MHRA-100492-PIP01-22-M02 (update)

Key Facts

Active Substance
Active Substance:
  • MOLGRAMOSTIM
Invented Name
MOLBREEVI
PIP Number MHRA-100492-PIP01-22-M02 (update)
Pharmaceutical form(s)
Pharmaceutical form(s):
  • Nebuliser solution
Therapeutic area
Therapeutic area:
  • Pneumology - Allergology
Conditions / Indications
Conditions / Indications:
  • Treatment of pulmonary alveolar proteinosis
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
07/10/2025
Compliance Check Procedure Number
Compliance procedure number
MHRA-100492-PIP01-22-M02-C1

Decision Document

Decision Document Decision Document on a Paediatric Investigation Plan (PIP):MOLGRAMOSTIM.pdf
Published Date 01/05/2026