Zinbryta
Withdrawn
This medicine's authorisation has been withdrawn
daclizumab
MedicineHumanWithdrawn
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- 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Assessment Report (EPAR) for Zinbryta is updated accordingly to reflect the fact that the marketing authorisation is no longer valid.
Product information
Latest procedure affecting product information:IB/0015
27/03/2018
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).
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
ImmunosuppressantsTherapeutic indication
Zinbryta is indicated in adult patients for the treatment of relapsing forms of multiple sclerosis (RMS).
News on Zinbryta
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