PIL - Olmesartan Medoxomil 10mg, 20mg, 40mg Film coated Tablets: Change history
View Patient Information Leaflet (PIL - Olmesartan Medoxomil 10mg, 20mg, 40mg Film coated Tablets)
Last updated on this site: 22 May 2025
Type IAIN (B.II.b.1.a) variation application for addition of Accord Healthcare Single Member S.A., Greece as an alternative site responsible for secondary packaging site.
Type IAIN (B.II.b.2.C.2) variation Application for addition of Accord Healthcare Single Member S.A., Greece as an alternative site responsible for importation and batch release including batch control/testing site.
PIL sections updated: 6 only.
Last updated on this site: 22 May 2025
Type IAIN (B.II.b.1.a) variation application for addition of Accord Healthcare Single Member S.A., Greece as an alternative site responsible for secondary packaging site.
Type IAIN (B.II.b.2.C.2) variation Application for addition of Accord Healthcare Single Member S.A., Greece as an alternative site responsible for importation and batch release including batch control/testing site.
PIL sections updated: 6 only.
-
Changes: (Updated: 22 May 2025)
Type IAIN (B.II.b.1.a) variation application for addition of Accord Healthcare Single Member S.A., Greece as an alternative site responsible for secondary packaging site.
Type IAIN (B.II.b.2.C.2) variation Application for addition of Accord Healthcare Single Member S.A., Greece as an alternative site responsible for importation and batch release including batch control/testing site.
PIL sections updated: 6 only.
-
Changes: (Updated: 27 Mar 2025)
To update sections 4.4, 4.8 of the SmPC and sections 2, 4 of the PIL 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: 21 Sep 2022)
Initial upload