Code | 9701B | ||||||||||
MA number | 44/0265/16-S | ||||||||||
Product Form: | plv iiv 5x10 mg (10 ml liek.inj.skl.) | ||||||||||
MA Status: | D - Marketing Authorisation valid for an unlimited period | ||||||||||
Type of procedure: | Decentralised | ||||||||||
MAH, country: | medac Gesellschaft für klinische Spezialpräparate m.b.H., Germany | ||||||||||
Therapeutic Class: | 44 - CYTOSTATICA | ||||||||||
ATC: |
|
||||||||||
Shelf life: | 24 | ||||||||||
Container: | glass vial | ||||||||||
Route of admin.: | Intravenous and intravesical use |
Prescription Status: | Medicinal product subject to restricted medical prescription. |
Legal basis: | Article 10(1) generic application |
MA issued: | 22.06.2016 |
SPC: | SPC_Mitomycin medac 1 mg_ml_09.2024.pdf |
PIL: | PIL_Mitomycin medac 1 mg_ml_09.2024.pdf |
Safety feature | Yes |
Data update: | 09.10.2020 |