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PIL - Fludarabine 50mg Powder for solution for injection or infusion: Change history

  • Description of update: To update sections 4.1, 4.4 and 4.6 of the SPC and PIL to bring in line with the reference product Fludara® 50mg powder for solution for injection or infusion (PL 12375/0039; MAH: Sanofi B.V.) dated 28th February 2024. In addition, editorial changes have been made to PIL.

    PIL sections updated: Heading, Introduction, 1, 2, 3, 4, 6 and HCP section.

    • Changes: (Updated: 20 May 2024)

      Description of update: To update sections 4.1, 4.4 and 4.6 of the SPC and PIL to bring in line with the reference product Fludara® 50mg powder for solution for injection or infusion (PL 12375/0039; MAH: Sanofi B.V.) dated 28th February 2024. In addition, editorial changes have been made to PIL.

      PIL sections updated: Heading, Introduction, 1, 2, 3, 4, 6 and HCP section.

    • Changes: (Updated: 21 Sep 2022)

      Initial upload

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