Zinbryta

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Withdrawn

This medicine's authorisation has been withdrawn

daclizumab
MedicineHumanWithdrawn
  • Application under evaluation
  • CHMP opinion
  • European Commission decision

Overview

On 27 March 2018, the European Commission withdrew the marketing authorisation for Zinbryta (daclizumab beta) in the European Union (EU). The withdrawal was at the request of the marketing authorisation holder, Biogen Idec Ltd, which notified the European Commission of its decision to permanently discontinue the marketing of the product. 

Zinbryta was granted marketing authorisation in the EU on 1 July 2016 for the treatment of relapsing forms of multiple sclerosis. 

The European Public Assessment Report (EPAR) for Zinbryta is updated accordingly to reflect the fact that the marketing authorisation is no longer valid.

Zinbryta : EPAR - Summary for the public

English (EN) (539.87 KB - PDF)

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български (BG) (623.68 KB - PDF)

First published: 19/07/2016Last updated: 02/05/2018
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español (ES) (541.35 KB - PDF)

First published: 19/07/2016Last updated: 02/05/2018
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čeština (CS) (551.54 KB - PDF)

First published: 19/07/2016Last updated: 02/05/2018
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dansk (DA) (510.69 KB - PDF)

First published: 19/07/2016Last updated: 02/05/2018
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Deutsch (DE) (543.23 KB - PDF)

First published: 19/07/2016Last updated: 02/05/2018
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eesti keel (ET) (536.52 KB - PDF)

First published: 19/07/2016Last updated: 02/05/2018
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ελληνικά (EL) (628.44 KB - PDF)

First published: 19/07/2016Last updated: 02/05/2018
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français (FR) (542.84 KB - PDF)

First published: 19/07/2016Last updated: 02/05/2018
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hrvatski (HR) (559.5 KB - PDF)

First published: 19/07/2016Last updated: 02/05/2018
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italiano (IT) (536.25 KB - PDF)

First published: 19/07/2016Last updated: 02/05/2018
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latviešu valoda (LV) (588.49 KB - PDF)

First published: 19/07/2016Last updated: 02/05/2018
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lietuvių kalba (LT) (563.73 KB - PDF)

First published: 19/07/2016Last updated: 02/05/2018
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magyar (HU) (598.14 KB - PDF)

First published: 19/07/2016Last updated: 02/05/2018
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Malti (MT) (591.98 KB - PDF)

First published: 19/07/2016Last updated: 02/05/2018
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Nederlands (NL) (541.57 KB - PDF)

First published: 19/07/2016Last updated: 02/05/2018
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polski (PL) (606.49 KB - PDF)

First published: 19/07/2016Last updated: 02/05/2018
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português (PT) (541.48 KB - PDF)

First published: 19/07/2016Last updated: 02/05/2018
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română (RO) (565.84 KB - PDF)

First published: 19/07/2016Last updated: 02/05/2018
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slovenčina (SK) (588.64 KB - PDF)

First published: 19/07/2016Last updated: 02/05/2018
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slovenščina (SL) (582.09 KB - PDF)

First published: 19/07/2016Last updated: 02/05/2018
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Suomi (FI) (536.58 KB - PDF)

First published: 19/07/2016Last updated: 02/05/2018
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svenska (SV) (537.64 KB - PDF)

First published: 19/07/2016Last updated: 02/05/2018
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Product information

Zinbryta : EPAR - Product Information

English (EN) (1.27 MB - PDF)

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български (BG) (2.25 MB - PDF)

First published: 19/07/2016Last updated: 28/06/2018
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español (ES) (1.32 MB - PDF)

First published: 19/07/2016Last updated: 28/06/2018
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čeština (CS) (2.16 MB - PDF)

First published: 19/07/2016Last updated: 28/06/2018
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dansk (DA) (1.31 MB - PDF)

First published: 19/07/2016Last updated: 28/06/2018
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Deutsch (DE) (1.41 MB - PDF)

First published: 19/07/2016Last updated: 28/06/2018
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eesti keel (ET) (1.23 MB - PDF)

First published: 19/07/2016Last updated: 28/06/2018
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ελληνικά (EL) (2.63 MB - PDF)

First published: 19/07/2016Last updated: 28/06/2018
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français (FR) (1.33 MB - PDF)

First published: 19/07/2016Last updated: 28/06/2018
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hrvatski (HR) (2.81 MB - PDF)

First published: 19/07/2016Last updated: 28/06/2018
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íslenska (IS) (1.08 MB - PDF)

