Register of
Medicinal Products

Product class: Authorized package
Medicinal product class: For human use
Package code: 1622461
Name of medicinal product: FLUDARABINE ACCORD 25 MG/ML
Active substances:
Estonian, English, Latin
ATC code: L01BB05
Dosage form: concentrate for solution for injection/infusion
Route of administration: intravenous use
Strengh: 25mg 1ml
Amount in package: 2ml 1TK
Legal status for supply*: Subject to medicinal prescription
Class of active substance:  
Additional information:  
Indication: Treatment of B-cell chronic lymphocytic leukaemia (CLL) in adult patients with sufficient bone marrow reserves. First line treatment with Fludarabine should only be initiated in adult patients with advanced disease, Rai stages III/IV (Binet stage C), or Rai stages I/II (Binet stage A/B) where the patient has disease related symptoms or evidence of progressive disease.
Safety features: Yes
Summary of product characteristics (SPC):  (last updated June 30, 2023)
Package information leaflet (PIL): EST  (last updated September 15, 2021)
Labelling:  (last updated September 30, 2019)
Last imported to Estonia: January 11, 2023
Marketing authorization holder: Accord Healthcare B.V. 
Marketing authorization number: 855314 
Marketing authorization issued on: September 30, 2014 
Marketing authorization expires on: Unlimited 
Marketing authorization procedure type: Decentralised 
Reference price:   
Under reference price:   
Reference price of daily dose:   
Entry/Changing date: April 4, 2024
Legal status for supply – medicinal product on medical prescription or not subject to medical prescription

You can download Acrobat Reader fromhere