EMEA-001397-PIP02-13 - paediatric investigation plan

Ibrutinib

Key facts

• Active substance:
  Ibrutinib
• Therapeutic area:
  Oncology
• Decision number:
  P/0271/2014
• PIP number:
  EMEA-001397-PIP02-13
• Pharmaceutical form(s):
  Capsule, hard
• Condition(s) / indication(s):
  Treatment of lymphoplasmacytic lymphoma
• Route(s) of administration:
  Oral use
• Decision type:
  W: decision granting a waiver in all age groups for all conditions or indications
• Decision date:
  27/10/2014
• Compliance check done:
  Не

Decision

P/0271/2014: EMA decision of 27 October 2014 on the granting of a product-specific waiver for ibrutinib (EMEA-001397-PIP02-13)

Adopted Reference Number: EMA/639585/2014