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01-02-2011 | Commentary

Rosiglitazone: a European regulatory perspective

Authors: E. Blind, K. Dunder, P. A. de Graeff, E. Abadie

Published in: Diabetologia | Issue 2/2011

Excerpt

Rosiglitazone, a drug for the treatment of type 2 diabetes, which has been authorised for use in the EU since 11 July 2000, has attracted continuous scrutiny with regard to its cardiovascular safety profile. The European Medicines Agency (EMA)’s scientific committee, the Committee for Medicinal Products for Human Use (CHMP), in its most recent comprehensive review of rosiglitazone (started 8 July 2010 and completed 22 September 2010), concluded that the benefits of rosiglitazone no longer outweigh the risks, and that the marketing authorisation of the drug in the EU should be suspended [1]. …

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Title: Rosiglitazone: a European regulatory perspective
Authors: E. Blind
K. Dunder
P. A. de Graeff
E. Abadie
Publication date: 01-02-2011
Publisher: Springer-Verlag
Published in: Diabetologia / Issue 2/2011
Print ISSN: 0012-186X
Electronic ISSN: 1432-0428
DOI: https://doi.org/10.1007/s00125-010-1992-5

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