FLUDARA 50 mg prašek za raztopino za injiciranje ali infundiranje
Fludarabin
General information
Drug nameFLUDARA 50 mg prašek za raztopino za injiciranje ali infundiranje
Medicine nameFludarabin
National drug code3000007
PMS ID—
SNOMED descriptive name code—
Legal statusZdravilo z dovoljenjem za promet
Drug groupChemical Medicinal Product
OriginatorNo
Orphan drugNo
Marketing authorization
Procedure typePrenehanje veljavnosti dovoljenja za promet
No. and date of decision/certificate103-190/2018-4, 17. 11. 2019
Authorization validity date17. 11. 2019
Marketing end date17. 11. 2019
Application type—
Authorization/certificate holderGENZYME EUROPE B.V.
Drug safety monitoring
Additional safety monitoringNo
Precautionary measure/dispensing restrictions—
Pregnancy prevention programmeNo
Controlled access programme(s)No
ATC codes
Route of administration
Route of administration name
Intravenska uporaba
Settlement data for compulsory health insurance billing
Substitute medicine
Preparation—
Valid from – to—
Clinical use data
Methods of use—
Indications—
Rounding factor—
DivisibleNo
Division for easier swallowingNo
Division for dosage adjustmentNo
Paediatric populationNo
Shortage actions
Substitute medicine in case of shortage - industrial medicine—
Substitute medicine in case of shortage - magistral or galenic medicine—
Prescribing restriction in case of drug shortageNo
Dispensing restriction in case of shortage or emergencyNo
Dispensing restriction for foreign prescriptions in case of shortage or emergencyNo
Export restrictionNo
Drug status
Permanent cessation of marketing of the medicinal product.
Last drug update date:9. 7. 2026