• Procedure started
  • Under evaluation
  • PRAC recommendation
  • CHMP opinion
  • European Commission final decision
Current status
European Commission final decision


Measures to minimise risk of serious side effects of multiple sclerosis medicine Lemtrada

On 14 November 2019, EMA recommended restricting the use of the multiple sclerosis medicine Lemtrada (alemtuzumab) due to reports of rare but serious side effects, including deaths. New measures to identify and manage the serious side effects were also recommended. The side effects include cardiovascular disorders (affecting the heart, circulation and bleeding as well as stroke) and immune-related disorders (caused by the body’s defence system not working properly).

Lemtrada should now only be used to treat relapsing-remitting multiple sclerosis if the disease is highly active despite treatment with at least one disease-modifying therapy or if the disease is worsening rapidly. Lemtrada must also no longer be used in patients with certain heart, circulation or bleeding disorders or in patients who have autoimmune disorders other than multiple sclerosis.

The medicine should only be given in a hospital with ready access to intensive care facilities and specialists who can manage serious adverse reactions.

EMA also recommended updating the physician’s guide and the patient information pack with advice on minimising the risk of serious cardiovascular disorders, which may occur shortly after a Lemtrada infusion (drip), and immune-related conditions, which may occur many months and possibly years after the last treatment.

These recommendations, issued by the EMA’s safety committee (PRAC), were endorsed by the Agency’s human medicines committee (CHMP). They replace the PDF icon temporary measures introduced in April 2019 while the review of Lemtrada was under way. The European Commission issued its decision on these changes on 16 January 2020.

Key facts

About this medicine
Approved name
International non-proprietary name (INN) or common name
Associated names
About this procedure
Current status
European Commission final decision
Reference number
Article 20 procedures

This type of procedure is triggered for medicines that have been authorised via the centralised procedure in case of quality, safety or efficacy issues.

Authorisation model
Centrally authorised product(s)
Decision making model
Key dates and outcomes
Procedure start date
PRAC recommendation date
CHMP opinion/CMDh position date
EC decision date
Risk minimisation measures

All documents

Procedure started

Under evaluation

  • List item

    Lemtrada Article 20 procedure - Product information (PDF/840.18 KB)

    First published: 08/05/2019

  • List item

    Lemtrada Article 20 procedure - Scientific conclusions (PDF/49.95 KB)

    First published: 08/05/2019

  • List item

    Lemtrada Article 20 procedure - Assessment report on provisional measures (PDF/126.37 KB)


    First published: 08/05/2019

  • Recommendation provided by Pharmacovigilance Risk Assessment Committee

    Opinion provided by Committee for Medicinal Products for Human Use

    European Commission final decision

  • List item

    Lemtrada Article 20 procedure - Measures to minimise risk of serious side effects of multiple sclerosis medicine Lemtrada (PDF/144.53 KB)

    First published: 04/02/2020

  • List item

    Lemtrada Article 20 procedure - Scientific conclusions (PDF/123.54 KB)

    First published: 04/02/2020

  • List item

    Lemtrada Article 20 procedure - CHMP divergent positions (PDF/116.82 KB)


    First published: 28/01/2020

  • List item

    Lemtrada Article 20 procedure - PRAC assessment report (PDF/884.23 KB)


    First published: 28/01/2020

  • 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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