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
• Contact for public enquiries:

  Janssen-Cilag International N.V.

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

• Decision type:
  W: decision granting a waiver in all age groups for all conditions or indications
• Decision date:
  27/10/2014

Decision

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

AdoptedReference Number: EMA/639585/2014