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: omega-3 fatty acids
The Federal Institute for Drugs and Medical Devices (BfArM) is implementing the implementing decision of the European Commission in its notification of 14 June 2019.
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.
Active substance: methotrexate
The Federal Institute for Drugs and Medical Devices (BfArM) is implementing the corresponding implementing decision of the European Commission C(2019) 7680 final of 21 October 2019 by decision of 20 November 2019.
Active substance: kava-kava
The Cologne Administrative Court issues a ruling regarding the legality of the decision in the national graduated plan procedure ("Stufenplanverfahren").
Active substance: Calcitonin
With regard to the intranasal route of administration for the osteoporosis indication, suspension of the marketing authorisations has been extended until 1 April 2020.
Active substance: tofacitinib
With the publication of the European Commission's decision, the risk assessment procedure in accordance with Article 20 of Regulation (EC) No. 726/2004 for Xeljanz® was completed.
Active substances: apixaban | dabigatran etexilate | rivaroxaban
Following a review of the results of a European study with real-world drug-related data from use, no change in the use criteria of the direct oral anticoagulants Eliquis® (apixaban), Pradaxa® (dabigatran etexilate), and Xarelto® (rivaroxaban) is required.
Active substance: estradiol
With its notice within the graduated plan procedure of 18 March 2020, the BfArM implements the unanimous decision of the coordination group, CMDh.
Active substance: cyproterone
The PRAC recommendations were adopted by the Co-ordination group for Mutual recognition and Decentralised procedures – human (CMDh) by consensus on 25 March 2020.