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SmPC - Etoposide 20mg/ml Concentrate for Solution for Infusion: Change history

  • Description of update: Update to section 4.4 and 4.8 of the SmPC and section 4 of the PIL to implement the wording agreed by PRAC following the outcome of the PSUR procedure PSUSA/00001333/202302.

    SmPC Sections updated: 4.4, 4.8 and 10.

    • Changes: (Updated: 13 Feb 2024)

      Description of update: Update to section 4.4 and 4.8 of the SmPC and section 4 of the PIL to implement the wording agreed by PRAC following the outcome of the PSUR procedure PSUSA/00001333/202302.

      SmPC Sections updated: 4.4, 4.8 and 10.

    • Changes: (Updated: 08 Feb 2023)

      To register an update to sections 4.2, 4.4 and 4.8 of the SPC in line with reference product (Etopophos 100 mg/1000mg powder for solution for infusion). Consequentially, the leaflet has been updated.

    • Changes: (Updated: 30 Dec 2022)

      To update SmPC and PIL information in-line with reference product.

    • Changes: (Updated: 20 Sep 2022)

      Initial upload

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