Fenspiride containing medicinal products

  • Procedure started
  • Under evaluation
  • PRAC recommendation
  • CMDh position
  • European Commission final decision
Current status:
Position provided by CMDh

Overview

Withdrawal of marketing authorisations for fenspiride medicines

On 16 May 2019, EMA’s safety committee (PRAC) recommended that the marketing authorisations for fenspiride medicines be revoked, so the medicines can no longer be marketed in the EU. This follows a review that confirmed that these cough medicines could cause heart rhythm problems.

The PRAC considered all the available evidence in its review. This included cases of QT prolongation and torsades de pointes (abnormalities of the heart’s electrical activity that may lead to heart rhythm disturbances) in patients using these medicines, results of laboratory studies, data from published literature and stakeholder input.

Heart rhythm problems can be serious and occur suddenly, and it is not feasible to identify in advance the patients who may be at risk of these problems with fenspiride. In contrast, fenspiride medicines are used to treat non-serious cough. Therefore, the PRAC considered that these medicines should no longer be marketed.

The PRAC recommendation was adopted by the CMDh* by consensus and will be implemented directly at national level.

 

*Co-ordination Group for Mutual Recognition and Decentralised Procedures – Human

Key facts

About this medicine
Approved name
Fenspiride containing medicinal products
International non-proprietary name (INN) or common name

fenspiride

Class
Drugs for obstructive airway diseases
About this procedure
Current status
Position provided by CMDh
Reference number
EMEA/H/A-107i/1480
Type
Article 107i procedures

This type of procedure is triggered when a Member State or the European Commission consider that urgent action is necessary because of a safety issue. Situations that fall under this procedure include consideration for suspension or revocation of the marketing authorisation for a medicine, the prohibition of supply of a medicine or major changes to the marketing authorisation such as deletion of indications, reduction of the recommended dose or new contraindications. The procedure is also applicable in case of a safety issue with a class of medicines.

Decision making model
PRAC-CMDh
Authorisation model
Nationally authorised product(s)
Key dates and outcomes
Procedure start date
14/02/2019
PRAC recommendation date
17/05/2019
CHMP opinion/CMDh position date
29/05/2019

All documents

Procedure started

Recommendation provided by Pharmacovigilance Risk Assessment Committee

Position provided by CMDh

  • List item

    Fenspiride containing medicinal products Article-107i referral - Withdrawal of marketing authorisations for fenspiride medicines (PDF/81.99 KB)


    First published: 17/05/2019
    Last updated: 29/05/2019
    EMA/285298/2019

  • List item

    Fenspiride containing medicinal products Article-107i referral - Annex I (PDF/70.06 KB)


    First published: 26/06/2019

  • List item

    Fenspiride containing medicinal products Article-107i referral - Annex II (PDF/58.49 KB)


    First published: 26/06/2019

  • List item

    Fenspiride containing medicinal products Article-107i referral - Assessment report (PDF/193.22 KB)

    Adopted

    First published: 12/06/2019
    EMA/317731/2019

  • List item

    Fenspiride containing medicinal products Article-107i referral - Annex III (PDF/12.66 KB)


    First published: 29/05/2019

  • 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

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