Product Information

• Package Insert and Information for the Patient - CINRYZE (PDF - 407KB)

Supporting Documents

• 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

Related Information

• FDA Online Label Repository
  Search this database for drug labeling and other information. The content has not been altered or verified by the FDA and may not be the labeling on currently distributed products or identical to the labeling that is approved.
• FDA Licenses for Marketing New Therapy for Rare Genetic Disease
  Press Release, 10/10/2008

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