January 15, 2010 Approval Letter - NovoSevenRT Package Insert Updated: To include a Black Box Warning on serious thrombotic adverse events associated with the use of NovoSeven® RT outside labeled indications.
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STN: BL 103665
Proper Name: Coagulation Factor VIIa (Recombinant)
Tradename: NovoSevenRT
Manufacturer: Novo Nordisk Inc, License #1261
Indication:
Product Information
Supporting Documents
Package Insert Updated: To include a Black Box Warning on serious thrombotic adverse events associated with the use of NovoSeven® RT outside labeled indications.
Indication: Room temperature stable formulation.
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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.
Press Release: May 9, 2008
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