Decision: Regulatory approval of COVID-19 Vaccine Janssen

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Medicines Healthcare Products Regulatory Agency

October 19

14:00 2023

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Last updated 26/9/23 - Summary of Product Characteristics for COVID-19 Vaccine Janssen

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Last updated 26/9/23 - Patient Information Leaflet (PIL) for COVID-19 Vaccine Janssen

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Summary of the Public Assessment Report for COVID-19 Vaccine Janssen

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Public Assessment Report for COVID-19 Vaccine Janssen

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Details

Information about the COVID-19 Vaccine Janssen, approved by the MHRA on 28 May 2021.

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 (PIL) provides information for patients on using the medicine safely. This is based on the Summary of Product Characteristics of the product.

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

The original Conditional Marketing Authorisation (CMA) granted by theMHRAwas approved via the European Commission (

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