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SmPC - Co-trimoxazole Tablets BP 80/400mg: Change history

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  • View Summary of Product Characteristics (SmPC - Co-trimoxazole Tablets BP 80/400mg)

    Last updated on this site: 23 Jul 2025

    PRAC recommendations on signals (EPITT no 20135): Update to SPC 4.8 and PIL for circulatory shock.

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    • Changes: (Updated: 23 Jul 2025)

      PRAC recommendations on signals (EPITT no 20135): Update to SPC 4.8 and PIL for circulatory shock.

    • Changes: (Updated: 11 Feb 2025)

      1. To update sections 4.1 and 4.2 of the SmPC in line with reference product Co-Trimoxazole 80 mg/400 mg Tablets (MA number: PL 39699/0036; MAH: Aspen Pharma Trading Limited; Dated: 27/02/2024). Consequently, the PIL has been updated. 2. To update section 5.1 of the SmPC in line with the EMA request to add new text regarding EUCAST breakpoint data.

    • Changes: (Updated: 20 Sep 2022)

      Initial upload

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