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SmPC - Paclitaxel 6mg/ml Concentrate for solution for infusion: Change history

  • Description of update: To update sections 4.4, 4.6, 4.8 of the SmPC and sections 2, 4 of the leaflet information in line with the information of reference product (Taxol 6 mg/ml, concentrate for solution for infusion; MAH: Cheplapharm Arzneimittel GmbH; procedure number: IT/H/0693/001).

    Date of approval: 23/12/2025

    SmPC sections updated: 4.4, 4.5, 4.6, 4.8 and 10

    • Changes: (Updated: 30 Dec 2025)

      Description of update: To update sections 4.4, 4.6, 4.8 of the SmPC and sections 2, 4 of the leaflet information in line with the information of reference product (Taxol 6 mg/ml, concentrate for solution for infusion; MAH: Cheplapharm Arzneimittel GmbH; procedure number: IT/H/0693/001).

      Date of approval: 23/12/2025

      SmPC sections updated: 4.4, 4.5, 4.6, 4.8 and 10

    • Changes: (Updated: 21 Sep 2022)

      Initial upload

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