Official announcements
Safety warnings
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messages in brief
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12/05/2015
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…
Safety warnings
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messages in brief
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28/04/2015
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…
Recall
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Medicines
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02/04/2015
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.
Recall
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Medicines
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27/03/2015
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…
27/02/2015
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…
Replacement
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Medicines
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26/02/2015
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…
Recall
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Medicines
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26/02/2015
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…
Recall
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Medicines
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10/02/2015
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.
Recall
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Medicines
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06/02/2015
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…
Safety warnings
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messages in brief
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23/01/2015
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…
