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: ambroxol | bromhexine
The BfArM issues information on the initiation of a European safety review according to Article 31 of Directive 2001/83/EC. This procedure was initiated at the request of the Belgian Federal Agency for Medicines and Health Products.
Active substance: combined hormonal contraceptives
In its notice of 31 March 2014, the Federal Institute for Drugs and Medical Devices has ruled the realisation of the corresponding implementing decisions of the EU Commission K(2014)307 of 16 January 2014.
Active substance: pelargonium
After having conducted a hearing within a graduated plan ("Stufenplan") procedure, the BfArM has now issued a notice regarding the risk of liver damage due to medicinal products containing pelargonium root.
Active substance: diacerein
The BfArM issues information on the PRAC's recommendation within the re-examination procedure following a European safety review in accordance with Article 31 of Directive 2001/83/EC.
Active substance: domperidone
The BfArM issues information on the PRAC's recommendation within a European safety review in accordance with Article 31 of Directive 2001/83/EC.
Active substance: iron
In its notice of 18 December 2013, the Federal Institute for Drugs and Medical Devices has ruled the realisation of the implementing decision of the European Commission regarding iron-containing medicinal products for parenteral use.
Active substance: flupirtine
In its notice of 18 December 2013, the Federal Institute for Drugs and Medical Devices has ruled the realisation of the implementing decision of the European Commission regarding medicinal products with the active substance flupirtine.
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: 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: valproate
At the request of Great Britain, the European Medicines Agency (EMA) has initiated a review procedure in accordance with Article 31 of Directive 2001/83/EC regarding valproate, valproic acid and related substances.