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SmPC - Cabazitaxel Accord 20 mg/ml Concentrate for solution for infusion: Change history

  • To update sections 4.4, 4.6 and 5.3 of the SmPC in line with the reference product, (JEVTANA 60 mg concentrate and

    solvent for solution for infusion; EU procedure reference number with outcome: EMEA/H/C/002018/II/0049; MAH: Sanofi

    Winthrop Industrie, France). Consequently, the PIL has been updated.

    • Changes: (Updated: 27 Jul 2023)

      To update sections 4.4, 4.6 and 5.3 of the SmPC in line with the reference product, (JEVTANA 60 mg concentrate and

      solvent for solution for infusion; EU procedure reference number with outcome: EMEA/H/C/002018/II/0049; MAH: Sanofi

      Winthrop Industrie, France). Consequently, the PIL has been updated.

    • Changes: (Updated: 31 May 2023)

      Website update: amended file name. No change to document.

    • Changes: (Updated: 31 May 2023)

      Website update: amended file name. No change to document.

    • Changes: (Updated: 20 Sep 2022)

      Initial upload

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