PIL - Esomeprazole 20mg, 40mg Gastro-resistant Tablets: Change history
View Patient Information Leaflet (PIL - Esomeprazole 20mg, 40mg Gastro-resistant Tablets)
Last updated on this site: 26 Nov 2024
Last updated on this site: 26 Nov 2024
To update SmPC sections 4.1 (20mg only), 4.4, 4.5, 4.8 and 5.1 in line with the reference product Nexium 20 mg gastro-resistant tablets (MAH: Grunenthal Pharma Ltd; MA number: PA2242/013/002; dated: 21/01/2022). Consequently, the PIL has been updated.
In addition; there are editorial updates to SmPC section 4.5 and PIL, SmPC section 5.1 pharmacotherapeutic group naming has been updated in line with the WHO ATC Index.
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Changes: (Updated: 26 Nov 2024)
To update SmPC sections 4.1 (20mg only), 4.4, 4.5, 4.8 and 5.1 in line with the reference product Nexium 20 mg gastro-resistant tablets (MAH: Grunenthal Pharma Ltd; MA number: PA2242/013/002; dated: 21/01/2022). Consequently, the PIL has been updated.
In addition; there are editorial updates to SmPC section 4.5 and PIL, SmPC section 5.1 pharmacotherapeutic group naming has been updated in line with the WHO ATC Index.
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Changes: (Updated: 07 May 2024)
Description of update: To register replacement carton, with the statement ‘UK Only’ added as part of the Windsor Framework agreement. Additionally, we have taken the opportunity to update section 2 and also minor typographical amends throughout the Joint PIL.
PIL sections updated: 2, 3, 4 and 6.
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Changes: (Updated: 27 Feb 2023)
Variation Description: To register at the request of the MHRA to update leaflet warning for esomeprazole - Section 2 -reduced vitamin B12 absorption.
PIL section(s) updated – 2 & 6.
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Changes: (Updated: 20 Sep 2022)
Initial upload