Zinbryta

daclizumab

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The marketing authorisation for Zinbryta has been withdrawn at the request of the marketing authorisation holder.

Name Language First published Last updated
Zinbryta : EPAR - Summary for the public BG = bălgarski 2016-07-19 2018-05-02
Zinbryta : EPAR - Summary for the public ES = español 2016-07-19 2018-05-02
Zinbryta : EPAR - Summary for the public CS = čeština 2016-07-19 2018-05-02
Zinbryta : EPAR - Summary for the public DA = dansk 2016-07-19 2018-05-02
Zinbryta : EPAR - Summary for the public DE = Deutsch 2016-07-19 2018-05-02
Zinbryta : EPAR - Summary for the public ET = eesti keel 2016-07-19 2018-05-02
Zinbryta : EPAR - Summary for the public EL = elliniká 2016-07-19 2018-05-02
Zinbryta : EPAR - Summary for the public EN = English 2016-07-19 2018-05-02
Zinbryta : EPAR - Summary for the public FR = français 2016-07-19 2018-05-02
Zinbryta : EPAR - Summary for the public IT = italiano 2016-07-19 2018-05-02
Zinbryta : EPAR - Summary for the public LV = latviešu valoda 2016-07-19 2018-05-02
Zinbryta : EPAR - Summary for the public LT = lietuvių kalba 2016-07-19 2018-05-02
Zinbryta : EPAR - Summary for the public HU = magyar 2016-07-19 2018-05-02
Zinbryta : EPAR - Summary for the public MT = Malti 2016-07-19 2018-05-02
Zinbryta : EPAR - Summary for the public NL = Nederlands 2016-07-19 2018-05-02
Zinbryta : EPAR - Summary for the public PL = polski 2016-07-19 2018-05-02
Zinbryta : EPAR - Summary for the public PT = português 2016-07-19 2018-05-02
Zinbryta : EPAR - Summary for the public RO = română 2016-07-19 2018-05-02
Zinbryta : EPAR - Summary for the public SK = slovenčina 2016-07-19 2018-05-02
Zinbryta : EPAR - Summary for the public SL = slovenščina 2016-07-19 2018-05-02
Zinbryta : EPAR - Summary for the public FI = suomi 2016-07-19 2018-05-02
Zinbryta : EPAR - Summary for the public SV = svenska 2016-07-19 2018-05-02
Zinbryta : EPAR - Summary for the public HR = Hrvatski 2016-07-19 2018-05-02

This EPAR was last updated on 28/06/2018 .

Authorisation details

Product details

Product details for Zinbryta
NameZinbryta
Agency product numberEMEA/H/C/003862
Active substance

daclizumab

International non-proprietary name (INN) or common name

daclizumab

Therapeutic area Multiple Sclerosis
Anatomical therapeutic chemical (ATC) code L04AC01
Additional monitoring

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

Publication details

Publication details for Zinbryta
Marketing-authorisation holder

Biogen Idec Ltd

Revision8
Date of issue of marketing authorisation valid throughout the European Union01/07/2016

Contact address:

Biogen Idec Ltd
Innovation House 
70 Norden Road 
Maidenhead 
Berkshire SL6 4AY 
United Kingdom

Product information

Product information

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

Name Language First published Last updated
Zinbryta : EPAR - Product Information HR = Hrvatski 2016-07-19 2018-06-28
Zinbryta : EPAR - Product Information HR = Hrvatski 2016-07-19 2018-06-28
Zinbryta : EPAR - Product Information HR = Hrvatski 2016-07-19 2018-06-28
Zinbryta : EPAR - Product Information HR = Hrvatski 2016-07-19 2018-06-28
Zinbryta : EPAR - Product Information HR = Hrvatski 2016-07-19 2018-06-28
Zinbryta : EPAR - Product Information HR = Hrvatski 2016-07-19 2018-06-28
Zinbryta : EPAR - Product Information HR = Hrvatski 2016-07-19 2018-06-28
Zinbryta : EPAR - Product Information HR = Hrvatski 2016-07-19 2018-06-28
Zinbryta : EPAR - Product Information HR = Hrvatski 2016-07-19 2018-06-28
Zinbryta : EPAR - Product Information HR = Hrvatski 2016-07-19 2018-06-28
Zinbryta : EPAR - Product Information HR = Hrvatski 2016-07-19 2018-06-28
Zinbryta : EPAR - Product Information HR = Hrvatski 2016-07-19 2018-06-28
Zinbryta : EPAR - Product Information HR = Hrvatski 2016-07-19 2018-06-28
Zinbryta : EPAR - Product Information HR = Hrvatski 2016-07-19 2018-06-28
Zinbryta : EPAR - Product Information HR = Hrvatski 2016-07-19 2018-06-28
Zinbryta : EPAR - Product Information HR = Hrvatski 2016-07-19 2018-06-28
Zinbryta : EPAR - Product Information HR = Hrvatski 2016-07-19 2018-06-28
Zinbryta : EPAR - Product Information HR = Hrvatski 2016-07-19 2018-06-28
Zinbryta : EPAR - Product Information HR = Hrvatski 2016-07-19 2018-06-28
Zinbryta : EPAR - Product Information HR = Hrvatski 2016-07-19 2018-06-28
Zinbryta : EPAR - Product Information HR = Hrvatski 2016-07-19 2018-06-28
Zinbryta : EPAR - Product Information HR = Hrvatski 2016-07-19 2018-06-28
Zinbryta : EPAR - Product Information HR = Hrvatski 2016-07-19 2018-06-28
Zinbryta : EPAR - Product Information HR = Hrvatski 2016-07-19 2018-06-28
Zinbryta : EPAR - Product Information HR = Hrvatski 2016-07-19 2018-06-28

