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: ambroxol, bromhexine
On 14 January 2016, the European Commission decided to update the texts of the Summaries of Product Characteristics/Package Leaflets of medicinal products containing ambroxol and bromhexine.
Active substance: 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: amfepramone
Following the recommendation of the Coordination Group on Mutual Recognition Procedures and Decentralised Procedures - Human (CMDh) on the revocation of marketing authorisations and prior to the final decision of the European Commission, all marketing authorisation holders of medicinal products containing amfepramone in Germany have declared a voluntary surrender of their marketing authorisations as of 01 December 2022.
Active substance: calcitonin
With regard to the intranasal route of administration for the osteoporosis indication, suspension of the marketing authorisations has been extended until 1 April 2020.
Active substance: calcium folinate, 5-fluorouracil
The BfArM has initiated a graduated plan procedure ("Stufenplanverfahren") in order to update the product informations of medicinal products containing calcium folinate for injection.
Active substance: codeine
Treatment of cough in children younger than 12 years with medicinal products containing codeine is no longer permitted due to the risk of respiratory depression.
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: ACE inhibitors, Angiotensin II receptor antagonists, 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: gadolinium
For contrast agents containing gadolinium, the suspension of marketing authorisations has been extended until 28 February 2026.
