Code | 1287C | ||||||||||
MA number | 44/0433/16-S | ||||||||||
Product Form: | plc ifc 1x25 mg (liek.inj.skl.) | ||||||||||
MA Status: | D - Marketing Authorisation valid for an unlimited period | ||||||||||
Type of procedure: | Decentralised | ||||||||||
MAH, country: | Fresenius Kabi s.r.o., Czechia | ||||||||||
Therapeutic Class: | 44 - CYTOSTATICA | ||||||||||
ATC: |
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Shelf life: | 36 | ||||||||||
Container: | glass vial | ||||||||||
Route of admin.: | Intravenous use |
Prescription Status: | Medicinal product subject to restricted medical prescription. |
Legal basis: | Article 10(1) generic application |
MA issued: | 28.09.2016 |
SPC: | SPC_Bendamustine Kabi 2,5 mg_ml_06.2024.pdf |
PIL: | PIL_Bendamustine Kabi 2,5 mg_ml_06.2024.pdf |
Safety feature | Yes |
Data update: | 04.05.2022 |