Fusafungine containing medicinal products for oromucosal and nasal use
- Procedure started
- Under evaluation
- PRAC recommendation
- CMDh position
- European Commission final decision
Table of contents
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Medicines to be withdrawn due to serious allergic reactions and limited evidence of benefit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
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Approved name |
Fusafungine containing medicinal products for oromucosal and nasal use
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International non-proprietary name (INN) or common name |
fusafungine
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Class |
-
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About this procedure
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Current status |
Position provided by CMDh
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Reference number |
EMEA/H/A-31/1420
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Type | |
Decision making model |
PRAC-CMDh
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Authorisation model |
Nationally authorised product(s)
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Key dates and outcomes
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Procedure start date |
10/09/2015
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PRAC recommendation date |
11/02/2016
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CHMP opinion/CMDh position date |
31/03/2016
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Outcome |
Revocation
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All documents
Procedure started
Fusafungine Article-31 referral - PRAC list of questions (PDF/73.17 KB)
First published: 11/09/2015
Last updated: 11/09/2015
Fusafungine Article-31 referral - Timetable for the procedure (PDF/79.31 KB)
First published: 11/09/2015
Last updated: 04/12/2015
Fusafungine Article-31 referral - Review started (PDF/67.92 KB)
First published: 11/09/2015
Last updated: 11/09/2015
Fusafungine Article-31 referral - Notification (PDF/33.98 KB)
First published: 11/09/2015
Last updated: 11/09/2015
Fusafungine Article-31 referral - Annex I (PDF/84.99 KB)
First published: 11/09/2015
Last updated: 11/09/2015
EMA/323030/2015
Recommendation provided by Pharmacovigilance Risk Assessment Committee
Position provided by CMDh
Fusafungine Article-31 referral - Annex II (PDF/98.99 KB)
First published: 14/04/2016
Last updated: 14/04/2016
Fusafungine Article-31 referral - Annex I (PDF/57.85 KB)
First published: 14/04/2016
Last updated: 14/04/2016
Fusafungine Article-31 referral - Assessment report (PDF/280.17 KB)
First published: 14/04/2016
Last updated: 14/04/2016
EMA/194153/2016
Fusafungine Article-31 referral - Annex III (PDF/21.71 KB)
First published: 01/04/2016
Last updated: 14/04/2016
EMA/227560/2016
Fusafungine Article-31 referral - CMDh endorses revocation of authorisations for fusafungine sprays used to treat airway infections (PDF/75.08 KB)
First published: 01/04/2016
Last updated: 01/04/2016
EMA/227560/2016
Document description
- Annex I - List of the medicines affected by the referral
- Annex II - Scientific conclusions of the CHMP or CMDh
- Annex III - Changes to the summary of product characteristics, labelling or package leaflet - available when the CHMP or CMDh recommends changes to the product information. Also includes conditions for lifting of suspensions, if applicable
- Annex IV - Conditions of the marketing authorisation - available when the CHMP or CMDh recommends other measures to be taken for the marketing authorisation such as safety measures or additional studies
- Notification - A letter from a Member State, the European Commission or a marketing-authorisation holder requesting the initiation of a referral procedure
- Rationale for triggering - Background provided by the party triggering the referral explaining the issues leading to the initiation of the procedure
- PRAC list of questions - Questions agreed by the PRAC requesting further information to evaluate the issues identified
- PRAC timetable - Timeframe agreed by the PRAC to receive information, assess the issues and adopt a recommendation
- PRAC / CHMP or CMDh assessment report - The assessment and conclusions of the PRAC and CHMP or CMDh on the issues investigated
News
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01/04/2016
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12/02/2016
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12/02/2016
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15/01/2016
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06/11/2015
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11/09/2015