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: hydroxyprogesterone
EMA’s safety committee, PRAC, has recommended the suspension of the marketing authorisations for medicines containing 17-hydroxyprogesterone caproate (17-OHPC) in the European Union (EU).
Active substance: pseudoephedrine
With the publication of the European Commission's decision, the risk assessment procedure according to Article 31 of Directive 2001/83/EC on medicinal products containing pseudoephedrine has been completed.
Active substance: various
On 21 March 2024, EMA’s human medicines committee (CHMP) confirmed its recommendation to suspend or not grant the marketing authorisations of a number of generic medicines tested by Synapse Labs Pvt. Ltd., a contract research organisation (CRO) located in Pune, India.
Active substance: gadolinium
For contrast agents containing gadolinium, the suspension of marketing authorisations has been extended until 28 February 2026.
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: hydroxyethyl starch | HES
The Federal Institute for Drugs and Medical Devices (BfArM) publishes updated information on marketability.
Active substance: obeticholic acid
EMA’s human medicines committee (CHMP) has started a review of the medicine Ocaliva (obeticholic acid), used to treat adults with primary biliary cholangitis (PBC).
Active substance: naltrexone, bupropion
EMA has started a review of Mysimba (naltrexone/bupropion), a medicine for weight management in adults who have obesity or are overweight.
