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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
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.