MHRA-100067-PIP01-21-M01 (update)

Key Facts

Active Substance
Active Substance:
  • nirsevimab (MEDI8897) (Anti-respiratory syncytial virus human IgG1κ monoclonal antibody)
Invented Name
Not yet available
PIP Number MHRA-100067-PIP01-21-M01 (update)
Pharmaceutical form(s)
Pharmaceutical form(s):
  • Solution for injection
Therapeutic area
  • Infectious diseases
  • Vaccines
Conditions / Indications
Conditions / Indications:
  • Prevention of lower respiratory tract infection caused by respiratory syncytial virus (RSV).
Route(s) of administration
Route(s) of administration:
  • Intramuscular use
PIP applicant
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):nirsevimab (MEDI8897) (Anti-respiratory syncytial virus human IgG1? monoclonal antibody).pdf
Published Date 03/11/2021