- Rolling review
- Application under evaluation
- CHMP opinion
- European Commission decision
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The European Public Assessment Report (EPAR) for Jcovden is updated to indicate that the marketing authorisation is no longer valid.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
English (EN) (269.31 KB - PDF)
български (BG) (384.63 KB - PDF)
español (ES) (280.53 KB - PDF)
čeština (CS) (366.2 KB - PDF)
dansk (DA) (272.51 KB - PDF)
Deutsch (DE) (298.27 KB - PDF)
eesti keel (ET) (253.17 KB - PDF)
ελληνικά (EL) (409 KB - PDF)
français (FR) (291.83 KB - PDF)
hrvatski (HR) (324.83 KB - PDF)
italiano (IT) (267.78 KB - PDF)
latviešu valoda (LV) (339.93 KB - PDF)
lietuvių kalba (LT) (339.51 KB - PDF)
magyar (HU) (342.54 KB - PDF)
Malti (MT) (361.54 KB - PDF)
Nederlands (NL) (292.74 KB - PDF)
polski (PL) (361.86 KB - PDF)
português (PT) (266.56 KB - PDF)
română (RO) (331.01 KB - PDF)
slovenčina (SK) (363.36 KB - PDF)
slovenščina (SL) (331.43 KB - PDF)
Suomi (FI) (264.7 KB - PDF)
svenska (SV) (263.78 KB - PDF)
COVID-19 Vaccine Janssen : EPAR - Risk-management-plan
English (EN) (2.9 MB - PDF)
Product information
Jcovden : EPAR - Product information
English (EN) (1.84 MB - PDF)
български (BG) (1.84 MB - PDF)
español (ES) (2.02 MB - PDF)
čeština (CS) (1.97 MB - PDF)
dansk (DA) (1.94 MB - PDF)
Deutsch (DE) (2 MB - PDF)
eesti keel (ET) (1.89 MB - PDF)
ελληνικά (EL) (1.83 MB - PDF)
français (FR) (1.85 MB - PDF)
hrvatski (HR) (1.93 MB - PDF)
íslenska (IS) (1.9 MB - PDF)
italiano (IT) (1.88 MB - PDF)
latviešu valoda (LV) (1.89 MB - PDF)
lietuvių kalba (LT) (1.84 MB - PDF)
magyar (HU) (1.99 MB - PDF)
Malti (MT) (2.26 MB - PDF)
Nederlands (NL) (1.99 MB - PDF)
norsk (NO) (1.97 MB - PDF)
polski (PL) (1.96 MB - PDF)
português (PT) (2.12 MB - PDF)
română (RO) (2.12 MB - PDF)
slovenčina (SK) (1.94 MB - PDF)
slovenščina (SL) (2.03 MB - PDF)
Suomi (FI) (1.95 MB - PDF)
svenska (SV) (1.83 MB - PDF)
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)
български (BG) (75.33 KB - PDF)
español (ES) (65.86 KB - PDF)
čeština (CS) (74.68 KB - PDF)
dansk (DA) (68.75 KB - PDF)
Deutsch (DE) (69.94 KB - PDF)
eesti keel (ET) (66.64 KB - PDF)
ελληνικά (EL) (77.61 KB - PDF)
français (FR) (79.26 KB - PDF)
hrvatski (HR) (77.95 KB - PDF)
íslenska (IS) (61.79 KB - PDF)
italiano (IT) (66.01 KB - PDF)
latviešu valoda (LV) (63.16 KB - PDF)
lietuvių kalba (LT) (70.62 KB - PDF)
magyar (HU) (67.71 KB - PDF)
Malti (MT) (79.76 KB - PDF)
Nederlands (NL) (70.24 KB - PDF)
norsk (NO) (63.5 KB - PDF)
polski (PL) (80.54 KB - PDF)
português (PT) (67.9 KB - PDF)
română (RO) (65.71 KB - PDF)
slovenčina (SK) (76.86 KB - PDF)
slovenščina (SL) (72.88 KB - PDF)
Suomi (FI) (61.94 KB - PDF)
svenska (SV) (66.68 KB - PDF)
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
VaccinesTherapeutic 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)
Jcovden (previously COVID-19 Vaccine Janssen)-H-C-005737-R-0063 : EPAR - Assessment report - Renewal
English (EN) (2.54 MB - PDF)
Jcovden (previously COVID-19 Vaccine Janssen)-H-C-005737-P46-073 : EPAR - Assessment report
English (EN) (1.6 MB - PDF)
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)
English (EN) (713.5 KB - PDF)
COVID-19 Vaccine Janssen-H-C-5737-II-0033 : EPAR - Assessment report - Variation
English (EN) (10.69 MB - PDF)
COVID-19 Vaccine Janssen-H-C-5737-R-0023 : EPAR - Assessment report - Renewal
English (EN) (2.31 MB - PDF)
COVID-19 Vaccine Janssen : EPAR - Public assessment report
English (EN) (13.21 MB - PDF)
CHMP summary of positive opinion for COVID-19 Vaccine Janssen
English (EN) (350.52 KB - PDF)
Safety updates
Jcovden : Periodic safety update report assessment 25 February 2023 to 24 February 2024
English (EN) (18.86 MB - PDF)
COVID-19 vaccine safety update for COVID-19 Vaccine Janssen: 22 April 2021
English (EN) (287.95 KB - PDF)
COVID-19 vaccine safety update for COVID-19 Vaccine Janssen: 14 April 2021
English (EN) (237.41 KB - PDF)
