EMEA-001006-PIP05-18-M01 - paediatric investigation plan

nintedanib

Key facts

• Invented name:
  • Ofev
  • Vargatef
• Active substance:
  nintedanib
• Therapeutic area:
  • Oncology
  • Pneumology-allergology
• Decision number:
  P/0438/2021
• PIP number:
  EMEA-001006-PIP05-18-M01
• Pharmaceutical form(s):
  Capsule, soft
• Condition(s) / indication(s):
  Treatment of fibrosing Interstitial Lung Diseases (ILD)
• Route(s) of administration:
  Oral use
• Decision type:
  PM: decision on the application for modification of an agreed PIP
• Decision date:
  29/10/2021
• Compliance check done:
  Yes
• Compliance procedure number:
  EMEA-C-001006-PIP05-18-M01
• Compliance opinion date:
  22/07/2022
• Compliance outcome:
  Positive

Decision

P/0438/2021: EMA decision of 29 October 2021 on the acceptance of a modification of an agreed paediatric investigation plan for nintedanib (Ofev, Vargatef), (EMEA-001006-PIP05-18-M01)

Adopted Reference Number: EMA/568301/2021