Xigris
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 recall | 2 |
| BASG reference number | INS-640.001-0269 |
Further inquiry note
Page last modified:
12/07/2022