| Code | 9715B | ||||||||||
| MA number | 44/0271/16-S | ||||||||||
| Product Form: | plv its 5x40 mg+5x40 ml solv. (liek.inj.skl.+ vrecká PVC+ katétre + konektory - povolenie uvádzať na trh končí dňa 31.08.2025) | ||||||||||
| 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: |
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| Shelf life: | 12 | ||||||||||
| Container: | glass vial | ||||||||||
| Route of admin.: | 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 40 mg prášok a rozpúšťadlo na intravezikálny roztok_03.2025.pdf
|
| PIL: |
PIL_Mitomycin medac 40 mg prášok a rozpúšťadlo na intravezikálny roztok_03.2025.pdf
|
| Safety feature | Yes |
| Data update: | 03.03.2025 |
