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SmPC - Mycophenolic acid 180mg Gastro-resistant Tablets: Change history

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  • View Summary of Product Characteristics (SmPC - Mycophenolic acid 180mg Gastro-resistant Tablets)

    Last updated on this site: 09 Aug 2024

    Update of the SmPC section 4.6 to implement the wording agreed by PRAC following the outcome of the PSUR procedure PSUSA/10550/202305.

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    • Changes: (Updated: 09 Aug 2024)

      Update of the SmPC section 4.6 to implement the wording agreed by PRAC following the outcome of the PSUR procedure PSUSA/10550/202305.

    • Changes: (Updated: 12 Jun 2023)

      Description of update: C.I.2.a Change(s) in the Summary of Product Characteristics, Labelling or Package Leaflet of a generic/hybrid/ biosimilar medicinal products following assessment of the same change for the reference product. Implementation of change(s) for which no new additional data is required to be submitted by the MAH.

      SmPC sections updated: 4.6, 4.7, 4.8, 10.

      PIL sections updated: 2, 3, 4, 6.

    • Changes: (Updated: 21 Sep 2022)

      Initial upload

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