European Medicines Agency: Committee for Medicinal Products for Human Use 13-16 September 2004

Press release 16/09/2004

The Committee adopted three positive opinions on initial marketing authorisation applications for:

  • Cymbalta (duloxetine hydrochloride), from Eli Lilly Netherlands B.V., and Xeristar (duloxetine hydrochloride), from Boehringer-Ingelheim International GmbH, for treatment of major depressive episodes. EMEA review began on 23 October 2003, with an active review time of 210 days.
  • Kivexa (abacavir/lamivudine), from Glaxo Group Limited, for the use in antiretroviral combination therapy for the treatment of Human Immunodeficiency Virus (HIV) infection in adults and adolescents from 12 years of age. Kivexa is a fixed dose combination of two antiretroviral agents (abacavir and lamivudine) to be administered once a day. EMEA review began on 22 December 2003, with an active review time of 175 days.

Summaries of these opinions, including the full indications for each product, are available on the EMEA website.

The Committee also gave positive opinions on the extension of indication for medicinal products that are already authorised in the EU:

  • Pegasys (peginterferon alfa-2a), Roche Registration Ltd, to extend its use in combination with rabivirin for the treatment of adult patients with chronic hepatitis C and persistently normal alanine aminotransferase (ALT) levels. Pegasys was first authorised in the European Union on 20 June 2002.
  • Taxotere (docetaxel), Aventis, to extend its use in combination with prednisone or prednisolone for the treatment of patients with hormone refractory metastatic prostate cancer. Taxotere was first authorised in the European Union on 27 November 1995.

The CHMP began a Community-wide review for Rigevidon (levonorgestrel and ethinylestradiol) from Gedeon Richter Ltd, following a referral by the Netherlands under Article 29(2) of the Community code on human medicines. The referral was initiated because of potential safety and efficacy concerns.

A more detailed CHMP meeting report will be published shortly.

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