Decision

Regulatory approval of Ronapreve

Information for healthcare professionals and the public about Ronapreve

Documents

Summary of Product Characteristics for Ronapreve

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Patient Information Leaflet for Ronapreve

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Conditions of Authorisation for Ronapreve (Regulation 174)

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Public Assessment Report for Ronapreve

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Details

The MHRA has issued a Conditional Marketing Authorisation for Ronapreve 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 Ronapreve 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 Ronapreve 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.

Ronapreve authorised under Regulation 174 is kept in line with the product information of the GB CMA.

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 20 August 2021
Last updated 19 November 2021 + show all updates
  1. Publication of PAR

  2. First published.