Jcovden (previously COVID-19 Vaccine Janssen)

Rolling review
Application under evaluation
CHMP opinion
European Commission decision

Overview

The marketing authorisation for Jcovden (previously COVID-19 Vaccine Janssen) has been withdrawn at the request of the marketing-authorisation holder.

Jcovden (previously COVID-19 Vaccine Janssen) : EPAR - Medicine overview

Reference Number: EMA/10056/2023

English (EN) (269.31 KB - PDF)

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

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Other languages (22)

COVID-19 Vaccine Janssen : EPAR - Risk-management-plan

English (EN) (2.9 MB - PDF)

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

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Product information

Jcovden : EPAR - Product information

English (EN) (1.84 MB - PDF)

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

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Other languages (24)

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).

Jcovden (previously COVID-19 Vaccine Janssen) : EPAR - All authorised presentations

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.

Authorisation details

EMA product number: EMEA/H/C/005737
Marketing authorisation holder: Janssen-Cilag International NV
Turnhoutseweg 30
B-2340 Beerse
Belgium
Opinion adopted: 11/03/2021
Marketing authorisation issued: 11/03/2021
Revision: 33

Assessment history

COVID-19 Vaccine Janssen : EPAR - Procedural steps taken and scientific information after authorisation

English (EN) (1.8 MB - PDF)

First published: 22/04/2021Last updated: 09/08/2024

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Jcovden (previously COVID-19 Vaccine Janssen)-H-C-005737-R-0063 : EPAR - Assessment report - Renewal

Reference Number: EMA/CHMP/766600/2022

English (EN) (2.54 MB - PDF)

First published: 10/01/2023Last updated: 09/08/2024

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Jcovden (previously COVID-19 Vaccine Janssen)-H-C-005737-P46-073 : EPAR - Assessment report

AdoptedReference Number: EMA/738/2023

English (EN) (1.6 MB - PDF)

First published: 10/01/2023Last updated: 09/08/2024

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Jcovden (previously COVID-19 Vaccine Janssen)-H-C-PSUSA-00010916-202202 : EPAR - Scientific conclusions and grounds for the variation to the terms of the marketing authorisation(s)

Reference Number: EMA/830480/2022

English (EN) (713.5 KB - PDF)

First published: 15/11/2022Last updated: 09/08/2024

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COVID-19 Vaccine Janssen-H-C-5737-II-0033 : EPAR - Assessment report - Variation

AdoptedReference Number: EMA/CHMP/695763/2021

English (EN) (10.69 MB - PDF)

First published: 14/01/2022Last updated: 09/08/2024

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COVID-19 Vaccine Janssen-H-C-5737-R-0023 : EPAR - Assessment report - Renewal

AdoptedReference Number: EMA/757560/2021

English (EN) (2.31 MB - PDF)

First published: 04/01/2022Last updated: 09/08/2024

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COVID-19 Vaccine Janssen : EPAR - Public assessment report

AdoptedReference Number: EMA/158424/2021

English (EN) (13.21 MB - PDF)

First published: 19/03/2021Last updated: 09/08/2024

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CHMP summary of positive opinion for COVID-19 Vaccine Janssen

AdoptedReference Number: EMA/146391/2021

English (EN) (350.52 KB - PDF)

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

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Safety updates

COVID-19 vaccine safety update for COVID-19 Vaccine Janssen: 22 April 2021

Adopted

English (EN) (287.95 KB - PDF)

First published: 23/04/2021Last updated: 09/08/2024

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COVID-19 vaccine safety update for COVID-19 Vaccine Janssen: 14 April 2021

Adopted

English (EN) (237.41 KB - PDF)

First published: 16/04/2021Last updated: 09/08/2024

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COVID-19 vaccine safety update for COVID-19 Vaccine Janssen: 18 June 2021

Adopted

English (EN) (363.03 KB - PDF)

First published: 18/06/2021Last updated: 09/08/2024

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COVID-19 vaccine safety update for COVID-19 Vaccine Janssen: 11 August 2021

Adopted

English (EN) (330.47 KB - PDF)

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

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COVID-19 vaccine safety update for COVID-19 Vaccine Janssen: 11 November 2021

