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SmPC- Ambrisentan Accord 10mg Film-coated Tablets: Change history

  • Administrative update only; no changes 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: 20 Sep 2022)

      initial upload

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