EMEA-001796-PIP03-16-M03 - paediatric investigation plan

acalabrutinib
PIPHuman

Key facts

Invented name
Calquence
Active Substance
acalabrutinib
Therapeutic area
Oncology
Decision number
P/0111/2023
PIP number
EMEA-001796-PIP03-16-M03
Pharmaceutical form(s)
  • Capsule, hard
  • Film-coated tablet
Condition(s) / indication(s)
Treatment of mature B-cell neoplasms
Route(s) of administration
Oral use
Contact for public enquiries

Acerta Pharma, BV
E-mail: paediatrics@astrazeneca.com 
Tel.: +46 855327591

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

Decision

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