Messages in brief
Warning against use of new hepatitis C drugs with amiodarone
The Federal Office informs about recommendations of the European Medicines Agency EMA regarding a restriction of the use of new hepatitis C drugs…
Results of review of generic approvals with respect to potentially falsified bioequivalence studies in India.
Measures at EU level
An inspection at the research service provider GVK Biosciences in Hyderabad (India) revealed serious deficiencies in the…
EU Commission releases "ellaOne" morning-after pill from prescription requirement
Measures at EU level The EU Commission has released the emergency contraceptive "ellaOne" (active ingredient: Ulipristal) from prescription-only…
Safety information for the use of isotretinoin
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…
Review of generic approvals with regard to potentially falsified bioequivalence studies.
An inspection by the French Medicines Agency (ANSM) of the research service provider GVK Biosciences in Hyderabad (India) has revealed serious…
Falsified bioequivalence studies could lead to approval suspensions for individual generic drugs
An inspection by the French Medicines Agency (ANSM) of the research service provider GVK Biosciences in Hyderabad (India) has revealed serious…
Deactivation of e-mail addresses "spc@ages.at" and "mrp-spc@ages.at for human medicines
Austrian "Summaries of Product…
Italy: suspension of 2 batches of Fluad, Austria not affected
Austria has been informed by the Italian Medicines Agency (AIFA) of a precautionary suspension of two batches (142701 and 143301) of the influenza…
Use of valproate during pregnancy
The Federal Office provides information on recommendations of the Committee for Risk Assessment and Pharmacovigilance (PRAC) within the framework of…
Telephone inquiries / calls on behalf of AGES - Update
Status 06.09.2014:
The BASG / AGES Medical Market Surveillance became aware that dubious persons were contacting by telephone in the name of AGES…
