Product Documentation

• View Patient Information Leaflet (PIL - Fludarabine phosphate 25 mg/ml Concentrate for solution for injection or infusion (20075))

  Last updated on this site: 31 Jul 2025

  The following changes have been notified:

   

  A.7 - ADMINISTRATIVE CHANGES - Deletion of manufacturing sites for an active substance, intermediate or finished product, packaging site, manufacturer responsible for batch release, site where batch control takes place, or supplier of a starting material, reagent or excipient (when mentioned in the dossier)*

  • A.7 Delete Accord Healthcare B.V. Utrecht, Winthontlaan 200 3526 KV at Utrecht Netherland, Netherland as Batch release site.

   

  B.III.1.a.2 - QUALITY CHANGES - CEP/TSE/MONOGRAPHS - Submission of a new or updated Ph. Eur. Certificate of suitability or deletion of Ph. Eur. certificate of suitability: For an active substance For a starting material/reagent/intermediate used in the manufacturing process of the active substance For an excipient - European Pharmacopoeial Certificate of Suitability to the relevant Ph. Eur. Monograph - Updated certificate from an already approved manufacturer

  • B.III.1.a.2 : Update the Ph. Eur. Certificate of Suitability for Fludarabine phosphate from R1-CEP 2005-257-Rev 04 to CEP 2005-257-Rev 05.

  As a consequence, the name of the manufacturer of the drug substance is updated as follows: from SICOR S.R.L. to SICOR SOCIETÀ ITALIANA CORTICOSTEROIDI S.R.L..

  The address of the manufacturer of the drug substance remain unchanged.

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• View Summary of Product Characteristics (SmPC - Fludarabine phosphate 25 mg/ml Concentrate for Solution for Injection or Infusion (20075))

  Last updated on this site: 02 Jun 2023

  Description of update: renewal approval.

  SmPC sections updated: 9, 10.

  No changes to PIL.

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