Budesonide SUN

  • Procedure started
  • Under evaluation
  • CHMP opinion
  • European Commission final decision
Current status:
Opinion provided by Committee for Medicinal Products for Human Use

Overview

Update of 30 April 2020: 

The applicant for Budesonide SUN has requested a re-examination of the CHMP’s March 2020 opinion. Following receipt of the grounds of the request, the CHMP will re-examine its opinion and issue a final recommendation.

On 26 March 2020, the European Medicines Agency completed a review of Budesonide Sun and associated names following a disagreement among EU Member States regarding its authorisation. The Agency concluded that the benefits of Budesonide Sun do not outweigh its risks, and the marketing authorisation cannot be granted in the Netherlands or in other Member States of the EU where the company has applied for a marketing authorisation (Germany, Italy, Poland, Spain and Sweden), or the United Kingdom.

Key facts

Approved name
Budesonide SUN
International non-proprietary name (INN) or common name

budesonide

Reference number
EMEA/H/A-29(4)/1492
Type
Article 29(4) referrals

This type of referral is triggered when there is a disagreement between Member States regarding a marketing authorisation application being evaluated in a mutual-recognition or decentralised procedure, on the grounds of a potential serious risk to public health.

Status
Opinion provided by Committee for Medicinal Products for Human Use
Opinion date
26/03/2020

All documents

Document description

  • Questions and answers (Q&A) - easy-to-understand summary of key issues and Committee conclusions
  • Summary of Opinion - contains the CHMP opinion of the referred medicine(s)
  • List of the medicines affected by the referral (Annex I)
  • Scientific conclusions of the Committee (Annex II)

The following two documents are sometimes available:

News

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