Review of Medications Containing Finasteride and Dutasteride Commences

The European Medicines Agency (EMA) has initiated a review concerning medicines that contain finasteride and dutasteride. This evaluation focuses on data pointing to suicidal thoughts and behaviors associated with these medications.

Agenda Overview

The agenda for the Pharmacovigilance Risk Assessment Committee (PRAC) meeting to be held from September 30 to October 03, 2024, includes discussions on various important matters concerning drug safety and regulatory assessments.

    Draft Reference Number:  EMA/PRAC/410474/2024
    

PRAC Statistics: October 2024

The latest statistics related to the PRAC for October 2024 can be referenced in a document that provides extensive insight into the safety signal assessments and other relevant data.

    PRAC statistics: October 2024
    

This document is available in English and has a size of 43.82 MB (PDF format), first published on October 4, 2024.

Understanding Safety Signals

A safety signal is defined as any information that indicates a new potentially causal link, or a novel dimension of an already recognized association. These assessments serve as critical components in the ongoing evaluation of drug safety and efficacy.