MHRA-100811-PIP01-22-M02 (update)

Key Facts

PIPS Key Facts
Active Substance
Active Substance:
  • Vamorolone
Invented Name
PIP Number MHRA-100811-PIP01-22-M02 (update)
Pharmaceutical form(s)
Pharmaceutical form(s):
  • Oral solution
Therapeutic area
Therapeutic area:
  • Neurology
Conditions / Indications
Conditions / Indications:
  • Treatment of Duchenne muscular dystrophy
Route(s) of administration
Route(s) of administration:
  • Oral use
PIP applicant
  • Santhera Pharmaceuticals (Deutschland) GmbH
  • Country Germany
  • Tel +4976211690200
  • Email
Decision Type
Decision Type
PM: decision on the application for modification of an agreed paediatric investigation plan.
Compliance Check
Compliance Check
Compliance Check Decision Date
Compliance Check Procedure Number

Decision Document

PIPS Decision Documents
Decision Document Decision Document on a Paediatric Investigation Plan (PIP):Vamorolone.pdf
Published Date 30/04/2024