| Code | 9705B | ||||||||||
| MA number | 44/0265/16-S | ||||||||||
| Product Form: | plv iiv 10x20 mg (20 ml liek.inj.skl.) | ||||||||||
| MA Status: | D - Marketing Authorisation valid for an unlimited period | ||||||||||
| Type of procedure: | Decentralised | ||||||||||
| Therapeutic Class: | 44 - CYTOSTATICA | ||||||||||
| ATC: |
|
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| 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 |
| PIL: |
PIL_Mitomycin-medac_1mg/ml_02/2021.docx
|
| SPC: |
SPC_Mitomycin medac_1mg/ml_02/2021.docx
|
| Safety feature | Yes |
| Data update: | 09.10.2020 |
