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General MedicationsSUBCUTANEOUSStandard

RYSTIGGO

ROZANOLIXIZUMAB-NOLI

Standard Dose
280MG/2ML(140MG/ML)
Max Dose
Refer to approved labeling
Primary Use
Review priority: STANDARD Marketing status: Prescription
Summary

Approval overview RYSTIGGO is listed in Drugs@FDA under application 761286 (BLA).

Review priority: STANDARD Marketing status: Prescription Active ingredient ROZANOLIXIZUMAB-NOLI Form and strength INJECTABLE;SUBCUTANEOUS - 280MG/2ML(140MG/ML) Sponsor UCB INC Submission history Latest submission status date: 2025-12-09 00:00:00.

Structured Monograph

Clinical summary

Approval overview RYSTIGGO is listed in Drugs@FDA under application 761286 (BLA). Review priority: STANDARD Marketing status: Prescription Active ingredient ROZANOLIXIZUMAB-NOLI Form and strength INJECTABLE;SUBCUTANEOUS - 280MG/2ML(140MG/ML) Sponsor UCB INC Submission history Latest submission status date: 2025-12-09 00:00:00. Submission type: SUPPL.

Monitoring

  • Marketing status: Prescription
  • Review priority: STANDARD

Interaction Notes

  • No interaction notes stored yet.