MHRA-100070-PIP01-21-M01 (update)

Key Facts

Active Substance
Active Substance:
  • molnupiravir
Invented Name
Lagevrio
PIP Number MHRA-100070-PIP01-21-M01 (update)
Pharmaceutical form(s)
  • Age appropriate dosage form (Granules)
  • Capsule, hard
Therapeutic area
Conditions / Indications
Conditions / Indications:
  • Treatment of coronavirus disease 2019 (COVID-19)
Route(s) of administration
Route(s) of administration:
  • ORAL USE ENTERAL USE
PIP applicant
Decision Type
Decision Type
PM: decision on the application for modification of an agreed paediatric investigation plan.
Compliance Check
Compliance Check
Yes
Compliance Check Decision Date
Compliance opinion date
12/07/2024
Compliance Check Procedure Number
Compliance procedure number
MHRA-100070-PIP01-21-M01-C1

Decision Document

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