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 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 substance: hydroxyzine
The Co-ordination group for Mutual Recognition and Decentralised Procedures - Human (CMDh) has unanimously decided further measures to minimise the risk of arrhythmias.
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 substances: ambroxol | bromhexine
The BfArM issues information on a recommendation by the PRAC and the resulting majority decision by the Co-ordination group for Mutual recognition and Decentralised procedures – human (CMDh) within a European safety review in accordance with Article 31 of Directive 2001/83/EC.
Active substances: colistin | colistimethate sodium
Based on the review of the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA), the European Commission decided on 16 December 2014 to update the product informations of medicinal products containing colistin and colistimethate.
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: 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: 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: estradiol
In its notice of 9 January 2015, the Federal Institute for Drugs and Medical Devices (BfArM) has ruled the realisation of the corresponding implementing decision of the EU Commission C(2014)6030 of 19 August 2014
Active substance: various
In a notice dated 8 December 2014, the Federal Institute for Drugs and Medical Devices (BfArM) has ruled the suspension of several marketing authorisations that were based on a clinical trial conducted by GVK Biosciences in India.