Register of
Medicinal Products

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 January 31, 2022)
Package information leaflet (PIL): EST  (last updated January 31, 2022)
Labelling:  (last updated November 12, 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: February 26, 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      08.09.2022     
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

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