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 recall||3|
|BASG reference number||INS-640.001-2484|