EMEA-001812-PIP01-15-M02 - paediatric investigation plan

Indacaterol (acetate)

mometasone (furoate)

glycopyrronium bromide

Key facts

• Invented name:
  • Enerzair Breezhaler
  • Zimbus Breezhaler
• Active substance:
  • Indacaterol (acetate)
  • mometasone (furoate)
  • glycopyrronium bromide
• Therapeutic area:
  Pneumology-allergology
• Decision number:
  P/0493/2023
• PIP number:
  EMEA-001812-PIP01-15-M02
• Pharmaceutical form(s):
  • Inhalation powder
  • Capsule, hard
• Condition(s) / indication(s):
  Treatment of asthma
• Route(s) of administration:
  Inhalation use
• Decision type:
  PM: decision on the application for modification of an agreed PIP
• Decision date:
  01/12/2023
• Compliance check done:
  No

Decision

P/0493/2023 : EMA decision of 1 Dec 2023 on the acceptance of a modification of an agreed PIP for indacaterol (acetate) / glycopyrronium (bromide) / mometasone (furoate), (Enerzair Breezhaler, Zimbus Breezhaler), (EMEA-001812-PIP01-15-M02)

Reference Number: EMA/530330/2023