Vaccines, Blood & Biologics
-
Alphanate
STN: BL 102475
Proper Name: Antihemophilic Factor/von Willebrand Factor Complex (Human)
Tradename: Alphanate
Manufacturer: Grifols Biologicals Inc, License #1694
Indication:
- Control and prevention of bleeding in patients with hemophilia A or acquired Factor VIII (FVIII) deficiency (1.1)
- Surgical and/or invasive procedures in adult and pediatric patients with von Willebrand Disease in whom desmopressin (DDAVP) is either ineffective or contraindicated. It is not indicated for patients with severe VWD (Type 3) undergoing major surgery (1.2)
-
Supporting Documents
October 25, 2010 Approval Letter - Alphanate
Update to package insertJanuary 31, 2007 Approval Letter - Alphanate
-
-
Related Information
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.FDA Approves New Product to Treat Von Willebrand Disease [ARCHIVED]
Press Release - February 2, 2007
-
-
-
