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PIL - Sumatriptan 50mg, 100mg Film-coated Tablets: Change history

  • 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

    PIL sections updated: 2, 4 and 6

    • 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

      PIL sections updated: 2, 4 and 6

    • Changes: (Updated: 22 Sep 2022)

      Initial upload

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