Details

Product Name in the RMS: Cytarabine 100mg/ml

MR Number: NL/H/4561/001
Date of outcome: 16.11.2009

Type of application
Level 1: Level 2: Level 3: Level 4: Level 5:	Abridged Initial Application Generic Chemical Substance Prescription Only
Active Substances	cytarabine 100 mg/ml
Form	solution for injection or infusion
MA Holder in the RMS	Accord Healthcare B.V., Winthontlaan 200, 3526 KV Utrecht, Nederland
RMS	Netherlands
Date of last change	18.04.2020
ATC-Code	L01BC01 Cytarabine

CMS Country	Domestic Product Name
Austria
Belgium
Bulgaria	Cytarabine Accord
Cyprus	CYTARABINE ACCORD SOL FOR INF/INJ
Czech Republic	Cytarabine Accord 100 mg/ml injekční nebo infuzní roztok
Denmark	Cytarabine "Accord"
Estonia	CYTARABINE ACCORD 100 MG/ML
France
Germany	Cytarabine Accord 100 mg / ml Lösung zur Injektion oder Infusion
Hungary	CYTARABINE ACCORD 100 mg/ml oldatos injekció vagy infúzió
Ireland
Italy
Latvia	Cytarabine Accord 100 mg/ml šķīdums injekcijām vai infūzijām
Lithuania	Cytarabine Accord 100 mg/ ml injekcinis/infuzinis tirpalas
Malta	Cytarabine 10mg/ml solution for injection or infusion
Norway
Portugal
Slovak Republic	Cytarabine Accord 100 mg/ml
Sweden
United Kingdom	PL 20075/0121 - 0024

Documents
PAR:	http://www.mhra.gov.uk/home/groups/par/documents/websiteresources/con070968.pdf (20.06.2014)
FinalLabelling:	NL_H_4561_001_FinalLabelling.pdf (03.06.2019)