European Medicines Agency notified of recall of swine fever vaccine (Porcilis Pesti) by Intervet International BV
Press releaseMedicines
The European Medicines Agency (EMEA) has been notified by the competent authority of The Netherlands of a recall of all batches of Porcilis Pesti, a centrally authorised marker vaccine used as part of vaccination campaigns to eradicate classical swine fever from the European Union.
The recall of the medicine was initiated by the marketing authorisation holder, Intervet International BV, as a precautionary measure following the detection of reduced stability in three batches during the routine stability testing of Porcilis Pesti. The root cause and the extent of the problem are still under investigation.
The EMEA's Committee for Medicinal Products for Veterinary Use (CVMP) has asked the marketing authorisation holder for further information, which will be considered at its 13-15 May meeting when the Committee will decide if any action is required with respect to the marketing authorisation for this medicinal product.