EMEA-002354-PIP02-18

Key facts

Active substance
zanubrutinib
Therapeutic area
Oncology
Decision number
P/0398/2019
PIP number
EMEA-002354-PIP02-18
Pharmaceutical form(s)
  • Capsule, hard
  • Age-appropriate oral solid dosage form
Condition(s) / indication(s)
  • Treatment of lymphoplasmacytic lymphoma
  • Treatment of mature B-cell neoplasms (excluding lymphoplasmacytic lymphoma)
Route(s) of administration
  • Oral use
  • Naso-gastric use
Contact for public enquiries
BeiGene Ireland, Ltd

E-mail: julie.boisvert@beigene.com
Tel.  +1 8312161352

Decision type
P: decision agreeing on a investigation plan, with or without partial waiver(s) and or deferral(s)

Decision

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