Hiprabovis IBR Marker Live

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چکیده

Hiprabovis IBR Marker Live was eligible for the submission of a dossier for granting of a Community marketing authorisation via the centralised procedure under Article 3.1 of Regulation (EC) No. 726/2004 as the antigen is obtained through recombinant DNA technology. The company Laboratorios Hipra S.A. submitted an application to the EMEA on 3 March 2009 for the granting of a Community marketing authorisation. The Rapporteur and Co-Rapporteur’s assessment reports were circulated to all CVMP Members on respectively 28 May 2009 and 12 June 2009. The consolidated list of questions was adopted on 15 July 2009 an the CVMP Opinion was adopted on 13 October 2010.

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تاریخ انتشار 2011