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: canagliflozin | dapagliflozin | empagliflozin
The Pharmacovigilance Risk Assessment Committee of the European Medicines Agency has completed the European safety review on SGLT2 inhibitors and has issued recommendations to minimise the risk of diabetic ketoacidosis.
Active substances: canagliflozin | dapagliflozin | empagliflozin
The BfArM issues information on the initiation of a European safety review according to Article 20 of Regulation (EC) No. 726/2004 regarding SGLT2 inhibitors.
Active substances: Canagliflozin | Dapagliflozin | Empagliflozin
The BfArM issues information on the extension of the European safety review regarding canagliflozin to include all SGLT2 inhibitors.
Active substances: valsartan | candesartan | irbesartan | losartan | olmesartan
The Federal Institute for Drugs and Medical Devices (BfArM) has withdrawn the suspension of some of axcount's marketing authorizations by decision dated December 22, 2022.
Active substance: rucaparib camsylate
With the publication of the European Commission Decision on 21 September 2022, the Risk Assessment Procedure under Article 20 of Regulation (EC) No 726/2004 concerning "Rubraca - Rucaparib" was finalised.
Active substances: acitretin | adapalene | alitretinoin | bexarotene | isotretinoin | tazarotene | tretinoin
The BfArM requires pharmaceutical companies to report annually all pregnancies reported in connection with the use of acitretin, alitretinoin and isotretinoin.
Active substance: ranitidine
The Federal Institute for Drugs and Medical Devices (BfArM) has ordered the temporary suspension of all holders of marketing authorisations for medicinal products containing ranitidine.
Active substance: quinine
The BfArM issues information on a national graduated plan procedure ("Stufenplanverfahren") regarding the active substance quinine for the indication nocturnal leg cramps.
Active substance: quinine
In its letter dated 19 December 2013, the German Federal Institute for Drugs and Medical Devices (Bundesinstitut für Arzneimittel und Medizinprodukte, BfArM) has initiated a written hearing regarding the risk of serious haematological reactions, especially thrombocytopenias, associated with medicinal products containing quinine in the indication "treatment and prevention of nocturnal leg cramps".
Active substance: pseudoephedrine
With the publication of the European Commission's decision, the risk assessment procedure according to Article 31 of Directive 2001/83/EC on medicinal products containing pseudoephedrine has been completed.