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Intended for UK patients and members of the public

SmPC- Metformin hydrochloride 1000 mg film-coated tablets: Change history

  • Description of update: To update section 4.4 of the SmPC and section 2 of the leaflet in line with the wording agreed by the PRAC following the outcome of the PSUR procedure (PSUSA/00002001/202404) for metformin

    Date of approval: 26/06/2025

    SmPC sections updated: 4.4 and 10

    • Changes: (Updated: 11 Jul 2025)

      Description of update: To update section 4.4 of the SmPC and section 2 of the leaflet in line with the wording agreed by the PRAC following the outcome of the PSUR procedure (PSUSA/00002001/202404) for metformin

      Date of approval: 26/06/2025

      SmPC sections updated: 4.4 and 10

    • Changes: (Updated: 04 Sep 2023)

      New product launch.

      Launch date: 25/08/2023.

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