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General MedicationsINJECTIONStandard

MIRCERA

METHOXY POLYETHYLENE GLYCOL-EPOETIN BETA

Standard Dose
0.6MG/KG
Max Dose
Refer to approved labeling
Primary Use
Review priority: STANDARD Marketing status: Prescription
Summary

Approval overview MIRCERA is listed in Drugs@FDA under application 125164 (BLA).

Review priority: STANDARD Marketing status: Prescription Active ingredient METHOXY POLYETHYLENE GLYCOL-EPOETIN BETA Form and strength SOLUTION; INJECTION - 0.6MG/KG Sponsor HOFFMAN-LA ROCHE Submission history Latest submission status date: 2024-06-04 00:00:00.

Structured Monograph

Clinical summary

Approval overview MIRCERA is listed in Drugs@FDA under application 125164 (BLA). Review priority: STANDARD Marketing status: Prescription Active ingredient METHOXY POLYETHYLENE GLYCOL-EPOETIN BETA Form and strength SOLUTION; INJECTION - 0.6MG/KG Sponsor HOFFMAN-LA ROCHE Submission history Latest submission status date: 2024-06-04 00:00:00. Submission type: SUPPL.

Monitoring

  • • Marketing status: Prescription
  • • Review priority: STANDARD

Interaction Notes

  • No interaction notes stored yet.
MIRCERA (METHOXY POLYETHYLENE GLYCOL-EPOETIN BETA) | Drug Monograph | MedicHelpline