Fenspiride containing medicinal products

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


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
Drugs for obstructive airway diseases
About this procedure
Current status
CMDh final position
Reference number
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.

Authorisation model
Nationally authorised product(s)
Decision making model
Key dates and outcomes
Procedure start date
PRAC recommendation date
CHMP opinion/CMDh position date

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

  • 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)


    First published: 12/06/2019

  • List item

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

    First published: 29/05/2019

  • 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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