Messages in brief
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…
Instructions for the correct use of auto-injectors with the active ingredient adrenaline (epinephrine) for emergency treatment
Auto-injectors containing adrenaline are used for emergency treatment of anaphylactic shock or allergic reaction (e.g. to insect stings or bites, food…
Current information on manipulated drugs
Situation EU: In addition to individual cases of manipulated, parallel distributed Italian Herceptin, manipulated, parallel distributed MabThera of…
"Operation Vigorali": Europe-wide trafficking of counterfeit medicines solved
"Morning-after pill" remains appropriate emergency contraception in every weight class
