We would like to point out that the deadline set in accordance with Section 94c(10) of the Austrian Medicines Act, Federal Law Gazette No. 185/1983, as amended, for the submission of documents relating to an extension of the marketing authorization will expire in a few weeks. For all medicinal products that have already been renewed at least once…

The marketing authorization holder has informed its supplied customers in a letter dated April 2, 2012, that a microbiological contamination has been detected at the manufacturer during a routine media filling in the production line for ViaSpan and thus a recall is being implemented as a precautionary measure. (Media filling is a method of…

The marketing authorization holder has informed its supplied customers by letter dated April 02, 2012, that an internal stability test after 15 months of storage has revealed the occurrence of visual particles. The recall affects all dose forms of Carboplatin 10 mg/ml vials (50mg/5ml, 150mg/15ml, 450mg/45ml and 1000mg/100ml).

The marketing authorization holder has informed its supplied customers in a letter dated March 22, 2012, that glass splinters were found in the product vials during routine quality control. Therefore, the above mentioned batches are recalled in Austria as a precautionary measure.

The distribution company Novartis Pharma GmbH has informed its supplied customers in a letter dated March 19, 2012, that due to water ingress in the manufacturer's warehouse, a batch of the injection syringes included in the Rabipur vaccine kit has become moist. Due to this moisture on the primary packaging of the enclosed application syringes, the…

The marketing authorization holder informed its supplied customers in a letter dated March 15, 2012, that a degradation product of the active ingredient cinchocaine hydrochloride exceeded the specification limit during the period of use and that a recall must therefore be carried out.

Methotrexate (MTX) is used to treat severe forms of psoriasis, autoimmune diseases (e.g., rheumatoid arthritis), and various tumor diseases. It is strictly available only on prescription. As a so-called "antimetabolite", the active ingredient methotrexate inhibits the formation of certain building blocks of the DNA of the cell nucleus and thus…

The marketing authorization holder has informed its supplied customers in a letter dated March 2, 2012, that the packages of the batches listed above contain a non-updated package insert. Since e.g. changes of the side effect profile as well as a new indication for use are missing, the affected batches will be recalled from the market.

The BASG / AGES Medical Market Inspectorate became aware that pharmaceutical companies were contacted by telephone in the name of AGES, or by persons claiming to be AGES employees, in order to request personal or company-related data. In this regard, we would like to inform you that we do not request personal or company-related data by telephone,…