MHRA-100999-PIP03-23

Key Facts

Active Substance
Active Substance:
  • Ensitrelvir
Invented Name
  • Zokovea
  • Xocova
PIP Number MHRA-100999-PIP03-23
Pharmaceutical form(s)
  • Tablet
  • Age-appropriate oral solid dosage form.
Therapeutic area
Therapeutic area:
  • Infectious diseases
Conditions / Indications
Conditions / Indications:
  • Prevention of coronavirus disease 2019 (COVID-19).
Route(s) of administration
Route(s) of administration:
  • Oral 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
04/09/2026
Compliance Check Procedure Number
Compliance procedure number
MHRA-100999-PIP03-23-C1

Decision Document

Decision Document Decision Document on a Paediatric Investigation Plan (PIP):Ensitrelvir.pdf
Published Date 14/10/2026