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PRAC Recommendations on Safety Signals
The European Medicines Agency's Pharmacovigilance Risk Assessment Committee (PRAC) has adopted recommendations on safety signals discussed in February 2026. These recommendations require marketing authorisation holders (MAHs) to provide supplementary information or take regulatory action, such as updating product information.
PRAC Recommendations on Signals - January 2026 Meeting
The European Medicines Agency's Pharmacovigilance Risk Assessment Committee (PRAC) has adopted recommendations on safety signals discussed in January 2026. Marketing Authorisation Holders (MAHs) for affected medicinal products are required to update product information within specified timelines.
PRAC Recommendations on Safety Signals
The European Medicines Agency's Pharmacovigilance Risk Assessment Committee (PRAC) has adopted recommendations on safety signals discussed in November 2025. Marketing Authorisation Holders (MAHs) are required to provide supplementary information or update product information based on these recommendations, with specific deadlines for certain signals.
PRAC Recommendations on Safety Signals
The European Medicines Agency's Pharmacovigilance Risk Assessment Committee (PRAC) has adopted recommendations on safety signals discussed in their October 2025 meeting. These recommendations are directly actionable by marketing authorisation holders (MAHs) for updates to product information.
PRAC Recommendations on Safety Signals
The European Medicines Agency's Pharmacovigilance Risk Assessment Committee (PRAC) has adopted recommendations on safety signals discussed between September 29 and October 2, 2025. These recommendations are directly actionable by marketing authorisation holders (MAHs) for both Centrally Authorised Products (CAPs) and Nationally Authorised Products (NAPs).
ArjoHuntleigh Tenor Mobile Hoist Safety Alert
The French National Agency for the Safety of Medicines and Health Products (ANSM) has announced a product recall for the ArjoHuntleigh Tenor mobile hoist. This action, registered under number R2606757, is being implemented by the manufacturer ArjoHuntleigh AB.
ANSM Safety Information: Mobile Hoist and Bath Elevator
The French National Agency for Medicines and Health Products Safety (ANSM) has issued safety information regarding a mobile hoist and bath elevator from Mangar International. This notice, registered under number R2607055, alerts home healthcare providers and retailers to a safety action implemented by the manufacturer.
Safety alert for DermaGenius 3.0 reagent
The French National Agency for Medicines and Health Products Safety (ANSM) has issued a safety alert regarding the DermaGenius 3.0 Complete Multiplex real-time PCR reagent. This alert, registered under number R2607183, informs medical biology analysis laboratories of a security action implemented by PathoNostics.
Spinal Plug Safety Alert for Pharmacies
The French ANSM has been informed of a lot recall action for spinal plugs (Airplug T10-T12) by Groupe Lépine, registered under action number R2607057. Pharmacies are directed to consult the provided letter from the manufacturer for details.
ANSM Safety Alert for Manosplint Cushionfoam Medical Device
The French National Agency for Medicines and Health Products Safety (ANSM) has issued a safety alert regarding the Manosplint Cushionfoam medical device, identified by safety action number R2606620. This alert concerns a safety action initiated by the manufacturer, Kinetec SAS.
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