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: 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 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 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 substance: flupirtine
In its notice of 18 December 2013, the Federal Institute for Drugs and Medical Devices has ruled the realisation of the implementing decision of the European Commission regarding medicinal products with the active substance flupirtine.
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: Fumarsäureester
After receiving reports of adverse reactions of currently nine cases of progressive multifocal leukoencephalopathy (PML) in connection with the use of Fumaderm®, the BfArM considers amendments of the section on adverse events in the product informations to be necessary.
Active substance: Fusafungin
In its notice within the graduated plan procedure the BfArM revoked all marketing authorizations for fusafungin-containing medicinal products in Germany.
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.