SmPC - Sumatriptan 50mg Film-coated Tablets: Change history
View Summary of Product Characteristics (SmPC - Sumatriptan 50mg Film-coated Tablets)
Last updated on this site: 26 Sep 2025
Description of update: To update sections 4.6 and 4.8 of the SmPC and sections 2 and 4 of the leaflet to implement the wording agreed by the PRAC following the outcome of the PSUR procedure (PSUSA/00002832/202409) for sumatriptan.
Date of approval: 19/09/2025
SmPC sections updated: 4.6, 4.8 and 10
Last updated on this site: 26 Sep 2025
Description of update: To update sections 4.6 and 4.8 of the SmPC and sections 2 and 4 of the leaflet to implement the wording agreed by the PRAC following the outcome of the PSUR procedure (PSUSA/00002832/202409) for sumatriptan.
Date of approval: 19/09/2025
SmPC sections updated: 4.6, 4.8 and 10
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Changes: (Updated: 26 Sep 2025)
Description of update: To update sections 4.6 and 4.8 of the SmPC and sections 2 and 4 of the leaflet to implement the wording agreed by the PRAC following the outcome of the PSUR procedure (PSUSA/00002832/202409) for sumatriptan.
Date of approval: 19/09/2025
SmPC sections updated: 4.6, 4.8 and 10
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Changes: (Updated: 26 Sep 2025)
Description of update: To update sections 4.6 and 4.8 of the SmPC and sections 2 and 4 of the leaflet to implement the wording agreed by the PRAC following the outcome of the PSUR procedure (PSUSA/00002832/202409) for sumatriptan.
Date of approval: 19/09/2025
SmPC sections updated: 4.6, 4.8 and 10
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Changes: (Updated: 26 Sep 2025)
Description of update: To update sections 4.6 and 4.8 of the SmPC and sections 2 and 4 of the leaflet to implement the wording agreed by the PRAC following the outcome of the PSUR procedure (PSUSA/00002832/202409) for sumatriptan.
Date of approval: 19/09/2025
SmPC sections updated: 4.6, 4.8 and 10
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Changes: (Updated: 30 Dec 2022)
Extension of shelf life from 2 years to 3 years.
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Changes: (Updated: 22 Sep 2022)
Initial upload