COVID-19 vaccine safety update for COVID-19 Vaccine Janssen: 18 June 2021
English (EN) (363.03 KB - PDF)
COVID-19 vaccine safety update for COVID-19 Vaccine Janssen: 11 August 2021
English (EN) (330.47 KB - PDF)
COVID-19 vaccine safety update for COVID-19 Vaccine Janssen: 11 November 2021
English (EN) (306.57 KB - PDF)
Jcovden (previously COVID-19 Vaccine Janssen): Periodic safety update report assessment 25 August 2022 to 24 February 2023
English (EN) (4.94 MB - PDF)
COVID-19 vaccines - Safety update: 14 July 2022
English (EN) (263.34 KB - PDF)
COVID-19 vaccines - Safety update: 8 September 2022
English (EN) (257.73 KB - PDF)
COVID-19 vaccines - Safety update: 17 March 2022
English (EN) (237.65 KB - PDF)
COVID-19 vaccines - Safety update: 6 October 2022
English (EN) (237.46 KB - PDF)
COVID-19 vaccines - Safety update: 8 December 2022
English (EN) (239.73 KB - PDF)
COVID-19 vaccines - Safety update: 10 November 2022
English (EN) (254.94 KB - PDF)
COVID-19 vaccines - Safety update: 12 May 2022
English (EN) (214.22 KB - PDF)
Jcovden (previously COVID-19 Vaccine Janssen): Periodic safety update report assessment 25 February 2022 to 24 August 2022
English (EN) (8.23 MB - PDF)
COVID-19 vaccine safety update for COVID-19 Vaccine Janssen: 9 December 2021
English (EN) (339.94 KB - PDF)
COVID-19 vaccine safety update for COVID-19 Vaccine Janssen: 6 October 2021
English (EN) (488.36 KB - PDF)
COVID-19 vaccine safety update for COVID-19 Vaccine Janssen: 8 September 2021
English (EN) (371.09 KB - PDF)
COVID-19 vaccine safety update for COVID-19 Vaccine Janssen: 14 July 2021
English (EN) (415.56 KB - PDF)
COVID-19 vaccine safety update for COVID-19 Vaccine Janssen: 11 May 2021
English (EN) (253.98 KB - PDF)
COVID-19 vaccines - Safety update: 13 April 2022
English (EN) (228.5 KB - PDF)
COVID-19 vaccines - Safety update: 17 February 2022
English (EN) (226.15 KB - PDF)
COVID-19 vaccines - Safety update: 17 June 2022
English (EN) (249.16 KB - PDF)
COVID-19 vaccines - Safety update: 20 January 2022
English (EN) (251.15 KB - PDF)
News on Jcovden (previously COVID-19 Vaccine Janssen)
Signal assessment reports
Signal assessment report on embolic and thrombotic events (SMQ) with COVID-19 Vaccine Janssen (Ad26.COV2-S [recombinant]) adopted at PRAC meeting 3-6 May 2021
English (EN) (10.43 MB - PDF)
Signal assessment report on embolic and thrombotic events (SMQ) with COVID-19 Vaccine Janssen (Ad26.COV2-S [recombinant]) adopted at PRAC meeting 20 April 2021
English (EN) (7.58 MB - PDF)
External links
- Clinical data (login required)
More information onJcovden (previously COVID-19 Vaccine Janssen)
- EMEA-002880-PIP01-20-M01 - paediatric investigation plan
- Jcovden (previously COVID-19 Vaccine Janssen) - direct healthcare professional communication (DHPC)
- Jcovden (previously COVID-19 Vaccine Janssen) - direct healthcare professional communication (DHPC)
- Jcovden (previously COVID-19 Vaccine Janssen) - direct healthcare professional communication (DHPC)
- id.DRIVE (former COVIDRIVE) study of brand-specific COVID-19 vaccine effectiveness against severe COVID-19 disease in Europe - post-authorisation study
- Vaccine Effectiveness, Burden and Impact Studies (VEBIS) - Healthcare worker cohort - post-authorisation study
- Vaccine Effectiveness, Burden and Impact Studies (VEBIS), Vaccine effectiveness against COVID-19 and seasonal influenza among patients presenting to primary care physicians in EU/EEA - post-authorisation study
- Vaccine Effectiveness, Burden and Impact Studies (VEBIS) - Vaccine effectiveness and the impact of COVID-19 vaccines through routinely collected exposure and outcome data using health registries - post-authorisation study
- Vaccine Effectiveness, Burden and Impact Studies (VEBIS) - Vaccine effectiveness hospital admission with Severe Acute Respiratory Infection - post-authorisation study
- An Observational Post-Authorization Safety Study to Assess the Safety of Ad26.COV2.S Using Health Insurance Databases in the United States - post-authorisation study