SmPC - Finasteride 1mg Film-coated Tablets: Change history
View Summary of Product Characteristics (SmPC - Finasteride 1mg Film-coated Tablets)
Last updated on this site: 05 Oct 2026
Description of update: To update section 4.4 of the SmPC to implement the wording agreed by the MHRA final recommendations following review of the EU referral recommendations for all finasteride and dutasteride containing products. In addition, an editorial update has been made to SmPC section 4.8.
Date of approval: 28/09/2026
SmPC sections updated: 4.4, 4.8 and 10
Last updated on this site: 05 Oct 2026
Description of update: To update section 4.4 of the SmPC to implement the wording agreed by the MHRA final recommendations following review of the EU referral recommendations for all finasteride and dutasteride containing products. In addition, an editorial update has been made to SmPC section 4.8.
Date of approval: 28/09/2026
SmPC sections updated: 4.4, 4.8 and 10
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Changes: (Updated: 05 Oct 2026)
Description of update: To update section 4.4 of the SmPC to implement the wording agreed by the MHRA final recommendations following review of the EU referral recommendations for all finasteride and dutasteride containing products. In addition, an editorial update has been made to SmPC section 4.8.
Date of approval: 28/09/2026
SmPC sections updated: 4.4, 4.8 and 10
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Changes: (Updated: 05 Oct 2026)
Description of update: To update section 4.4 of the SmPC to implement the wording agreed by the MHRA final recommendations following review of the EU referral recommendations for all finasteride and dutasteride containing products. In adddition, an editorial update has been made to SmPC section 4.8.
Date of approval: 28/09/2026
SmPC sections updated: 4.4, 4.8 and 10
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Changes: (Updated: 14 Nov 2025)
Description of update: To update finasteride- and dutasteride-containing medicinal products in line with PRAC recommendation - New measures to minimise the risk of suicidal ideation (EMEA-H-A-31-1539).
Date of approval: 12/11/2025
SmPC sections updated: 4.4 and 10
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Changes: (Updated: 17 Jul 2025)
To update SmPC sections 4.4, 4.8, 5.1, 5.2 and 10 and PIL sections Header, 2, 4, 5 and 6 in-line with the product information of the reference product.
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Changes: (Updated: 21 Oct 2022)
Update
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Changes: (Updated: 21 Sep 2022)
Initial upload