CHMP meets to discuss Avandia and Pandemrix

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08/09/2010

CHMP meets to discuss Avandia and Pandemrix

08/09/2010 - The Committee for Medicinal Products for Human Use (CHMP) met on Wednesday 8 September to discuss the ongoing benefit-risk review of the rosiglitazone-containing medicines Avandia, Avandamet and Avaglim.

The Committee discussed all of the available data on the risk of cardiovascular problems associated with rosiglitazone in order to prepare for its next scheduled meeting of 20-23 September 2010, when it expects to finalise its review.

The CHMP identified a number of further questions that it is putting to the marketing authorisation holder, GlaxoSmithKline. The responses to these questions will help the Committee to reach its opinion on whether the marketing authorisations for rosiglitazone-containing medicines should be maintained, changed, suspended or revoked.

The CHMP also discussed the available data on the possible risk of narcolepsy with the influenza vaccine Pandemrix, in order to prepare for its plenary meeting later this month.

After the plenary meeting of 20-23 September, the Agency will publish the Committee’s conclusions.

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Contact point:

Monika Benstetter or Sabine Haubenreisser
Tel. +44 (0)20 7418 8427
E-mail: press@ema.europa.eu