# MIRCERA
> **BLA125164** · Biologics License Application · Sponsor: HOFFMAN-LA ROCHE · Approved 2007-11-14
## Drug
- **FDA Application Number:** 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
- [Drugs@FDA application overview](https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=125164)
---
*AI Analytics · CC0 1.0*