SmPC- Almotriptan 12.5mg Film-coated Tablets: Change history
View Summary of Product Characteristics (SmPC- Almotriptan 12.5mg Film-coated Tablets)
Last updated on this site: 07 Oct 2026
IB: Q.II.f.1.a.1 - Reduction of the shelf life of the finished product from 48M to 36M (as a proactive quality measure following a comprehensive risk assessment for nitrosamine impurities (NDALM)). SmPC 6.3 updated.
View Summary of Product Characteristics (SmPC- Almotriptan 12.5mg Film-coated Tablets)
Last updated on this site: 07 Oct 2026
IB: Q.II.f.1.a.1 - Reduction of the shelf life of the finished product from 48M to 36M (as a proactive quality measure following a comprehensive risk assessment for nitrosamine impurities (NDALM)). SmPC 6.3 updated.
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Changes: (Updated: 07 Oct 2026)
IB: Q.II.f.1.a.1 - Reduction of the shelf life of the finished product from 48M to 36M (as a proactive quality measure following a comprehensive risk assessment for nitrosamine impurities (NDALM)). SmPC 6.3 updated.
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Changes: (Updated: 15 Jan 2024)
Description of update: An Unlimited MA has been granted, 3 yearly PSURs will be submitted.
SmPC Sections updated: 9 & 10.
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Changes: (Updated: 20 Sep 2022)
initial upload