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ADEC 244th meeting resolutions, 2-3 February 2006

Australian Drug Evaluation Committee

2 February 2006

Published in the Commonwealth of Australia Gazette, No. GN 9, 8 March 2006

GAZETTAL NOTICE

THERAPEUTIC GOODS ACT 1989

AUSTRALIAN DRUG EVALUATION COMMITTEE

RECOMMENDATIONS

The 244th (2006/1) meeting of the Australian Drug Evaluation Committee (ADEC) (2-3 Feb 2006) resolved to advise the Parliamentary Secretary to the Minister for Health and Ageing and the Secretary, Department of Health and Ageing that the following medicines should be approved for registration, subject to the resolution of all outstanding matters to the satisfaction of the Committee and the Therapeutic Goods Administration. These recommendations for approval may be subject to specific conditions.

OXCARBAZEPINE 150mg, 300mg, 600mg & 60 mg/mL
Trilepal
Oral Suspension and Tablets
Novartis Pharmaceuticals Australia Pty Ltd
New dose form and Extension of Indication - For use as monotherapy or adjunctive therapy for the treatment of partial seizures and generalised tonic-clonic seizures in children and adults.
The Dosage and Administration section of the Product Information should be amended to lower the age of patients from 2 years of age to 1 month of age.

POSACONAZOLE 40mg/mL
Noxafil
Oral suspension
Schering-Plough Pty Limited
New Chemical Entity - The treatment of the following fungal infections in patients 13 years and older:

  • invasive aspergillosis in patients intolerant to, or with disease refractory to, alternative therapy.
  • fusariosis, zygomycosis, coccidiodomycosis, chromoblastomycosis, and mycetoma in patients intolerant to, or with disease refractory to, other therapy.

MEASLES, MUMPS, RUBELLA AND VARICELLA VACCINE 0.5mL
ProQuad
Powder for Injection
Merck Sharp & Dohme (Australia) Pty Limited
New Combination and New Dosage Regimen - The simultaneous vaccination against measles, mumps, rubella and varicella in individuals 12 months to 12 years of age.

ROTAVIRUS VACCINE 1mL
Rotarix
Powder for oral administration (reconstituted)
GlaxoSmithKline Australia Pty Ltd
New Chemical Entity - The prevention of rotavirus gastroenteritis.

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ENTECAVIR 0.5mg, 1mg and 0.05 mg/mL
Baraclude
Tablets and Oral solution
Bristol-Myers Squibb Australia Pty Ltd
New Chemical Entity - Treatment of chronic hepatitis B virus infection in adults 16 years or older with evidence of active liver inflammation for a period no longer than 48 weeks.

ERTAPENEM sodium 1g
Invanz
Powder for Injection
Merck Sharp & Dohme (Australia) Pty Limited
Extension of Indication -

  • The treatment of patients, aged 3 months or more, with moderate to severe infections (except meningitis) caused by susceptible strains of micro-organisms which are suspected or proven to be resistant to all other antibiotics, or for patients unable to tolerate other antibiotics.
  • Initial empiric therapy for the treatment of complicated intra-abdominal infections and acute pelvic infections including post-partum endomyometritis, septic abortion and post-surgical gynaecological infections.

MENINGOCOCCAL GROUP C POLYSACCHARIDE CONJUGATE VACCINE 0.5mL
NeisVac-C
Injection
Baxter Healthcare Pty Limited
New dosage regimen - To vary the dosage recommendations for administration in a two dose infant vaccination schedule.

THYROTROPIN ALFA(rch) 1.1 mg
Thyrogen
Powder for Injection
Genzyme Australasia Pty Ltd
Extension of Indication - Therapeutic use in post-thyroidectomy patients maintained on hormone suppressive therapy in the ablation of thyroid remnant tissue in combination with radioactive iodine.

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VORICONAZOLE 50mg, 200mg & 40mg/mL
Vfend
Tablets, Powder for Injection, Powder for Suspension and Tablets
Pfizer Australia Pty Ltd
Clinical Changes to PI - Changes to the Product Information

CYTARABINE (LIPID ENCAPSULATED) 50mg/5mL
Depocyt
Suspension for Injection
Novotech (Australia) Pty Ltd
Extension of indication - The intrathecal treatment of neoplastic meningeal disease.

HUMAN NORMAL IMMUNOGLOBULIN 10%
Gamunex
Solution for Injection
Bayer Australia Limited
New Chemical Entity -

  • Primary Humoral Immunodeficiency (PID) - replacement therapy of primary immunodeficiency states in which severe impairment of antibody-forming capacity has been shown, such as:
    • congenital agammaglobulinaemia
    • common variable immunodeficiency
    • X-linked immunodeficiency with hyper IgM
    • Wiskott Aldrich syndrome and
    • severe combined immunodeficiencies.
  • Idiopathic Thrombocytopenic Purpura (ITP) - to rapidly raise platelet counts to prevent bleeding or to allow a patient with ITP to undergo surgery.

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MANNITOL 5mg, 10mg, 20 and 40mg
Aridol
Powder for Inhalation
Pharmaxis Ltd
New dose form, New Route of Administration and Extension of Indication - For identifying bronchial hyper responsiveness to assist in the diagnosis of asthma.

DARBEPOETIN ALFA (various strengths)
Aranesp
Solution for Injection
Amgen Australia Pty Ltd
New dosage regimen

  • The correction and maintenance treatment of anaemia associated with chronic renal failure (two weekly and monthly dosing regimens)
  • The treatment of chemotherapy induced anaemia in patients with non-myeloid malignancy (three weekly dosing regimens)

ALEFACEPT 7.5 amd 15mg
Amevive
Powder for Injection
Biogen Idec Australia Pty Ltd
Extension of Indication - Extend the indications for use beyond 12 months.

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INFLIXIMAB 100mg
Remicade
Powder for Injection
Schering-Plough Pty Limited
Extension of Indication - The treatment of adult patients with moderate to severe plaque psoriasis for whom phototherapy or conventional systemic treatments have been inadequate or are inappropriate. Safety and efficacy beyond 12 months have not been established.

LETROZOLE 2.5mg
Femara
Tablet
Novartis Pharmaceuticals Australia Pty Ltd
Extension of Indication - The treatment of postmenopausal women with hormone receptor positive breast cancer (see Clinical Trials).

ZOLEDRONIC Acid 5mg/100mL
Aclasta
Injection solution
Novartis Pharmaceuticals Australia Pty Ltd
Extension of Indication - Single dose treatment of Paget's disease for patients considered to be at low risk of osteonecrosis of the jaw who are refractory to oral bisphosphonates and unsuitable for other treatments.

ROSIGLITAZONE MALEATE 2mg and 4mg with METFORMIN HYDROCLORIDE 1000mg
Avandamet
Tablets
GlaxoSmithKline Australia Pty Ltd
New Strengths and Extension of indication - As an adjunct to diet and exercise to improve glycaemic control in patients with Type 2 diabetes mellitus (non-insulin dependent diabetes mellitus).

  • as dual combination therapy in patients who are already treated with rosiglitazone and metformin in combination, or who are inadequately treated on metformin or rosiglitazone alone, or
  • in triple combination therapy with sulfonylureas in patients already stabilised on triple therapy with separate dose forms of rosiglitazone, metformin and sulfonylureas, see Dosage and Administration

24th February 2006

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