EMEA-002077-PIP01-16

Key facts

Active substance
Fc- and CDR-modified humanised monoclonal antibody against C5
Therapeutic area
Haematology-Hemostaseology
Decision number
P/0199/2017
PIP number
EMEA-002077-PIP01-16
Pharmaceutical form(s)
Concentrate for solution for infusion
Condition(s) / indication(s)
Treatment of paroxysmal nocturnal haemoglobinuria
Route(s) of administration
Intravenous use
Contact for public enquiries
Alexion Europe SAS
France
Tel. +33 14100606
E-mail: pip.enquiries@alexion.com 
Decision type
P: decision agreeing on a investigation plan, with or without partial waiver(s) and or deferral(s)

Decision

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