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ADEC 217th meeting resolutions, 2-3 August 2001

Australian Drug Evaluation Committee

2 August 2001

Published in the Commonwealth of Australia Gazette

GAZETTAL NOTICE

THERAPEUTIC GOODS ACT 1989

AUSTRALIAN DRUG EVALUATION COMMITTEE

RECOMMENDATIONS

The 217th (2001/4) meeting of the Australian Drug Evaluation Committee (ADEC) (2-3 August 2001) resolved to advise the Parliamentary Secretary to the Minister for Health and Aged Care and the Secretary, Department of Health and Aged Care 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.

INFLIXIMAB Remicade
Sterile powder for intravenous injection, 100 mg
Schering-Plough Pty Ltd
Variation: Extension of indications to include the treatment of rheumatoid arthritis in adults.

ETANERCEPT Enbrel
Sterile powder for subcutaneous injection, 10 mg and 25 mg
Wyeth Australia Pty Limited
Variation: Extension of indications to include "the treatment of active polyarticular-course juvenile chronic arthritis in patients (4-17 years) who have had inadequate response to one or more disease-modifying anti-rheumatic drugs. Enbrel has not been studied in children less than four years of age."

FOLLITROPIN ALPHA [RCH] Gonal-F
Sterile powder for subcutaneous injection, containing follitropin alfa 37.5 IU, 75 IU and 150 IU, in single-dose ampoules
Serono Australia Pty Ltd
Variation: Rewording of the indications in the product information to the following:

  • for the treatment of anovulatory infertility in women after inadequate response to clomiphene or where clomiphene is contraindicated;
  • for controlled ovarian hyperstimulation in women undergoing assisted reproductive technologies; and
  • with concomitant human chorionic gonadotrophin (hCG) therapy for the stimulation of spermatogenesis in gonadotrophin-deficient men in whom hCG alone in ineffective.

FOLLITROPIN ALPHA [RCH] Gonal-F
Sterile powder for subcutaneous injection in multidose vials, containing follitropin alfa 1200 IU/2 mL, presented with pre-filled syringes of diluent
Serono Australia Pty Ltd
Variation: New presentation indicated for the following:

  • for the treatment of anovulatory infertility in women after inadequate response to clomiphene or where clomiphene is contraindicated;
  • for controlled ovarian hyperstimulation in women undergoing assisted reproductive technologies; and
  • with concomitant human chorionic gonadotrophin (hCG) therapy for the stimulation of spermatogenesis in gonadotrophin-deficient men in whom hCG alone is ineffective.

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SIBUTRAMINE HYDROCHLORIDE Reductil
Capsules, 10 mg and 15 mg
Knoll Australia Pty Limited
Indication: For the management of obesity.

LEVONORGESTREL Postinor-2
Tablets, 750 µg
Southern Cross Pharma (On behalf of Medipharma Pty Ltd)
Variation: New dosage regimen indicated for use as an emergency oral contraceptive within 72 hours of unprotected intercourse.

NORETHISTERONE ACETATE/ETHINYLOESTRADIOL Femhrt
Tablets, 1 mg/5 µg
Parke Davis Pty Ltd
Variation: New combination for use in women with an intact uterus for the treatment of vasomotor symptoms associated with menopause.

AMINO ACIDS Primene
Sterile solution for intravenous injection, 10%
Baxter Healthcare Pty Ltd
Indication: Indicated in infants and neonates at term or premature for short-term use, of normal or low birth-weight when oral or enteral nutrition is impossible, insufficient or contraindicated. It is used as an amino acid component in a composite admixture of total parenteral nutrition.

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GESTODENE/ETHINYLOESTRADIOL Minesse/Mirelle
Film-coated tablets, gestodene 60 µg/ethinyloestradiol 15 µg, in packs of 24 active tablets plus four inactive tablets
Wyeth Australia Pty Limited/Schering Pty Limited
Variation: New Strength for use as an oral contraceptive.

PROPOFOL Diprivan
Sterile solution for injection, 10 mg/mL
Astra Zeneca Pty Ltd
Variation: Revision of dosage regimen for the elderly.

