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: Riluzol
In a notice dated 13 October 2016, the Federal Institute for Drugs and Medical Devices (BfArM) ruled the provisional suspension of a generic marketing authorisation that was based on a clinical trial conducted by the company Alkem Laboratories Ltd. in India. This is the realisation of the EU Commission's implementing decision of 8 September 2016.
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.
Active substances: levonorgestrel | ulipristal acetate
In its notice of 5 November 2014, the Federal Institute for Drugs and Medical Devices (BfArM) has ruled the realisation of the corresponding implementing decision C(2014)7147of the EU Commission.
Active substance: leuprorelin
With its decision of 29 July 2020, the BfArM implements the unanimous decision of the CMDh of 25 June 2020 for depot drugs containing leuprorelin.
Active substance: Janus kinase inhibitors
With the publication of the European Commission's decision on March 10, 2023, the risk assessment procedure in accordance with Article 20 of Regulation (EC) No. 726/2004 on Janus kinase inhibitors was completed. The warnings and precautions for using these medicines have been updated.
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: methylprednisolone
At the request of Croatia, the European Medicines Agency EMA has initiated a review procedure on 1 December 2016. It concerns injectable medicinal products with the active substance methylprednisolone that additionally contain lactose from cows' milk (and thus traces of milk protein).
Active substances: corticosteroids | inhalative
The EMA's Pharmacovigilance Risk Assessment Committee (PRAC) has now completed its review of this known risk and has confirmed the increased risk of pneumonia.
Active substance: ifosfamide
The CMDh, having considered the PRAC assessment report and recommendation, agreed by majority that the benefits of ifosfamide solutions for infusion continue to outweigh their risks in the treatment of different types of cancers, including various solid tumours and blood cancers such as lymphomas (cancer of white blood cells).