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: 22 Apr 2026
Description of update: To update sections 4.4, 4.6 & 5.1 of the SmPC to bring product information for the finished products Bleomycin 15000 IU Powder for solution for injection/ infusion in-line with the reference product Bleomycine Sanofi 15 000 I.E. poeder voor oplossing voor injectie following assessment of the same change. To update section 4.8 of the SPC with reference to the Yellow Card reporting system. Consequently, the PiL is also being updated.
Date of approval: 19/02/2026
SmPC sections updated: Title, 4.4, 4.6, 5.1 and 10
Last updated on this site: 22 Apr 2026
Description of update: To update sections 4.4, 4.6 & 5.1 of the SmPC to bring product information for the finished products Bleomycin 15000 IU Powder for solution for injection/ infusion in-line with the reference product Bleomycine Sanofi 15 000 I.E. poeder voor oplossing voor injectie following assessment of the same change. To update section 4.8 of the SPC with reference to the Yellow Card reporting system. Consequently, the PiL is also being updated.
Date of approval: 19/02/2026
SmPC sections updated: Title, 4.4, 4.6, 5.1 and 10
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Changes: (Updated: 22 Apr 2026)
Description of update: To update sections 4.4, 4.6 & 5.1 of the SmPC to bring product information for the finished products Bleomycin 15000 IU Powder for solution for injection/ infusion in-line with the reference product Bleomycine Sanofi 15 000 I.E. poeder voor oplossing voor injectie following assessment of the same change. To update section 4.8 of the SPC with reference to the Yellow Card reporting system. Consequently, the PiL is also being updated.
Date of approval: 19/02/2026
SmPC sections updated: Title, 4.4, 4.6, 5.1 and 10
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Changes: (Updated: 21 Apr 2026)
Description of update: To update sections 4.4, 4.6 & 5.1 of the SmPC to bring product information for the finished products Bleomycin 15000 IU Powder for solution for injection/ infusion in-line with the reference roduct Bleomycine Sanofi 15 000 I.E. poeder voor oplossing voor injectie following assessment of the same change. To update section 4.8 of the SPC with reference to the Yellow Card reporting system. Consequently, the PiL is also being updated.
Date of approval: 19/02/2026
SmPC sections updated: Title, 4.4, 4.6, 5.1 and 10
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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/
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Changes: (Updated: 06 Jul 2023)
Approval date added
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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.
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Changes: (Updated: 20 Sep 2022)
Initial upload