Type IA A.5. b: The activities for which the manufacturer/importer is responsible do not include batch release - variation to change the name of the site responsible for batch control/testing of the finished product from Eurofins Analytical Services Hungary Kft., Anonymus u. 6., Budapest, 1045, Hungary to Eurofins BioPharma Product Testing Budapest Kft., Anonymus u. 6., Budapest, 1045, Hungary. The address remains unchanged.
Type IA A.5. b: The activities for which the manufacturer/importer is responsible do not include batch release - variation to change the name of the site responsible for batch control/testing of the finished product from Lab Analysis S.r.l. Via Europa 5, Casanova Lonati (Pavia), 27041, Italy to Labanalysis Life Science S.r.l., Via Europa 5, Casanova Lonati (Pavia), 27041, Italy. The address remains unchanged.
Type IA A.7: Deletion of manufacturing sites for an active substance, intermediate or finished product, packaging site, manufacturer responsible for batch release, site where batch control takes place, or supplier of a starting material, reagent or excipient (when mentioned in the dossier)* - variation to delete Accord Healthcare B.V., Winthontlaan 200, 3526 KV Utrecht, Netherland as a site responsible for Batch release.