EMEA-002077-PIP01-16

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Overview

Product details for -
Invented name-
Active substance

Fc- and CDR-modified humanised monoclonal antibody against C5

Decision numberP/0199/2017
PIP numberEMEA-002077-PIP01-16
Pharmaceutical form(s)Concentrate for solution for infusion
Condition(s)/indication(s)

Treatment of paroxysmal nocturnal haemoglobinuria

Route(s) of administrationIntravenous use
PIP applicant

Alexion Europe SAS
France
Tel. +33 14100606
E-mail: pip.enquiries@alexion.com 

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

Decision