Product class: Medicinal product with marketing authorization
Medicinal product class: Human medicine
Name of medicinal product: 5-FLUOROURACIL "EBEWE"
Active substances:
Fluorouracil
Estonian, English, Latin
ATC code: L01BC02
Dosage form: solution for injection/infusion
Strength: 50mg 1ml
Legal status for supply*: Subject to medicinal prescription
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)
Indication: Colorectal, rectal, breast, gastric, pancreatic, hepatic, uterine, ovarian and bladder carcinoma.
Safety features: Yes
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 
Assessment report:   
Package code Name of medicinal product Dosage form Package Legal status Reimbursements Reference price Last imported PƤritolumaa Additional information
1021778  5-FLUOROURACIL "EBEWE"  solution for injection/infusion  50mg 1ml 5ml 1TK  Prescription      21/01/2011     
1069400  5-FLUOROURACIL "EBEWE"  solution for injection/infusion  50mg 1ml 10ml 1TK  Prescription      30/12/2011     
1069411  5-FLUOROURACIL "EBEWE"  solution for injection/infusion  50mg 1ml 20ml 1TK  Prescription      15/02/2012     
1069422  5-FLUOROURACIL "EBEWE"  solution for injection/infusion  50mg 1ml 100ml 1TK  Prescription      03/07/2024     
1069433  5-FLUOROURACIL "EBEWE"  solution for injection/infusion  50mg 1ml 20ml 5TK  Prescription      26/04/2007     
1136540  5-FLUOROURACIL "EBEWE"  solution for injection/infusion  50mg 1ml 5ml 5TK  Prescription      26/04/2007     
1150018  5-FLUOROURACIL "EBEWE"  solution for injection/infusion  50mg 1ml 10ml 5TK  Prescription      09/07/2010     
Legal status for supply – medicinal product on medical prescription or not subject to medical prescription