General MedicationsINJECTIONStandard
IMAAVY
NIPOCALIMAB-AAHU
Standard Dose
1200MG/6.5ML(185MG/ML)
Max Dose
Refer to approved labeling
Primary Use
Review priority: PRIORITY Marketing status: Prescription
Summary
Approval overview IMAAVY is listed in Drugs@FDA under application 761430 (BLA).
Review priority: PRIORITY Marketing status: Prescription Active ingredient NIPOCALIMAB-AAHU Form and strength INJECTABLE;INJECTION - 1200MG/6.5ML(185MG/ML) Sponsor JANSSEN BIOTECH Submission history Latest submission status date: 2025-04-29 00:00:00.
Structured Monograph
Clinical summary
Approval overview IMAAVY is listed in Drugs@FDA under application 761430 (BLA). Review priority: PRIORITY Marketing status: Prescription Active ingredient NIPOCALIMAB-AAHU Form and strength INJECTABLE;INJECTION - 1200MG/6.5ML(185MG/ML) Sponsor JANSSEN BIOTECH Submission history Latest submission status date: 2025-04-29 00:00:00. Submission type: ORIG.
Monitoring
- • Marketing status: Prescription
- • Review priority: PRIORITY
Interaction Notes
- No interaction notes stored yet.