Jcovden (previously COVID-19 Vaccine Janssen)
COVID-19 vaccine (Ad26.COV2-S [recombinant])
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.
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Jcovden (previously COVID-19 Vaccine Janssen) : EPAR - Medicine overview (PDF/125.71 KB)
First published: 11/03/2021
Last updated: 04/07/2023
EMA/10056/2023 -
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COVID-19 Vaccine Janssen : EPAR - Risk-management-plan (PDF/593.69 KB)
First published: 11/03/2021
Last updated: 15/06/2023
Authorisation details
Product details | |
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Name |
Jcovden (previously COVID-19 Vaccine Janssen)
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Agency product number |
EMEA/H/C/005737
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Active substance |
adenovirus type 26 encoding the SARS-CoV-2 spike glycoprotein (Ad26.COV2-S)
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International non-proprietary name (INN) or common name |
COVID-19 vaccine (Ad26.COV2-S [recombinant])
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Therapeutic area (MeSH) |
COVID-19 virus infection
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Anatomical therapeutic chemical (ATC) code |
J07BN02
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Additional 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. |
Publication details | |
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Marketing-authorisation holder |
Janssen-Cilag International NV
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Revision |
30
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Date of issue of marketing authorisation valid throughout the European Union |
11/03/2021
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Contact address |
Turnhoutseweg 30 |
Product information
29/06/2023 Jcovden (previously COVID-19 Vaccine Janssen) - EMEA/H/C/005737 - II/0072/G
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).
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
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Jcovden (previously COVID-19 Vaccine Janssen): Periodic safety update report assessment 25 February 2022 to 24 August 2022 (PDF/7.87 MB)
First published: 10/10/2023 -
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COVID-19 vaccines - Safety update: 8 December 2022 (PDF/720.9 KB) (updated)
First published: 08/12/2022
Last updated: 01/12/2023 -
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COVID-19 vaccines - Safety update: 10 November 2022 (PDF/726.69 KB) (updated)
Adopted
First published: 10/11/2022
Last updated: 01/12/2023 -
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COVID-19 vaccines - Safety update: 6 October 2022 (PDF/716.78 KB) (updated)
Adopted
First published: 06/10/2022
Last updated: 01/12/2023 -
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COVID-19 vaccines - Safety update: 8 September 2022 (PDF/729.47 KB) (updated)
Adopted
First published: 08/09/2022
Last updated: 01/12/2023 -
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COVID-19 vaccines - Safety update: 14 July 2022 (PDF/731.54 KB) (updated)
Adopted
First published: 14/07/2022
Last updated: 01/12/2023
Rev. 1 -
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COVID-19 vaccines - Safety update: 17 June 2022 (PDF/235.43 KB)
Adopted
First published: 17/06/2022 -
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COVID-19 vaccines - Safety update: 12 May 2022 (PDF/203.03 KB)
Adopted
First published: 12/05/2022 -
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COVID-19 vaccines - Safety update: 13 April 2022 (PDF/214.65 KB)
Adopted
First published: 13/04/2022 -
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COVID-19 vaccines - Safety update: 17 March 2022 (PDF/221.74 KB)
Adopted
First published: 17/03/2022 -
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COVID-19 vaccines - Safety update: 17 February 2022 (PDF/212.51 KB)
Adopted
First published: 17/02/2022 -
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COVID-19 vaccines - Safety update: 20 January 2022 (PDF/234.12 KB)
Adopted
First published: 20/01/2022 -
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COVID-19 vaccine safety update for COVID-19 Vaccine Janssen: 9 December 2021 (PDF/188.43 KB)
Adopted
First published: 09/12/2021 -
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COVID-19 vaccine safety update for COVID-19 Vaccine Janssen: 11 November 2021 (PDF/88.19 KB)
Adopted
First published: 11/11/2021 -
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COVID-19 vaccine safety update for COVID-19 Vaccine Janssen: 6 October 2021 (PDF/134.54 KB)
First published: 06/10/2021 -
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COVID-19 vaccine safety update for COVID-19 Vaccine Janssen: 8 September 2021 (PDF/112.24 KB)
Adopted
First published: 08/09/2021 -
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COVID-19 vaccine safety update for COVID-19 Vaccine Janssen: 11 August 2021 (PDF/95.91 KB)
Adopted
First published: 11/08/2021 -
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COVID-19 vaccine safety update for COVID-19 Vaccine Janssen: 14 July 2021 (PDF/107.36 KB)
First published: 14/07/2021 -
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COVID-19 vaccine safety update for COVID-19 Vaccine Janssen: 18 June 2021 (PDF/173.91 KB)
Adopted
First published: 18/06/2021 -
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COVID-19 vaccine safety update for COVID-19 Vaccine Janssen: 11 May 2021 (PDF/82.5 KB)
Adopted
First published: 12/05/2021 -
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COVID-19 vaccine safety update for COVID-19 Vaccine Janssen: 22 April 2021 (PDF/87.51 KB)
Adopted
First published: 23/04/2021 -
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COVID-19 vaccine safety update for COVID-19 Vaccine Janssen: 14 April 2021 (PDF/80.63 KB)
Adopted
First published: 16/04/2021