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 The European Public Assessment Report (EPAR) for Jcovden is updated to indicate that the marketing authorisation is no longer valid.
Therapeutic Indication
### 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.
Therapeutic Area (MeSH)
ATC Code
J07BN02
ATC Item
covid-19, viral vector, non-replicating
Pharmacotherapeutic Group
Vaccines
Active Substance (Summary)
INN / Common Names
| Substance | CAS | Monograph |
|---|---|---|
| adenovirus type 26 encoding the SARS-CoV-2 spike glycoprotein (Ad26.COV2-S) | N/A | adenovirus type 26 encoding the sars-cov-2 spike glycoprotein (ad 26.cov 2-s) |
EMA Name
Jcovden (previously COVID-19 Vaccine Janssen)
Medicine Name
Jcovden (previously COVID-19 Vaccine Janssen)
Aliases
N/ANo risk management plan link.