SmPC - Finasteride 5mg Film-coated Tablets: Change history
View Summary of Product Characteristics (SmPC - Finasteride 5mg Film-coated Tablets)
Last updated on this site: 08 Jun 2026
Description of update: To update sections 4.2, 4.4, 4.6, 4.8, 4.9, 5.1, 5.2 of the SmPC
in-line with the reference product PROSCAR® 5mg film-coated Tablets; MAH: Organon NV, Netherlands; MA number: RVG15482. Consequentially, the patient information leaflet has been updated.
Date of approval: 13/05/2026
SmPC sections updated: 4.2, 4.4, 4.6, 4.8, 4.9, 5.1, 5.2 and 10
Last updated on this site: 08 Jun 2026
Description of update: To update sections 4.2, 4.4, 4.6, 4.8, 4.9, 5.1, 5.2 of the SmPC
in-line with the reference product PROSCAR® 5mg film-coated Tablets; MAH: Organon NV, Netherlands; MA number: RVG15482. Consequentially, the patient information leaflet has been updated.
Date of approval: 13/05/2026
SmPC sections updated: 4.2, 4.4, 4.6, 4.8, 4.9, 5.1, 5.2 and 10
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Changes: (Updated: 08 Jun 2026)
Description of update: To update sections 4.2, 4.4, 4.6, 4.8, 4.9, 5.1, 5.2 of the SmPC
in-line with the reference product PROSCAR® 5mg film-coated Tablets; MAH: Organon NV, Netherlands; MA number: RVG15482. Consequentially, the patient information leaflet has been updated.
Date of approval: 13/05/2026
SmPC sections updated: 4.2, 4.4, 4.6, 4.8, 4.9, 5.1, 5.2 and 10
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Changes: (Updated: 24 May 2023)
N/A
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Changes: (Updated: 21 Oct 2022)
Update
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Changes: (Updated: 21 Sep 2022)
Initial upload