SmPC- Bosentan Accord 62.5mg Film-coated Tablets: Change history
View Summary of Product Characteristics (SmPC- Bosentan Accord 62.5mg Film-coated Tablets)
Last updated on this site: 07 Oct 2026
Description of update: To update sections 3, 4.4, 4.8, 6.4, 6.5, 6.6 of the SmPC and sections 1, 9, 18 sections of the Labelling and sections 2, 5, 6 of the PL for the medicinal products Bosentan 62.5 mg Film-coated Tablets and Bosentan 125 mg Film-coated Tablets to implement the commitment to amend the PI documents further to the comments received from CMS within three months of RUP procedure. Additional updates have been made to SmPC sections 4.2, 4.3, 4.5, 5.1 and 5.2.
Date of approval: 01/10/2026
SmPC sections updated: 3, 4.2, 4.3, 4.4, 4.5, 4.8, 5.1, 5.2, 6.4, 6.5, 6.6 and 10
Last updated on this site: 07 Oct 2026
Description of update: To update sections 3, 4.4, 4.8, 6.4, 6.5, 6.6 of the SmPC and sections 1, 9, 18 sections of the Labelling and sections 2, 5, 6 of the PL for the medicinal products Bosentan 62.5 mg Film-coated Tablets and Bosentan 125 mg Film-coated Tablets to implement the commitment to amend the PI documents further to the comments received from CMS within three months of RUP procedure. Additional updates have been made to SmPC sections 4.2, 4.3, 4.5, 5.1 and 5.2.
Date of approval: 01/10/2026
SmPC sections updated: 3, 4.2, 4.3, 4.4, 4.5, 4.8, 5.1, 5.2, 6.4, 6.5, 6.6 and 10
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Changes: (Updated: 07 Oct 2026)
Description of update: To update sections 3, 4.4, 4.8, 6.4, 6.5, 6.6 of the SmPC and sections 1, 9, 18 sections of the Labelling and sections 2, 5, 6 of the PL for the medicinal products Bosentan 62.5 mg Film-coated Tablets and Bosentan 125 mg Film-coated Tablets to implement the commitment to amend the PI documents further to the comments received from CMS within three months of RUP procedure. Additional updates have been made to SmPC sections 4.2, 4.3, 4.5, 5.1 and 5.2.
Date of approval: 01/10/2026
SmPC sections updated: 3, 4.2, 4.3, 4.4, 4.5, 4.8, 5.1, 5.2, 6.4, 6.5, 6.6 and 10
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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: 20 Sep 2022)
Initial upload