EMEA-001397-PIP04-17-M02 - paediatric investigation plan

Ibrutinib

Key facts

• Invented name:
  Imbruvica
• Active substance:
  Ibrutinib
• Therapeutic area:
  Immunology-Rheumatology-Transplantation
• Decision number:
  P/0295/2023
• PIP number:
  EMEA-001397-PIP04-17-M02
• 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
• Decision type:
  PM: decision on the application for modification of an agreed PIP
• Decision date:
  11/08/2023
• Compliance check done:
  No

Decision

P/0295/2023 : EMA decision of 11 August 2023 on the acceptance of a modification of an agreed paediatric investigation plan for ibrutinib (Imbruvica), (EMEA-001397-PIP04-17-M02)

Reference Number: EMA/336523/2023