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SmPC - Co-codamol Tablets BP 8/500mg: Change history

  • Description of update: To update section 4.5 of the SmPC in line with the reference product Co-codamol 8/500 Tablets (PL 17780/0071; MAH: Zentiva Pharma UK Limited) dated 16th June 2023. Additionally, the cartons have been updated with corrected paracetamol warning text.

    SmPC Sections updated: 4.5 and 10.

    No changes to PIL.

    • Changes: (Updated: 08 Apr 2024)

      Description of update: To update section 4.5 of the SmPC in line with the reference product Co-codamol 8/500 Tablets (PL 17780/0071; MAH: Zentiva Pharma UK Limited) dated 16th June 2023. Additionally, the cartons have been updated with corrected paracetamol warning text.

      SmPC Sections updated: 4.5 and 10.

      No changes to PIL.

    • Changes: (Updated: 16 May 2023)

      Variation Description: To update section 2 of the PIL following an MHRA review of CNS depressants (SA 18643283). Editorial changes have also been made throughout the PIL.

      SmPC sections updated – 4.4 and 10.

    • Changes: (Updated: 22 Sep 2022)

      initial upload

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