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SmPC- Betahistine dihydrochloride 8mg Tablets: Change history

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  • View Summary of Product Characteristics (SmPC- Betahistine dihydrochloride 8mg Tablets)

    Last updated on this site: 21 Aug 2025

    Update to SmPC sections 4.2, 4.3, 4.4, 4.5, 4.6, 4.7, 4.8, 4.9, 5.1, 5.2, 5.3 and 6.1, and the PIL in line with information of reference product.

    Variation approved 20/06/2025

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    • Changes: (Updated: 21 Aug 2025)

      Update to SmPC sections 4.2, 4.3, 4.4, 4.5, 4.6, 4.7, 4.8, 4.9, 5.1, 5.2, 5.3 and 6.1, and the PIL in line with information of reference product.

      Variation approved 20/06/2025

    • Changes: (Updated: 18 Jan 2023)

      Website administration update.

    • Changes: (Updated: 20 Sep 2022)

      Initial upload

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