Source: European Medicines Agency (EU) Revision Year: 2024 Publisher: BeiGene Ireland Limited., 10 Earlsfort Terrace, Dublin 2, D02 T380, Ireland, Tel. +353 1 566 7660, E-mail bg.ireland@beigene.com
BRUKINSA 80 mg hard capsules.
| Pharmaceutical Form |
|---|
|
Hard capsule. White to off-white opaque hard capsule of 22 mm in length, marked with “ZANU 80” in black ink. |
Each hard capsule contains 80 mg of zanubrutinib.
For the full list of excipients, see section 6.1.
| Active Ingredient | Description | |
|---|---|---|
| Zanubrutinib |
Zanubrutinib is an inhibitor of Bruton’s tyrosine kinase (BTK). Zanubrutinib forms a covalent bond with a cysteine residue in the BTK active site, leading to inhibition of BTK activity. BTK is a signalling molecule of the B-cell antigen receptor (BCR) and cytokine receptor pathways. In B-cells, BTK signalling results in activation of pathways necessary for B-cell proliferation, trafficking, chemotaxis, and adhesion. |
| List of Excipients |
|---|
|
Capsule content: Microcrystalline cellulose Capsule shell: Gelatin |
HDPE bottles with a child-resistant polypropylene closure. Each bottle contains 120 hard capsules.
BeiGene Ireland Limited., 10 Earlsfort Terrace, Dublin 2, D02 T380, Ireland, Tel. +353 1 566 7660, E-mail bg.ireland@beigene.com
EU/1/21/1576/001
Date of first authorisation: 22 November 2021
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