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MIRCERA

BLA · Biologics License Application · Sponsor: HOFFMAN-LA ROCHE · Approved 2007-11-14

Drug application

FDA Application #

BLA125164

Application type

Biologics License Application

Brand name

MIRCERA

Generic name

METHOXY POLYETHYLENE GLYCOL-EPOETIN BETA

Active ingredients

METHOXY POLYETHYLENE GLYCOL-EPOETIN BETA

Dosage form

SOLUTION

Route

INJECTION

Marketing status

Prescription

Sponsor

HOFFMAN-LA ROCHE

Manufacturer

Vifor (International) Inc.

First approval

2007-11-14

Source

Authoritative

Drugs@FDA application overview

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