Details

Product Name in the RMS: Bendamustin Actavis

MR Number: DK/H/2378/001
Date of outcome: 18.02.2015

Type of application
Level 1: Level 2: Level 3: Level 4: Level 5:	Abridged Initial 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	Actavis Group PTC ehf Reykjavikurvegi 76-78 220 Hafnarfjördur Iceland
RMS	Denmark
Date of last change	21.07.2021
ATC-Code	L01AA09 bendamustine

CMS Country	Domestic Product Name
Austria	Bendamustin Actavis 2,5 mg/ml Pulver für ein Konzentrat zur Herstellung einer Infusionslösung
Bulgaria	Bendamustine Actavis
Croatia
Estonia	BENDAMUSTINE ACTAVIS
Greece	BENDAMUSTINE/ACTAVIS
Hungary	Bendamustin Teva
Ireland
Netherlands	Bendamustine HCl Teva 2,5 mg/ml, poeder voor concentraat voor oplossing voor infusie
Norway	Bendamustin Actavis
Romania	Bendamustina Actavis 2,5 mg/ml pulbere pentru concentrat pentru solutie perfuzabila
Sweden

Documents
PAR:	DK_H_2378_001_PAR_1of2.pdf (22.10.2018)
PAR:	DK_H_2378_001_PAR_2of2.pdf (22.10.2018)
PARSummary:	DK_H_2378_001_PARSummary.pdf (22.05.2015)
FinalSPC:	DK_H_2378_001_FinalSPC.pdf (05.02.2021)
FinalPL:	DK_H_2378_001_FinalPL.pdf (21.07.2021)
Finalised Product Information:	DK_H_2378_001_FinalPI.pdf (01.04.2019)