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ADEC 202nd meeting resolutions, 8-9 April 1999

Australian Drug Evaluation Committee

8 April 1999

Published in the Commonwealth of Australia Gazette

GAZETTAL NOTICE

THERAPEUTIC GOODS ACT 1989

AUSTRALIAN DRUG EVALUATION COMMITTEE

RECOMMENDATIONS

The 202nd (1999/2) Meeting of the Australian Drug Evaluation Committee (ADEC) (8-9 April 1999) 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 drugs 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.

CIPRAMIL Citalopram hydrobromide tablets 10mg, 20mg and 40mg
Lundbeck Australia Pty Ltd
Indications: To include treatment of panic disorder.

KLIOVANCE Oestradiol 1mg (as hemihydrate) norethisterone acetate 0.5mg fixed combination tablets
Novo Nordisk Pharmaceuticals Pty Ltd
Indications: For the treatment of menopausal symptoms related to oestrogen deficiency.

KAPANOL Morphine sulfate capsules 20mg, 50mg and 100mg
Glaxo Wellcome Australia Ltd
Indications: To include treatment for the relief of chronic pain unresponsive to non-narcotic analgesia.

ZENAPAX Daclizumab concentrate for intravenous infusion 25mg/5mls
Roche Products Pty Limited
Indications: For the prevention of acute organ rejection in patients receiving renal transplants.

CELLCEPT Mycophenolate mofetil capsules 250mg and tablets 500mg
Roche Products Pty Limited
Indications: To include the prophylaxis of allogeneic cardiac transplant rejection.

STOCRIN Efavirenz capsules 50mg, 100mg and 200mg
Merck Sharp & Dohme (Australia) Pty Limited
Indications: For use in combination with other antiviral agents for the treatment of HIV-1 infection in adults and children.

SYNAGIS Palivizumab powder for injection 50mg and 100mg
Abbott Australasia Pty Ltd
Indications: For the prevention of serious lower respiratory tract disease caused by respiratory syncytial virus (RSV) in children at high risk of RSV disease.

ZIAGEN Abacavir sulfate tablets 300mg and oral solution 20 mg/ml
Glaxo Wellcome Australia Ltd
Indications: For use in antiretroviral combination therapy for the treatment of HIV infection in adults and children.

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FOSAMAX Alendronate sodium tablets 5mg, 10mg and 40mg
Merck Sharp & Dohme (Australia) Pty Limited
Indications: To include the treatment of glucocorticoid-induced osteoporosis and prevention of bone mass mineral loss in patients on long-term steroid therapy.

LEUSTATIN Cladribine solution for injection 1mg/ml
Janssen-Cilag Pty Ltd
Indications: To include the treatment of patients with B-cell chronic lymphocytic leukaemia in whom treatment with alkylating agents has failed.

LIQUID PEDVAXHIB Haemophilus influenzae type b conjugate vaccine 7.5mg/0.5ml
Merck Sharp & Dohme (Australia) Pty Limited
Indications: For active immunisation against invasive disease caused by Haemophilus influenzae type b in infants and children 2 to 71 months of age.

CLEXANE Enoxaparin sodium injection 40mg
Rhone-Poulenc Rorer Australia Pty Ltd
Indications: To include the prevention of thrombo-embolism after total hip replacement surgery.

TAXOTERE Docetaxel concentrated solution for injection 20mg and 80mg
Rhone-Poulenc Rorer Australia Pty Ltd
Dose: Amend the recommended dosage from 75mg/m' to 75-100mg/m'.

CRIXIVAN Indinavir sulfate capsules 200mg and 400mg
Merck Sharp & Dohme (Australia) Pty Limited
Dose: Amend the recommended dosage from 800mg to 1000mg every eight hours, when indinavir is taken concomitantly with rifabutin.

HUMATROPE Somatropin 4 IU and 6 IU vials and 18 IU, 36 IU and 72 IU cartridges
Eli Lilly Australia Pty Limited
Indications: To include treatment of growth disturbances associated with gonadal dysgenesis (Turner Syndrome)

MICANOL Dithranol Cream 1%
F H Faulding & Co Limited
Indications: For the treatment of stable chronic plaque-type psoriasis.

CEREZYME Imiglucerase powder for injection 200 units
Genzyme Australasia Pty Ltd
Indications: For use as long-term enzyme replacement in patients with a confirmed diagnosis of Type 1 Gaucher disease.

