EMA/PE/0000244179 - 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:
  Respiratory, thoracic and mediastinal disorders
• Decision number:
  EMA/PE/0000244179
• PIP number:
  EMA/PE/0000244179
• 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:
  13/06/2025
• Compliance check done:
  No

Decision

EMA/PE/0000244179 : EMA decision of 13 June 2025 on the acceptance of a modification of an agreed paediatric investigation plan for indacaterol (acetate) / glycopyrronium (bromide) / mometasone (furoate) (QVM149)

Adopted Reference Number: EMADOC-1700519818-2192969