EMEA-001397-PIP04-17-M01 - paediatric investigation plan

Ibrutinib

Key facts

• Invented name:
  • undefined
  • Imbruvica
• Active Substance:
  Ibrutinib
• Therapeutic area:
  Immunology-Rheumatology-Transplantation
• Decision number:
  P/0421/2019
• PIP number:
  EMEA-001397-PIP04-17-M01
• Pharmaceutical form(s):
  • Capsule (hard)
  • Film-coated tablet
  • Oral suspension
• Condition(s) / indication(s):
  Treatment of chronic Graft versus Host Disease (cGvHD)
• Route(s) of administration:
  • Oral use
  • Gastric use
• Contact for public enquiries:

  Janssen-Cilag International N.V.

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

• Decision type:
  PM: decision on the application for modification of an agreed PIP
• Decision date:
  06/12/2019

Decision

P/0421/2019: EMA decision of 6 December 2019 on the acceptance of a modification of an agreed paediatric investigation plan for ibrutinib (Imbruvica), (EMEA-001397-PIP04-17-M01)

AdoptedReference Number: EMA/557300/2019