SmPC - Esomeprazole 40mg Gastro-resistant Tablets: Change history
View Summary of Product Characteristics (SmPC - Esomeprazole 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: 20 Sep 2022)
Initial upload