Drug Approval Package: GIVLAARI (givosiran)Injection

Company: Alnylam Pharmaceuticals Inc.
Application Number: 212194
Approval Date: 11/20/2019

Drugs@FDA information available about GIVLAARI

Persons with disabilities having problems accessing the PDF files below may call (301) 796-3634 for assistance.

FDA Approval Letter and Labeling

• Approval Letter(s) (PDF)
• Printed Labeling (PDF)

FDA Application Review Files

• Officer/Employee List (PDF)
• Multi-Discipline Review (PDF)
• Chemistry Review(s) (PDF)
• Risk Assessment and Risk Mitigation Review(s)
• Proprietary Name Review(s) (PDF)
• Other Review(s) (PDF)
• Administrative Document(s) & Correspondence (PDF)

Date created: December 16, 2019

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