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 May 26, 2023)
Package information leaflet (PIL): EST  (last updated May 26, 2023)
Labelling:  (last updated May 26, 2023)
Indication: Colorectal, rectal, breast, gastric, pancreatic, hepatic, uterine, ovarian and bladder carcinoma.
Safety features: Yes
Marketing authorization holder: Ideal Trade Links UAB 
Marketing authorization number: 1114423 
Marketing authorization issued on: May 26, 2023 
Marketing authorization expires on: Unlimited 
Marketing authorization procedure type: National 
Secondary marketing authorization: Yes 
Assessment report:   
Package code Name of medicinal product Dosage form Package Legal status Reimbursements Reference price Last imported PƤritolumaa Additional information
1895542  5-FLUOROURACIL "EBEWE"  solution for injection/infusion  50mg 1ml 10ml 1TK  Prescription        Tšehhi  Tšehhi pakend 
1895553  5-FLUOROURACIL "EBEWE"  solution for injection/infusion  50mg 1ml 20ml 1TK  Prescription        Tšehhi  Tšehhi pakend 
1895564  5-FLUOROURACIL "EBEWE"  solution for injection/infusion  50mg 1ml 100ml 1TK  Prescription        Tšehhi  Tšehhi pakend 
Legal status for supply – medicinal product on medical prescription or not subject to medical prescription

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