EMEA-001796-PIP03-16-M02

Table of contents

Key facts

Invented name
Calquence
Active substance
Acalabrutinib
Therapeutic area
Oncology
Decision number
P/0408/2021
PIP number
EMEA-001796-PIP03-16-M02
Pharmaceutical form(s)
  • Capsule, hard
  • Age-appropriate oral liquid dosage form
  • Age-appropriate oral solid dosage form
  • 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

Tel. +31  412700 576
E-mail: pediatrics@acerta-pharma.com

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

Decision

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