Details

Product Name in the RMS: Bendamustin Stada

MR Number: DK/H/2413/001
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	STADA Arzneimittel AG Stadastraße 2 – 18, 61118 Bad Vilbel Germany
RMS	Denmark
Date of last change	28.04.2018
ATC-Code	L01AA09 bendamustine

CMS Country	Domestic Product Name
Austria	Bendamustin STADA 2,5 mg/ml Pulver für ein Konzentrat zur Herstellung einer Infusionslösung
Poland	Bendamustine Stada

Documents
PAR:	DK_H_2413_001_PAR.pdf (06.07.2015)
PARSummary:	DK_H_2413_001_PARSummary.pdf (06.07.2015)
FinalSPC:	DK_H_2413_001_FinalSPC.pdf (03.04.2018)
FinalPL:	DK_H_2413_001_FinalPL.pdf (03.04.2018)
FinalLabelling:	DK_H_2413_001_FinalLabelling.pdf (13.05.2015)
Finalised Product Information:	DK_H_2413_001_FinalPI.pdf (04.09.2017)