First published: 19/07/2016Last updated: 28/06/2018
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italiano (IT) (1.09 MB - PDF)

First published: 19/07/2016Last updated: 28/06/2018
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latviešu valoda (LV) (1.88 MB - PDF)

First published: 19/07/2016Last updated: 28/06/2018
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lietuvių kalba (LT) (1.16 MB - PDF)

First published: 19/07/2016Last updated: 28/06/2018
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magyar (HU) (1.88 MB - PDF)

First published: 19/07/2016Last updated: 28/06/2018
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Malti (MT) (1.91 MB - PDF)

First published: 19/07/2016Last updated: 28/06/2018
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Nederlands (NL) (1.07 MB - PDF)

First published: 19/07/2016Last updated: 28/06/2018
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norsk (NO) (1.11 MB - PDF)

First published: 19/07/2016Last updated: 28/06/2018
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polski (PL) (1.87 MB - PDF)

First published: 19/07/2016Last updated: 28/06/2018
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português (PT) (1.09 MB - PDF)

First published: 19/07/2016Last updated: 28/06/2018
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română (RO) (1.22 MB - PDF)

First published: 19/07/2016Last updated: 28/06/2018
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slovenčina (SK) (1.86 MB - PDF)

First published: 19/07/2016Last updated: 28/06/2018
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slovenščina (SL) (1.88 MB - PDF)

First published: 19/07/2016Last updated: 28/06/2018
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Suomi (FI) (1.33 MB - PDF)

First published: 19/07/2016Last updated: 28/06/2018
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svenska (SV) (1.08 MB - PDF)

First published: 19/07/2016Last updated: 28/06/2018
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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)

First published: 19/07/2016Last updated: 02/05/2018
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čeština (CS) (488.17 KB - PDF)

First published: 19/07/2016Last updated: 02/05/2018
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dansk (DA) (459.95 KB - PDF)

First published: 19/07/2016Last updated: 02/05/2018
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Deutsch (DE) (479.68 KB - PDF)

First published: 19/07/2016Last updated: 02/05/2018
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eesti keel (ET) (483.13 KB - PDF)

First published: 19/07/2016Last updated: 02/05/2018
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ελληνικά (EL) (518.75 KB - PDF)

First published: 19/07/2016Last updated: 02/05/2018
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français (FR) (493.52 KB - PDF)

First published: 19/07/2016Last updated: 02/05/2018
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hrvatski (HR) (488.31 KB - PDF)

First published: 19/07/2016Last updated: 02/05/2018
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íslenska (IS) (481.38 KB - PDF)

First published: 19/07/2016Last updated: 02/05/2018
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italiano (IT) (481.24 KB - PDF)

First published: 19/07/2016Last updated: 02/05/2018
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latviešu valoda (LV) (511.88 KB - PDF)

First published: 19/07/2016Last updated: 02/05/2018
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lietuvių kalba (LT) (498.05 KB - PDF)

First published: 19/07/2016Last updated: 02/05/2018
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magyar (HU) (510.29 KB - PDF)

First published: 19/07/2016Last updated: 02/05/2018
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Malti (MT) (511.19 KB - PDF)

First published: 19/07/2016Last updated: 02/05/2018
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Nederlands (NL) (480.33 KB - PDF)

First published: 19/07/2016Last updated: 02/05/2018
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norsk (NO) (487.39 KB - PDF)

First published: 19/07/2016Last updated: 02/05/2018
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polski (PL) (525.13 KB - PDF)

First published: 19/07/2016Last updated: 02/05/2018
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português (PT) (480.86 KB - PDF)

First published: 19/07/2016Last updated: 02/05/2018
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română (RO) (498.61 KB - PDF)

First published: 19/07/2016Last updated: 02/05/2018
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slovenčina (SK) (508.81 KB - PDF)

First published: 19/07/2016Last updated: 02/05/2018
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slovenščina (SL) (37.55 KB - PDF)

First published: 19/07/2016Last updated: 02/05/2018
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Suomi (FI) (480.09 KB - PDF)

First published: 19/07/2016Last updated: 02/05/2018
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svenska (SV) (17.62 KB - PDF)

First published: 19/07/2016Last updated: 02/05/2018
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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
Withdrawal of marketing authorisation
27/03/2018
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

English (EN) (567.72 KB - PDF)

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Zinbryta : EPAR - Scientific Conclusion

English (EN) (518.34 KB - PDF)

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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)

First published: Last updated:
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