Occurrence of new diseases in the districts of Ialomita, Giurgi as well as city of Bucharest.

In accordance with Section 1 (3b) of the Austrian Medicines Act, Federal Law Gazette No. 185/1983, as amended, the following official demarcation has been made in response to questions submitted to the Federal Office for Safety in Health Care with…

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…

Dealing with people willing to donate from various areas of Romania.

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,…