You are here

TGA Internet site archive

The content on this page and other TGA archive pages is provided to assist research and may contain references to activities or policies that have no current application. See the full archive disclaimer.

ADEC 266th meeting resolutions, 2 October 2009

Australian Drug Evaluation Committee

2 October 2009

Published in the Commonwealth of Australia Gazette, No. GN 43, 4 November 2009

GAZETTAL NOTICE

THERAPEUTIC GOODS ACT 1989

AUSTRALIAN DRUG EVALUATION COMMITTEE

RECOMMENDATIONS

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.

RESOLUTION 9333

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.

RESOLUTION 9334

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).

RESOLUTION 9335

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.

RESOLUTION 9336

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.

RESOLUTION 9338

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.

RESOLUTION 9339

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.

RESOLUTION 9340

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.

RESOLUTION 9341

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.

RESOLUTION 9343

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

Top of page