Blood —

  1. Schedule 1, omit item dealing with Irbesartan with Hydrochlorothiazide

and substitute:

Irbesartan with Hydrochlorothiazide Hypertension in a patient who is not adequately controlled with either of the drugs in the combination

  1. Schedule 1, omit item dealing with Lercanidipine with enalapril

and substitute:

Lercanidipine with enalapril Hypertension in a patient who is not adequately controlled with either of the drugs in the combination

  1. Schedule 1, item dealing with Mesalazine

omit from the column headed “Circumstances”:

In respect of the sachet containing granules, 500 mg per sachet, sachet containing granules, 1 g per sachet and sachet containing granules, 1.5 g per sachet:

and substitute:

In respect of the tablet 1.2 g (prolonged release), sachet containing granules, 500 mg per sachet, sachet containing granules, 1 g per sachet and sachet containing granules, 1.5 g per sachet:

  1. Schedule 1, omit item dealing with Mineral mixture

  1. Schedule 1, omit item dealing with Olmesartan with Hydrochlorothiazide

and substitute:

Olmesartan with Hydrochlorothiazide Hypertension in a patient who is not adequately controlled with either of the drugs in the combination

  1. Schedule 1, after item dealing with Perindopril

insert in the columns in the order indicated:

Perindopril with amlodipine Hypertension in a patient who is not adequately controlled with either of the drugs in the combination
Stable coronary heart disease in a patient who is stabilised on treatment with perindopril and amlodipine at the same doses

  1. Schedule 1, omit item dealing with Perindopril with Indapamide

and substitute:

Perindopril with Indapamide

In respect of the tablet containing perindopril arginine 2.5 mg with indapamide hemihydrate 0.625 mg:

—

In respect of the tablet containing perindopril erbumine 4 mg with indapamide hemihydrate 1.25 mg and tablet containing perindopril arginine 5 mg with indapamide hemihydrate 1.25 mg:

Hypertension in a patient who is not adequately controlled with either of the drugs in the combination

  1. Schedule 1, omit item dealing with Quinapril with Hydrochlorothiazide

and substitute:

Quinapril with Hydrochlorothiazide Hypertension in a patient who is not adequately controlled with either of the drugs in the combination

  1. Schedule 1, omit item dealing with Ramipril with Felodipine

and substitute:

Ramipril with Felodipine Hypertension in a patient who is not adequately controlled with either of the drugs in the combination

  1. Schedule 1, omit item dealing with Rivaroxaban

and substitute:

Rivaroxaban

In respect of the tablets 10 mg, 30:

In compliance with authority procedures set out in subparagraph 14 (d):
Prevention of venous thromboembolism in a patient undergoing total hip replacement

In respect of the tablets 10 mg, 10 and tablet 10 mg:

In compliance with authority procedures set out in subparagraph 14 (d):
Prevention of venous thromboembolism in a patient undergoing total knee replacement
Prevention of venous thromboembolism in a patient undergoing total hip replacement

  1. Schedule 1, omit item dealing with Telmisartan with Hydrochlorothiazide

and substitute:

Telmisartan with Hydrochlorothiazide Hypertension in a patient who is not adequately controlled with either of the drugs in the combination

  1. Schedule 1, omit item dealing with Trandolapril with Verapamil

and substitute:

Trandolapril with Verapamil Hypertension in a patient who is not adequately controlled with either of the drugs in the combination

  1. Schedule 1, omit item dealing with Valsartan with hydrochlorothiazide

and substitute:

Valsartan with hydrochlorothiazide Hypertension in a patient who is not adequately controlled with either of the drugs in the combination

  1. Schedule 3, item dealing with Amlodipine

insert in the column headed “Allowable compounds” below the existing entries:

Perindopril with Amlodipine

  1. Schedule 3, item dealing with Perindopril

insert in the column headed “Allowable compounds” above the existing entry:

Perindopril with Amlodipine

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