Zinbryta
daclizumab
Table of contents
Overview
The marketing authorisation for Zinbryta has been withdrawn at the request of the marketing authorisation holder.
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
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).
You can find product information documents for centrally authorised human medicines on this website. For centrally authorised veterinary medicines authorised or updated from February 2022, see the Veterinary Medicines Information website.
Pharmacotherapeutic group
Immunosuppressants
Therapeutic indication
Zinbryta is indicated in adult patients for the treatment of relapsing forms of multiple sclerosis (RMS).