MHRA-100796-PIP01-22

Key Facts

Active Substance
Active Substance:
  • Single-stranded 5' capped mRNA encoding the Respiratory syncytial virus glycoprotein F stabilized in the prefusion conformation
Invented Name
Not available at present
PIP Number MHRA-100796-PIP01-22
Pharmaceutical form(s)
Pharmaceutical form(s):
  • Dispersion for injection
Therapeutic area
Therapeutic area:
  • Vaccines
Conditions / Indications
Conditions / Indications:
  • Prevention of lower respiratory tract illness (LRTI) caused by respiratory syncytial virus (RSV)
Route(s) of administration
Route(s) of administration:
  • Intramuscular 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
08/07/2025
Compliance Check Procedure Number
Compliance procedure number
MHRA-100796-PIP01-22-C1

Decision Document

Decision Document Decision Document on a Paediatric Investigation Plan (PIP):Single-stranded 5' capped mRNA encoding the Respiratory syncytial virus glycoprotein Fstabilized in the prefusion conformation .pdf
Published Date 15/07/2026