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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…
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…
messages in brief
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15/01/2015
Measures at EU level The EU Commission has released the emergency contraceptive "ellaOne" (active ingredient: Ulipristal) from prescription-only status. In doing so, the Brussels-based authority has followed the recommendation of the European…
Safety warnings
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messages in brief
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04/01/2015
Isotretinoin is a highly effective vitamin A analogue that has been used since the early 1980s to treat severe, therapy-resistant forms of acne. When isotretinoin is taken during pregnancy, the risk of severe congenital malformations or spontaneous…
Safety warnings
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messages in brief
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12/12/2014
An inspection by the French Medicines Agency (ANSM) of the research service provider GVK Biosciences in Hyderabad (India) has revealed serious deficiencies in the conduct of bioequivalence studies for the approval of generic drugs. There is suspicion…
Safety warnings
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messages in brief
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06/12/2014
An inspection by the French Medicines Agency (ANSM) of the research service provider GVK Biosciences in Hyderabad (India) has revealed serious deficiencies in the conduct of bioequivalence studies for the approval of generic drugs. There is suspicion…
messages in brief
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03/12/2014
As previously announced, the following e-mail addresses spc@ages.at and mrp-spc@ages.at are deactivated on 31.01.2014. Austrian "Summaries of Product Characteristics", "Labellings" and "Patient Information Leaflets" should now be submitted via PHAROS…
Safety warnings
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messages in brief
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28/11/2014
Austria has been informed by the Italian Medicines Agency (AIFA) of a precautionary suspension of two batches (142701 and 143301) of the influenza vaccine Fluad. The reason for the suspension is the occurrence of serious adverse events that have been…
Safety warnings
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messages in brief
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17/10/2014
The Federal Office provides information on recommendations of the Committee for Risk Assessment and Pharmacovigilance (PRAC) within the framework of the European risk assessment procedure according to Article 31 of Directive 2001/83/EC regarding the…