MHRA-101047-PIP01-23

Key Facts

Active Substance
Active Substance:
  • vesleteplirsen
Invented Name
Not yet available
PIP Number MHRA-101047-PIP01-23
Pharmaceutical form(s)
Pharmaceutical form(s):
  • Powder for concentrate for solution for infusion
Therapeutic area
Therapeutic area:
  • Neurology
Conditions / Indications
Conditions / Indications:
  • Treatment of Duchenne muscular dystrophy
Route(s) of administration
Route(s) of administration:
  • Intravenous use
PIP applicant
  • Sarepta International UK LTD.
  • Country United Kingdom
  • Tel +12078441804
  • Email RDavan@sarepta.com
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):vesleteplirsen.pdf
Published Date 28/10/2024