MHRA-100249-PIP01-21-M01 (update)

Key Facts

Active Substance
  • BUDESONIDE
  • GLYCOPYRRONIUM BROMIDE
  • FORMOTEROL FUMARATE DIHYDRATE
Invented Name
Not yet available
PIP Number MHRA-100249-PIP01-21-M01 (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
No
Compliance Check Decision Date
Compliance Check Procedure Number

Decision Document

Decision Document Decision Document on a Paediatric Investigation Plan (PIP):BUDESONIDE;GLYCOPYRRONIUM BROMIDE;FORMOTEROL FUMARATE DIHYDRATE.pdf
Published Date 27/09/2022