EMEA-001217-PIP01-11-M08 - paediatric investigation plan

Indacaterol (acetate)

Mometasone furoate

Key facts

• Invented name:
  • Atectura Breezhaler
  • Bemrist Breezhaler
• Active Substance:
  • Indacaterol (acetate)
  • Mometasone furoate
• Therapeutic area:
  Pneumology-allergology
• Decision number:
  P/0226/2022
• PIP number:
  EMEA-001217-PIP01-11-M08
• 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 Limited

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

• Decision type:
  PM: decision on the application for modification of an agreed PIP
• Decision date:
  08/07/2022

Decision

P/0226/2022 : EMA decision of 8 July 2022on the acceptance of a modification of an agreed paediatric investigation plan for indacaterol (acetate) / mometasone (furoate) (Atectura Breezhaler and its duplicate authorization ...), (EMEA-001217-PIP01-11-M08)

Reference Number: EMA/575722/2022