Recall | Medicines | 27/10/2011

The marketing authorization holder, in agreement with the European Medicines Agency (EMA), has informed its supplied customers by letter dated October 27, 2011, that all batches of the product Xigris are being recalled. The reason for this withdrawal is the results from a recently completed study that showed no statistical superiority of efficacy parameters over placebo, calling into question the benefit-risk profile of the product for the treatment of severe sepsis.

Note: Please also read the safety information of the Institute of Pharmacovigilance dated 25.10.2011 regarding Xigris (drotrecogin alfa).

Name of the medicinal product (1) Xigris 5 mg Pulver zur Herstellung einer Infusionslösung
(2) Xigris 20 mg Pulver zur Herstellung einer Infusionslösung
Marketing authorisation number(s) (1) EU/1/02/225/001
(2) EU/1/02/225/002
Marketing authorisation holder Eli Lilly Nederland B.V.

Durchführung Rückruf:
Eli Lilly GmbH
Kölblgasse 8-10, A-1030 Wien
Batch number(s) Alle Chargen
Classification of the recall2
BASG reference number INS-640.001-0269

Further inquiry note