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28/05/2015
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:…
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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…
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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…
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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…
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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…
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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…
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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…
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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…
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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…