General MedicationsSUBCUTANEOUSStandard
GIVLAARI
GIVOSIRAN SODIUM
Standard Dose
EQ 189MG BASE/ML (EQ 189MG BASE/ML)
Max Dose
Refer to approved labeling
Primary Use
Review priority: STANDARD Marketing status: Prescription
Summary
Approval overview GIVLAARI is listed in Drugs@FDA under application 212194 (NDA).
Review priority: STANDARD Marketing status: Prescription Active ingredient GIVOSIRAN SODIUM Form and strength SOLUTION;SUBCUTANEOUS - EQ 189MG BASE/ML (EQ 189MG BASE/ML) Sponsor ALNYLAM PHARMS INC Submission history Latest submission status date: 2024-04-29 00:00:00.
Structured Monograph
Clinical summary
Approval overview GIVLAARI is listed in Drugs@FDA under application 212194 (NDA). Review priority: STANDARD Marketing status: Prescription Active ingredient GIVOSIRAN SODIUM Form and strength SOLUTION;SUBCUTANEOUS - EQ 189MG BASE/ML (EQ 189MG BASE/ML) Sponsor ALNYLAM PHARMS INC 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.