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General MedicationsINJECTIONStandard

OPDIVO QVANTIG

NIVOLUMAB;HYALURONIDASE-NVHY

Standard Dose
600MG;10000 UNITS PER 5ML(120MG/2000UNITS PER ML)
Max Dose
Refer to approved labeling
Primary Use
Review priority: STANDARD Marketing status: Prescription
Summary

Approval overview OPDIVO QVANTIG is listed in Drugs@FDA under application 761429 (BLA).

Review priority: STANDARD Marketing status: Prescription Active ingredient NIVOLUMAB;HYALURONIDASE-NVHY Form and strength INJECTABLE;INJECTION - 600MG;10000 UNITS PER 5ML(120MG/2000UNITS PER ML) Sponsor BRISTOL-MYERS SQUIBB Submission history Latest submission status date: 2024-12-27 00:00:00.

Structured Monograph

Clinical summary

Approval overview OPDIVO QVANTIG is listed in Drugs@FDA under application 761429 (BLA). Review priority: STANDARD Marketing status: Prescription Active ingredient NIVOLUMAB;HYALURONIDASE-NVHY Form and strength INJECTABLE;INJECTION - 600MG;10000 UNITS PER 5ML(120MG/2000UNITS PER ML) Sponsor BRISTOL-MYERS SQUIBB Submission history Latest submission status date: 2024-12-27 00:00:00. Submission type: ORIG.

Monitoring

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

Interaction Notes

  • No interaction notes stored yet.