Vaccines, Blood & Biologics


STN: BL 125063
Proper Name: Antihemophilic Factor (Recombinant), Plasma/Albumin Free Method
Tradename: Advate
Manufacturer: Baxter Healthcare Corp, License #0140


  • An Antihemophilic Factor (Recombinant) indicated for:  
    • Control and prevention of bleeding episodes in adults and children (0-16 16 years) with Hemophilia A.
    • Perioperative management in adults and children (0-16 years) with 18 Hemophilia A.
    • Routine prophylaxis to prevent or reduce the frequency of bleeding 20 episodes in adults and children (0-16 years) with Hemophilia A.  
  • Advate is not indicated for the treatment of von Willebrand disease.

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.

Contact FDA

(800) 835-4709
(240) 402-8010
Consumer Affairs Branch (CBER)

Division of Communication and Consumer Affairs

Office of Communication, Outreach and Development

Food and Drug Administration

10903 New Hampshire Avenue

Building 71 Room 3103

Silver Spring, MD 20993-0002

Page Last Updated: 11/18/2014
Note: If you need help accessing information in different file formats, see Instructions for Downloading Viewers and Players.
Language Assistance Available: Español | 繁體中文 | Tiếng Việt | 한국어 | Tagalog | Русский | العربية | Kreyòl Ayisyen | Français | Polski | Português | Italiano | Deutsch | 日本語 | فارسی | English