Nasolam and associated names

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

Overview

On 27 January 2022, the European Medicines Agency completed a review of Nasolam following a disagreement among EU Member States regarding its authorisation. The Agency concluded that the benefits of Nasolam outweigh its risks and the marketing authorisation should be granted in the Netherlands and in the Member States of the EU and other countries where the company has applied for a marketing authorisation: Denmark, Germany, Finland, Ireland, Norway Sweden, and the United Kingdom (Northern Ireland).

Key facts

About this medicine
Approved name
Nasolam and associated names
International non-proprietary name (INN) or common name
midazolam
Class
Hypnotics and sedatives (benzodiazepine derivatives)
About this procedure
Current status
European Commission final decision
Reference number
EMEA/H/A-29(4)/1511
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)
Decision making model
CHMP-EC
Key dates and outcomes
CHMP opinion date
27/01/2022
EC decision date
01/04/2022

All documents

European Commission final decision

  • List item

    Nasolam Article 29(4) referral - EMA recommends authorisation of Nasolam (midazolam, nasal spray) in the EU (PDF/127.56 KB)


    First published: 28/01/2022
    Last updated: 29/04/2022
    EMA/223719/2022

  • List item

    Nasolam and associated names Article 29(4) referral - Annex III (PDF/180.78 KB)


    First published: 29/04/2022

  • List item

    Nasolam and associated names Article 29(4) referral - Annex II (PDF/122.94 KB)


    First published: 29/04/2022

  • List item

    Nasolam and associated names Article 29(4) referral - Annex I (PDF/156.02 KB)


    First published: 29/04/2022

  • List item

    Nasolam and associated names Article 29(4) referral - Public Assessment Report including divergent positions to CHMP Opinion (PDF/1.16 MB)

    Adopted

    First published: 12/04/2022
    EMA/190723/2022

  • 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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