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ADEC 230th meeting resolutions, 2-3 October 2003

Australian Drug Evaluation Committee

2 October 2003

Published in the Commowealth of Australia Gazette, No. GN 43, 29 October 2003

GAZETTAL NOTICE

THERAPEUTIC GOODS ACT 1989

AUSTRALIAN DRUG EVALUATION COMMITTEE

RECOMMENDATIONS

The 230th (2003/5) meeting of the Australian Drug Evaluation Committee (ADEC) (2-3 October 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.

Adalimumab - HUMIRA
Injection solution 40mg
Abbott Australasia Pty Ltd
New Chemical Entity: Humira is indicated for reducing signs and symptoms and inhibiting the progression of structural damage in adult patients with moderate to severely active rheumatoid arthritis when the response to disease-modifying anti-rheumatic drugs has been inadequate. Humira can be used alone or in combination with methotrexate.

Iloprost - VENTAVIS
Solution for Inhalation 10µg/mL
Schering Pty. Limited
New Chemical Entity: Treatment of patient with primary pulmonary hypertension or secondary pulmonary hypertension due to connective tissue disease or drug induced, in moderate or severe stages of the disease. In addition, treatment of moderate or severe secondary pulmonary hypertension due to chronic pulmonary thromboembolism, where surgery is not possible.

Leuprorelin acetate - ELIGARD
Extended release subcutaneous injection 7.5mg, 22.5mg and 30mg
Mayne Pharma Pty Ltd
New Dose Form: For the palliative treatment of advanced prostate cancer.

Gemicitabine HCl - GEMZAR
Powder for injection 200mg and 1.0g
Eli Lilly Australia Pty Ltd
New Indication: In combination with paclitaxel, the treatment of patients with unresectable, locally recurrent or metastatic breast cancer who have relapsed following adjuvant or neoadjuvant chemotherapy. Prior chemotherapy should have included an anthracycline unless clinically contraindicated.

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Oestradiol valerate/dienogest - CLIMODIEN
Tablet sugar coated 2mg/2mg
Schering Pty. Limited
New Fixed Combination: Hormone replacement therapy (HRT) for the short term treatment of symptoms of oestrogen deficiency in women who are at least one year past their menopause.

Sodium Glycerophosphate - KABIVEN CENTRAL & KABIVEN PERIPHERAL
Glucose, amino acid solution with electrolytes and soya oil emulsion for intravenous infusion injection bag
Fresenius Medical Care Australia Pty Ltd
New Dose Form: For parenteral nutrition in adult patients when oral or enteral nutrition is impossible or insufficient or contraindicated.

Venlafaxine HCl - EFEXOR-XR
Capsules modified release 75mg & 150mg
Wyeth Australia Pty Limited
New Indication: For the treatment of social anxiety disorder.

Olanzapine - ZYPREXA & ZYPREXA ZYDIS
ZYPREXA Tablets 2.5mg, 5mg, 7.5mg, 10mg, 15mg & 20mg
ZYPREXA ZYDIS Wafers 5mg, 10mg, 15mg & 20mg
Eli Lilly Australia Pty Ltd
New Indication: Alone or in combination with lithium for the short-term treatment of acute manic episodes associated with bipolar 1 disorder and preventing recurrence of manic, mixed or depressive episodes in bipolar I disorder.

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Mesalazine - PENTASA
Rectal suspension enema 1g
Rectal suppository 1g
Ferring Pharmaceuticals Pty Ltd
New Dose Form: Mesalazine is indicated for the following:

  • Rectal suspension enema is indicated for the treatment of ulcerative proctosigmoiditis
  • Suppository is indicated for the treatment of ulcerative proctitis.

Sertraline HCl - ZOLOFT
Tablets 50mg, 100mg & 200mg
Pfizer Pty Ltd
New Indication: For the treatment of Premenstrual Dysphoric Disorder (PMDD) as defined by the DSM-IV criterion in adults (18 years and above).

Amoxycillin (as trihydrate) - CLIAMOX & CILAMOX sugar free syrup
Powder for Oral liquid, Sugar free syrup, 125mg/5mL & 250mg/5mL
Capsules, 250mg & 500mg
Sigma Phamaceuticals Pty Ltd
New Indication: For the treatment of infections due to susceptible strains of the organism Bacillus anthracis. [Penicillins are now generally regarded only as adjunctive to some other established first-line antibiotic therapy in the treatment of anthrax, because of concerns of constitutive and inducible beta-lactamase in Bacillus anthracis. If use of penicillin/amoxycillin is contemplated, appropriate bacteriological studies must be performed by a reliable and established test method. Amoxycillin may then be suitable if the specific B. anthracis strain has been shown definitively to be sensitive to penicillin/amoxycillin].

Iohexol - OMNIPAQUE
Sterile aqueous injection vial 388mg, 518mg ampoules, 647mL, 755g/mL bottles
Amersham Health Pty Limited
New Route of Administration: OMNIPAQUE is indicated in adults for arthrography, endoscopic retrograde cholangiopancreatography (ERCP), endoscopic retrograde pancreatography (ERP), hysterosalphingography and herniography, in adults and for examination of the gastrointestinal tract in adults, children and premature babies.

Iobenguane [123I] sulphate - MIBGen
Intravenous infusion Injection 100MBq/mL
Australian Radioisotopes (ANSTO)
New Chemical Entity: For the treatment of diagnostic scintigraphic localisation of phaeochromocytomas, paragangliomas (chemodectomas), ganglioneuroblastomas and ganglioneuromas; and detection, staging and follow-up on therapy of neuroblastomas.

Professor Martin Tattersall
Chairman
Australian Drug Evaluation Committee

20 October 2003

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