Product class: Authorized package
Medicinal product class: For human use
Package code: 1021778
Name of medicinal product: 5-FLUOROURACIL "EBEWE"
Active substances:
Estonian, English, Latin
ATC code: L01BC02
Dosage form: solution for injection/infusion
Route of administration: intravenous use; intraarterial use
Strengh: 50mg 1ml
Amount in package: 5ml 1TK
Legal status for supply*: Subject to medicinal prescription
Class of active substance:  
Additional information:  
Indication: Colorectal, rectal, breast, gastric, pancreatic, hepatic, uterine, ovarian and bladder carcinoma.
Safety features: Yes
Summary of product characteristics (SPC):  (last updated 31 January 2022)
Package information leaflet (PIL): EST  (last updated 31 January 2022)
Labelling:  (last updated 12 November 2020)
Last imported to Estonia: 21 January 2011
Marketing authorization holder: Sandoz Pharmaceuticals d.d. 
Marketing authorization number: 245099 
Marketing authorization issued on: 26 February 1999 
Marketing authorization expires on: Unlimited 
Marketing authorization procedure type: National 
Reference price:   
Under reference price:   
Reference price of daily dose:   
Entry/Changing date: 16 November 2023
Legal status for supply – medicinal product on medical prescription or not subject to medical prescription