Key facts

Invented name
Jcovden (previously COVID-19 Vaccine Janssen)
Active Substance
COVID-19 vaccine (Ad26.COV2-S (recombinant))
Therapeutic area
  • Infectious diseases
  • Vaccines
Decision number
P/0542/2022
PIP number
EMEA-002880-PIP01-20-M01
Pharmaceutical form(s)
Suspension for injection in cartridge
Condition(s) / indication(s)
Prevention of Coronavirus disease 2019 (COVID-19)
Route(s) of administration
Intramuscular use
Contact for public enquiries

Janssen-Cilag International N.V.

Tel. +32 14602111
E-mail: contact@Janssen-emea.com

Decision type
PM: decision on the application for modification of an agreed PIP
Decision date

Decision

P/0542/2022 : EMA decision of 30 December 2022 on the acceptance of a modification of an agreed paediatric investigation plan for COVID-19 vaccine (Ad26.COV2-S [recombinant]) (JCOVDEN) (EMEA-002880-PIP01-20-M01)

AdoptedReference Number: EMA/876009/2022

English (EN) (179.51 KB - PDF)

First published:
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