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
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About this medicine
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|---|---|
| Approved name |
Budesonide SUN
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| International non-proprietary name (INN) or common name |
budesonide
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About this procedure
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|---|---|
| Current status |
European Commission final decision
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| Reference number |
EMEA/H/A-29(4)/1492
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| 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. |
| Authorisation model |
Nationally authorised product(s)
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Key dates and outcomes
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|---|---|
| CHMP opinion date |
25/06/2020
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| EC decision date |
19/08/2020
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All documents
Opinion provided by Committee for Medicinal Products for Human Use
European Commission final decision
Budesonide Sun Article 29(4) referral - Annex I (PDF/96.54 KB)
First published: 16/09/2020
Budesonide Sun Article 29(4) referral - Annex II (PDF/150.9 KB)
First published: 16/09/2020
Budesonide Sun Article 29(4) referral - Assessment report (PDF/740.89 KB)
First published: 27/08/2020
EMA/442670/2020
Description of documents published
Please note that some of the listed documents apply only to certain procedures.
- Overview - lay-language summary of the stage of the procedure
- Notification – a letter from a Member State, the European Commission or the marketing authorisation holder requesting the initiation of the procedure
- Scientific background – further background information from the triggering Member State on the issues leading to the initiation of the procedure (if applicable)
- List of questions – questions agreed by the Committee requesting further information from the marketing authorisation holder(s) / applicant(s) to evaluate the issues identified
- Timetable for the procedure – agreed timeframe to respond to the list of questions, to assess the issues and to adopt a conclusion
- List of medicines concerned by the procedure – medicine(s) / active substance(s) concerned, and marketing authorisation holder(s) / applicant(s)
- List of questions to be addressed by the stakeholders – call for data to be submitted by stakeholders (e.g. healthcare professionals, patient organisations, individual patients) (if applicable)
- Stakeholder submission form – form to be used by stakeholders to submit data (if applicable)
- Scientific conclusions – scientific conclusions of the PRAC and/or CHMP and/or CMDh
- Assessment report – PRAC or CHMP assessment and conclusions on the issues investigated, including divergent positions (if applicable)
- Divergent positions – divergent positions of the CHMP or CMDh members for pharmacovigilance procedures (if applicable)
- Changes to the summary of product characteristics, labelling and package leaflet (amended sections or fully revised version) (if applicable)
- Condition(s) to the marketing authorisation(s) – condition(s) for the safe and effective use of the medicine(s) (if applicable)
- Condition for lifting the suspension – condition to be fulfilled for the suspension of the marketing authorisation(s) to be lifted (if applicable)
- Timetable for implementation of CMDh position – agreed timeframe to submit and finalise the variation(s) implementing the outcome of the procedure (if applicable)
Note that older documents may have different titles.
News
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26/06/2020
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30/04/2020
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27/03/2020