Pregsure BVD vaccine for veterinary use: suspension of the marketing authorisation (MA)

Following the appearance of bovine neonatal pancytopenia reported after using Pregsure BVD, the Committee for Medicinal Products for Veterinary Use (CVMP) of the European Medicines Agency (EMA) has recommended the suspension of the marketing authorisation of this inactivated vaccine indicated for immunisation of cows to prevent transplacental infection caused by the bovine viral diarrhea virus. After evaluating all available data, the CVMP considered that the benefit-risk balance for Pregsure BVD was unfavourable. It has also recommended the recall of all batches at the wholesale level.

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Commission decision based on the opinion of the CVMP + adoption of the décision

Last updated on 15/10/2010