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Intended for UK patients and members of the public

SmPC- Bosentan Accord 62.5mg Film-coated Tablets: Change history

  • To update the SmPC and package leaflet in-line with the reference product (Tracleer 62.5/125 mg film-coated tablets; EU procedure number: EMEA/H/C/000401/PSUR/0000257801).

    • Changes: (Updated: 20 Feb 2026)

      To update the SmPC and package leaflet in-line with the reference product (Tracleer 62.5/125 mg film-coated tablets; EU procedure number: EMEA/H/C/000401/PSUR/0000257801).

    • Changes: (Updated: 20 Sep 2022)

      Initial upload

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