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SmPC - Esomeprazole 40mg Gastro-resistant Tablets: Change history

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  • 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.

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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.

    • Changes: (Updated: 20 Sep 2022)

      Initial upload

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