SmPC - Fludarabine 50mg Powder for solution for injection or infusion: Change history
View Summary of Product Characteristics (SmPC - Fludarabine 50mg Powder for solution for injection or infusion)
Last updated on this site: 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.
SmPC Sections updated: 4.1, 4.4, 4.6 and 10.
View Summary of Product Characteristics (SmPC - Fludarabine 50mg Powder for solution for injection or infusion)
Last updated on this site: 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.
SmPC Sections updated: 4.1, 4.4, 4.6 and 10.
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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.
SmPC Sections updated: 4.1, 4.4, 4.6 and 10.
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Changes: (Updated: 21 Sep 2022)
Initial upload