Budesonide SUN

  • Procedure started
  • Under evaluation
  • CHMP opinion
  • European Commission final decision
Current status:
European Commission final decision

Overview

Refusal of marketing authorisation for Budesonide Sun (budesonide, nebuliser suspension)

On 25 June 2020, after re-examining its initial opinion, the European Medicines Agency confirmed its recommendation that the marketing authorisation of Budesonide Sun and associated names 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.

The Agency had issued its initial opinion on 27 March 2020. The company that applied for marketing authorisation of Budesonide Sun was Sun Pharmaceutical Industries Europe B.V.

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
European Commission final decision
Opinion date
25/06/2020
EC decision date
19/08/2020

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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