The distribution partner sanofi-aventis GmbH Austria informed its supplied customers by letter dated August 13, 2012, that aggregates above the specification limit of 5% occurred after reconstitution of reserve samples of a batch sold in the USA. As…

Emergence of new confirmed cases in the province of Venezia.

Misleading wording in package insert, see related file.

Packaged finished product batches as of May 2011 contain incorrect information in the package insert, see associated file.

SOKO Temp II

The marketing authorization holder has informed its supplied customers in a letter dated July 25, 2012, that the folding box of batch 1261105 is incorrectly labeled "For intramuscular injection", but the product is injected subcutaneously. Therefore,…

The marketing authorization holder informed its supplied customers by letter dated July 12, 2012, that batches 20528D and 20532E are to be blocked immediately. The recall of these batches was initiated by letter dated 18.07.2012. The recall was…

The marketing authorization holder informed its customers by letters dated July 10 and 13, 2012, that the patient-specific batches could have an elevated protein-nitrogen content and that the manufacturer could not rule out the possibility that the…

Occurrence of a confirmed case in Palaio Faliro.

The following innovations are planned throughout Europe: Risk and risk managementAll medicinal products carry known and unknown risks at the time of their authorization. The previous version of Regulation 726/2004 already takes this knowledge into…