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: 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: 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: 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 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: Amfepramone
Following the recommendation of the Coordination Group on Mutual Recognition Procedures and Decentralised Procedures - Human (CMDh) on the revocation of marketing authorisations and prior to the final decision of the European Commission, all marketing authorisation holders of medicinal products containing amfepramone in Germany have declared a voluntary surrender of their marketing authorisations as of 01 December 2022.
Active substances: valsartan | candesartan | irbesartan | losartan | olmesartan
The Federal Institute for Drugs and Medical Devices (BfArM) has withdrawn the suspension of some of axcount's marketing authorizations by decision dated December 22, 2022.
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: 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: nomegestrol- and chlormadinone-containing medicines
The Federal Institute for Drugs and Medical Devices (BfArM) implements the decision of the European Commission C(2022) 7954 (final) of 28.10.2022 with a notice in the national graduated plan procedure, dated 22 November 2022.