COVID-19 Vaccine Moderna
COVID-19 mRNA Vaccine (nucleoside modified)
Overview
COVID-19 Vaccine Moderna is a vaccine for preventing coronavirus disease 2019 (COVID-19) in people aged 18 years and older.
COVID-19 Vaccine Moderna contains a molecule called messenger RNA (mRNA) with instructions for producing a protein from SARS-CoV-2, the virus that causes COVID-19. COVID-19 Vaccine Moderna does not contain the virus itself and cannot cause COVID-19.
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COVID-19 Vaccine Moderna: EPAR - Medicine overview (PDF/128.97 KB)
First published: 20/01/2021
EMA/704373/2020 -
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COVID-19 Vaccine Moderna: EPAR - Risk-management-plan (PDF/1.96 MB)
First published: 20/01/2021
Authorisation details
Product details | |
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Name |
COVID-19 Vaccine Moderna
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Agency product number |
EMEA/H/C/005791
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Active substance |
CX-024414 (single-stranded, 5’-capped messenger RNA (mRNA) produced using a cell-free in vitro transcription from the corresponding DNA templates, encoding the viral spike (S) protein of SARS-CoV-2)
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International non-proprietary name (INN) or common name |
COVID-19 mRNA Vaccine (nucleoside modified)
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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 |
Moderna Biotech Spain, S.L.
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Date of issue of marketing authorisation valid throughout the European Union |
06/01/2021
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Contact address |
Product information
06/01/2021 COVID-19 Vaccine Moderna - EMEA/H/C/005791 -
Contents
- Annex I - Summary of product characteristics
- Annex IIA - Manufacturing-authorisation holder responsible for batch release
- Annex IIB - Conditions of the marketing authorisation
- Annex IIIA - Labelling
- Annex IIIB - Package leaflet
Please note that the size of the above document can exceed 50 pages.
You are therefore advised to be selective about which sections or pages you wish to print.
Pharmacotherapeutic group
Vaccines
Therapeutic indication
COVID-19 Vaccine Moderna 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.