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: dexamethasone
The European Medicines Agency (EMA) supports the use of dexamethasone in COVID-19 patients on oxygen or artificial respiration.
Active substance: cyproterone acetate/ethinylestradiol
In a notice dated 8 August 2013, the Federal Institute for Drugs and Medical Devices has ruled the realisation of the European Commission's implementing decision on medicinal products containing the combination cyproterone acetate/ethinylestradiol.
Active substance: diclofenac
Based on the recommendation of the Pharmacovigilance Risk Assessment Committee (PRAC) of the European Medicines Agency (EMA) and on the position of the Coordination Group (CMDh), the European Commission decided on 25 September 2013 to adapt the Summaries of Product Characteristics/Package Leaflets for the marketing authorisations of medicinal products containing diclofenac to the scientific state of the art. In a notice dated 4 December 2013, the Federal Institute for Drugs and Medical Devices (BfArM) has ruled that these texts are to be adapted accordingly.
Active substance: dienogest, ethinylestradiol
In its notice of 5 April 2017, the Federal Institute for Drugs and Medical Devices (BfArM) has ruled the realisation of the corresponding implementing decision of the EU Commission C(2017) 2057 final of 22 March 2017. The European safety review according to Article 31 of Directive 2001/83/EC regarding medicinal products containing dienogest 2 mg und ethinylestradiol 0.03 mg is thus now concluded.
Active substances: dihydroergotamine | dihydroergotoxine
In a notice dated 15. January 2018, the Federal Institute for Drugs and Medical Devices (BfArM) has ruled further suspension of marketing authorisation until 01. February 2020
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 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 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.