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Melphalan AqVida: Risk of Overdose Due to Higher Concentration

The German Federal Institute for Drugs and Medical Devices (BfArM) issued a communication regarding Melphalan AqVida RTD 90 mg/ml, a new formulation with an 18-fold higher concentration than existing melphalan products. This increased concentration poses a potential risk of overdose for patients.

Digimerck Tablets Quality Defect: Degradation Products May Exceed Limit

The German Federal Institute for Drugs and Medical Devices (BfArM) issued a Direct Healthcare Professional Communication regarding Digimerck 0.07 mg tablets. A quality defect has been identified where degradation products may slightly exceed the specification limit by the end of the product's shelf life. Distribution was discontinued in 2022.

Tegretal Suspension Use Restricted in Newborns

The German Federal Institute for Drugs and Medical Devices (BfArM) has issued a direct healthcare professional communication restricting the use of Tegretal Suspension (carbamazepine) in newborns due to high propylene glycol content. This restriction is to prevent serious side effects in infants.

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 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 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 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).

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.

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.

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.