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: 07 Jul 2025
Variation: To update SmPC section 4.8 and PIL section 2 in line with PRAC recommendation (PSUSA/00000464/202407/024) - addition of side effect pulmonary hypertension.
Variation approval date 01/07/2025.
Last updated on this site: 07 Jul 2025
Variation: To update SmPC section 4.8 and PIL section 2 in line with PRAC recommendation (PSUSA/00000464/202407/024) - addition of side effect pulmonary hypertension.
Variation approval date 01/07/2025.
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Changes: (Updated: 07 Jul 2025)
Variation: To update SmPC section 4.8 and PIL section 2 in line with PRAC recommendation (PSUSA/00000464/202407/024) - addition of side effect pulmonary hypertension.
Variation approval date 01/07/2025.
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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.
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Changes: (Updated: 20 Sep 2022)
Initial upload