STN: 125267
Proper Name: C1 Esterase Inhibitor (Human)
Tradename: CINRYZE
Manufacturer: Lev Pharmaceuticals, Inc., License #1780
Indication:

• For routine prophylaxis against angioedema attacks in adolescent and adult patients with Hereditary Angioedema (HAE).

Product Information

• Package Insert - CINRYZE

Supporting Documents

• June 20, 2018 Approval Letter - CINRYZE
• June 20, 2018 Summary Basis for Regulatory Action - CINRYZE
• Approval History, Letters, Reviews and Related Documents - CINRYZE
• Supporting Documents older than three years - CINRYZE

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Related Information

• C1 Esterase Inhibitor