Nuvaxovid
COVID-19 Vaccine (recombinant, adjuvanted)
Overview
Nuvaxovid is a vaccine for preventing coronavirus disease 2019 (COVID-19) in people aged 12 years and older.
Nuvaxovid contains a version of a protein found on the surface of SARS-CoV-2 (the spike protein of the virus that causes COVID-19), which has been produced in the laboratory.
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Nuvaxovid : EPAR - Medicine overview (PDF/135.67 KB)
First published: 20/12/2021
Last updated: 16/11/2022
EMA/110896/2022 -
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Nuvaxovid : EPAR - Risk-management-plan (PDF/1.66 MB)
First published: 20/12/2021
Last updated: 10/01/2023
Authorisation details
Product details | |
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Name |
Nuvaxovid
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Agency product number |
EMEA/H/C/005808
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Active substance |
SARS-CoV-2 recombinant spike protein
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International non-proprietary name (INN) or common name |
COVID-19 Vaccine (recombinant, adjuvanted)
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Therapeutic area (MeSH) |
COVID-19 virus infection
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Anatomical therapeutic chemical (ATC) code |
J07BX03
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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. |
Conditional approval |
This medicine received a conditional marketing authorisation. This was granted in the interest of public health because the medicine addresses an unmet medical need and the benefit of immediate availability outweighs the risk from less comprehensive data than normally required. For more information, see Conditional marketing authorisation. |
Publication details | |
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Marketing-authorisation holder |
Novavax CZ, a.s.
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Revision |
7
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Date of issue of marketing authorisation valid throughout the European Union |
20/12/2021
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Contact address |
Bohumil 138 |
Product information
05/01/2023 Nuvaxovid - EMEA/H/C/005808 - IB/0033
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
Nuvaxovid is indicated for active immunisation to prevent COVID-19 caused by SARS-CoV-2 in individuals 18 years of age and older.
Assessment history
Safety updates
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COVID-19 vaccines - Safety update: 8 December 2022 (PDF/181.16 KB)
First published: 08/12/2022 -
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COVID-19 vaccines - Safety update: 10 November 2022 (PDF/193.65 KB)
Adopted
First published: 10/11/2022 -
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COVID-19 vaccines - Safety update: 6 October 2022 (PDF/179.91 KB)
Adopted
First published: 06/10/2022 -
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COVID-19 vaccines - Safety update: 8 September 2022 (PDF/194.49 KB)
Adopted
First published: 08/09/2022 -
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COVID-19 vaccines - Safety update: 14 July 2022 (PDF/198.21 KB)
Adopted
First published: 14/07/2022
Last updated: 03/08/2022
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