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BRUKINSA 160 mg film-coated tablets

Licence status
Authorised: 14/08/2025
Active substances
Zanubrutinib
Dosage Form
Film-coated tablet
Licence number
EU/1/21/1576/002
Licence holder
BeiGene Ireland Limited

Licence information

ATC code
L01EL03 Zanubrutinib
Legal supply status
Product subject to prescription which may not be renewed (A)
Place of sale
Supply through pharmacies only
Conditions of Licence
Medicinal product subject to restricted medical prescription (see Annex I: Summary of Product Characteristics, section 4.2).
Marketing availability
Unknown
Advertising conditions
Advertising to healthcare professionals only
Licence issued
14/08/2025