EMA/PE/0000181335 - paediatric investigation plan

Budesonide

Formoterol (fumarate)

glycopyrronium bromide

Key facts

• Invented name:
  Trixeo Aerosphere
• Active substance:
  • Budesonide
  • Formoterol (fumarate)
  • glycopyrronium bromide
• Therapeutic area:
  Respiratory, thoracic and mediastinal disorders
• Decision number:
  EMA/PE/0000181335
• PIP number:
  EMA/PE/0000181335
• Pharmaceutical form(s):
  • Pressurised inhalation
  • Suspension
• 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:
  05/12/2024
• Compliance check done:
  No

Decision

EMA/PE/0000181335: EMA decision of 5 December 2024 on the acceptance of a modification of an agreed paediatric investigation plan for budesonide / glycopyrronium bromide / formoterol (fumarate) (Trixeo Aerosphere)

Adopted Reference Number: EMADOC-1700519818-1791535