MHRA-100053-PIP01-21-M01 (update)

Key Facts

Active Substance
Active Substance:
  • IMDEVIMAB
Invented Name
  • Ronapreve
  • Ronapreve
  • Ronapreve
  • Ronapreve
PIP Number MHRA-100053-PIP01-21-M01 (update)
Pharmaceutical form(s)
Pharmaceutical form(s):
  • Solution for injection/infusion
Therapeutic area
Therapeutic area:
  • Infectious diseases
Conditions / Indications
  • Treatment of coronavirus disease 2019 (COVID-19)
  • Prevention of Coronavirus Disease 2019 (COVID-19)
Route(s) of administration
  • Intravenous use
  • Subcutaneous use
PIP applicant
  • Roche Products Limited
  • Country United Kingdom
  • Tel 01707366000
  • Email uk.dra@roche.com
Decision Type
Decision Type
PM: decision on the application for modification of an agreed paediatric investigation plan.
Compliance Check
Compliance Check
No
Compliance Check Decision Date
Compliance Check Procedure Number

Decision Document

Decision Document Decision Document on a Paediatric Investigation Plan (PIP):IMDEVIMAB.pdf
Published Date 04/05/2022