EMEA-001006-PIP03-16 - paediatric investigation plan

nintedanib

Key facts

• Invented name:
  • Vargatef; Ofev
  • • Vargatef
    • Ofev
• Active substance:
  nintedanib
• Therapeutic area:
  Oncology
• Decision number:
  P/0124/2017
• PIP number:
  EMEA-001006-PIP03-16
• Pharmaceutical form(s):
  Capsule, soft
• Condition(s) / indication(s):
  • Treatment of lung carcinoma (small cell and non-small cell carcinoma)
  • Treatment of mesothelioma
• Route(s) of administration:
  Oral use
• Decision type:
  W: decision granting a waiver in all age groups for all conditions or indications
• Decision date:
  05/05/2017
• Compliance check done:
  Ei

Decision

P/0124/2017: EMA decision of 5 May 2017 on the granting of a product-specific waiver for nintedanib (Vargatef, Ofev), (EMEA-001006-PIP03-16)

Adopted Reference Number: EMA/260237/2017