SmPC - Irbesartan Accord 150mg Film-coated Tablets: Change history
View Summary of Product Characteristics (SmPC - Irbesartan Accord 150mg Film-coated Tablets)
Last updated on this site: 05 Oct 2026
Description of update: To update sections 4.1, 4.2, 4.4, 5.1, 5.3 of the SmPC and sections 2, 3 of the leaflet in-line with information of reference product (Aprovel 75mg, 150 mg and 300 mg tablets; MAH: Sanofi Winthrop Industrie, France; EU procedure number: EMEA/H/C/000141). Additionally, applicant has updated sections 2, 3, 4.3, 4.5, 4.6, 4.8, 4.9, 5.2 of the SmPC and sections 1, 4, 5 and 6 of the leaflet with editorial changes.
Date of approval: 01/10/2026
SmPC sections updated: 2, 3, 4.1, 4.2, 4.3, 4.4, 4.5, 4.6, 4.7, 4.8, 4.9, 5.1, 5.2, 5.3 and 10
Last updated on this site: 05 Oct 2026
Description of update: To update sections 4.1, 4.2, 4.4, 5.1, 5.3 of the SmPC and sections 2, 3 of the leaflet in-line with information of reference product (Aprovel 75mg, 150 mg and 300 mg tablets; MAH: Sanofi Winthrop Industrie, France; EU procedure number: EMEA/H/C/000141). Additionally, applicant has updated sections 2, 3, 4.3, 4.5, 4.6, 4.8, 4.9, 5.2 of the SmPC and sections 1, 4, 5 and 6 of the leaflet with editorial changes.
Date of approval: 01/10/2026
SmPC sections updated: 2, 3, 4.1, 4.2, 4.3, 4.4, 4.5, 4.6, 4.7, 4.8, 4.9, 5.1, 5.2, 5.3 and 10
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Changes: (Updated: 05 Oct 2026)
Description of update: To update sections 4.1, 4.2, 4.4, 5.1, 5.3 of the SmPC and sections 2, 3 of the leaflet in-line with information of reference product (Aprovel 75mg, 150 mg and 300 mg tablets; MAH: Sanofi Winthrop Industrie, France; EU procedure number: EMEA/H/C/000141). Additionally, applicant has updated sections 2, 3, 4.3, 4.5, 4.6, 4.8, 4.9, 5.2 of the SmPC and sections 1, 4, 5 and 6 of the leaflet with editorial changes.
Date of approval: 01/10/2026
SmPC sections updated: 2, 3, 4.1, 4.2, 4.3, 4.4, 4.5, 4.6, 4.7, 4.8, 4.9, 5.1, 5.2, 5.3 and 10
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Changes: (Updated: 13 May 2025)
To update sections 4.4, 4.8 of the SmPC and sections 2, 4 of the PL to implement the signal recommendations on Angiotensin II receptor blockers (ARBs): azilsartan; candesartan; eprosartan; irbesartan; losartan; olmesartan; telmisartan; valsartan (single ingredient and fixed dose combinations) - Intestinal angioedema (EPITT no 20104) adopted at the 28-31 October 2024 PRAC meeting
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Changes: (Updated: 20 Sep 2022)
Initial upload