EMEA-002354-PIP02-18-M01

Key facts

Invented name
Brukinsa
Active substance
zanubrutinib
Therapeutic area
Oncology
Decision number
P/0205/2022
PIP number
EMEA-002354-PIP02-18-M01
Pharmaceutical form(s)
Capsule, hard
Condition(s) / indication(s)
  • Treatment of lymphoplasmacytic lymphoma
  • Treatment of mature B-cell neoplasms (excluding lymphoplasmacytic lymphoma)
Route(s) of administration
Oral use
Contact for public enquiries
BeiGene Ireland Ltd.

E-mail: bg.ireland@beigene.com

Tel. +353 15667660

Decision type
PM: decision on the application for modification of an agreed PIP

Decision

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