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: atovaquone/proguanil hydrochloride | celecoxib | eprosartan | pregabalin | saquinavir
No more medicinal products are authorised in Germany that were based on studies conducted by the Semler Research Center (SRC) in India.
Active substance: Pholcodine
The European Commission made its final legally binding decision on March 06, 2023, resulting in the revocation of national authorizations. This decision, addressed to the EU member states, is valid in all EU member states. This concludes the European risk assessment procedure under Article 107i of Directive 2001/83/EC on medicinal products containing pholcodine.
Active substance: Janus kinase inhibitors
With the publication of the European Commission's decision on March 10, 2023, the risk assessment procedure in accordance with Article 20 of Regulation (EC) No. 726/2004 on Janus kinase inhibitors was completed. The warnings and precautions for using these medicines have been updated.
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.
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 substances: hydroxyethyl starch | HES
The Federal Institute for Drugs and Medical Devices (BfArM) publishes updated information on marketability.
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.