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PIL- Betahistine dihydrochloride 8, 16mg Tablets: Change history

  • 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 approval 20/06/2025.

    • 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 approval 20/06/2025.

    • Changes: (Updated: 20 Sep 2022)

      Initial upload

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