EMEA-002354-PIP03-24 - paediatric investigation plan
zanubrutinib
PIPHuman
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Key facts
- Invented name
- Brukinsa
- Active substance
- zanubrutinib
- Therapeutic area
- Blood and lymphatic system disorders
- Decision number
- P/0226/2024
- PIP number
- EMEA-002354-PIP03-24
- Pharmaceutical form(s)
- Film-coated tablet
- 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
Beone Medicines Ireland Limited
E-mail: bg.ireland@beigene.com
Tel.: +353 1 566 7660- Decision type
- W: decision granting a waiver in all age groups for all conditions or indications
- Decision date
- Compliance check done
- Ei