BfArM - Federal Institute for Drugs and Medical Devices
Navigation and service
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
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: Ponatinib
With the publication of the decision of the European Commission on 15 January 2015, the risk assessment procedure for Iclusig® was completed.
Active substance: testosterone
The Pharmacovigilance Risk Assessment Committee (PRAC) of the European Medicines Agency (EMA) has reviewed the risk of cardiovascular diseases, particularly heart attacks, under treatment with testosterone.
Active substance: valproate
On 19 November 2014, the Co-ordination group for Mutual recognition and Decentralised procedures – human (CMDh) decided unanimously based on the recommendations of the European Medicines Agency’s (EMA) Pharmacovigilance Risk Assessment Committee (PRAC) that valproate and related substances should only be used for treatment of manic episodes in bipolar disorders and of epilepsy in girls and women of childbearing potential if other medicinal products are ineffective or not tolerated.
Active substance: valproate
In view of renewed discussions and assessments on a European level as well as current findings and discussions with scientific societies, the BfArM also considers it necessary to introduce a patient alert card as a further measure in addition to previous risk minimisation measures. The following notice in this regard was prepared after the hearing of 1 March 2017.
Active substance: Valproate
A notice of annulment was sent out for medicinal products for which the marketing authorisation holder had renounced the marketing authorisation.
Active substance: zolpidem
By decision of 22 August 2014, the Federal Institute for Drugs and Medical Devices (BfArM) implements the corresponding implementing decision of the EU Commission of 23 June 2014 on zolpidem-containing medicinal products. The Implementing Decision contains amendments to the SPC and package leaflet.
Active substances: ACE-Hemmer | Angiotensin-II-Rezeptor-Antagonisten | Aliskiren
In its notice of 31 October 2014, the Federal Institute for Drugs and Medical Devices (BfArM) has ruled the realisation of the corresponding implementing decision (2014) 6371 of the EU Commission.
Active substance: nomegestrol- and chlormadinone-containing medicines
The Federal Institute for Drugs and Medical Devices (BfArM) implements the decision of the European Commission C(2022) 7954 (final) of 28.10.2022 with a notice in the national graduated plan procedure, dated 22 November 2022.
Active substance: metamizole
With the publication of the European Commission's decision, the risk assessment procedure on the medicinal products containing metamizole has been completed.
