Etifoxine-containing medicinal products

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

Overview

On 27 January 2022, EMA’s human medicines committee (CHMP) finalised its review of Stresam (etifoxine) and concluded that the medicine can continue to be used for the treatment of anxiety disorders, but it must not be used in patients who previously had severe skin reactions or severe liver problems after taking etifoxine.

During the review, the CHMP assessed all available data on the benefits and risks of Stresam, including the results of a study (AMETIS) on the efficacy of etifoxine in treating adjustment disorders with anxiety (where people have difficulty coping with stressful events). The Committee also assessed safety data from clinical studies and post-marketing experience.

EMA concluded that Stresam can continue to be used for the treatment of anxiety disorders in some patients, but restrictions on its use have been put in place to minimise the risk of very rare but serious side effects that may occur with etifoxine. The medicine must not be used in patients who experienced severe skin reactions (including DRESS syndrome, Stevens Johnson syndrome and generalised exfoliative dermatitis) or severe liver damage (severe hepatitis or cytolytic hepatitis) with previous etifoxine treatment, and treatment must be stopped if signs of skin reactions or liver problems appear. In patients at risk of liver problems, liver function tests should be performed before starting treatment and around one month after treatment has started. In addition, the company that markets Stresam will have to conduct a study to further characterise the effects of etifoxine in patients with anxiety.

The product information for Stresam will be updated to include the above recommendations.

Key facts

About this medicine
Approved name
Etifoxine-containing medicinal products
International non-proprietary name (INN) or common name
etifoxine
Associated names
Stresam
Class
Non-benzodiazepine anxiolytic
About this procedure
Current status
European Commission final decision
Reference number
EMEA/H/A-31/1509
Type
Article 31 referrals

This type of referral is triggered when the interest of the Union is involved, following concerns relating to the quality, safety or efficacy of a medicine or a class of medicines.

Authorisation model
Nationally authorised product(s)
Decision making model
CHMP-EC
Key dates and outcomes
CHMP opinion date
24/06/2021
EC decision date
24/03/2022

All documents

Procedure started

Opinion provided by Committee for Medicinal Products for Human Use

  • List item

    Etifoxine-containing medicinal products Article-31 referral - EMA concludes review of anxiety medicine Stresam (etifoxine) (PDF/107.07 KB)


    First published: 28/01/2022
    Last updated: 21/04/2022
    EMA/46972/2022

  • European Commission final decision

  • List item

    Etifoxine-containing medicinal products Article-31 referral - Annex IV (PDF/52.55 KB)


    First published: 21/04/2022

  • List item

    Etifoxine-containing medicinal products Article-31 referral - Annex III (PDF/85.79 KB)


    First published: 21/04/2022

  • List item

    Etifoxine-containing medicinal products Article-31 referral - Annex II (PDF/87.08 KB)


    First published: 21/04/2022

  • List item

    Etifoxine-containing medicinal products Article-31 referral - Annex I (PDF/75.21 KB)


    First published: 21/04/2022

  • List item

    Etifoxine-containing medicinal products Article-31 referral - Public Assessment Report including divergent positions to CHMP Opinion (PDF/1008.1 KB)


    First published: 31/03/2022
    EMA/148255/2022

  • 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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