ZIPRASIDONE HYDROCHLORIDE Zeldox
Capsules, 20 mg, 40 mg, 60 mg and 80 mg
Pfizer Pty Limited
Indication: Indicated for the treatment of schizophrenia, related psychoses, prevention of relapse and for maintenance of clinical improvement during continuation therapy.

VENLAFAXINE Efexor/Altven and Efexor-XR/Altven-XR
Tablets and modified-release capsules, 25 mg, 37.5 mg, 50 mg, 75 mg and 150 mg
Wyeth Australia Pty Limited
Variation: Extension of indications to include the prevention of relapse and recurrence of major depression where appropriate.

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CLOSTRIDIUM BOTULINUM TYPE A TOXIN HAEMAGGLUTININ COMPLEX Dysport
Sterile powder for intramuscular injection, 500 Ipsen Units per vial of Clostridium botulinum type A toxin haemagglutinin complex, 125 µg human serum albumin and 2.5 mg lactose per vial
O'Shea and Associates (on behalf of Ipsen Pty Ltd)
Variation: Extension of indications to include the treatment of dynamic equinus foot deformity due to spasticity in ambulant paediatric cerebral palsy patients, two years of age or older.

INACTIVATED INFLUENZA VACCINE (SURFACE ANTIGEN) Influvac
Sterile suspension for intramuscular injection, 15 µg of surface antigens from influenza A and B, in 0.5 mL ampoules and pre-filled syringes
Solvay Biosciences Pty Ltd
Indication: Indicated for the prevention of influenza caused by influenza virus, types A and B, in adults aged 18 years and older.

AMOXYCILLIN TRIHYDRATE Maxamox
Tablets, 1000 mg
Biochemie Australia Pty Ltd
Variation: New dosage form indicated for the treatment of acute exacerbation of chronic bronchitis.

INDINAVIR SULFATE Crixivan
Capsules, 100 mg
Merck Sharp & Dohme (Australia) Pty Limited
Variation: New strength for use in combination therapy for the treatment of HIV-1 infection in the new patient population of children aged from three years who are able to swallow capsules.

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AMINO ACIDS/DIPEPTIDE Glamin
Sterile solution for intravenous injection, 13.4%
Fresenius Medical Care Australia Pty Ltd
Indication: Indicated for use as part of parenteral nutrition therapy, when oral or enteral nutrition is impossible, insufficient or contraindicated especially in patients with a moderate to severe catabolic status.

FLUTICASONE PROPIONATE Flixonase
Nasal spray, 50 µg per actuation
Glaxo Wellcome Australia Ltd
Variation: Revision of product information to include further clinical data in the Clinical Trials section.

EPOETIN ALFA [rch] Eprex
Sterile solution for injection, various strengths in vials and pre-filled syringes
Janssen-Cilag Pty Ltd
Variation: Extension of indications to include: To augment autogous blood collection and to limit the decline in haemoglobin in anaemic adult patients who are scheduled for major elective surgery and who are not expected to predeposit their complete perioperative blood needs.

IMATINIB MESILATE Glivec
Capsules, 50 mg and 100 mg
Novartis Pharmaceuticals Australia Pty Ltd
Indication: Indicated for the treatment of patients with chronic myeliod leukaemia (CML) in blast crisis, accelerated phase or in chronic phase after failure of interferon-alfa therapy.

SOMATROPIN [rbe], RECOMBINANT HUMAN GROWTH HORMONE Genotropin
Sterile powder for subcutaneous injection, 4 IU/mL and 16 IU/mL
Pharmacia Australia Pty Limited
Variation: Extension of indications to include the treatment of adults with severe growth hormone deficiency as diagnosed in the insulin tolerance test for growth hormone deficiency and defined by peak growth hormone concentrations of less than 2.5 ng/mL.

FILGRASTIM Neupogen
Sterile solution for intravenous or subcutaneous injection, 300 µg/mL and 400 µg/1.6 mL in vials, and 300 µg/0.5 mL and 480 µg/0.5 mL in pre-filled syringes
Amgen Australia Pty Ltd
Variation: Extension of indications to include the mobilisation of peripheral blood progenitor cells in normal volunteers, for use in allogeneic peripheral blood progenitor cell transplantation.

Professor Martin Tattersall
Chairman
Australian Drug Evaluation Committee

August 2001

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