MHRA-100126-PIP01-21-M01 (update)

Key Facts

Active Substance
Active Substance:
  • Adeno-associated viral vector serotype 9 containing the human mini-dystrophin gene
Invented Name
fordadistrogene movaparvovec
PIP Number MHRA-100126-PIP01-21-M01 (update)
Pharmaceutical form(s)
Pharmaceutical form(s):
  • Solution for infusion
Therapeutic area
Therapeutic area:
  • Neurology
Conditions / Indications
Conditions / Indications:
  • Duchenne Muscular Dystrophy
Route(s) of administration
Route(s) of administration:
  • Intravenous use
PIP applicant
Decision Type
Decision Type
P: decision agreeing on a paediatric investigation plan, with or without partial waiver(s) or deferrals(s)
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):Adeno-associated viral vector serotype 9 containing the human mini-dystrophin gene.pdf
Published Date 15/06/2023