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: 19 Jun 2026
Type IB (C.I.z) To update Environmental Risk Assessment in line with the current version of the Guideline on the environmental risk assessment of medicinal products for human use as committed in SE/H/1906/001-002/E/001.
Last updated on this site: 19 Jun 2026
Type IB (C.I.z) To update Environmental Risk Assessment in line with the current version of the Guideline on the environmental risk assessment of medicinal products for human use as committed in SE/H/1906/001-002/E/001.
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Changes: (Updated: 19 Jun 2026)
Type IB (C.I.z) To update Environmental Risk Assessment in line with the current version of the Guideline on the environmental risk assessment of medicinal products for human use as committed in SE/H/1906/001-002/E/001.
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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