Pharmacovigilance

Withdrawal of the Marketing Authorisation for Raptiva 100 mg/ml (efalizumab)

06.08.2009

Following the News issued by the Agency for Medicinal Products and Medical Devices on February 2009, the marketing authorisation of the finished medicinal product Raptiva 100 mg/ml (efalizumab) in the Republic of Croatia, has been withdrawn in accordance with the European Medicines Agency recommendation and the decision by the European Commission.

This medicinal product has never been placed on the Croatian market or prescribed to patients in Croatia.

EMEA's statement can be found at the following link: http://www.emea.europa.eu/humandocs/PDFs/EPAR/raptiva/48710709en.pdf

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