SmPC - Mitomycin 40mg Powder for solution for injection/infusion: Change history
View Summary of Product Characteristics (SmPC - Mitomycin 40mg Powder for solution for injection/infusion)
Last updated on this site: 17 Aug 2026
Description of update: To update sections 4.1, 4.2, 4.3, 4.4, 4.5, 4.8 and 5.1 of the SmPC in-line with information of reference product (Mitomycin 1 mg Pulver zur Herstellung einer Lösung zur intravesikalen Anwendung; MAH: Medac Gesellschaft für klinische Spezialpräparate m.b.H.; Germany; EU procedure number: DE/H/3943/001). Consequently, the leaflet has been updated.
Date of approval: 12/08/2026
SmPC sections updated: 4.1, 4.2, 4.3, 4.4, 4.5, 4.6, 4.7, 4.8, 5.1, 5.2 and 10
Last updated on this site: 17 Aug 2026
Description of update: To update sections 4.1, 4.2, 4.3, 4.4, 4.5, 4.8 and 5.1 of the SmPC in-line with information of reference product (Mitomycin 1 mg Pulver zur Herstellung einer Lösung zur intravesikalen Anwendung; MAH: Medac Gesellschaft für klinische Spezialpräparate m.b.H.; Germany; EU procedure number: DE/H/3943/001). Consequently, the leaflet has been updated.
Date of approval: 12/08/2026
SmPC sections updated: 4.1, 4.2, 4.3, 4.4, 4.5, 4.6, 4.7, 4.8, 5.1, 5.2 and 10
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Changes: (Updated: 17 Aug 2026)
Description of update: To update sections 4.1, 4.2, 4.3, 4.4, 4.5, 4.8 and 5.1 of the SmPC in-line with information of reference product (Mitomycin 1 mg Pulver zur Herstellung einer Lösung zur intravesikalen Anwendung; MAH: Medac Gesellschaft für klinische Spezialpräparate m.b.H.; Germany; EU procedure number: DE/H/3943/001). Consequently, the leaflet has been updated.
Date of approval: 12/08/2026
SmPC sections updated: 4.1, 4.2, 4.3, 4.4, 4.5, 4.6, 4.7, 4.8, 5.1, 5.2 and 10
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Changes: (Updated: 21 Sep 2022)
Initial upload