The Agency approves the future use of the batch of Cordarone 150 mg/3 ml injection previously withdrawn for preventive reasons
23.03.2009
Having verified the adequate quality of this medicine, the Agency for Medicinal Products and Medical Devices approved the future use and marketing of the batch no. 1388 of Cordarone 150mg/3 ml injection, of the marketing authorisation holder Sanofi-Aventis Croatia d.o.o., which had been withdrawn for preventive reasons.
The Cordarone batch was withdrawn from the market for preventive reasons on 26 February 2009 pursuant to a decision of the Agency, due to suspected quality defect, and its use was suspended pending quality control. All healthcare institutions in the Republic of Croatia were notified accordingly.
The results of a comprehensive study conducted independently by the Agency for Medicinal Products and Medical Devices and the marketing authorisation holder Sanofi-Aventis, confirmed the adequate quality of the batch no. 1388 of the Cordarone 150 mg/3 ml injection whereupon the Agency issued an approval for its use.
