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ADEC 226th meeting resolutions, 6-7 February 2003

Australian Drug Evaluation Committee

6 February 2003

Published in the Commonwealth of Australia Gazette

GAZETTAL NOTICE

THERAPEUTIC GOODS ACT 1989

AUSTRALIAN DRUG EVALUATION COMMITTEE

RECOMMENDATIONS

The 226th (2003/1) meeting of the Australian Drug Evaluation Committee (ADEC) (6-7 February 2003) 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.

SODIUM CROMOGLYCATE Intal CFC-free inhaler
CFC-free pressurised metered dose inhaler - 1 mg per actuation.
Aventis Pharma Pty Ltd
Variation: Replacement product for the registered CFC-containing product. Approved indication: For the prophylactic treatment of bronchial asthma, including the prevention of exercise induced bronchospasm.

IPRATROPIUM BROMIDE Atrovent (CFC-free) pressurised metered dose inhaler 21 mcg per actuation.
Boehringer Ingelheim Pty Ltd
Variation: Replacement product for the registered CFC-containing product. Approved indication: As a bronchodilator for maintenance treatment of bronchospasm associated with chronic obstructive pulmonary disease and asthma.

ANASTROZOLE Arimidex 1mg tablets.
AstraZeneca Pty Ltd
Variation: Extension of registered indications to include: "Adjuvant treatment of early breast cancer in postmenopausal women with oestrogen / progesterone receptor positive disease."

LIPOSOMAL DOXORUBICIN HCl Caelyx suspension for IV infusion - 20mg in 10mL and 50mg in 25mL vials.
Schering Plough Pty Ltd
Variation: Extension of registered indications to include treatment of metastatic breast cancer. Approved indication: "Caelyx, as monotherapy, is indicated for the treatment of metastatic breast cancer."

IMATINIB MESYLATE Glivec capsules - 50 and 100mg.
Novartis Pharmaceuticals Australia Pty Ltd
Variation: Extension of registered indications to include: "For the treatment of chronic myeloid leukaemia."

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TERIPARATIDE Fortéo® - solution for injection, containing teriparatide 250µg/mL x 3mL cartridges (multidose presentation, pen injection device, 20µg per activation).
Eli Lilly Australia Pty. Ltd
Indication: Registration of a new chemical entity for the treatment of postmenopausal osteoporosis and the treatment of primary osteoporosis in men when other agents are considered unsuitable and when there is a high risk of fractures.

SOMATROPIN Genotropin powder for injection and diluent 1.3mg/mL (with and without preservative), 5mg/mL (with preservative) and 5.3mg/mL (with preservative).
Pharmacia Australia Pty Limited
Variation: Extension of registered indications to include: "For the treatment of growth disturbance in children with chronic renal insufficiency (CRI)".

METHYL-5-AMINOLEVULINATE Metvix 160mg/g: 2g cream.
Photocure Australia Pty Ltd
Indication: Registration of a new chemical entity for the treatment of thin or non-hyperkeratotic and non-pigmented actinic keratoses on the face and scalp, when other treatments are considered unsuitable.

NORMAL IMMUNOGLOBULIN (HUMAN) Intragam®P - (IV) at a dose of 0.4g IgG per kilogram body weight per day.
CSL Bioplasma
Variation: Extension of registered indications to include: "The treatment of Guillain-Barré Syndrome."

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RISPERIDONE Risperdal Consta - Strengths of 25mg, 37.5mg and 50mg when suspended in 2mL diluent for extended release intramuscular injection.
Janssen-Cilag Pty. Ltd
Variation: Registration of a new route of administration, new strength and new dosage form for the treatment of Schizophrenia and related psychoses.

COMBINED DIPHTHERIA, TETANUS, ACELLULAR PERTUSSIS, HEPATITIS B, INACTIVATED POLIOVIRUS AND HAEMOPHILUS INFLUENZAE TYPE B VACCINE Infanrix Hexa - Combination Pack - 0.5mL suspension for injection in pre-filled syringes & lyophilised Hib vaccine in glass vials.
GlaxoSmithKline Australia Pty Ltd
Variation: Extension of registered indications to include: "for primary immunisation of infants from the age of 6 weeks against diphtheria, tetanus, pertussis, hepatitis b, poliomyelitis, and haemophilus influenzae type b". The primary immunisation course of INFANRIX HEXA consists of three doses, recommended for administration at 2, 4 and 6 months of age.

CASPOFUNGIN ACETATE Cancidas - 50 mg and 70 mg vials containing powder for injection.
Merck Sharp & Dohme Pty Ltd
Variation: Extension of registered indications to include: "for the treatment of invasive candidiasis, including candidaemia and for the treatment of oesophageal candidiasis."

VARDENAFIL HCl TRIHYDRATE Levitra - 5, 10 and 20 mg tablets.
Bayer Australia Limited.
Indication: Registration of a new chemical entity for the treatment of erectile dysfunction (inability to achieve or maintain penile erection sufficient for satisfactory sexual performance).

Professor Martin Tattersall
Chairman
Australian Drug Evaluation Committee

20 February 2003

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