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SmPC- Celecoxib 100mg Capsules, hard: Change history

  • Update in line with reference product, Celebrex. Additional update to 6.1 to correct Sodium lauryl sulfate to Sodium Laurilsulfate as per the Ph. Eur. monograph 0098.

     

    Date of approval: 07/07/2026

    SmPC sections updated: 4.2, 4.3, 4.4, 4.5, 4.6, 4.8, 5.1, 5.2, 6.1

    • Changes: (Updated: 29 Jul 2026)

      Update in line with reference product, Celebrex. Additional update to 6.1 to correct Sodium lauryl sulfate to Sodium Laurilsulfate as per the Ph. Eur. monograph 0098.

       

      Date of approval: 07/07/2026

      SmPC sections updated: 4.2, 4.3, 4.4, 4.5, 4.6, 4.8, 5.1, 5.2, 6.1

    • Changes: (Updated: 30 May 2025)

      Renewal. Date of MHRA approval: 17/09/2024

      SmPC sections updated: 9 & 10

    • Changes: (Updated: 27 Jan 2025)

      To update sections 4.5 and 5.3 of the SmPC in line with EoP text approved in SmPC sections following V004. In addition, an update has been made to the lactose excipient warning in section 4.4 of the SmPC.

    • Changes: (Updated: 20 Jan 2025)

      To update sections 4.5 and 5.3 of the SmPC in line with EoP text approved in SmPC sections following V004. In addition, an update has been made to the lactose excipient warning in section 4.4 of the SmPC.

    • Changes: (Updated: 20 Sep 2022)

      Initial upload

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