Description of update: Quality changes. Finished product. Manufacture. Change to importer, batch release arrangements and quality control testing of the finished product. Replacement or addition of a manufacturer responsible for importation and/or batch release. Not including batch control/testing.:
Addition of manufacturer "Accord Healthcare B.V. (Fab. Utrecht) Winthontlaan 200, Postbus 85183 3508 AD Utrecht NL" as responsible for importation and batch release.
Administrative changes. 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).:
Delete the manufacturer "Pharmacare Premium Limited (Fab. Birzebbugia) HHF 003, Hal Far Industrial Estate - BBG 3000 - Birzebbugia - MT" as batch control/testing takes place.
PIL sections affected: 2, 3, 4, 6.