EMEA-000876-PIP01-10-M01

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Overview

Product details for Soliris
Invented nameSoliris
Active substance

Eculizumab

Decision numberP/0290/2014
PIP numberEMEA-000876-PIP01-10-M01
Pharmaceutical form(s)Concentrate for solution for infusion
Condition(s)/indication(s)

Treatment of Atypical Haemolytic Uraemic Syndrome

Treatment of Paroxysmal Nocturnal Haemoglobinuria

Route(s) of administrationIntravenous use
PIP applicant

Alexion Europe SAS
France
Tel. +33 1536 43800
Fax +33 1536 43820
E-mail: pip.enquiries.eu@alxn.com

Decision typePM: decision on the application for modification of an agreed PIP

Decision