EMEA-001812-PIP01-15-M01 - paediatric investigation plan

Indacaterol (acetate)

Mometasone (furoate) (QVM149)

Glycopyrronium bromide

Key facts

• Invented name:
  • • Enerzair Breezhaler
    • Zimbus Breezhaler
  • • Enerzair Breezhaler
    • Zimbus Breezhaler
• Active Substance:
  • Indacaterol (acetate)
  • Mometasone (furoate) (QVM149)
  • Glycopyrronium bromide
• Therapeutic area:
  Pneumology-allergology
• Decision number:
  P/0362/2021
• PIP number:
  EMEA-001812-PIP01-15-M01
• Pharmaceutical form(s):
  • Inhalation powder
  • Capsule (hard)
• Condition(s) / indication(s):
  Treatment of asthma
• Route(s) of administration:
  Inhalation use
• Contact for public enquiries:

  Novartis Europharm Ltd.

  Tel. [phone]; E-mail: [e-mail];

• Decision type:
  PM: decision on the application for modification of an agreed PIP
• Decision date:
  08/09/2021

Decision

P/0362/2021 : EMA decision of 8 September 2021 on the acceptance of a modification of an agreed paediatric investigation plan for indacaterol (acetate)/glycopyrronium (bromide)/mometasone (furoate) (Enerzair Breezhaler and...)(EMEA-001812-PIP01-15-M01)

AdoptedReference Number: EMA/418750/2021