Details

Product Name in the RMS: Fludarabine 25 mg/ml Concentrate for Solution for Injection or Infusion

MR Number: NL/H/4563/001
Date of outcome: 08.08.2014

Type of application
Level 1: Level 2: Level 3: Level 4: Level 5:	Abridged Initial Application Other Chemical Substance Prescription Only
Active Substances	fludarabine 25 mg/ml
Form	Solution for injection/infusion
MA Holder in the RMS	Accord Healthcare Ltd Sage House, 319 Pinner Road HA1 4HF North Harrow, Middlesex United Kingdom
RMS	Netherlands
Date of last change	10.11.2021
ATC-Code	L01BB05 Fludarabine

CMS Country	Domestic Product Name
Austria	Fludarabin Accord 25 mg/ml Konzentrat zur Herstellung einer Injektions- oder Infusionslösung
Belgium	Fludarabine Accord Healthcare 25 mg/ml concentraat voor oplossing voor injectie of infusie
Bulgaria	Fludarabine Accord
Croatia
Cyprus	FLUDARABINE ACCORD CON FOR SOL FOR INJ/INF
Czech Republic	Fludarabine Accord 25 mg/ml Koncentrát pro přípravu injekčního nebo infuzního roztoku
Estonia	FLUDARABINE ACCORD 25 MG/ML
Finland
France
Germany	Fludarabin Accord 25 mg7ml Konzentrat zur Herstellung einer Injektions- oder Infusionslösung
Hungary	FLUDARABIN ACCORD 25 mg/ml koncentrátum oldatos injekcióhoz vagy infúzióhoz
Ireland
Italy
Lithuania	Fludarabino Accord 25 mg/ml koncentratas injekciniam ar infuziniam tirpalui
Malta
Poland	Fludarabine Accord
Portugal
Romania
Slovenia
Spain
Sweden
XI	Fludarabine 25 mg/ml Concentrate for Solution for Injection or Infusion

Documents
FinalPL:	NL_H_4563_001_FinalPL.pdf (14.11.2019)