Is Daclizumab approved by the US FDA?

Drugs@FDA lists 1 application product line for Daclizumab, including ZINBRYTA (Prescription).

Is Daclizumab authorised in the European Union?

EMA lists 0 centrally authorised medicines containing Daclizumab.

Are there safety signals or safety updates for Daclizumab?

US FDA: 1 entry; MHRA: 1 entry (latest 2018-03-08).

Active substance

Daclizumab

US FDA 1
EMA 2
Safety 2

Open in the medicines table

US FDA United States — FDA approvals (Drugs@FDA)

Product	Strength	Form · route	Applicant	Status	First approved
ZINBRYTA	150MG/ML	injectable · injection	BIOGEN	Prescription	27 May 2016

EMA European Union — centrally authorised medicines

Zenapax Roche Registration Ltd. · Withdrawn · authorised 26 Feb 1999 · ATC L04AA08

Therapeutic indication (EMA)

Zenapax is indicated for the prophylaxis of acute organ rejection in de novo allogenic renal transplantation and is to be used concomitantly with an immunosuppressive regimen, including cyclosporine and corticosteroids in patients who are not highly immunised.

Zinbryta Biogen Idec Ltd · Withdrawn · authorised 1 Jul 2016 · ATC L04AC01

Therapeutic indication (EMA)

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

Safety signals and safety-related labeling changes

MHRA 8 Mar 2018 Daclizumab (Zinbryta▼): suspension and recall for safety reasons; review patients as soon as possible and start alternative therapy
The European Medicines Agency (EMA) has recommended the immediate suspension of the marketing authorisation and recall of daclizumab (Zinbryta) in the EU following reports of serious inflammatory brain disorders, including encephalitis and meningoencephalitis, in patients with multiple sclerosis.
US FDA 28 Aug 2017 ZINBRYTA — safety-related labeling change
Labeling sections changed: Boxed Warning; Warnings and Precautions; Adverse Reactions; Patient Counseling Information / Patient Information / Medication Guide

All safety entries for daclizumab →

Values as published by each source: SFDA human drug list (4-2026, as published by the Council of Health Insurance; indications from the CHI Daman Drug Formulary), Drugs@FDA, EMA medicines data, Health Canada Drug Product Database (Open Government Licence – Canada), CMS NADAC, NHS Drug Tariff Part VIIIA (NHSBSA Copyright, Open Government Licence v3.0), WHO Model List of Essential Medicines (CC BY 3.0 IGO; regrouped by active substance, not created by WHO), EMA PRAC, US FDA safety-related labeling changes and MHRA Drug Safety Update (Open Government Licence v3.0). Sources and reuse. Not a substitute for the official registers or the product information.