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
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.
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