Decision

Regulatory approval of Paxlovid

Information for healthcare professionals and the public about Paxlovid

• From: Medicines and Healthcare products Regulatory Agency
• Published: 31 December 2021
• Last updated: 26 October 2022 — See all updates

Documents

Summary of Product Characteristics for Paxlovid

HTML

Summary of Product Characteristics for Paxlovid

PDF, 146 KB, 39 pages

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Patient Information Leaflet for Paxlovid

HTML

Patient Information Leaflet for Paxlovid

PDF, 117 KB, 3 pages

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Conditions for Authorisation Paxlovid (Regulation 174)

PDF, 122 KB, 3 pages

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Summary of the Public Assessment Report (PAR) for Paxlovid 150 mg/100 mg film-coated tablets

HTML

Public Assessment Report (PAR) for Paxlovid 150 mg/100 mg film-coated tablets

PDF, 1.54 MB, 43 pages

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Details

The MHRA has issued a Conditional Marketing Authorisation for Paxlovid in Great Britain and a temporary Regulation 174 authorisation for Northern Ireland to ensure supply across all of the UK. If the European Medicines Agency grants a CMA for Paxlovid it would apply in Northern Ireland and the Regulation 174 authorisation would no longer be in place.

Supply of this product will be subject to the same requirements in Great Britain and Northern Ireland, and the product information on this page applies to both authorisations.

The information for healthcare professionals and UK recipients on using Paxlovid safely will be periodically updated as new data become available and this will continue when the CMA is converted to a MA. Please regularly check this information as it is often updated.

Paxlovid authorised under Regulation 174 is kept in line with the product information of the GB CMA. The Public Assessment Report will be published shortly.

Summary of Product Characteristics

This 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.

Patient Information Leaflet

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.

Public Assessment Report

The Public Assessment Report is a scientific report, written by the MHRA. It explains how this product was assessed and its authorisation recommended, as well as its conditions of use. It is not intended to provide practical advice on how to use this product.

Published 31 December 2021
Last updated 26 October 2022 + show all updates

1. 26 October 2022

   The SmPC (HTML) and SmPC (PDF) attachments have been updated as the shelf life of Paxlovid has been extended from 18 to 24 months from initial manufacture.

2. 12 August 2022

   The SmPC attachments have been updated as the shelf life of Paxlovid has been extended from 12 to 18 months from initial manufacture.

3. 9 February 2022

   PAR & Summary of PAR added

4. 11 January 2022

   Updated the SPC and PIL for Paxlovid

5. 31 December 2021

   First published.