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European re-evaluation of the benefit/risk balance of medicinal products containing finasteride or dutasteride

News Healthcare & Pharma Sanctions & Fines
Date: 17th Oct, 2024 Source: French National Agency for the Safety of Medicines and Health Products (ANSM) Country: France Original Source

Brief

On "17/10/2024", the French National Agency for the Safety of Medicines and Health Products (ANSM) issued an update regarding European re-evaluation of the benefit/risk balance of medicinal products containing finasteride or dutasteride. The PRAC committee has begun a new arbitration following ANSM's request to reassess the balance between the benefits and risks of these medications, particularly due to concerns over suicidal thoughts.

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French National Agency for the Safety of Medicines and Health Products (ANSM)

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