Fusafungine containing medicinal products for oromucosal and nasal use

  • Procedure started
  • Under evaluation
  • PRAC recommendation
  • CMDh final position

Table of contents

Current status
CMDh final position

Overview

 

CMDh endorses revocation of authorisations for fusafungine sprays used to treat airway infections

Medicines to be withdrawn due to serious allergic reactions and limited evidence of benefit

The CMDh1 has endorsed by consensus the revocation of marketing authorisations for fusafungine sprays in the EU. This follows a review by EMA's Pharmacovigilance Risk Assessment Committee (PRAC) which concluded that the benefits of fusafungine do not outweigh its risks, particularly the risk of serious allergic reactions.

Fusafungine is an antibiotic and anti-inflammatory nose and mouth spray used to treat upper airway infections such as rhinopharyngitis (common cold).

Serious allergic reactions have occurred soon after the use of these sprays and involved bronchospasm (excessive and prolonged contractions of the airway muscles leading to difficulty breathing). Although the review found that serious allergic reactions are rare, they can be life-threatening and no measures have been identified to sufficiently reduce or manage this risk.

With regard to the benefits, the evidence for beneficial effects of fusafungine is weak. Taking into account the mild and self-limiting nature of upper airway infections such as rhinopharyngitis, the benefits of fusafungine were not considered to outweigh the risks.

In addition, there were concerns about the potential for fusafungine to promote antibiotic resistance (the ability of bacteria to grow in the presence of an antibiotic that would normally kill them or limit their growth). Although there is insufficient evidence to establish that fusafungine can increase the risk of resistance, this risk could not be ruled out. The benefit-risk balance for fusafungine-containing medicines is therefore negative for all currently authorised uses.

Following the CMDh consensus position, EU Member States will start revoking the marketing authorisations of these medicines in their territories, according to an agreed timetable.

1 The CMDh is a medicines regulatory body representing the European Union (EU) Member States.

Key facts

About this medicine
Approved name
Fusafungine containing medicinal products for oromucosal and nasal use
International non-proprietary name (INN) or common name
fusafungine
Class
-
About this procedure
Current status
CMDh final position
Reference number
EMEA/H/A-31/1420
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
PRAC-CMDh
Key dates and outcomes
Procedure start date
10/09/2015
PRAC recommendation date
11/02/2016
CHMP opinion/CMDh position date
31/03/2016
Outcome
Revocation

All documents

Procedure started

Recommendation provided by Pharmacovigilance Risk Assessment Committee

Position provided by CMDh

  • List item

    Fusafungine Article-31 referral - CMDh endorses revocation of authorisations for fusafungine sprays used to treat airway infections (PDF/75.08 KB)

    Adopted

    First published: 01/04/2016
    Last updated: 01/04/2016
    EMA/227560/2016

  • List item

    Fusafungine Article-31 referral - Annex II (PDF/98.99 KB)


    First published: 14/04/2016
    Last updated: 14/04/2016

  • List item

    Fusafungine Article-31 referral - Annex I (PDF/57.85 KB)


    First published: 14/04/2016
    Last updated: 14/04/2016

  • List item

    Fusafungine Article-31 referral - Assessment report (PDF/280.17 KB)

    Adopted

    First published: 14/04/2016
    Last updated: 14/04/2016
    EMA/194153/2016

  • List item

    Fusafungine Article-31 referral - Annex III (PDF/21.71 KB)

    Adopted

    First published: 01/04/2016
    Last updated: 14/04/2016
    EMA/227560/2016

  • List item

    Fusafungine Article-31 referral - CMDh endorses revocation of authorisations for fusafungine sprays used to treat airway infections (PDF/75.08 KB)

    Adopted

    First published: 01/04/2016
    Last updated: 01/04/2016
    EMA/227560/2016

    • 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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