Safety Advisory Notice on Barium selenate injectable

Notice type: Advisory

Date: 13/06/2014

 

Product name or type:
BVP Barium Selenate Injection 50, VPA 10956/008/002 & BVP Barium Selenate Injection 100, VPA 10956/008/003. Selenate Long Acting 50 mg/ml suspension, VPA 10960/073/001


Authorisation Number:
VPA 10956/008/002, 10956/008/003 & 10960/073/001


Product Classification:
Prescription-only medicine


Authorisation Holder:
BVP Animal Care, Cross Vetpharm Group


Target Audience:
Veterinary Practitioners and distributors of veterinary medicines


Problem Or Issue:
Further to a binding decision of the European Commission on 28 March 2014 that the marketing authorisation of all long acting formulations containing barium selenate for injection that are indicated for all food producing species be suspended on the basis that the benefit-risk balance is negative, the marketing authorisations of all products containing the substance in Ireland have been suspended. 

Please be advised that no new batches of these products will be available in Ireland, until the suspension has been lifted.


Background Information Or Related Documents:
Safety Advisory Notice on Barium selenate injectables Document

The decision of the European Commission is attached 
http://ec.europa.eu/health/documents/community-register/html/vo24894.htm  

The decision follows the outcome of a referral procedure to the European Medicines Agency which led to a scientific evaluation of injectable barium selenate veterinary medicines marketed in the EU which was conducted by the Committee for Medicinal Products for Veterinary Use
http://www.ema.europa.eu/docs/en_GB/document_library/Press_release/2013/04/WC500142028.pdf


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