The marketing authorization holder has informed its supplied customers in a letter dated 11.10.2013 that complaints have arisen describing the disintegration of the pen after repeated use. Since the pen can no longer be used after this, a…

Several regions are affected by WNV infections.

NAT testing was implemented in the Nestos and Kavala regions. A total of 11 cases documented.

On October 8, 2013, the marketing authorization holder informed its customers that injection vials may have an externally invisible defect under the crimp cap due to the capping machine and that product leakage may occur when the vial is shaken.…

Policy 0070 on publication and access to clinical-trial data

New management of AGES Medical Market Surveillance

The European Union has introduced a new labeling for medicinal products that are subject to particularly close monitoring. These medicines are identified in the package leaflet by a black triangle ▼ standing on its tip with the words: "This medicinal…

During a routine quality check, a small number of prefilled syringes were found to contain particles consisting mainly of cellulose fibers. The voluntary exchange only affects investigational products with the above batch numbers that were marketed…

Many medicinal products, when stored appropriately, remain in compliance with their specifications for much longer than can be expected on the basis of their expiration date. If you want to use such stocks of medicinal products safely and…

Four more confirmed cases in Constanta, Ialomita, Galati, and Bucharest districts 2 and 5.