Almitrine-containing medicines

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

Overview


Oral almitrine to be withdrawn by EU Member States

The Coordination Group for Mutual Recognition and Decentralised Procedures – Human (CMDh), a medicines regulatory body representing the European Union (EU) Member States, has endorsed the recommendation by the European Medicines Agency's (EMA's) Pharmacovigilance Risk Assessment Committee (PRAC), that permission to market oral medicines containing almitrine should be withdrawn across the EU.

As the PRAC recommendation was endorsed by consensus by the CMDh, it will now be implemented directly by the Member States where oral almitrine is authorised, according to an agreed timetable, which should be completed by 25 July 2013.

Almitrine is a stimulant of the part of the brain responsible for the breathing reflex. In the EU, it is authorised in France, Poland and Portugal to be taken orally for the treatment of chronic respiratory failure (inability of the lungs to take in oxygen and get rid of carbon dioxide properly), which is associated with hypoxaemia (lower than normal levels of oxygen in the blood). These conditions pose a particular problem in patients with lung conditions known as chronic obstructive pulmonary disease (COPD), where the airways and air sacs inside the lungs become damaged or blocked.

The safety review of oral almitrine was requested by the French medicines agency, the National Agency for the Safety of Medicine and Health Products (ANSM), because of concerns about side effects and a view that the available evidence did not support the use of the medicine in the current management of COPD. The PRAC concluded that there is a clear association between oral almitrine treatment and potentially serious and long-lasting peripheral neuropathy (damage to the nerves in the hands and feet) and significant weight loss that further weakens patients. The PRAC noted that cases continue to be reported even after additional precautions on the use of the medicines were put in place. Furthermore, oral almitrine is no longer included as a recommended therapy in international treatment guidelines for the management of COPD.

The CMDh agreed with the PRAC conclusion that the benefits of these medicines do not outweigh their risks, and adopted a final position that the marketing authorisations should be withdrawn throughout the EU.

Key facts

About this medicine
Approved name
Almitrine-containing medicines
International non-proprietary name (INN) or common name
almitrine
Associated names
  • Vectarion
  • Armanor
About this procedure
Current status
CMDh final position
Reference number
EMEA/H/A-31/1346
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.

Decision making model
PRAC-CMDh
Authorisation model
Nationally authorised product(s)
Key dates and outcomes
Procedure start date
29/11/2012
PRAC recommendation date
16/05/2013
CHMP opinion/CMDh position date
29/05/2013
Outcome
Suspension

All documents

Procedure started

Recommendation provided by Pharmacovigilance Risk Assessment Committee

Position provided by CMDh

  • List item

    Almitrine Article-31 - Oral almitrine to be withdrawn by EU Member States (PDF/94.05 KB)


    First published: 31/05/2013
    Last updated: 31/05/2013
    EMA/313994/2013

  • List item

    Almitrine Article-31 referral - Annex I (PDF/28.55 KB)


    First published: 10/06/2013
    Last updated: 10/06/2013

  • List item

    Almitrine Article-31 referral - Annex II (PDF/88.64 KB)


    First published: 10/06/2013
    Last updated: 02/12/2013

  • List item

    Almitrine Article-31 referral - Annex III (PDF/39.38 KB)


    First published: 10/06/2013
    Last updated: 02/12/2013

  • List item

    Almitrine Article-31 - Oral almitrine to be withdrawn by EU Member States (PDF/94.05 KB)


    First published: 31/05/2013
    Last updated: 31/05/2013
    EMA/313994/2013

  • 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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