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: 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: 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The Federal Institute for Drugs and Medical Devices (BfArM) has withdrawn the suspension of some of axcount's marketing authorizations by decision dated December 22, 2022.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 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: 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 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 substance: sibutramine
On 30 September 2010, the Federal Institute for Drugs and Medical Devices (BfArM) ordered the implementation of the European Commission's decision on drugs containing sibutramine and the increased risk of cardiovascular events. In a letter dated 13 September 2019, the BfArM again ordered the further suspension of the marketing authorisations.
Active substance: various
On 21 March 2024, EMA’s human medicines committee (CHMP) confirmed its recommendation to suspend or not grant the marketing authorisations of a number of generic medicines tested by Synapse Labs Pvt. Ltd., a contract research organisation (CRO) located in Pune, India.
Active substance: strontium ranelate
The BfArM issues information on the implementing decision of the Commission within a European safety review in accordance with Article 20 of Regulation (EC-European Community) No. 726/2004.
Active substance: various
The Federal Institute for Drugs and Medical Devices (BfArM) implements the EU Commission's implementing decision of 28.11.2022 nationally by notice of 13 December 2022.
Active substance: escherichia coli
In its review of Symbioflor 2, the European Medicines Agency EMA has concluded that the medicinal product can continue to be used for treatment of irritable bowel syndrome in adults. However, it should no longer be taken to treat so-called functional gastrointestinal disorders.