MHRA-100029-PIP01-21-M01 (update)

Key Facts

Active Substance
  • RECOMBINANT REPLICATION-INCOMPETENT ADENOVIRUS SEROTYPE 26 VECTOR ENCODING THE SARS-COV-2 SPIKE PROTEIN PER.C6 CELL LINE
  • COVID-19 vaccine (Ad26.COV2-S [recombinant])
Invented Name
  • COVID-19 vaccine Janssen
  • Jcovden (previously COVID-19 Vaccine Janssen)
PIP Number MHRA-100029-PIP01-21-M01 (update)
Pharmaceutical form(s)
Pharmaceutical form(s):
  • Suspension for injection
Therapeutic area
  • Infectious diseases
  • Vaccines
Conditions / Indications
Conditions / Indications:
  • Prevention of coronavirus disease-2019 (COVID-19)
Route(s) of administration
Route(s) of administration:
  • Intramuscular use
PIP applicant
Decision Type
Decision Type
W: decision granting a waiver in all age groups for the listed condition(s).
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):RECOMBINANT REPLICATION-INCOMPETENT ADENOVIRUS SEROTYPE 26 VECTOR ENCODING THE SARS-COV-2 SPIKE PROTEIN PER.C6 CELL LINECOVID-19 vaccine (Ad26.COV2-S [recombinant]).pdf
Published Date 30/06/2023