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SmPC- Ambrisentan Accord 5mg Film-coated Tablets: Change history

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  • View Summary of Product Characteristics (SmPC- Ambrisentan Accord 5mg Film-coated Tablets)

    Last updated on this site: 07 Nov 2024

    Adaptation of the SmPC to the reference product Volibris (EU/1/08/451) following EMEA/H/C/000839/II/0067; further editorial changes have been made

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    • Changes: (Updated: 07 Nov 2024)

      Adaptation of the SmPC to the reference product Volibris (EU/1/08/451) following EMEA/H/C/000839/II/0067; further editorial changes have been made

    • Changes: (Updated: 23 Aug 2023)

      Website administration update only- no change to file

    • Changes: (Updated: 25 May 2023)

      Administrative update only; no changes to file.

    • Changes: (Updated: 25 May 2023)

      Description of update: The proposed change is: C.I.2. a) Implementation of change(s) for which no new additional data is required to be submitted by the MAH. Adaptation of the PI to reference product Volibris. (EMEA/H/C/000839)

      SmPC sections updated: 4.1, 4.2, 4.3, 4.4, 4.5, 4.8, 4.9, 5.1, 5.2, 5.3, 10.

    • Changes: (Updated: 06 Feb 2023)

      Website administration update

    • Changes: (Updated: 06 Feb 2023)

      Initial upload

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