EMEA-002196-PIP01-17 - paediatric investigation plan

Human Neutrophil Elastase Inhibitor (CHF6333)

Key facts

• Active Substance:
  Human Neutrophil Elastase Inhibitor (CHF6333)
• Therapeutic area:
  Pneumology-allergology
• Decision number:
  P/0367/2017
• PIP number:
  EMEA-002196-PIP01-17
• Pharmaceutical form(s):
  Pressurised inhalation (suspension)
• Condition(s) / indication(s):
  Treatment of bronchiectasis
• Route(s) of administration:
  Inhalation use
• Decision type:
  RW: decision refers to a refusal on a request for waiver in all age groups for the listed condition(s)
• Decision date:
  01/12/2017

Decision

P/0367/2017: EMA decision of 1 December 2017 on the refusal of a product specific waiver for human neutrophil elastase inhibitor (CHF6333) (EMEA-002196-PIP01-17)

Reference Number: EMA/723579/2017