SmPC - Dutasteride/tamsulosin hydrochloride 0.5mg/0.4mg Hard Capsules: Change history
View Summary of Product Characteristics (SmPC - Dutasteride/tamsulosin hydrochloride 0.5mg/0.4mg Hard Capsules)
Last updated on this site: 15 Oct 2025
Description of update: To submit Type IAIN (C.I.1.a) variation to update section 4.4 of the SmPC and section 2 of the leaflet to implement the outcome of a Union referral procedure (EMEA-H-A-31-1539).
Date of approval: 08/10/2025
SmPC sections updated: 4.4 and 10
View Summary of Product Characteristics (SmPC - Dutasteride/tamsulosin hydrochloride 0.5mg/0.4mg Hard Capsules)
Last updated on this site: 15 Oct 2025
Description of update: To submit Type IAIN (C.I.1.a) variation to update section 4.4 of the SmPC and section 2 of the leaflet to implement the outcome of a Union referral procedure (EMEA-H-A-31-1539).
Date of approval: 08/10/2025
SmPC sections updated: 4.4 and 10
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Changes: (Updated: 15 Oct 2025)
Description of update: To submit Type IAIN (C.I.1.a) variation to update section 4.4 of the SmPC and section 2 of the leaflet to implement the outcome of a Union referral procedure (EMEA-H-A-31-1539).
Date of approval: 08/10/2025
SmPC sections updated: 4.4 and 10
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Changes: (Updated: 11 Feb 2025)
Renewal approval
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Changes: (Updated: 20 Sep 2022)
Initial upload