Pregsure BVD - Notice of Suspension of the Marketing Authorisation and Recall

01 September 2010

The European Commission, acting on the advice of the Committee for Medicinal Products for Veterinary Use (CVMP), has instructed European Member States to suspend the marketing authorisations for PregSure BVD and to withdraw the product from the distribution chain at wholesaler level.

The basis for the advice of the CVMP relates to a possible link between use of the vaccine in dams and the development of Bovine Neonatal Pancytopenia (BNP) in calves. The CVMP evaluated all available post-authorisation safety data from European Member States. While the aetiology of the disorder remains obscure at present and the associated risk factors have yet to be determined, it concluded that the information available is sufficient to indicate a potential association with the product. Accordingly, it decided that the benefit/risk balance for PregSure BVD had changed and advised that the marketing authorisation be suspended. Further details are available on the EMA website (www.ema.europa.eu).

The Irish Medicines Board (IMB) is continuing to monitor reports of BNP in calves in this country for a possible association with use of PregSure BVD vaccine. To August 24th 2010, some eight adverse reaction reports linked to confirmed or suspected cases of BNP have been reported in Ireland.

The IMB, acting in accordance with the requirements of national legislation (SI No 786 of 2007), suspended the marketing of PregSure BVD (VPA 10019/104/1), effective from 1 September 2010. A product recall to wholesaler level has also been initiated.

Ger McCarthy/Orla Molloy     Tel: 01 676 01 68
Weber Shandwick                Tel: 086 233 3590 or 087 770 5108