Vaccines, Blood & Biologics
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Berinert
STN: BL 125287
Proper Name: C1 Esterase Inhibitor (Human)
Tradename: Berinert
Manufacturer: CSL Behring GmbH, License #1765
Indication: Treatment of acute abdominal or facial attacks of hereditary angioedema (HAE) in adult and adolescent patients.
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Supporting Documents
Summary Basis for Regulatory Action - Berinert, December 11, 2011 (PDF - 173KB)December 22, 2011 Approval Letter - Berinert October 9, 2009 Approval Letter - Berinert Summary Basis for Regulatory Action - Berinert, October 8, 2009 (PDF - 264KB)Approval History, Letters, Reviews and Related Documents - Berinert
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Related Information
FDA Online Label Repository
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