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PRODUCT DETAIL

Xospata 40 mg filmom obalené tablety

Code 2827D
MA number EU/1/19/1399/001
Product Form: tbl flm 84x40 mg (blis.OPA/Al/PVC/Al)
MA Status: E - Valid centralised marketing authorisation
Type of procedure: EU Orphan
Therapeutic Class: 44 - CYTOSTATICA
ATC:
L ANTINEOPLASTIC AND IMMUNOMODULATING AGENTS
L01 ANTINEOPLASTIC AGENTS
L01E Protein kinase inhibitors
L01EX Other protein kinase inhibitors
L01EX13 Gilteritinib
Shelf life: 48
Container: blister OPA/Al/PVC/Al
Route of admin.: Oral use
Prescription Status: Medicinal product subject to restricted medical prescription.
Legal basis: Article 8(3) application - new active substance
MA issued: 24.10.2019
Validity: 24.10.2024
SmPC + PL: European Medicines Agency's database
Safety feature Yes
Data update: 28.01.2022
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