Suvaxyn PCV Vaccine - European Commission Article 45 Procedure

EU - Zoetis Inc. acknowledges that the European Commission started a procedure under Article 45 of Regulation (EC) No. 726/2004 regarding the EU marketing authorization for Suvaxyn PCV, a centrally-authorized vaccine against Porcine Circovirus 2 in swine.
calendar icon 21 May 2013
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As part of this procedure, the European Medicines Agency’s (EMA) Committee for Medicinal Products for Veterinary Use (CVMP) discussed the issue during its latest monthly meeting (14-16 May 2013) .

The initiation of the above procedure follows Zoetis’ proactive decision, on 25 March 2013, to stop the distribution of two batches of Suvaxyn PCV as a result of higher than expected adverse reactions, reported mainly in Spain. The two batches were later recalled by Zoetis, following subsequent discussions with the Spanish authorities and the EMA.

Zoetis continues to investigate the potential root cause for the reported adverse reactions and is committed to working with the EMA, the European Commission, and National Competent Authorities to best address this situation.

Zoetis affirms that all batches of Suvaxyn PCV released globally, including the EU, have been produced and tested in compliance with all regulatory requirements and the approved marketing authorization dossiers.

Zoetis is fully committed to supplying the market only with veterinary medicinal products meeting the highest quality and safety standards. Our company takes quality and pharmacovigilance responsibilities very seriously and will continue to actively monitor this issue and regularly inform the relevant authorities on the progress of these investigations.

Suvaxyn PCV2 is a vaccine used for healthy pigs three weeks of age or older as an aid in the prevention of viremia and as an aid in the control of lymphoid depletion caused by Porcine Circovirus Type 2. This vaccine was launched in EU in December 2012-January 2013.

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