Overview

The marketing authorisation for Zinbryta has been withdrawn at the request of the marketing authorisation holder.

Zinbryta : EPAR - Summary for the public

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Product information

Zinbryta : EPAR - Product Information

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Latest procedure affecting product information: IB/0015

27/03/2018

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This medicine’s product information is available in all official EU languages.
Select 'available languages' to access the language you need.

 

Product information documents contain:

  • summary of product characteristics (annex I);
  • manufacturing authorisation holder responsible for batch release (annex IIA);
  • conditions of the marketing authorisation (annex IIB);
  • labelling (annex IIIA);
  • package leaflet (annex IIIB).

Zinbryta : EPAR - All Authorised presentations

English (EN) (477.64 KB - PDF)

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български (BG) (517.25 KB - PDF)

First published: 19/07/2016Last updated: 02/05/2018
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español (ES) (481.09 KB - PDF)

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čeština (CS) (488.17 KB - PDF)

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dansk (DA) (459.95 KB - PDF)

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Deutsch (DE) (479.68 KB - PDF)

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eesti keel (ET) (483.13 KB - PDF)

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ελληνικά (EL) (518.75 KB - PDF)

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français (FR) (493.52 KB - PDF)

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hrvatski (HR) (488.31 KB - PDF)

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íslenska (IS) (481.38 KB - PDF)

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italiano (IT) (481.24 KB - PDF)

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latviešu valoda (LV) (511.88 KB - PDF)

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lietuvių kalba (LT) (498.05 KB - PDF)

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magyar (HU) (510.29 KB - PDF)

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Malti (MT) (511.19 KB - PDF)

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Nederlands (NL) (480.33 KB - PDF)

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norsk (NO) (487.39 KB - PDF)

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polski (PL) (525.13 KB - PDF)

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português (PT) (480.86 KB - PDF)

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română (RO) (498.61 KB - PDF)

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slovenčina (SK) (508.81 KB - PDF)

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slovenščina (SL) (37.55 KB - PDF)

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Suomi (FI) (480.09 KB - PDF)

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svenska (SV) (17.62 KB - PDF)

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Product details

Name of medicine
Zinbryta
Active substance
daclizumab
International non-proprietary name (INN) or common name
daclizumab
Therapeutic area (MeSH)
Multiple Sclerosis
Anatomical therapeutic chemical (ATC) code
L04AC01

Pharmacotherapeutic group

Immunosuppressants

Therapeutic indication

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

Authorisation details

EMA product number
EMEA/H/C/003862
Marketing authorisation holder
Biogen Idec Ltd

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

Opinion adopted
31/03/2016
Marketing authorisation issued
01/07/2016
Revision
8

Assessment history

Zinbryta Article-20 referral - PRAC assessment report

Reference Number: EMA/779877/2017

English (EN) (241.57 KB - PDF)

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Zinbryta Article-20 referral - PRAC recommends further restrictions for multiple sclerosis medicine Zinbryta due to risk of serious liver damage

Reference Number: EMEA/H/A-20/1456/C/003862/0010

English (EN) (193.2 KB - PDF)

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Zinbryta : EPAR - Procedural steps taken and scientific information after authorisation

Adopted

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Zinbryta : EPAR - Scientific Conclusion

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Zinbryta-H-A20-1456-C-3862-0010 : EPAR - Assessment Report - Article 20

Reference Number: EMA/779877/2017

English (EN) (847.17 KB - PDF)

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Zinbryta : EPAR - Public assessment report

AdoptedReference Number: EMA/458317/2016

English (EN) (6.09 MB - PDF)

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CHMP summary of opinion for Zinbryta

AdoptedReference Number: EMA/CHMP/268320/2016

English (EN) (540.19 KB - PDF)

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More information on Zinbryta

Public statement on Zinbryta: Withdrawal of the marketing authorisation in the European Union

Reference Number: EMA/247897/2018

English (EN) (65.95 KB - PDF)

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