MHRA-100811-PIP01-22-M01 (update)

Key Facts

Active Substance
Active Substance:
  • Vamorolone
Invented Name
Not yet available
PIP Number MHRA-100811-PIP01-22-M01 (update)
Pharmaceutical form(s)
Pharmaceutical form(s):
  • Oral suspension
Therapeutic area
Therapeutic area:
  • Other: Neuromuscular Diseases
Conditions / Indications
Conditions / Indications:
  • Treatment of Duchenne muscular dystrophy
Route(s) of administration
Route(s) of administration:
  • Oral 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
06/03/2023
Compliance Check Procedure Number
Compliance procedure number
MHRA-100811-PIP01-22-M01-C1

Decision Document

Decision Document Decision Document on a Paediatric Investigation Plan (PIP):Vamorolone.pdf
Published Date 25/05/2023