MHRA-100249-PIP01-21-M04 (update)

Key Facts

Active Substance
  • BUDESONIDE
  • GLYCOPYRRONIUM
  • FORMOTEROL FUMARATE DIHYDRATE
Invented Name
  • Trixeo Aerosphere
  • Trixeo Aerosphere
  • Trixeo Aerosphere
  • BREZTRI AEROSPHERE
  • BREZTRI AEROSPHERE
PIP Number MHRA-100249-PIP01-21-M04 (update)
Pharmaceutical form(s)
Pharmaceutical form(s):
  • Pressurised inhalation, suspension
Therapeutic area
Therapeutic area:
  • Pneumology - Allergology
Conditions / Indications
Conditions / Indications:
  • Treatment of asthma
Route(s) of administration
Route(s) of administration:
  • Inhalation use
PIP applicant
Decision Type
Decision Type
PM: decision on the application for modification of an agreed paediatric investigation plan.
Compliance Check
Compliance Check
Yes
Compliance Check Decision Date
Compliance opinion date
13/07/2026
Compliance Check Procedure Number
Compliance procedure number
MHRA-100249-PIP01-21-M04-C1

Decision Document

Decision Document Decision Document on a Paediatric Investigation Plan (PIP):BUDESONIDEGLYCOPYRRONIUMFORMOTEROL FUMARATE DIHYDRATE.pdf
Published Date 23/07/2026