SmPC - Mitomycin 10mg Powder for solution for injection/infusion or intravesical use: Change history
View Summary of Product Characteristics (SmPC - Mitomycin 10mg Powder for solution for injection/infusion or intravesical use)
Last updated on this site: 13 Jul 2023
Description of update: To add Water for injection (WFI) as an additional diluent for the intravesical use only of Mitomycin Accord 2 mg/10 mg/20 mg Powder for solution for injection/infusion or intravesical use. Consequently, sections 4.2, 4.8 and 6.6 of the SPC and the package leaflet were updated accordingly.
SmPC Sections updated: 4.2, 4.8, 6.6, 10.
Last updated on this site: 13 Jul 2023
Description of update: To add Water for injection (WFI) as an additional diluent for the intravesical use only of Mitomycin Accord 2 mg/10 mg/20 mg Powder for solution for injection/infusion or intravesical use. Consequently, sections 4.2, 4.8 and 6.6 of the SPC and the package leaflet were updated accordingly.
SmPC Sections updated: 4.2, 4.8, 6.6, 10.
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Changes: (Updated: 13 Jul 2023)
Description of update: To add Water for injection (WFI) as an additional diluent for the intravesical use only of Mitomycin Accord 2 mg/10 mg/20 mg Powder for solution for injection/infusion or intravesical use. Consequently, sections 4.2, 4.8 and 6.6 of the SPC and the package leaflet were updated accordingly.
SmPC Sections updated: 4.2, 4.8, 6.6, 10.
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Changes: (Updated: 29 Jun 2023)
Revert to old approved version
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Changes: (Updated: 16 May 2023)
Description of update: Type II (B.II.z) variation application to add Water for injection (WFI) as an additional diluent
SmPC sections updated: 4.2, 4.8, 10.
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Changes: (Updated: 21 Sep 2022)
Initial upload