MHRA-100441-PIP01-22-M01 (update)

Key Facts

Active Substance
Active Substance:
  • Delandistrogene moxeparvovec
Invented Name
Elevidys
PIP Number MHRA-100441-PIP01-22-M01 (update)
Pharmaceutical form(s)
Pharmaceutical form(s):
  • Solution for infusion
Therapeutic area
Therapeutic area:
  • Neurology
Conditions / Indications
Conditions / Indications:
  • Treatment of Duchenne Muscular Dystrophy (DMD)
Route(s) of administration
Route(s) of administration:
  • Intravenous use
PIP applicant
  • Roche Products Limited
  • Country United Kingdom
  • Tel 01707366000
  • Email uk.dra@roche.com
Decision Type
Decision Type
PM: decision on the application for modification of an agreed paediatric investigation plan.
Compliance Check
Compliance Check
No
Compliance Check Decision Date
Compliance Check Procedure Number

Decision Document

Decision Document Decision Document on a Paediatric Investigation Plan (PIP):Delandistrogene moxeparvovec.pdf
Published Date 07/12/2022