SmPC - Losartan potassium 100mg Film-coated Tablets (20075): Change history
View Summary of Product Characteristics (SmPC - Losartan potassium 100mg Film-coated Tablets (20075))
Last updated on this site: 21 Jul 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.
Last updated on this site: 21 Jul 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: 21 Jul 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: 25 Apr 2023)
Description of update: Type IB: C.I.2.a: To update SmPC and PIL information in-line with the product information of reference product (Cozaar 12.5/25/50/100 mg film-coated tablets with Procedure reference number: NL/H/1457/001-004/DC and MAH: Merck Sharp & Dohme BV, NL) for Losartan Potassium Accord 25mg/50mg/100mg filmomhulde tabletten.
SmPC sections updated: 4.2, 4.3, 4.4, 4.5, 4.6, 4.8, 5.1, 10.
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Changes: (Updated: 27 Sep 2022)
Initial upload