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PRODUCT DETAIL

Balversa 4 mg filmom obalené tablety

Code 7421E
MA number EU/1/24/1841/009
Product Form: tbl flm 56x4 mg (fľ.HDPE)
MA Status: E - Valid centralised marketing authorisation
Type of procedure: EU
MAH, country: Janssen - Cilag International N.V., Belgium
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
L01EN01 Erdafitinib
Shelf life: 48
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: 22.08.2024
Validity: 22.08.2029
Safety feature Yes
Data update: 06.09.2024
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