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SmPC-Zercepac 60 mg powder for concentrate for solution for infusion: Change history

  • Description of update: To update SmPC sections 2, 4.4 and 6.1 and the PIL in line with the reference product information (reference product: Herceptin). Consequently, the PIL has been updated.

    Date of approval: 20/07/2026

    SmPC sections updated: 2, 4.4, 6.1 and 10

    • Changes: (Updated: 31 Jul 2026)

      Description of update: To update SmPC sections 2, 4.4 and 6.1 and the PIL in line with the reference product information (reference product: Herceptin). Consequently, the PIL has been updated.

      Date of approval: 20/07/2026

      SmPC sections updated: 2, 4.4, 6.1 and 10

    • Changes: (Updated: 25 Feb 2025)

      Renewal Approval

    • Changes: (Updated: 04 Sep 2023)

      To register a change in the ATC code following a WHO Recommendation from "L01XC03" to "L01FD01." Consequentially, section 5.1 of the SmPC has been updated.

    • Changes: (Updated: 08 Dec 2022)

      Updated document from Word to PDF

    • Changes: (Updated: 08 Dec 2022)

      Initial upload

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