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 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: 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 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: terfenadine
After a hearing regarding terfenadine, including evaluation of the safety report, no changes in the benefit/risk profile could be determined.
Active substance: escherichia coli
In its review of Symbioflor 2, the European Medicines Agency EMA has concluded that the medicinal product can continue to be used for treatment of irritable bowel syndrome in adults. However, it should no longer be taken to treat so-called functional gastrointestinal disorders.
Active substance: various
The Federal Institute for Drugs and Medical Devices (BfArM) implements the EU Commission's implementing decision of 28.11.2022 nationally by notice of 13 December 2022.
Active substance: strontium ranelate
The BfArM issues information on the implementing decision of the Commission within a European safety review in accordance with Article 20 of Regulation (EC-European Community) No. 726/2004.
Active substance: various
The Federal Institute for Drugs and Medical Devices (BfArM) implements the decision of the European Commission of 24 May 2024 for the German marketing authorisations with its decision of 17 June 2024.
Active substance: sibutramine
On 30 September 2010, the Federal Institute for Drugs and Medical Devices (BfArM) ordered the implementation of the European Commission's decision on drugs containing sibutramine and the increased risk of cardiovascular events. In a letter dated 13 September 2019, the BfArM again ordered the further suspension of the marketing authorisations.