MHRA-101879-PIP01-25-M01 (update)

Key Facts

PIPS Key Facts
Active Substance	BECLOMETASONE DIPROPIONATE FORMOTEROL FUMARATE DIHYDRATE GLYCOPYRRONIUM BROMIDE
Invented Name	Trimbow Trimbow Trimbow Trimbow Trimbow Trimbow Trimbow Trimbow Trimbow Trimbow Trimbow Trimbow Trimbow Trimbow Trimbow Trimbow Trimbow Trimbow Trimbow Trimbow Trimbow Trimbow Trimbow Trimbow Trimbow Trimbow Trimbow Trimbow
PIP Number	MHRA-101879-PIP01-25-M01 (update)
Pharmaceutical form(s)	Pressurised inhalation, solution Inhalation powder
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	Chiesi Ltd Country United Kingdom Tel 003905212791 Email info@chiesi.com
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 Check Procedure Number	Compliance procedure number MHRA-101879-PIP01-25-M01-C1

Decision Document

PIPS Decision Documents
Decision Document	Decision Document on a Paediatric Investigation Plan (PIP):BECLOMETASONE DIPROPIONATEFORMOTEROL FUMARATE DIHYDRATEGLYCOPYRRONIUM BROMIDE.pdf
Published Date	21/08/2025