Situation in Austria As of June 25, 2015, remote sales of over-the-counter pharmaceutical specialties approved in Austria will be made possible. Interested domestic, public pharmacies can register for this with immediate effect. more information:…

The marketing authorization holder has informed its supplied customers that a slightly increased level of oxidized methionine was found in stability tests after 12 months of storage. Methionine is part of the structure of erythropoietin, and…

Sandoz GmbH has informed all supplied customers in a letter dated 20.05.2015 that deviations in the release of the active ingredient were found in stability tests for batches with the old shelf life of 36 months. These deviations are due to the aging…

Measures at EU level The European Medicines Agency (EMA) would like to increase the acceptance of participation of children and adolescents in clinical trials. To this end, a questionnaire has been designed that is aimed at children and adolescents…

The Federal Office informs about recommendations of the European Medicines Agency EMA regarding a restriction of the use of new hepatitis C drugs together with amiodarone. Measures at EU level The European Medicines Agency (EMA) has confirmed that…

The distribution company informed its supplied customers by letter dated 01.04.2015 that various finished product batches from a single bulk are being recalled because black visible particles were detected.

In a letter dated March 26, 2015, "Bayer Austria Ges.m.b.H." informed its supplied customers that there was a single deviation in the ambient monitoring during aseptic filling and therefore the four batches listed above are being recalled as a…

The marketing authorization holder has informed its supplied customers both by telephone and in writing that individual leaking sachets have been detected, which affect the product quality due to moisture penetration. Thus, an exchange of the…

The distribution company has informed its supplied customers in a letter dated 25.02.2015 that in the instructions for use of this batch the wrong daily maximum dose of ten capsules is indicated. This medicinal product is placed on the market in…

The marketing authorization holder informed its supplied customers in a letter dated February 9, 2015, that the specified batches were being recalled because deviations from the specified dissolution value had been detected in the samples returned.