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 | 05.02.2021 |
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 | |
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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 (05.02.2021) |
Finalised Product Information: | DK_H_2378_001_FinalPI.pdf (01.04.2019) |