General MedicationsINTRAMUSCULARStandard

CABENUVA KIT

CABOTEGRAVIR; RILPIVIRINE

Standard Dose

600MG/3ML (200MG/ML);900MG/3ML (300MG/ML)

Max Dose

Refer to approved labeling

Primary Use

Review priority: STANDARD Marketing status: Prescription

Summary

Approval overview CABENUVA KIT is listed in Drugs@FDA under application 212888 (NDA).

Review priority: STANDARD Marketing status: Prescription Active ingredient CABOTEGRAVIR; RILPIVIRINE Form and strength SUSPENSION, EXTENDED RELEASE;INTRAMUSCULAR - 600MG/3ML (200MG/ML);900MG/3ML (300MG/ML) Sponsor VIIV HLTHCARE Submission history Latest submission status date: 2025-11-26 00:00:00.

Structured Monograph

Clinical summary

Approval overview CABENUVA KIT is listed in Drugs@FDA under application 212888 (NDA). Review priority: STANDARD Marketing status: Prescription Active ingredient CABOTEGRAVIR; RILPIVIRINE Form and strength SUSPENSION, EXTENDED RELEASE;INTRAMUSCULAR - 600MG/3ML (200MG/ML);900MG/3ML (300MG/ML) Sponsor VIIV HLTHCARE Submission history Latest submission status date: 2025-11-26 00:00:00. Submission type: SUPPL.

Monitoring

• Marketing status: Prescription
• Review priority: STANDARD

Interaction Notes

No interaction notes stored yet.