Budesonide SUN

  • Procedure started
  • Under evaluation
  • CHMP opinion
  • European Commission final decision

Table of contents

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

About this medicine
Approved name
Budesonide SUN
International non-proprietary name (INN) or common name
budesonide
About this procedure
Current status
European Commission final decision
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.
Authorisation model
Nationally authorised product(s)
Key dates and outcomes
CHMP opinion date
25/06/2020
EC decision date
19/08/2020

All documents

Opinion provided by Committee for Medicinal Products for Human Use

European Commission final decision

  • 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

  • List item

    Budesonide Sun Article 29(4) referral - Annex I (PDF/96.54 KB)


    First published: 16/09/2020

  • List item

    Budesonide Sun Article 29(4) referral - Annex II (PDF/150.9 KB)


    First published: 16/09/2020

  • List item

    Budesonide Sun Article 29(4) referral - Assessment report (PDF/740.89 KB)

    Adopted

    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.

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