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PRODUCT DETAIL

Fludara

Code 58897
MA number 44/0001/03-S
Product Form: tbl flm 15x10 mg (blis.PA/Al/PP)
MA Status: D - Marketing Authorisation valid for an unlimited period
Type of procedure: National
Therapeutic Class: 44 - CYTOSTATICA
ATC:
L ANTINEOPLASTIC AND IMMUNOMODULATING AGENTS
L01 ANTINEOPLASTIC AGENTS
L01B ANTIMETABOLITES
L01BB Purine analogues
L01BB05 Fludarabine
Shelf life: 36
Container: blister PA/Al/PP
Route of admin.: Oral use
Prescription Status: Medicinal product subject to medical prescription.
Legal basis: Article 8(3) application - known active substance
MA issued: 22.01.2003
Pediatric warnings: Yes
SPC: SPC_Fludara_04.2024.pdf  
PIL: PIL_Fludara_04.2024.pdf  
Safety feature Yes
Data update: 10.04.2024
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