Replacement | Medicines | 22/08/2013

The marketing authorization holder informed its supplied customers in a letter dated August 22, 2013, that visible particles were detected in some vials and that a recall of the two affected batches will therefore be carried out.

Name of the medicinal product Soliris 300mg Konzentrat zur Herstellung einer Infusionslösung
Marketing authorisation number(s) EU/1/07/393/001
Marketing authorisation holder Alexion Europe SAS

Zurückrufende Firma:
Alexion Pharma Germany GmbH
Batch number(s) 00010D, 00010DR
Classification of the recall2
BASG reference number INS-640.001-0870

Further inquiry note