Details

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

MR Number: UK/H/5290/001
Date of outcome: 25.04.2013

Type of application
Level 1: Level 2: Level 3: Level 4: Level 5:	Abridged Initial Application Other Chemical Substance Prescription Only
Active Substances	fludarabine phosphate 25 mg/ml
Form	solution for injection or infusion
MA Holder in the RMS	Actavis Group PTC ehf.
RMS	United Kingdom
Date of last change	25.09.2018
ATC-Code	L01BB05 Fludarabine

CMS Country	Domestic Product Name
Austria	Fludarabinphosphat Actavis 25 mg/ml Konzentrat zur Herstellung einer Injektions- oder Infusionslösun
Denmark	Fludarabinphosphat "Actavis"
Estonia	FLUDARABINE ACTAVIS
Finland
Germany	Fludarabin-Actavis 50 mg / ml Konzentrat zur Herstellung einer Infusionslösung
Greece
Iceland	Fludarabin Actavis 25 mg/ml Stungulyfs-/innrennslisþykkni, lausn
Ireland
Italy
Latvia	Fludarabine Actavis 25 mg/ml koncentrāts injekciju vai infūziju šķīduma pagatavošanai
Lithuania	Fludarabine Actavis 25 mg/ml koncentratas injekciniam/infuziniam tirpalui
Netherlands	Fludarabinefosfaat Actavis 25 mg/ml, concentraat voor oplossing voor injectie of infusie
Norway	Fludarabin Actavis
Poland	Fludarabine Actavis
Romania	Fludarabina Actavis 25 mg/ml concentrat pentru solutie injectabila sau perfuzabila
Slovenia
Spain
Sweden	48182

Documents
PAR:	http://www.mhra.gov.uk/home/groups/par/documents/websiteresources/con306139.pdf (11.07.2014)