The marketing authorization holder informed its supplied customers in a letter dated August 27, 2012, that in the course of stability tests at the manufacturer Ben Venue Laboratories, Ohio, USA, an overfill was detected in a single dry-stone ampoule…

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…

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 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…

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…

The marketing authorization holder informed its supplied customers in a letter dated July 2, 2012, that quality deviations were detected in current batches during stability tests. Therefore, as a precautionary measure, the delivery will be stopped…

The marketing authorization holder informed its supplied customers by letter dated 28.06.2012 that the transport carton of batch A010816 is labeled with the strength "Propofol ratiopharm 10 mg/ml emulsion for injection or infusion" (500 mg/50 ml),…

The occurrence of venous thromboembolic events (VTE) is a rare but long-known adverse effect of combined oral contraceptives (COCs), which is explicitly mentioned in the technical and instructions for use of the preparations. Recent studies have…