SmPC- Bleomycin 15000 IU Powder for solution for injection/ infusion: Change history
View Summary of Product Characteristics (SmPC- Bleomycin 15000 IU Powder for solution for injection/ infusion)
Last updated on this site: 25 Nov 2024
Type IB: B.II.f.1.b.3 - addition of shelf-life of the finished product after dilution/reconstitution, for 10 days when stored at 2 °C to 8 °C and for 48 hours at normal room temperature for Bleomycin 15000 IU Powder for solution for injection/
Last updated on this site: 25 Nov 2024
Type IB: B.II.f.1.b.3 - addition of shelf-life of the finished product after dilution/reconstitution, for 10 days when stored at 2 °C to 8 °C and for 48 hours at normal room temperature for Bleomycin 15000 IU Powder for solution for injection/
-
Changes: (Updated: 25 Nov 2024)
Type IB: B.II.f.1.b.3 - addition of shelf-life of the finished product after dilution/reconstitution, for 10 days when stored at 2 °C to 8 °C and for 48 hours at normal room temperature for Bleomycin 15000 IU Powder for solution for injection/
-
Changes: (Updated: 06 Jul 2023)
Approval date added
-
Changes: (Updated: 23 Jun 2023)
Description of update: The following change(s) has been notified:
Type IAIN variation (C.I.3.a) application to update the SmPC section 4.4 and leaflet section 2 in-line with the agreed wordings of PSUSA procedure outcome (PSUSA//00000422/202203) for Bleomycin 15000 IU Powder for solution for injection/infusion.
SmPC sections updated: 4.4, 10.
-
Changes: (Updated: 20 Sep 2022)
Initial upload