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SmPC- Telmisartan 40mgTablets: Change history

  • Description of update: To update the SmPC and PIL in line with the reference product, Micardis.

    Date of approval: 22/12/2025

    SmPC sections updated: 4.2, 4.4, 4.5, 4.6, 4.7, 4.8, 4.9, 5.1, 5.2, 5.3 and 10

    PIL sections updated: 1, 2, 3, 4, 5 and 6

    • Changes: (Updated: 29 Dec 2025)

      Description of update: To update the SmPC and PIL in line with the reference product, Micardis.

      Date of approval: 22/12/2025

      SmPC sections updated: 4.2, 4.4, 4.5, 4.6, 4.7, 4.8, 4.9, 5.1, 5.2, 5.3 and 10

      PIL sections updated: 1, 2, 3, 4, 5 and 6

    • Changes: (Updated: 13 May 2025)

      Type IAIN variation to Update to SmPC sections 4.4, 4.8 and PIL sections 2 and 4 in line with PRAC recommendations (EPITTNo 20104) for intestinal angioedema.

    • Changes: (Updated: 19 Dec 2022)

      SmPC sections updated – 9 and 10

      MHRA Renewal approval date – 14/12/2022

    • Changes: (Updated: 22 Sep 2022)

      initial upload

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