PIL- Busulfan 6 mg/ml concentrate for solution for infusion: Change history
View Patient Information Leaflet (PIL- Busulfan 6 mg/ml concentrate for solution for infusion)
Last updated on this site: 31 May 2024
Description of update:
A.5. b) The activities for which the manufacturer/importer is responsible do not include batch release:
A.5.b.: Change in the name of the batch quality control testing site, from "WESSLING Hungary Kft." to "Eurofins Analytical Services Hungary Kft.". The address "Anonymus utca 6, Budapest H-1045, Hungary" is still the same.
A.7. 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.: Deletion of "Wessling Hungary Kft, Fòti ùt 56, Budapest 1047, Hungary" as batch release site.
PIL sections updated: 6 only.
No changes to SmPC.
Last updated on this site: 31 May 2024
Description of update:
A.5. b) The activities for which the manufacturer/importer is responsible do not include batch release:
A.5.b.: Change in the name of the batch quality control testing site, from "WESSLING Hungary Kft." to "Eurofins Analytical Services Hungary Kft.". The address "Anonymus utca 6, Budapest H-1045, Hungary" is still the same.
A.7. 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.: Deletion of "Wessling Hungary Kft, Fòti ùt 56, Budapest 1047, Hungary" as batch release site.
PIL sections updated: 6 only.
No changes to SmPC.
-
Changes: (Updated: 31 May 2024)
Description of update:
A.5. b) The activities for which the manufacturer/importer is responsible do not include batch release:
A.5.b.: Change in the name of the batch quality control testing site, from "WESSLING Hungary Kft." to "Eurofins Analytical Services Hungary Kft.". The address "Anonymus utca 6, Budapest H-1045, Hungary" is still the same.
A.7. 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.: Deletion of "Wessling Hungary Kft, Fòti ùt 56, Budapest 1047, Hungary" as batch release site.
PIL sections updated: 6 only.
No changes to SmPC.
-
Changes: (Updated: 20 Sep 2022)
Initial upload