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ADEC 266th meeting resolutions, 2 October 2009
Australian Drug Evaluation Committee
Published in the Commonwealth of Australia Gazette, No. GN 43, 4 November 2009
THERAPEUTIC GOODS ACT 1989
AUSTRALIAN DRUG EVALUATION COMMITTEE
The 266th (2009/5) meeting of the Australian Drug Evaluation Committee (ADEC) (2 October 2009) 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.
Everolimus (CERTICAN) - Novartis Pharmaceuticals Pty Ltd
ADEC recommends approval of the application to change the dosage and administration recommendations for everolimus (CERTICAN) uncoated tablets 0.25, 0.5, 0.75 and 1 mg and dispersible tablets 0.1, 0.25 mg for the indication:
Prophylaxis of organ rejection in adult patients at mild to moderate immunological risk receiving an allogeneic cardiac transplant.
Certolizumab pegol (CIMZIA) - UCB Australia Pty Ltd
ADEC recommends approval of the application for registration of certolizumab pegol (CIMZIA), solution for injection 200 mg/mL for the indication:
Cimzia is indicated for the treatment of moderate to severe active rheumatoid arthritis in adult patients:
- combined with methotrexate in case of either an inadequate response or intolerance to previous therapy with one or more disease-modifying antirheumatic drugs (DMARDs), or
- as monotherapy in case of a contraindication or intolerance to methotrexate (see DOSAGE AND ADMINISTRATION).
Melatonin (CIRCADIN) - Commercial Eyes Pty Ltd
ADEC recommends approval of the application for registration of melatonin (CIRCADIN) modified release tablet, 2 mg for the indication:
Monotherapy for the short term treatment (up to three weeks) of primary insomnia characterised by poor quality of sleep in patients who are aged 55 or over.
Perindopril arginine / amlodipine (as besylate) (COVERAM) - Servier Laboratories (Australia) Pty Ltd
ADEC recommends approval of the application for registration of perindopril arginine plus amlodipine (as besylate) (COVERAM) uncoated tablets, 5 mg / 5 mg, 5 mg / 10 mg, 10 mg / 5 mg and 10 mg / 10 mg for the indication:
Coveram is indicated as substitution therapy for the treatment of hypertension and/or stable coronary heart disease in patients already controlled with separate doses of perindopril and amlodipine, given concurrently at the same dose level. Treatment should not be initiated with this combination.
Paliperidone (INVEGA) - Janssen Cilag Pty Ltd
ADEC recommends approval of the application for registration of paliperidone (INVEGA) modified release tablets, 3 mg, 6 mg, 9 mg and 12 mg for the indication:
Treatment of acute exacerbations of schizoaffective disorder as monotherapy and in combination with antidepressants and/ or lithium or sodium valproate.
Follitropin alfa (rch) / lutropin alfa (rch) (PERGOVERIS) - Merck Serono Australia Pty Ltd
ADEC recommends approval of the application for registration of follitropin alfa (rch) lutropin alfa (rch) (PERGOVERIS) powder for injection 150 IU / 75 IU for the indication:
PERGOVERIS is recommended for the stimulation of follicular development in women with severe LH and FSH deficiency. In clinical trials, these patients were defined by an endogenous serum LH < 1.2 IU/L.
Risperidone (RISPERDAL CONSTA) - Janssen Cilag Pty Ltd
ADEC recommends approval of the application for registration of risperidone (RISPERDAL CONSTA) modified release injection, 25 mg, 37.5 mg and 50 mg for the indication:
Monotherapy for maintenance treatment to prevent the recurrence of manic or mixed episodes of bipolar I disorder in patients with a manic or mixed episode, following stabilisation with oral risperidone.
Golimumab (rmc) (SIMPONI and SIMPONI SMARTJECT INJECTOR) - Schering-Plough Pty Limited
ADEC recommends approval of the application for registration of golimumab (rmc) (SIMPONI and SIMPONI SMARTJECT INJECTOR) solution for injection, 50 mg, for the indications:
- Rheumatoid arthritis (RA): SIMPONI, in combination with methotrexate, is indicated for the treatment of moderate to severely active rheumatoid arthritis in adult patients when the response to disease modifying anti rheumatic drug (DMARD) therapy, including methotrexate, has been inadequate.
- Psoriatic arthritis (PsA): SIMPONI, alone or in combination with methotrexate, is indicated for the treatment of active and progressive psoriatic arthritis in adult patients when the response to previous disease modifying anti rheumatic drug (DMARD) therapy has been inadequate. Simponi has also been shown to improve physical functioning.
- Ankylosing spondylitis (AS): SIMPONI is indicated for the treatment of active ankylosing spondylitis in adult patients.
Ziprasidone (as mesilate) (ZELDOX) - Pfizer Australia Pty Ltd
ADEC recommends approval of the application for registration of ziprasidone (as mesilate) (ZELDOX) powder for injection, 20 mg for the indication:
Acute control and short term management of agitation and disturbed behaviours in patients with schizophrenia and related psychoses when oral therapy is not appropriate.
9 October 2009