Bimervax
COVID-19 Vaccine (recombinant, adjuvanted)
Table of contents
Overview
Bimervax is a vaccine for preventing coronavirus disease 2019 (COVID-19) in people aged 16 years and older. It can be used as a booster in people who have previously received an mRNA COVID-19 vaccine.
Bimervax contains a protein produced in the laboratory that consists of part of the SARS-CoV-2 spike protein from the Alpha and Beta virus variants.
-
List item
Bimervax : EPAR - Medicine overview (PDF/124.52 KB)
First published: 31/03/2023
Last updated: 05/04/2023
EMA/151429/2023 -
-
List item
Bimervax : EPAR - Risk-management-plan (PDF/1.79 MB)
First published: 31/03/2023
Last updated: 01/09/2023
Authorisation details
Product details | |
---|---|
Name |
Bimervax
|
Agency product number |
EMEA/H/C/006058
|
Active substance |
SARS-CoV-2 virus recombinant spike (S) protein receptor binding domain (RBD) fusion heterodimer – B.1.351-B.1.1.7 strains
|
International non-proprietary name (INN) or common name |
COVID-19 Vaccine (recombinant, adjuvanted)
|
Therapeutic area (MeSH) |
COVID-19 virus infection
|
Anatomical therapeutic chemical (ATC) code |
J07BN
|
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. |
Publication details | |
---|---|
Marketing-authorisation holder |
Hipra Human Health S.L.
|
Revision |
2
|
Date of issue of marketing authorisation valid throughout the European Union |
30/03/2023
|
Contact address |
Avinguda Selva 135 |
Product information
18/08/2023 Bimervax - EMEA/H/C/006058 - IB/0003
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
Bimervax is indicated as a booster for active immunisation to prevent COVID-19 in individuals 16 years of age and older who have previously received a mRNA COVID-19 vaccine