MHRA-101705-PIP01-24

Key Facts

Active Substance
Active Substance:
  • Elamipretide
Invented Name
Not available at present
PIP Number MHRA-101705-PIP01-24
Pharmaceutical form(s)
Pharmaceutical form(s):
  • Solution for injection
Therapeutic area
Therapeutic area:
  • Endocrinology-Gynaecology-Fertility-metabolism
Conditions / Indications
Conditions / Indications:
  • Treatment of Barth syndrome
Route(s) of administration
Route(s) of administration:
  • Subcutaneous 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
Yes
Compliance Check Decision Date
Compliance opinion date
24/07/2026
Compliance Check Procedure Number
Compliance procedure number
MHRA-101705-PIP01-24 -C1

Decision Document

Decision Document Decision Document on a Paediatric Investigation Plan (PIP):Elamipretide.pdf
Published Date 24/07/2026