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General MedicationsSUBCUTANEOUSStandard

BESREMI

ROPEGINTERFERON ALFA-2B-NJFT

Standard Dose
500 MCG/ML
Max Dose
Refer to approved labeling
Primary Use
Review priority: STANDARD Marketing status: Prescription
Summary

Approval overview BESREMI is listed in Drugs@FDA under application 761166 (BLA).

Review priority: STANDARD Marketing status: Prescription Active ingredient ROPEGINTERFERON ALFA-2B-NJFT Form and strength INJECTABLE;SUBCUTANEOUS - 500 MCG/ML Sponsor PHARMAESSENTIA CORP Submission history Latest submission status date: 2024-04-29 00:00:00.

Structured Monograph

Clinical summary

Approval overview BESREMI is listed in Drugs@FDA under application 761166 (BLA). Review priority: STANDARD Marketing status: Prescription Active ingredient ROPEGINTERFERON ALFA-2B-NJFT Form and strength INJECTABLE;SUBCUTANEOUS - 500 MCG/ML Sponsor PHARMAESSENTIA CORP Submission history Latest submission status date: 2024-04-29 00:00:00. Submission type: SUPPL.

Monitoring

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

Interaction Notes

  • No interaction notes stored yet.