Latest hum. ProductsDetails
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 | 20.08.2020 |
| 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 (14.04.2020) |
| FinalPL: | DK_H_2418_001_FinalPL.pdf (14.04.2020) |
| FinalLabelling: | DK_H_2418_001_FinalLabelling.pdf (17.05.2018) |
| Finalised Product Information: | DK_H_2418_001_FinalPI.pdf (04.05.2017) |
