MHRA-100811-PIP01-22-M03 (update)

Key Facts

Active Substance
Active Substance:
  • Vamorolone
Invented Name
  • AGAMREE
  • AGAMREE
  • Agmaree
  • AGAMREE
PIP Number MHRA-100811-PIP01-22-M03 (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
  • Santhera Pharmaceuticals (Deutschland) GmbH
  • Country Germany
  • Tel 004976211690200
  • Email office@santhera.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 opinion date
04/02/2025
Compliance Check Procedure Number
Compliance procedure number
MHRA-100811-PIP01-22-M03-C1

Decision Document

Decision Document Decision Document on a Paediatric Investigation Plan (PIP):Vamorolone.pdf
Published Date 11/02/2025