Details
Product Name in the RMS: Kleileuk
MR Number: DK/H/2418/001
Date of outcome: 13.05.2015
Type of application | |
---|---|
Level 1: Level 2: Level 3: Level 4: Level 5: |
Abridged Multiple (Copy) Application Generic Chemical Substance Prescription Only |
Active Substances |
bendamustine hydrochloride 2,5 mg/ml |
Form | POWDER FOR CONCENTRATE FOR SOLUTION FOR INFUSION |
MA Holder in the RMS |
Glenmark Pharmaceuticals s.r.o. Hvezdova 1716/2b 140 78 Praha 4 Czech Republic |
RMS | Denmark |
Date of last change | 18.08.2018 |
ATC-Code |
L01AA09 bendamustine |
CMS Country | Domestic Product Name |
---|---|
Czech Republic | Bendamustine Glenmark 2,5 mg/ml |
Netherlands | Bendamustine Glenmark |
Poland | Bendamustine Glenmark |
Slovak Republic | Bendamustine Glenmark 2,5 mg/ml |
Spain |
Documents | |
---|---|
PAR: | DK_H_2418_001_PAR_1of2.pdf (18.05.2018) |
PAR: | DK_H_2418_001_PAR_2of2.pdf (18.05.2018) |
PARSummary: | DK_H_2418_001_PARSummary.pdf (06.07.2015) |
FinalSPC: | DK_H_2418_001_FinalSPC.pdf (19.07.2018) |
FinalPL: | DK_H_2418_001_FinalPL.pdf (19.07.2018) |
FinalLabelling: | DK_H_2418_001_FinalLabelling.pdf (17.05.2018) |
Finalised Product Information: | DK_H_2418_001_FinalPI.pdf (04.05.2017) |