Jcovden (previously COVID-19 Vaccine Janssen)

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

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

Overview

Jcovden 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.

Jcovden 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.

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

This EPAR was last updated on 28/07/2022

Authorisation details

Product details
Name
Jcovden (previously 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
22
Date of issue of marketing authorisation valid throughout the European Union
11/03/2021
Contact address

Turnhoutseweg 30
B-2340 Beerse
Belgium

Product information

07/07/2022 Jcovden (previously COVID-19 Vaccine Janssen) - EMEA/H/C/005737 - II/0048/G

Product information documents contain:

You can find product information documents for centrally authorised human medicines on this website. For centrally authorised veterinary medicines authorised or updated from February 2022, see the Veterinary Medicines Information website.

Pharmacotherapeutic group

Vaccines

Therapeutic indication

Jcovden is indicated for active immunisation to prevent COVID-19 caused by SARS-CoV-2 in individuals 18 years of age and older.

The use of this vaccine should be in accordance with official recommendations.

Assessment history

Safety updates

News

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