MHRA-100654-PIP01-22

Key Facts

Active Substance
Active Substance:
  • triheptanoin
Invented Name
  • Dojolvi
  • Dojolvi
  • Dojolvi
  • Dojolvi
  • Dojolvi
PIP Number MHRA-100654-PIP01-22
Pharmaceutical form(s)
Pharmaceutical form(s):
  • Oral liquid
Therapeutic area
Therapeutic area:
  • Endocrinology-Gynaecology-Fertility-metabolism
Conditions / Indications
Conditions / Indications:
  • Treatment of long-chain fatty acid oxidation disorders (LC-FAOD)
Route(s) of administration
  • Oral use
  • ENTERAL 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
04/04/2024
Compliance Check Procedure Number
Compliance procedure number
MHRA-100654-PIP01-22-C1

Decision Document

Decision Document Decision Document on a Paediatric Investigation Plan (PIP):triheptanoin.pdf
Published Date 15/08/2024