Jcovden (previously COVID-19 Vaccine Janssen)

Withdrawn

This medicine's authorisation has been withdrawn

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

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The European Public Assessment Report (EPAR) for Jcovden is updated to indicate that the marketing authorisation is no longer valid.

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

Reference Number: EMA/10056/2023

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

Product information

Jcovden : EPAR - Product information

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

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

Changes since initial authorisation of medicine

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

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

Reference Number: EMA/CHMP/766600/2022

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

AdoptedReference Number: EMA/738/2023

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

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

AdoptedReference Number: EMA/CHMP/695763/2021

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

AdoptedReference Number: EMA/757560/2021

Initial marketing authorisation documents

COVID-19 Vaccine Janssen : EPAR - Public assessment report

AdoptedReference Number: EMA/158424/2021

CHMP summary of positive opinion for COVID-19 Vaccine Janssen

AdoptedReference Number: EMA/146391/2021