Recall | Medicines | 15/03/2018

The marketing authorization holder has informed its supplied customers in a letter dated March 13, 2018, that cases of immune-mediated encephalitis and meningoencephalitis have been reported in patients treated with Zinbryta. This has resulted in an immediate suspension of the marketing authorization in the European Union, which means that all batches on the market must be recalled.

Name of the medicinal product Zinbryta 150 mg Injektionslösung in einem Fertigpen
Zinbryta 150 mg Injektionslösung in einer Fertigspritze
Marketing authorisation number(s) EU/1/16/1107/003
Marketing authorisation holder Biogen Idec Ltd.
Batch number(s) Alle Chargen
Classification of the recall3
BASG reference number INS-640.001-2484

Further inquiry note