Regulatory PathRegulatory requirements compared

Active substance

Covid 19 vaccine

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EMA European Union — centrally authorised medicines

Bimervax Hipra Human Health S.L. · Authorised · authorised 30 Mar 2023 · ATC J07BN

Therapeutic indication (EMA)

Bimervax is indicated as a booster for active immunisation to prevent COVID-19 in individuals 12 years of age and older who have previously received a mRNA COVID-19 vaccine (see sections 4.2 and 5.1). The use of this vaccine should be in accordance with official recommendations. Bimervax XBB.1.16 is indicated for active immunisation to prevent COVID-19 caused by SARS-CoV-2 in individuals 12 years of age and older. The use of this vaccine should be in accordance with official recommendations. Bimervax LP.8.1 is indicated for active immunisation to prevent COVID-19 caused by SARS CoV-2 in individuals 12 years of age and older. The use of this vaccine should be in accordance with official recommendations.

COVID-19 Vaccine (inactivated, adjuvanted) Valneva Valneva Austria GmbH · Withdrawn · authorised 24 Jun 2022 · ATC J07BX03

Therapeutic indication (EMA)

COVID-19 Vaccine (inactivated, adjuvanted) Valneva is indicated for active immunisation to prevent COVID-19 caused by SARS-CoV-2 in individuals 18 to 50 years of age. The use of this vaccine should be in accordance with official recommendations.

Safety signals and safety-related labeling changes

All safety entries for covid 19 vaccine →

Values as published by each source: SFDA human drug list (4-2026, as published by the Council of Health Insurance; indications from the CHI Daman Drug Formulary), Drugs@FDA, EMA medicines data, Health Canada Drug Product Database (Open Government Licence – Canada), CMS NADAC, NHS Drug Tariff Part VIIIA (NHSBSA Copyright, Open Government Licence v3.0), WHO Model List of Essential Medicines (CC BY 3.0 IGO; regrouped by active substance, not created by WHO), EMA PRAC, US FDA safety-related labeling changes and MHRA Drug Safety Update (Open Government Licence v3.0). Sources and reuse. Not a substitute for the official registers or the product information.