EMEA-002063-PIP01-16-M02 - paediatric investigation plan

Budesonide

Formoterol (fumarate)

Glycopyrronium bromide

Key facts

• Invented name:
  Trixeo Aerosphere
• Active Substance:
  • Budesonide
  • Formoterol (fumarate)
  • Glycopyrronium bromide
• Therapeutic area:
  Pneumology-allergology
• Decision number:
  P/0068/2023
• PIP number:
  EMEA-002063-PIP01-16-M02
• Pharmaceutical form(s):
  • Pressurised inhalation
  • Suspension
• Condition(s) / indication(s):
  Treatment of asthma
• Route(s) of administration:
  Inhalation use
• Contact for public enquiries:

  AstraZeneca AB

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

• Decision type:
  PM: decision on the application for modification of an agreed PIP
• Decision date:
  10/03/2023

Decision

P/0068/2023 : EMA decision of 10 March 2023 on the acceptance of a modification of an agreed paediatric investigation plan for budesonide / glycopyrronium bromide / formoterol (fumarate), (Trixeo Aerosphere), (EMEA-002063-PIP01-16-M02)