SmPC - Finasteride 1mg Film-coated Tablets: Change history
View Summary of Product Characteristics (SmPC - Finasteride 1mg Film-coated Tablets)
Last updated on this site: 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
View Summary of Product Characteristics (SmPC - Finasteride 1mg Film-coated Tablets)
Last updated on this site: 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: 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