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SmPC- Isosorbide Dinitrate Tablets BP 10mg: Change history

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  • View Summary of Product Characteristics (SmPC- Isosorbide Dinitrate Tablets BP 10mg)

    Last updated on this site: 06 Oct 2023

    Description of update: To update sections 4.7 and 4.8 of the SmPC in line with the

    reference product, Isoket Retard 20mg Tablets (MA Number:

    PL 20011/0048; MAH: Norgine Pharmaceuticals Limited;

    02/06/2023).

    SmPC sections updated: 4.7, 4.8 and 10.

    View change history

    • Changes: (Updated: 06 Oct 2023)

      Description of update: To update sections 4.7 and 4.8 of the SmPC in line with the

      reference product, Isoket Retard 20mg Tablets (MA Number:

      PL 20011/0048; MAH: Norgine Pharmaceuticals Limited;

      02/06/2023).

      SmPC sections updated: 4.7, 4.8 and 10.

    • Changes: (Updated: 27 Jul 2023)

      Variation Description: To register section 3.2.P.7  Container Closure System for 20μ Aluminium/250μ PVC blister packaging and to remove reference to the heat seal lacquer from section 6.5 of the SmPC

    • Changes: (Updated: 20 Sep 2022)

      initial upload

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