Adopted

English (EN) (306.57 KB - PDF)

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

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Jcovden (previously COVID-19 Vaccine Janssen): Periodic safety update report assessment 25 August 2022 to 24 February 2023

English (EN) (4.94 MB - PDF)

First published: 08/02/2024Last updated: 09/08/2024

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COVID-19 vaccines - Safety update: 14 July 2022

AdoptedReference Number: Rev. 1

English (EN) (263.34 KB - PDF)

First published: 14/07/2022Last updated: 09/08/2024

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COVID-19 vaccines - Safety update: 8 September 2022

Adopted

English (EN) (257.73 KB - PDF)

First published: 08/09/2022Last updated: 09/08/2024

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COVID-19 vaccines - Safety update: 17 March 2022

Adopted

English (EN) (237.65 KB - PDF)

First published: 17/03/2022Last updated: 09/08/2024

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COVID-19 vaccines - Safety update: 6 October 2022

Adopted

English (EN) (237.46 KB - PDF)

First published: 06/10/2022Last updated: 09/08/2024

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COVID-19 vaccines - Safety update: 8 December 2022

Reference Number: Rev. 2

English (EN) (239.73 KB - PDF)

First published: 08/12/2022Last updated: 09/08/2024

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COVID-19 vaccines - Safety update: 10 November 2022

Adopted

English (EN) (254.94 KB - PDF)

First published: 10/11/2022Last updated: 09/08/2024

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COVID-19 vaccines - Safety update: 12 May 2022

Adopted

English (EN) (214.22 KB - PDF)

First published: 12/05/2022Last updated: 09/08/2024

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Jcovden (previously COVID-19 Vaccine Janssen): Periodic safety update report assessment 25 February 2022 to 24 August 2022

English (EN) (8.23 MB - PDF)

First published: 10/10/2023Last updated: 09/08/2024

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COVID-19 vaccine safety update for COVID-19 Vaccine Janssen: 9 December 2021

Adopted

English (EN) (339.94 KB - PDF)

First published: 09/12/2021Last updated: 09/08/2024

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COVID-19 vaccine safety update for COVID-19 Vaccine Janssen: 6 October 2021

English (EN) (488.36 KB - PDF)

First published: 06/10/2021Last updated: 09/08/2024

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COVID-19 vaccine safety update for COVID-19 Vaccine Janssen: 8 September 2021

Adopted

English (EN) (371.09 KB - PDF)

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

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COVID-19 vaccine safety update for COVID-19 Vaccine Janssen: 14 July 2021

English (EN) (415.56 KB - PDF)

First published: 14/07/2021Last updated: 09/08/2024

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COVID-19 vaccine safety update for COVID-19 Vaccine Janssen: 11 May 2021

Adopted

English (EN) (253.98 KB - PDF)

First published: 12/05/2021Last updated: 09/08/2024

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COVID-19 vaccines - Safety update: 13 April 2022

Adopted

English (EN) (228.5 KB - PDF)

First published: 13/04/2022Last updated: 09/08/2024

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COVID-19 vaccines - Safety update: 17 February 2022

Adopted

English (EN) (226.15 KB - PDF)

First published: 17/02/2022Last updated: 09/08/2024

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COVID-19 vaccines - Safety update: 17 June 2022

Adopted

English (EN) (249.16 KB - PDF)

First published: 17/06/2022Last updated: 09/08/2024

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COVID-19 vaccines - Safety update: 20 January 2022

Adopted

English (EN) (251.15 KB - PDF)

First published: 20/01/2022Last updated: 09/08/2024

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News on Jcovden (previously COVID-19 Vaccine Janssen)

This page was last updated on 09/08/2024

Withdrawn

Overview

Product information

Product details

Pharmacotherapeutic group

Therapeutic indication

Authorisation details

Assessment history

Changes since initial authorisation of medicine

Initial marketing authorisation documents

Safety updates

News on Jcovden (previously COVID-19 Vaccine Janssen)

Signal assessment reports

External links

More information on Jcovden (previously COVID-19 Vaccine Janssen)

More information on Jcovden (previously COVID-19 Vaccine Janssen)

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