EMEA-001006-PIP02-15 - paediatric investigation plan

nintedanib

Key facts

• Invented name:
  • Ofev
  • Ofev
• Active Substance:
  nintedanib
• Therapeutic area:
  Pneumology-allergology
• Decision number:
  P/0233/2015
• PIP number:
  EMEA-001006-PIP02-15
• Pharmaceutical form(s):
  Capsule (soft)
• Condition(s) / indication(s):
  Treatment of systemic sclerosis
• Route(s) of administration:
  Oral use
• Decision type:
  W: decision granting a waiver in all age groups for all conditions or indications
• Decision date:
  27/10/2015

Decision

P/0233/2015: EMA decision of 27 October 2015 on the granting of a product-specific waiver for nintedanib (Ofev) (EMEA-001006-PIP02-15)

AdoptedReference Number: EMA/619831/2015