BfArM - Federal Institute for Drugs and Medical Devices
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If you use the services of this provider, it is possible that usage data will be collected and, if necessary, stored in server logs.The BfArM has no influence on the type and scope of the transmitted or stored data. Go to LinkedIn
Risk Assessment Procedures
Here you will find information on the risk assessment procedures including national graduated plan procedures (“Stufenplanverfahren”). This list is compiled in a chronological order according to the date of the most recent update.
After clicking on the "search all risk assessment procedures" button, the total amount of all risk assessment procedures can be searched in the website search.
Active substance: terfenadine
After a hearing regarding terfenadine, including evaluation of the safety report, no changes in the benefit/risk profile could be determined.
Active substance: terlipressin
The BfArM has implemented the decision of the CMDh dated 10 November 2022 regarding terlipressin-containing drugs at national level by official notice, dated 19 December 2022.
Active substance: Topiramate
In a decision dated 22 November 2023, the Federal Institute for Drugs and Medical Devices (BfArM) implements the unanimous decision of the Coordination Group for Mutual Recognition Procedures and Decentralized Procedures - Human (CMDh) of 11 October 2023 on medicinal products containing topiramate.
Active substances: niacin | laropiprant
The European Medicines Agency (EMA) has initiated a review procedure regarding the lipid-lowering drugs Tredaptive®/Pelzont®/Trevaclyn® after the MAH of the medicinal products had published preliminary results of a large, long-term study.
Active substance: ulipristal acetate
The Federal Institute for Drugs and Medical Devices (BfArM) has revoked the provisional suspension of the marketing authorisations for medicinal products and ordered changes to the marketing authorisations.
Active substance: valproate
At the request of Great Britain, the European Medicines Agency (EMA) has initiated a review procedure in accordance with Article 31 of Directive 2001/83/EC regarding valproate, valproic acid and related substances.
Active substance: valproate
The BfArM issues information on the PRAC's recommendation within a European safety review according to Article 31 of Directive 2001/83/EC.
Active substance: valproic acid
The product information texts on all valproic acid or products containing valproates should include warnings about clinically relevant interactions with carbapenems (decreased valproate plasma concentration) to come up to the latest findings. The intended measures are due to an EU recommendation. A hearing in writing under the graduated plan procedure (Stufenplan), stage II, will follow.