EMEA-001875-PIP02-18-M04 - paediatric investigation plan

beclometasone dipropionate

formoterol fumarate dihydrate

glycopyrronium bromide

Key facts

• Invented name:
  • Trimbow and associated names
  • Trimbow
• Active substance:
  • beclometasone dipropionate
  • formoterol fumarate dihydrate
  • glycopyrronium bromide
• Therapeutic area:
  Respiratory, thoracic and mediastinal disorders
• Decision number:
  P/0167/2024
• PIP number:
  EMEA-001875-PIP02-18-M04
• Pharmaceutical form(s):
  • Pressurised inhalation (solution)
  • Inhalation powder
• 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:
  06/05/2024
• Compliance check done:
  No

Decision

P/0167/2024: EMA decision of 6 May 2024 on the acceptance of a modification of an agreed PIP for beclometasone (dipropionate) / formoterol (fumarate dihydrate) / glycopyrronium bromide (Trimbow and associated names), (EMEA-001875-PIP02-18-M04)

Adopted Reference Number: EMA/178722/2024