PIL - Fludarabine phosphate 25 mg/ml Concentrate for solution for injection or infusion (20075): Change history
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.
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.
-
Changes: (Updated: 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.
-
Changes: (Updated: 23 Sep 2022)
Initial upload