SmPC- Bosentan Accord 125mg Film-coated Tablets: Change history
View Summary of Product Characteristics (SmPC- Bosentan Accord 125mg Film-coated Tablets)
Last updated on this site: 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).
View Summary of Product Characteristics (SmPC- Bosentan Accord 125mg Film-coated Tablets)
Last updated on this site: 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).
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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).
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Changes: (Updated: 06 Dec 2022)
Section 6.5 - Addition of - "Aluminium-aluminium blister and PVC/PE/PVDC-aluminium blisters containing 10 film-coated tablets.
Bosentan Accord 125 mg film-coated tablets are available in cartons containing 120 film-coated tablets."
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Changes: (Updated: 20 Sep 2022)
Initial upload