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

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  • View Summary of Product Characteristics (SmPC- Busulfan 6 mg/ml Concentrate for solution for infusion)

    Last updated on this site: 07 Jul 2025

    Variation: To update SmPC section 4.8 and PIL section 2 in line with PRAC recommendation (PSUSA/00000464/202407/024) - addition of side effect pulmonary hypertension.

    Variation approval date 01/07/2025.

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    • Changes: (Updated: 07 Jul 2025)

      Variation: To update SmPC section 4.8 and PIL section 2 in line with PRAC recommendation (PSUSA/00000464/202407/024) - addition of side effect pulmonary hypertension.

      Variation approval date 01/07/2025.

    • Changes: (Updated: 03 Oct 2024)

      Renewal approval

    • Changes: (Updated: 31 May 2023)

      website administration update

    • Changes: (Updated: 31 May 2023)

      SmPC Tab title changed from Ibandronic Acid to Busulfan - Document information still the same, re-uploaded

    • Changes: (Updated: 20 Sep 2022)

      Initial upload

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