Zinbryta

RSS

daclizumab

Withdrawn
This medicine is now withdrawn from use in the European Union.

Overview

The marketing authorisation for Zinbryta has been withdrawn at the request of the marketing authorisation holder.

This EPAR was last updated on 28/06/2018

Authorisation details

Product details
Name
Zinbryta
Agency product number
EMEA/H/C/003862
Active substance
daclizumab
International non-proprietary name (INN) or common name
daclizumab
Therapeutic area (MeSH)
Multiple Sclerosis
Anatomical therapeutic chemical (ATC) code
L04AC01
Additional monitoring

This medicine is under additional monitoring, meaning that it is monitored even more intensively than other medicines. For more information, see Medicines under additional monitoring.

Publication details
Marketing-authorisation holder
Biogen Idec Ltd
Revision
8
Date of issue of marketing authorisation valid throughout the European Union
01/07/2016
Contact address
Innovation House
70 Norden Road
Maidenhead
Berkshire SL6 4AY
United Kingdom

Product information

27/03/2018 Zinbryta - EMEA/H/C/003862 - IB/0015

Contents

  • Annex I - Summary of product characteristics
  • Annex IIA - Manufacturing-authorisation holder responsible for batch release
  • Annex IIB - Conditions of the marketing authorisation
  • Annex IIIA - Labelling
  • Annex IIIB - Package leaflet

Please note that the size of the above document can exceed 50 pages.

You are therefore advised to be selective about which sections or pages you wish to print.

Pharmacotherapeutic group

IMMUNOSUPPRESSANTS

Therapeutic indication

Zinbryta is indicated in adult patients for the treatment of relapsing forms of multiple sclerosis (RMS).

Assessment history

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