MHRA-101897-PIP01-25

Key Facts

Active Substance
  • doxecitine
  • doxribtimine
Invented Name
KYGEVVI
PIP Number MHRA-101897-PIP01-25
Pharmaceutical form(s)
Pharmaceutical form(s):
  • Powder for oral solution
Therapeutic area
Therapeutic area:
  • Endocrinology-Gynaecology-Fertility-metabolism
Conditions / Indications
Conditions / Indications:
  • Treatment of thymidine kinase 2 deficiency
Route(s) of administration
Route(s) of administration:
  • ORAL USE GASTRIC 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 Check Procedure Number
Compliance procedure number
MHRA-101897-PIP01-25-C

Decision Document

Decision Document Decision Document on a Paediatric Investigation Plan (PIP):doxecitinedoxribtimine.pdf
Published Date 14/07/2025