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: fluorouracil | capecitabine | tegafur | flucytosine
The Federal Institute for Drugs and Medical Devices (BfArM) implements the decision of the European Commission with a notice in the national graduated plan procedure.
Active substances: methocarbamol | paracetamol
With regard to the combination drug methocarbamol/paracetamol 380 mg/300 mg, the final decision of the EU Commission was issued on 10.06.2020.
Active substance: trabectedin
EMA has recommended that the use of Yondelis (trabectedin) in treating ovarian cancer remain unchanged following a review of a study that investigated Yondelis as a third-line treatment in patients with ovarian cancer.
Active substance: Fosfomycin
The BfArM informs about the initiation of a European risk assessment procedure according to Art. 31 of Directive 2001/83/EC for fosfomycin.
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.
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 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: 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.