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: flupirtine
In its notices and/or ascertainment decision of 26 April 2018, the Federal Institute for Drugs and Medical Devices (BfArM) has ruled the realisation of the unanimous CMDh position of 21 March 2018.
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: fluoroquinolones | quinolones
In response to enquiries, the BfArM refers at this point to Annex II of the Commission Decision, which describes areas of application in Category 1.
Active substance: domperidone
In its notice of 8 September 2014, the Federal Institute for Drugs and Medical Devices (BfArM) has ruled the realisation of the corresponding implementing decision of the EU Commission C(2014)5113. The European safety review according to Article 31 of Directive 2001/83/EC regarding medicinal products containing domperidone is thus now concluded.
Active substances: daclatasvir | dasabuvir | sofosbuvir/ledipasvir | simeprevir | sofosbuvir | ombitasvir/paritaprevir/ritonavir
The European Medicines Agency (EMA) confirms its recommendation for hepatitis B screening of all patients before starting treatment with direct-acting antiviral drugs for the treatment of hepatitis C
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.