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PRODUCT DETAIL

BRUKINSA 80 mg tvrdé kapsuly

Code 9166D
MA number EU/1/21/1576/001
Product Form: cps dur 120x80 mg (fľ.HDPE)
MA Status: E - Valid centralised marketing authorisation
Type of procedure: EU
Therapeutic Class: 44 - CYTOSTATICA
ATC:
L ANTINEOPLASTIC AND IMMUNOMODULATING AGENTS
L01 ANTINEOPLASTIC AGENTS
L01E Protein kinase inhibitors
L01EL Bruton`s tyrosine kinase (BTK) inhibitors
L01EL03 Zanubrutinib
Shelf life: 36
Container: bottle HDPE
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: 22.11.2021
Validity: 22.11.2026
SmPC + PL: European Medicines Agency's database
Safety feature Yes
Data update: 10.12.2021
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