Register of
Medicinal Products

Product class: Authorized package
Medicinal product class: For human use
Package code: 1269660
Name of medicinal product: FLUDARABINE "EBEWE" 25MG/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 leukemia (CLL) in patients with sufficient bone marrow reserves. First line treatment with Fludarabin "Ebewe" should only be initiated in patients with advanced disease, Rai stages III/IV (Binet stages C), or Rai stages I/II (Binet stages A/B) where the patient has disease related symptoms or evidence of progressive disease.
Safety features: Yes
Summary of product characteristics (SPC):  (last updated May 31, 2022)
Package information leaflet (PIL): EST  (last updated May 31, 2022)
Labelling:  (last updated September 10, 2018)
Last imported to Estonia: Never imported to Estonia
Marketing authorization holder: Sandoz Pharmaceuticals d.d. 
Marketing authorization number: 592808 
Marketing authorization issued on: August 22, 2008 
Marketing authorization expires on: Unlimited 
Marketing authorization procedure type: Decentralised 
Reference price:   
Under reference price:   
Reference price of daily dose:   
Entry/Changing date: November 2, 2023
Legal status for supply – medicinal product on medical prescription or not subject to medical prescription

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