EMEA-001493-PIP02-18 - paediatric investigation plan

crizotinib

Key facts

• Invented name:
  Xalkori
• Active substance:
  crizotinib
• Therapeutic area:
  Oncology
• Decision number:
  P/0361/2018
• PIP number:
  EMEA-001493-PIP02-18
• Pharmaceutical form(s):
  Capsule, hard
• Condition(s) / indication(s):
  Treatment of lung malignant neoplasms
• Route(s) of administration:
  Oral use
• Decision type:
  W: decision granting a waiver in all age groups for all conditions or indications
• Decision date:
  07/12/2018
• Compliance check done:
  Nem

Decision

P/0361/2018: EMA decision of 7 December 2018 on the granting of a product specific waiver for crizotinib (Xalkori), (EMEA-001493-PIP02-18)

Adopted Reference Number: EMA/762548/2018