COVID-19 Vaccine Janssen

RSS

COVID-19 vaccine (Ad26.COV2-S [recombinant])

Authorised
This medicine is authorised for use in the European Union.

Overview

COVID-19 Vaccine Janssen is a vaccine for preventing coronavirus disease 2019 (COVID-19) in people aged 18 years and older. COVID-19 is caused by SARS-CoV-2 virus.

COVID-19 Vaccine Janssen is made up of another virus (of the adenovirus family) that has been modified to contain the gene for making a protein found on SARS-CoV-2.

COVID-19 Vaccine Janssen does not contain SARS-CoV-2 itself and cannot cause COVID-19. 

Detailed information about this vaccine is available in the product information, which includes the package leaflet.

This EPAR was last updated on 22/09/2021

Authorisation details

Product details
Name
COVID-19 Vaccine Janssen
Agency product number
EMEA/H/C/005737
Active substance
adenovirus type 26 encoding the SARS-CoV-2 spike glycoprotein (Ad26.COV2-S)
International non-proprietary name (INN) or common name
COVID-19 vaccine (Ad26.COV2-S [recombinant])
Therapeutic area (MeSH)
COVID-19 virus infection
Anatomical therapeutic chemical (ATC) code
J07BX03
Additional monitoringAdditional monitoring

This medicine is under additional monitoring, meaning that it is monitored even more intensively than other medicines. For more information, see Medicines under additional monitoring.

Conditional approvalConditional approval

This medicine received a conditional marketing authorisation. This was granted in the interest of public health because the medicine addresses an unmet medical need and the benefit of immediate availability outweighs the risk from less comprehensive data than normally required. For more information, see Conditional marketing authorisation.

Publication details
Marketing-authorisation holder
Janssen-Cilag International NV
Revision
8
Date of issue of marketing authorisation valid throughout the European Union
11/03/2021
Contact address

Turnhoutseweg 30
B-2340 Beerse
Belgium

Product information

21/09/2021 COVID-19 Vaccine Janssen - EMEA/H/C/005737 - IB/0024/G

Contents

Please note that the size of the above document can exceed 50 pages.

You are therefore advised to be selective about which sections or pages you wish to print.

Pharmacotherapeutic group

Vaccines

Therapeutic indication

Prevention of coronavirus disease-2019 (COVID-19).

Assessment history

Safety updates

How useful was this page?

Add your rating
Average
37 ratings
21 ratings
2 ratings
5 ratings
12 ratings