PIL - Mitomycin 2mg, 10mg, 20mg Powder for solution for injection/infusion or intravesical use: Change history
View Patient Information Leaflet (PIL - Mitomycin 2mg, 10mg, 20mg 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
PIL sections updated: Introduction, 1, 2, 3, 4, 5 and 6
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
PIL sections updated: Introduction, 1, 2, 3, 4, 5 and 6
-
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
PIL sections updated: Introduction, 1, 2, 3, 4, 5 and 6
-
Changes: (Updated: 28 Nov 2025)
Type IAIN (B.II.b.2.C.2): To add Accord Healthcare single member S.A., 64th Km National Road Athens, Lamia, Schimatari, 32009, Greece as an alternative site responsible for importation and batch release including batch control/testing of the finished product.
-
Changes: (Updated: 28 Nov 2025)
Type IAIN (B.II.b.2.C.2): To add Accord Healthcare single member S.A., 64th Km National Road Athens, Lamia, Schimatari, 32009, Greece as an alternative site responsible for importation and batch release including batch control/testing of the finished product.
-
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.
PIL sections updated: 4, 6.
-
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
PIL sections updated: 4, 6.
-
Changes: (Updated: 21 Sep 2022)
Initial upload