PIL- Dutasteride 0.5 mg Soft Capsules: Change history
View Patient Information Leaflet (PIL- Dutasteride 0.5 mg Soft Capsules)
Last updated on this site: 31 Oct 2025
Description of update: To update section 4.4 of the SmPC and section 2 of the leaflet to implement the outcome of a Union referral procedure - new measures to minimise the risk of suicidal ideation (EMEA-H-A-31-1539).
Date of approval: 09/10/2025
PIL sections updated: 2 and 6
Last updated on this site: 31 Oct 2025
Description of update: To update section 4.4 of the SmPC and section 2 of the leaflet to implement the outcome of a Union referral procedure - new measures to minimise the risk of suicidal ideation (EMEA-H-A-31-1539).
Date of approval: 09/10/2025
PIL sections updated: 2 and 6
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Changes: (Updated: 31 Oct 2025)
Description of update: To update section 4.4 of the SmPC and section 2 of the leaflet to implement the outcome of a Union referral procedure - new measures to minimise the risk of suicidal ideation (EMEA-H-A-31-1539).
Date of approval: 09/10/2025
PIL sections updated: 2 and 6
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Changes: (Updated: 28 Mar 2024)
Description of update: The following change has been notified:MT/H/0177/001/IA/021. Type IAIN (B.II.b.2.c.2) variation Application to replace Galenicum Health, S.L. Avda. Cornellá 144, 7º-1ª Edificio Lekla, Esplugues de Llobregat, 08950 Barcelona with Galenicum Health S.L.U. San Gabriel, 50, Esplugues de Llobregat, 08950, Barcelona (Spain) as a site responsible for batch release (including batch control/testing).
PIL sections updated: Section 6 only.
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Changes: (Updated: 29 Aug 2023)
1) Type IAIN (B.II.b.1.a) Variation for addition of SAG Manufacturing, S.L.U. Crta. N-I, Km 36 San Agustin de Guadalix 28750 Madrid, Spain as Secondary Packaging site.
2) Type IAIN (B.II.b.1.b) Variation for addition of SAG Manufacturing, S.L.U. Crta. N-I, Km 36 San Agustin de Guadalix 28750 Madrid, Spain as Primary Packaging site.
3) Type IA (B.II.b.2.c.1) Variation for addition of SAG Manufacturing, S.L.U. Crta. N-I, Km 36 San Agustin de Guadalix 28750 Madrid, Spain as batch release site.
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Changes: (Updated: 20 Sep 2022)
Initial upload