As part of its transparency policy, the EMA has made data on adverse reaction reports publicly available at www.adrreports.eu since May 31, 2012. This website provides access to aggregated data on adverse drug reactions submitted by national authorities and marketing authorization holders to the pan-European database EudraVigilance in accordance…

The marketing authorization holder informed its supplied customers in a letter dated May 22, 2012, that visual particles resulting from precipitate formation were detected in individual batches during quality control and that a recall was therefore being implemented as a precautionary measure.

On this occasion, the minister reminded the audience that many countries in Europe are cutting back on health care, and sometimes health care facilities are being dismantled. "It is different in Austria: the federal government has clearly stated that we want to further develop the healthcare system. Therefore, I am particularly pleased that we are…

In a letter dated April 26, 2012, the marketing authorization holder informed its supplied customers that the active ingredient content of the above-mentioned batches could be outside the product specification at the end of the shelf life and that a recall would therefore be carried out as a precautionary measure.

Around 30 girls between the ages of ten and 16 learned more about the assessment and control of medicines on today's Girl's Day. They were able to actively and passively deal with the challenges of drug control at four stations. The focus was on the high-performance analysis of drugs, pharmaceutical methods and the analysis of plant drugs. At the…

The increasing complexity of the legal materials AMG and MPG, in particular the areas of clinical testing, medical devices in general, in vitro diagnostics, etc., increasingly lead to ambiguities in the implementation of research projects. In order to provide appropriate support, the BASG is offering a "consultation hour" for western Austria from…

The distributor has informed its supplied customers in a letter dated April 5, 2012, that the sterility of the batches listed above can no longer be guaranteed and therefore a recall is being carried out as a precautionary measure.

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).