STN: BL 125287
Proper Name: C1 Esterase Inhibitor (Human)
Manufacturer: CSL Behring GmbH, License #1765
- Treatment of acute abdominal or facial attacks of hereditary angioedema (HAE) in adult and adolescent patients.
February 11, 2014 Approval Letter - Berinert
To include revisions to the Warnings and Precautions section of the package insert to include the risk factors for thromboembolic events.
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[ARCHIVED]
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