Decision

Regulatory approval of COVID-19 Vaccine Valneva

Information for healthcare professionals and the public about the COVID-19 Vaccine Valneva

• From: Medicines and Healthcare products Regulatory Agency
• Published: 14 April 2022
• Last updated: 13 July 2022 — See all updates

Documents

Summary of Product Characteristics for COVID-19 Vaccine Valneva

HTML

Summary of Product Characteristics for COVID-19 Vaccine Valneva

PDF, 197 KB, 9 pages

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Patient Information Leaflet for COVID-19 Vaccine Valneva

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Patient Information Leaflet for COVID-19 Vaccine Valneva

PDF, 116 KB, 6 pages

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Public Assessment Report for COVID-19 Vaccine Valneva

PDF, 895 KB, 31 pages

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Details

Information about COVID-19 Vaccine Valneva suspension for injection, approved by the MHRA on 13 April 2022.

The Summary of Product Characteristics is a description of a medicinal product’s 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 Conditional Marketing Authorisation (CMA) granted by the MHRA is valid in the United Kingdom (UK).

See further information in our press release.

Ingredients

The MHRA can confirm that COVID-19 Vaccine Valneva suspension for injection does not contain any components of animal origin.

A full list of ingredients for the qualitative and quantitative composition of the vaccine can be found at point 2 in the Summary of Product Characteristics for COVID-19 Vaccine Valneva suspension for injection.

A full list of ingredients for the excipient composition of the vaccine can be found at point 6.1 in the Summary of Product Characteristics for COVID-19 Vaccine Valneva suspension for injection.

A full list of ingredients for the qualitative and quantitative composition of the vaccine and a full list of the excipient composition of the vaccine can be found at point 6 in the Patient Information Leaflet for COVID-19 Vaccine Valneva suspension for injection.

Published 14 April 2022
Last updated 13 July 2022 + show all updates

1. 13 July 2022

   Added Public Assessment Report (PAR) PDF.

2. 14 April 2022

   First published.