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: 18 Mar 2026
To update sections 4.2, 4.4, 4.8 and 5.2 of the SmPC in line with the reference product (Mitomycin 1 mg/ml powder for solution for injection/infusion or intravesical use; MAH: Medac G.m.b.H. Consequently, the leaflet has been updated.
Additionally, editorial changes have been made to sections 4.1, 4.3, 4.5 and 4.9 of the SmPC in line with reference text to improve the readability of the information and in-line with QRD requirements.
Approval date: 10/03/2026
SmPC sections updated 4.1, 4.2, 4.3, 4.4, 4.5, 4.8, 4.9, 5.2 and 10
Last updated on this site: 18 Mar 2026
To update sections 4.2, 4.4, 4.8 and 5.2 of the SmPC in line with the reference product (Mitomycin 1 mg/ml powder for solution for injection/infusion or intravesical use; MAH: Medac G.m.b.H. Consequently, the leaflet has been updated.
Additionally, editorial changes have been made to sections 4.1, 4.3, 4.5 and 4.9 of the SmPC in line with reference text to improve the readability of the information and in-line with QRD requirements.
Approval date: 10/03/2026
SmPC sections updated 4.1, 4.2, 4.3, 4.4, 4.5, 4.8, 4.9, 5.2 and 10
-
Changes: (Updated: 18 Mar 2026)
To update sections 4.2, 4.4, 4.8 and 5.2 of the SmPC in line with the reference product (Mitomycin 1 mg/ml powder for solution for injection/infusion or intravesical use; MAH: Medac G.m.b.H. Consequently, the leaflet has been updated.
Additionally, editorial changes have been made to sections 4.1, 4.3, 4.5 and 4.9 of the SmPC in line with reference text to improve the readability of the information and in-line with QRD requirements.
Approval date: 10/03/2026
SmPC sections updated 4.1, 4.2, 4.3, 4.4, 4.5, 4.8, 4.9, 5.2 and 10
-
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.
-
Changes: (Updated: 29 Jun 2023)
Revert to old approved version
-
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.
-
Changes: (Updated: 21 Sep 2022)
Initial upload