Budesonide SUN
- Procedure started
- Under evaluation
- CHMP opinion
- European Commission final decision
Table of contents
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
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List item
Refusal of marketing authorisation for Budesonide Sun (budesonide, nebuliser suspension) (PDF/114.19 KB)
Adopted
First published: 27/08/2020
EMA/444805/2020 -
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List item
Budesonide Sun Article 29(4) referral - Timetable of procedure (PDF/111.21 KB)
First published: 30/04/2020
EMA/CHMP/544996/2019 Rev. 2 -
List item
Budesonide Sun Article 29(4) referral - Assessment report (PDF/740.89 KB)
Adopted
First published: 27/08/2020
EMA/442670/2020 -
List item
Budesonide Sun Article 29(4) referral - Annex I (PDF/96.54 KB)
First published: 16/09/2020 -
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List item
Budesonide Sun Article 29(4) referral - Annex II (PDF/150.9 KB)
First published: 16/09/2020 -
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:
- Changes to the summary of product characteristics, labeling or package leaflet (also known as Annex III) - available when changes havebeen recommended by the Committee
- Conditions of the marketing authorisation (also known as Annex IV) - available when the Committee recommends measures to be takenfor the marketing authorisation(s) such as safety measures or extra studies
News
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26/06/2020
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30/04/2020
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27/03/2020