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TYPHERIX Salmonella typhi Vi polysaccharide vaccine 25mg/0.5ml
SmithKline Beecham (Aust) Pty Ltd
Indications: For active immunisation against typhoid fever of adults and children two years of age and older.

REBETRON Interferon alfa-2b injection and ribavirin oral capsules combination pack
Schering-Plough Pty Ltd
Indications: For the treatment of chronic hepatitis C that has relapsed following monotherapy with interferon alfa in patients over 18 years of age with compensated liver disease.

CIPRO HC OTIC SUSPENSION Ciprofloxacin hydrochloride 2mg/ml and hydrocortisone 10mg/ml otic suspension
Bayer Australia Ltd
Indications: For the treatment of acute bacterial otitis externa in adults and children aged 2 years and older with an intact tympanic membrane.

INTRAGAM-P Normal Immunoglobulin solution for intravenous injection 6% in 10, 50 and 200 ml vials
CSL Limited
Indications: For replacement immunoglobulin therapy in:

  • Primary immunodeficiency;
  • Myeloma and chronic lypmhatic leukaemia with severe secondary hypogammaglobulinaemia and recurrent infections; and
  • Congenital acquired immune deficiency syndrome with recurrent infections.

TEMODAL/ZODOL Temozolomide capsules 5mg, 20mg, 100mg and 250mg
Schering-Plough Pty Limited
Indications: For the treatment of recurrent anaplastic astrocytoma and glioblastoma multiforme following standard therapy, including chemotherapy with cytotoxic drugs.

HUMALOG NPL, HUMALOG MIX 25, HUMALOG MIX 50 Insulin lispro 10ml vials, 3.0ml cartridges and 3.0ml disposable injection
Eli Lilly Australia Pty Limited
Indications: For the treatment of patients with Type 1 and Type II diabetes mellitus who require insulin for the maintenance of normal glucose homeostatis.

COMTAN Entacapone tablets 200mg
Novartis Pharmaceuticals Australia Pty Limited
Indications: For use in the management of patients with Parkinson's disease as an adjunct to L-dopa/dopa decarboxylase inhibitor therapy, in patients with motor fluctuations.

ALIATIS AND ESTALIS Oestradiol hemihydrate/norethisterone acetate transdermal matrix patch 50mg/140mg and 50mg/250mg
Rhone-Poulenc Rorer Australia Pty Ltd
Indications: For the treatment of symptoms of oestrogen deficiency in menopausal women who have an intact uterus and for the prevention of bone mineral density loss in post-menopausal women.

BOTOX Purified clostridium botulinum type A neurotoxin complex powder for injection
100 units/vial
Allergan Australia Pty Ltd
Indications: For the treatment of: (a) blepharospasm associated with dystonia, including benign blepharospasm and VII nerve disorders (especially hemifacial spasm) in patients 12 years and over; and (b) equinus foot deformity due to spasticity in juvenile cerebral palsy in patients two years of age or older.

The ADEC also resolved to advise the Minister and the Secretary about the listing of organisms susceptible to antibiotics in the Product Information:

Resolution No: 7660

The ADEC has reviewed its policy on antibiotics of permitting only those organisms for which both in vivo and in vitro activity has been demonstrated to be included in the Product Information (PI) and recommends that:

  1. In vitro only information may be included in the PI provided that the statement "the following in vitro MIC data are available but their clinical significance is unknown", or similar, is also included. MIC data should be included for organisms with known resistance mechanisms, when relevant to the registered indications. These changes are in line with practice in the USA, Europe and Canada.
  2. Susceptibility information in the PI should be updated every five years as a condition of registration because antibiotics may show rapidly changing patterns of susceptibility.
  3. The inclusion of specific Australian susceptibility data, particularly MIC data, is very desirable as resistance rates may vary between different countries.
  4. To facilitate the amendment of the PI for currently registered products:
    1. Where an application was first submitted on or after 1 January 1994, sponsors should apply to amend their susceptibility information on the basis of the initially submitted data.
    2. For applications first submitted prior to 1 January 1994, the sponsor should submit an application supported by a systematic review of the sensitivities documented in the original application. This review should take into account available information about current susceptibilities, including any available Australian information.

Professor Martin Tattersall
Chairman
Australian Drug Evaluation Committee

29 April 1999

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