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.


Name Language First published Last updated
Zinbryta : EPAR - All Authorised presentations HR = Hrvatski 2016-07-19 2018-05-02
Zinbryta : EPAR - All Authorised presentations HR = Hrvatski 2016-07-19 2018-05-02
Zinbryta : EPAR - All Authorised presentations HR = Hrvatski 2016-07-19 2018-05-02
Zinbryta : EPAR - All Authorised presentations HR = Hrvatski 2016-07-19 2018-05-02
Zinbryta : EPAR - All Authorised presentations HR = Hrvatski 2016-07-19 2018-05-02
Zinbryta : EPAR - All Authorised presentations HR = Hrvatski 2016-07-19 2018-05-02
Zinbryta : EPAR - All Authorised presentations HR = Hrvatski 2016-07-19 2018-05-02
Zinbryta : EPAR - All Authorised presentations HR = Hrvatski 2016-07-19 2018-05-02
Zinbryta : EPAR - All Authorised presentations HR = Hrvatski 2016-07-19 2018-05-02
Zinbryta : EPAR - All Authorised presentations HR = Hrvatski 2016-07-19 2018-05-02
Zinbryta : EPAR - All Authorised presentations HR = Hrvatski 2016-07-19 2018-05-02
Zinbryta : EPAR - All Authorised presentations HR = Hrvatski 2016-07-19 2018-05-02
Zinbryta : EPAR - All Authorised presentations HR = Hrvatski 2016-07-19 2018-05-02
Zinbryta : EPAR - All Authorised presentations HR = Hrvatski 2016-07-19 2018-05-02
Zinbryta : EPAR - All Authorised presentations HR = Hrvatski 2016-07-19 2018-05-02
Zinbryta : EPAR - All Authorised presentations HR = Hrvatski 2016-07-19 2018-05-02
Zinbryta : EPAR - All Authorised presentations HR = Hrvatski 2016-07-19 2018-05-02
Zinbryta : EPAR - All Authorised presentations HR = Hrvatski 2016-07-19 2018-05-02
Zinbryta : EPAR - All Authorised presentations HR = Hrvatski 2016-07-19 2018-05-02
Zinbryta : EPAR - All Authorised presentations HR = Hrvatski 2016-07-19 2018-05-02
Zinbryta : EPAR - All Authorised presentations HR = Hrvatski 2016-07-19 2018-05-02
Zinbryta : EPAR - All Authorised presentations HR = Hrvatski 2016-07-19 2018-05-02
Zinbryta : EPAR - All Authorised presentations HR = Hrvatski 2016-07-19 2018-05-02
Zinbryta : EPAR - All Authorised presentations HR = Hrvatski 2016-07-19 2018-05-02
Zinbryta : EPAR - All Authorised presentations HR = Hrvatski 2016-07-19 2018-05-02

Pharmacotherapeutic group

Immunosuppressants

Therapeutic indication

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

Assessment History

Changes since initial authorisation of medicine

Name Language First published Last updated
Zinbryta : EPAR - Procedural steps taken and scientific information after authorisation HR = Hrvatski 2016-09-22 2018-06-28
Zinbryta-H-A20-1456-C-3862-0010 : EPAR - Assessment Report - Article 20 HR = Hrvatski 2018-01-12 2018-05-02
Zinbryta : EPAR - Scientific Conclusion HR = Hrvatski 2018-01-12 2018-05-02

Initial marketing-authorisation documents

Name Language First published Last updated
Zinbryta : EPAR - Public assessment report HR = Hrvatski 2016-07-19 2018-05-02
CHMP summary of opinion for Zinbryta HR = Hrvatski 2016-04-29 2018-05-02

Withdrawn

This medicine is now withdrawn from use in the European Union

More information on Zinbryta