Europe's CHMP adopts opinions on Allergan's Ozurdex and generic leflunomide and use extensions; proposes Zeffix restriction; backs rotavirus vacci

24 May 2010

At its meetings last week, the European Medicines Agency's (EMEA) Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion, recommending the granting of a marketing authorization for Ozurdex (dexamethasone), from Allergan Pharmaceuticals Ireland, intended for the treatment of macular oedema. The review for Ozurdex began on 25 March 2009 with an active review time of 210 days.

The Committee also recommended granting approval for the generic medicine Leflunomide medac (leflunomide), from medac GmbH, for the treatment of active rheumatoid arthritis. Leflunomide medac is a generic version of Sanofi-Aventis' Arava.

Extensions for Orencia and Taxotere

Positive opinions were also given for applications for extensions of the therapeutic indications, adding new treatment options for medicines that are already authorized in the European Union, for:

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