Bimervax

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COVID-19 Vaccine (recombinant, adjuvanted)

Authorised
This medicine is authorised for use in the European Union.

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.

This EPAR was last updated on 05/04/2023

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 monitoringAdditional 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.
Date of issue of marketing authorisation valid throughout the European Union
30/03/2023
Contact address

Avinguda Selva 135
17170 Amer
Spain

Product information

30/03/2023 Bimervax - EMEA/H/C/006058 -

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Product information documents contain:

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

Assessment history

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