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 between the ages of 10 and 18. It contains 11 questions and is divided into two parts. The first part…

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 there is an increased risk of severe bradycardia (abnormally slowed heartbeat) or cardiac conduction…

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 precautionary measure.

Situation on EU level and in Austria Several European medicinal product authorities are currently warning against the use of the "Miracle Mineral Supplement" products "MMS" and "MMS2", as there is a well-founded suspicion that they cause harmful effects that go beyond an acceptable level when used as intended. The Austrian drug authority, the…

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 affected batch was initiated.

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 Austria within the scope of a transfer notification pursuant to the Austrian Medicinal Products Import…

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.

The marketing authorization holder has informed its supplied customers that due to Commission Implementing Decision C(2014) 6030 of 19.08.2014 concerning marketing authorizations for medicinal products for human use for topical application with high concentrations of estradiol in accordance with Article 31 of Directive 2001/83/EC, the following…

Measures at EU level An inspection at the research service provider GVK Biosciences in Hyderabad (India) revealed serious deficiencies in the bioequivalence studies conducted there, which serve as the basis for the approval of generic drugs. Across Europe, more than 1,000 medicines were affected. The European Medicines Agency (EMA) has completed…