- For routine prophylaxis against angioedema attacks in adolescent and adult patients with Hereditary Angioedema (HAE).
- February 11, 2014 Approval Letter - CINRYZE
To include revisions to the Warnings and Precautions section of the package insert to include the risk factors for thromboembolic events.
January 3, 2012 Summary Basis for Regulatory Action - Cinryze(PDF - 153KB) January 9, 2012 Approval Letter-CINRYZE
To include the incorporation of additional safety data from the open-label uncontrolled routine prophylaxis trial protocol LEVP2006-4 (“Change 3” study) into the labeling.
October 10, 2008 Approval Letter - CINRYZE
Product is intended for routine prophylaxis against angioedema attacks in patients with Hereditary Angioedema (HAE).
Summary Basis for Regulatory Action - CINRYZE Approval History, Letters, Reviews and Related Documents - CINRYZE[ARCHIVED]
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