Details
Product Name in the RMS: Bendamustine Accord 2.5 mg/ml Powder for concentrate for solution for infusion
MR Number: AT/H/0497/001
Date of outcome: 17.07.2014
Type of application | |
---|---|
Level 1: Level 2: Level 3: Level 4: Level 5: |
Abridged Initial Application Generic Chemical Substance Prescription Only |
Active Substances |
bendamustine 2,5 mg |
Form | Powder for concentrate for solution for infusion/injection |
MA Holder in the RMS |
Accord Healthcare Limited, Sage House, 319 Pinner Road, North Harrow, Middlesex, HA1 4HF, UK |
RMS | Austria |
Date of last change | 04.11.2020 |
ATC-Code |
L01AA09 bendamustine |
CMS Country | Domestic Product Name |
---|---|
Belgium | |
Bulgaria | Bendamustine Accord |
Cyprus | BENDAMUSTINE ACCORD |
Czech Republic | Bendamustine Accord 2,5 mg/ml prášek pro koncentrát pro infuzní roztok |
Denmark | |
Estonia | Bendamustine Accord |
Finland | |
France | |
Germany | Bendamustine Accord 2,5 mg/ml Pulver für ein Konzentrat zur Herstellung einer Infusionslösung |
Greece | BENDAMUSTINE/ACCORD |
Hungary | BENDAMUSTINE ACCORD 2,5 mg/ml por oldatos infúzióhoz való koncentrátumhoz |
Iceland | Bendamustine Accord 2,5 mg/ml Stofn fyrir innrennslisþykkni, lausn |
Ireland | |
Italy | |
Latvia | Bendamustine Accord 2,5 mg/ml pulveris infūziju šķīduma koncentrāta pagatavošanai |
Lithuania | Bendamustine Accord 2,5 mg/ml milteliai infuzinio tirpalo koncentratui |
Malta | |
Netherlands | |
Norway | Bendamustine Accord |
Poland | Bendamustine Accord |
Portugal | |
Romania | Bendamustina Accord 2,5 mg/ml pulbere pentru concentrat pentru solutie perfuzabila |
Slovak Republic | Bendamustine Accord 2,5 mg/ml prášok na infúzny koncentrát |
Slovenia | |
Spain | |
Sweden | |
United Kingdom |
Documents | |
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PAR: | AT_H_0497_001_PAR.pdf (25.10.2017) |
FinalSPC: | AT_H_0497_001_FinalSPC.pdf (08.09.2020) |
FinalPL: | AT_H_0497_001_FinalPL.pdf (08.09.2020) |
FinalLabelling: | AT_H_0497_001_FinalLabelling.pdf (08.09.2020) |