SmPC_Trabectedin 0.25 mg powder for concentrate for solution for infusion: Change history
View Summary of Product Characteristics (SmPC_Trabectedin 0.25 mg powder for concentrate for solution for infusion)
Last updated on this site: 23 Apr 2026
Type IB (Q.II.f.1.b.1) variation to extend the shelf-life of the finished product Trabectedin Accord 0.25 mg powder for concentrate for solution for infusion as packaged for sale from 18 months to 24 months when stored at 2°C–8°C in a refrigerator. SmPC 6.3 updated.
View Summary of Product Characteristics (SmPC_Trabectedin 0.25 mg powder for concentrate for solution for infusion)
Last updated on this site: 23 Apr 2026
Type IB (Q.II.f.1.b.1) variation to extend the shelf-life of the finished product Trabectedin Accord 0.25 mg powder for concentrate for solution for infusion as packaged for sale from 18 months to 24 months when stored at 2°C–8°C in a refrigerator. SmPC 6.3 updated.
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Changes: (Updated: 23 Apr 2026)
Type IB (Q.II.f.1.b.1) variation to extend the shelf-life of the finished product Trabectedin Accord 0.25 mg powder for concentrate for solution for infusion as packaged for sale from 18 months to 24 months when stored at 2°C–8°C in a refrigerator. SmPC 6.3 updated.
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Changes: (Updated: 07 Nov 2025)
New product launch: 04/11/2025