SmPC- Dutasteride 0.5 mg Soft Capsules: Change history
View Summary of Product Characteristics (SmPC- 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
SmPC sections updated: 4.4 and 10
View Summary of Product Characteristics (SmPC- 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
SmPC sections updated: 4.4 and 10
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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
SmPC sections updated: 4.4 and 10
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Changes: (Updated: 20 Sep 2022)
Initial upload