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Human medicines European public assessment report (EPAR): Clopidogrel Krka d.d. (previously Zopya), clopidogrel, Date of authorisation: 20/09/2009, Revision: 15, Status: Authorised

The CHMP concluded that, in accordance with EU requirements, Clopidogrel Krka d.d. has been shown to have comparable quality and to be bioequivalent to Plavix. Therefore, the CHMP’s view was that, as for Plavix, the benefit outweighs the identified risk. The Committee recommended that Clopidogrel Krka d.d. be given marketing authorisation.

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