EMEA-001397-PIP01-12 - paediatric investigation plan

Ibrutinib

Key facts

• Active Substance:
  Ibrutinib
• Therapeutic area:
  Oncology
• Decision number:
  P/0149/2013
• PIP number:
  EMEA-001397-PIP01-12
• Pharmaceutical form(s):
  Capsule, hard
• Condition(s) / indication(s):
  Treatment of mantle cell 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:
  03/07/2013

Decision

P/0149/2013: EMA decision of 3 July 2013 on the granting of a product-specific waiver for ibrutinib (EMEA-001397-PIP01-12)

AdoptedReference Number: EMA/311887/2013