Jcovden (previously COVID-19 Vaccine Janssen)

September 1, 2025

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Overview

On 26 July 2024, the European Commission withdrew the marketing authorisation for Jcovden (COVID19 Vaccine Janssen (Ad26.COV2.S)) in the European Union (EU). The withdrawal was at the request of the marketing authorisation holder, Janssen-Cilag International N.V., which notified the European Commission of its decision to permanently discontinue the marketing of the product for commercial reasons.

Jcovden was granted conditional marketing authorisation in the EU on 11 March 2021 for active immunisation against coronavirus disease 2019 (COVID-19). The conditional marketing authorisation was switched to a standard marketing authorisation, valid for 5 years, on 09 January 2023.

The European Public Assessment Report (EPAR) for Jcovden is updated to indicate that the marketing authorisation is no longer valid.

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First published: 11/03/2021Last updated: 09/08/2024

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English (EN)
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First published: 11/03/2021Last updated: 09/08/2024

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Product information

English (EN)
(1.84 MB – PDF)

First published: 11/03/2021Last updated: 09/08/2024

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Latest procedure affecting product information:
II/0076

26/07/2024

This medicine’s product information is available in all official EU languages.
Select ‘available languages’ to access the language you need.

Product information documents contain:

summary of product characteristics (annex I);
manufacturing authorisation holder responsible for batch release (annex IIA);
conditions of the marketing authorisation (annex IIB);
labelling (annex IIIA);
package leaflet (annex IIIB).

English (EN)
(64.79 KB – PDF)

First published: 11/03/2021Last updated: 09/08/2024

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Product details

Name of medicine: Jcovden (previously COVID-19 Vaccine Janssen)
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: J07BN02

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.

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Jcovden (previously COVID-19 Vaccine Janssen)

Overview

Product information

Product details

Pharmacotherapeutic group

Therapeutic indication

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Overview

Product information

Product details

Pharmacotherapeutic group

Therapeutic indication

Signal assessment reports

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