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Decision: Regulatory approval of COVID-19 vaccine Nuvaxovid

Medicines Healthcare Products Regulatory Agency

December 22
09:33 2023

Last updated 17/11/2023 - Summary of Product Characteristics for Nuvaxovid dispersion for injection

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Last updated 10/2023 - Product Information Leaflet (PIL) for Nuvaxovid dispersion for injection

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If you use assistive technology (such as a screen reader) and need a version of this document in a more accessible format, please email webupdates@mhra.gov.uk. Please tell us what format you need. It will help us if you say what assistive technology you use.

Public Assessment Report for Nuvaxovid dispersion for injection

Request an accessible format.
If you use assistive technology (such as a screen reader) and need a version of this document in a more accessible format, please email webupdates@mhra.gov.uk. Please tell us what format you need. It will help us if you say what assistive technology you use.

Details

Information about the COVID-19 vaccine Nuvaxovid, approved by the MHRA on 3 February 2022.

The Summary of Product Characteristics is a description of a medicinal products properties and the conditions attached to its use. It explains how to use and prescribe a medicine. It is used by healthcare professionals, such as doctors, nurses and pharmacists.

The Patient Information Leaflet provides information for patients on using the medicine safely. This is based on the Summary of Product Characteristics of the product.

The original Conditional Marketing Authorisation (CMA) granted by the MHRA wais valid in Great Britain only. This was converted to a full GB Marketing Authorisation (MA) on 2 October 2023. Nuvaxovid is authorised in Northern Ireland under the CMA granted by the European Medicines Agency. on 20 December 2021. This CMA has similar requirements to that granted by the MHRA.

Seefurther information in our press release.

Published 3 February 2022
Last updated 22 December 2023

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