EMEA-000876-PIP03-14

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Overview

Product details for Soliris
Invented nameSoliris
Active substance

Eculizumab

Decision numberP/0356/2016
PIP numberEMEA-000876-PIP03-14
Pharmaceutical form(s)Concentrate for solution for infusion
Condition(s)/indication(s)

Treatment of neuromyelitis optica spectrum disorders

Route(s) of administrationIntravenous use
PIP applicant

Alexion Europe SAS
France
E-mail: pip.enquiries.eu@alexion.com
Tel. +33 153643800
Fax: +33 153643820

Decision typeP: decision agreeing on a investigation plan, with or without partial waiver(s) and or deferral(s)

Decision