MHRA-100334-PIP01-21-M01 (update)

Key Facts

Active Substance
  • INDACATEROL ACETATE
  • GLYCOPYRRONIUM BROMIDE
  • MOMETASONE FUROATE
Invented Name
  • Enerzair Breezhaler
  • Enerzair Breezhaler
  • Enerzair Breezhaler
  • Enerzair Breezhaler
  • Enerzair Breezhaler
  • Enerzair Breezhaler
  • Enerzair Breezhaler
  • Zimbus Breezhaler
  • Zimbus Breezhaler
  • Zimbus Breezhaler
  • Zimbus Breezhaler
  • Zimbus Breezhaler
PIP Number MHRA-100334-PIP01-21-M01 (update)
Pharmaceutical form(s)
Pharmaceutical form(s):
  • Inhalation powder, hard capsule
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):INDACATEROL ACETATEGLYCOPYRRONIUM BROMIDEMOMETASONE FUROATE.pdf
Published Date 02/11/2022