The Agency approves the future use of the Augmentin injection 1.2 g packaging with 5 vials/box series withdrawn for precautionary reasons
05.05.2009
Having confirmed the adequate quality of the Augmentin injection 1.2 g packaging with 5 vials/box series no. 392761, of the marketing authorisation holder GlaxoSmithKline d.o.o., Zagreb, previously withdrawn for precautionary reasons, the Agency approved its future use and marketing.
The series had been withdrawn for precautionary reasons on 28 March 2009 pursuant to an Agency decision due to suspected quality defect, its use was suspended pending quality review, and all health institutions in the Republic of Croatia were advised accordingly.
The results of a comprehensive study carried out by the Agency for Medicinal Products and Medical Devices confirmed the safety of the 392761 series of Augmentin injection 1.2 g packaging with 5 vials/box, whereupon the Agency issued an approval for its future use.
