Zinbryta

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

Overview

EMA review of Zinbryta confirms medicine's risks outweigh its benefits

Multiple sclerosis medicine no longer authorised and has been recalled from hospitals and pharmacies

EMA's Pharmacovigilance Risk Assessment Committee (PRAC) has confirmed that the multiple sclerosis medicine Zinbryta (daclizumab beta) poses a risk of serious and potentially fatal immune reactions affecting the brain, liver and other organs.

Patients could be at risk from the start of treatment and for several months after stopping treatment, and it is not possible to predict which patients will be affected. The PRAC therefore confirmed its previous conclusions that risks of Zinbryta outweigh its benefits for patients with multiple sclerosis.

Healthcare professionals should continue monitoring patients who have been treated with Zinbryta in line with recommendations issued in PDF icon March 2018 .

There are no immediate consequences of the PRAC's review as Zinbryta is no longer authorised in the EU. On 27 March 2018, the marketing authorisation was withdrawn at the request of Biogen Idec Ltd, the company that marketed the medicine. Zinbryta is no longer available in hospitals and pharmacies in the EU.

A full assessment report on the review will be published shortly.

Key facts

About this medicine
Approved name
Zinbryta
Associated names
Zinbryta
About this procedure
Current status
European Commission final decision
Reference number
EMEA/H/A-20/1462/C/003862/0018
Type
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.

Decision making model
PRAC-CHMP-EC
Authorisation model
Centrally authorised product(s)
Key dates and outcomes
Procedure start date
02/03/2018
PRAC recommendation date
17/05/2018
EC decision date
27/03/2018
Outcome
Suspension

All documents

Procedure started

Under evaluation

  • List item

    Zinbryta Article-20 procedure - Scientific conclusions (PDF/49.53 KB)


    First published: 14/03/2018
    Last updated: 14/03/2018

  • List item

    Zinbryta Article-20 procedure - Assessment report on provisional measures (PDF/169.92 KB)


    First published: 14/03/2018
    Last updated: 14/03/2018
    EMA/159031/2018

  • List item

    Zinbryta Article-20 procedure - Multiple sclerosis medicine Zinbryta suspended in the EU (PDF/86.41 KB)


    First published: 07/03/2018
    Last updated: 14/03/2018
    EMA/134289/2018

  • Recommendation provided by Pharmacovigilance Risk Assessment Committee

  • List item

    Zinbryta Article-20 procedure - EMA review of Zinbryta confirms medicine’s risks outweigh its benefits (PDF/74.71 KB)


    First published: 18/05/2018
    Last updated: 11/07/2018
    EMA/286850/2018

  • European Commission final decision

    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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