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SOLIRIS

BLA · Biologics License Application · Sponsor: ALEXION PHARM · Approved 2007-03-16

Drug application

FDA Application #

BLA125166

Application type

Biologics License Application

Brand name

SOLIRIS

Generic name

ECULIZUMAB

Active ingredients

ECULIZUMAB

Dosage form

INJECTABLE

Route

IV (INFUSION)

Marketing status

Prescription

Sponsor

ALEXION PHARM

Manufacturer

Alexion Pharmaceuticals Inc.

First approval

2007-03-16

Source

Authoritative

Drugs@FDA application overview

Machine

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