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: valproic acid
The product information texts on all valproic acid or products containing valproates should include warnings about clinically relevant interactions with carbapenems (decreased valproate plasma concentration) to come up to the latest findings. The intended measures are due to an EU recommendation. A hearing in writing under the graduated plan procedure (Stufenplan), stage II, will follow.
Active substance: gestagen
In a Notice (Bescheid) of 23 August 2010 relating to medicinal products for sequential HRT with gestagen addition on less than 12 days per treatment cycle, the BfArM ruled that the product information be supplemented. It is stated that there is no clear evidence of endometrial safety similar to that when gestagen is added on 12 days.
Active substances: niacin | laropiprant
The European Medicines Agency (EMA) has initiated a review procedure regarding the lipid-lowering drugs Tredaptive®/Pelzont®/Trevaclyn® after the MAH of the medicinal products had published preliminary results of a large, long-term study.
Active substances: ACE-inhibitors | angiotensin II receptor antagonists or aliskiren
The BfArM issues information on the PRAC recommendation within the European safety review according to Article 31 of Directive 2001/83/EC.
Active substance: cyproterone acetate/ethinylestradiol
In a notice dated 8 August 2013, the Federal Institute for Drugs and Medical Devices has ruled the realisation of the European Commission's implementing decision on medicinal products containing the combination cyproterone acetate/ethinylestradiol.
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.
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: 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: 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: 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.