EMEA-001397-PIP03-14-M06 - paediatric investigation plan

Ibrutinib

Key facts

• Invented name:
  Imbruvica
• Active Substance:
  Ibrutinib
• Therapeutic area:
  Oncology
• Decision number:
  P/0337/2021
• PIP number:
  EMEA-001397-PIP03-14-M06
• Pharmaceutical form(s):
  • Film-coated tablet
  • Capsule (hard)
• Condition(s) / indication(s):
  Treatment of mature B-cell neoplasms
• Route(s) of administration:
  Oral use
• Contact for public enquiries:

  Janssen-Cilag International N.V.

  E-mail: [e-mail]; Tel: [phone]

• Decision type:
  PM: decision on the application for modification of an agreed PIP
• Decision date:
  11/08/2021
• Compliance procedure number:
  EMEA-C-001397-PIP03-14-M06
• Compliance opinion date:
  25/02/2022
• Compliance outcome:
  Positive

Decision

P/0337/2021 : EMA decision of 11 August 2021 on the acceptance of a modification of an agreed paediatric investigation plan for ibrutinib (Imbruvica) (EMEA-001397-PIP03-14-M06)

AdoptedReference Number: EMA/432866/2021