Finasteride 1 mg (Propecia and generics): added warning statements on boxes to reinforce information on adverse effects
French Agency for the Safety of Health Products (ANSM)
ANSM (ansm.sante.fr) — English translation hosted on pfsfoundation.org2022-11-30
Summary (paraphrased)
France's medicines agency announced that manufacturers must affix a red warning box and a QR code to every finasteride 1 mg pack, stating that sexual and/or psychiatric adverse reactions may occur during and after treatment. The measure was to be on all boxes by 28 April 2023 at the latest, alongside an updated patient information sheet. The document explains that the step extends earlier French efforts to strengthen patient awareness of finasteride's psychiatric and sexual effects, and reminds readers that reporting side effects directly is encouraged. It was this French regulatory pressure that later triggered the 2025 EU-wide Article 31 review.
Why it’s in the corpus
The strongest single-country packaging intervention on finasteride — an on-box red warning covering effects "during and after treatment" — and the origin of the Article 31 referral. Essential context for the EMA 2025 items.
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