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SmPC - Mycophenolate Mofetil 500 mg Film-coated Tablets: Change history

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  • View Summary of Product Characteristics (SmPC - Mycophenolate Mofetil 500 mg Film-coated Tablets)

    Last updated on this site: 16 Jul 2024

    To update SmPC section 4.6 to implement the wording agreed by the CHMP following the outcome of the PSUR procedure EMEA/H/C/PSUSA/10550/202305.

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    • Changes: (Updated: 16 Jul 2024)

      To update SmPC section 4.6 to implement the wording agreed by the CHMP following the outcome of the PSUR procedure EMEA/H/C/PSUSA/10550/202305.

    • Changes: (Updated: 30 Nov 2023)

      Description of update: To update SmPC sections 4.6, 4.8, 5.1, 5.2 and 5.3 and leaflet section 2 and 3 in-line with the information of reference product (Cellcept 500mg Film-Coated Tablets, MAH: Roche Registration GmbH, Germany; EU procedure number: EMEA/H/C/000082).

      SmPC Sections updated: 4.3, 4.4, 4.5, 4.6, 4.8, 5.1, 5.2 and 5.3.

      PIL sections updated: Title, 1, 2, 3 and 6.

    • Changes: (Updated: 21 Sep 2022)

      Initial upload

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