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PRODUCT DETAIL

Lytgobi 4 mg filmom obalené tablety

Code 4129E
MA number EU/1/23/1741/003
Product Form: tbl flm 35x4 mg (blis.PVC/PCTFE/Al)
MA Status: Ex - Conditional centralised marketing authorisation
Type of procedure: EU
Therapeutic Class: 44 - CYTOSTATICA
ATC:
L ANTINEOPLASTIC AND IMMUNOMODULATING AGENTS
L01 ANTINEOPLASTIC AGENTS
L01E Protein kinase inhibitors
L01EN Fibroblast growth factor receptor (FGFR) tyrosine kinase inhibitors
L01EN04 Futibatinib
Shelf life: 48
Container: blister PVC/PCTFE/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: 04.07.2023
Validity: 04.07.2024
SmPC + PL: European Medicines Agency's database
Safety feature Yes
Data update: 24.07.2023
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