MHRA-101497-PIP01-24

Key Facts

Active Substance
  • laruparetigene zovaparvovec
  • Recombinant Adeno-Associated Viral Vector Expressing a Human RPGR1-14,ORF15gene (rAAV2tYF-GRK1-RPGR)
Invented Name
Not available at present
PIP Number MHRA-101497-PIP01-24
Pharmaceutical form(s)
Pharmaceutical form(s):
  • Solution for injection
Therapeutic area
Therapeutic area:
  • Ophthamology
Conditions / Indications
Conditions / Indications:
  • Treatment of X-linked retinitis pigmentosa (XLRP)
Route(s) of administration
Route(s) of administration:
  • INTRAOCULAR 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):laruparetigene zovaparvovecRecombinant Adeno-Associated Viral Vector Expressing a Human RPGR1-14,ORF15gene (rAAV2tYF-GRK1-RPGR).pdf
Published Date 28/11/2024