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SmPC - Irbesartan Accord 75mg Film-coated Tablets: Change history

  • 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.

    • 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.

    • Changes: (Updated: 20 Sep 2022)

      Initial upload

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