Overview
The marketing authorisation for Zinbryta has been withdrawn at the request of the marketing authorisation holder.
Zinbryta : EPAR - Summary for the public
Product information
Zinbryta : EPAR - 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).
Zinbryta : EPAR - All Authorised presentations
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).
Assessment history
Zinbryta Article-20 referral - PRAC assessment report
Zinbryta Article-20 referral - PRAC recommends further restrictions for multiple sclerosis medicine Zinbryta due to risk of serious liver damage
Zinbryta : EPAR - Procedural steps taken and scientific information after authorisation
Zinbryta : EPAR - Scientific Conclusion
Zinbryta-H-A20-1456-C-3862-0010 : EPAR - Assessment Report - Article 20