Quick Links: Skip to main page content
Skip to Search
Skip to Topics Menu
Skip to Common Links
U.S. Food & Drug Administration
Follow FDA
En Español
Search FDA
Home
Food
Drugs
Medical Devices
Radiation-Emitting Products
Vaccines, Blood & Biologics
Animal & Veterinary
Cosmetics
Tobacco Products
New Pediatric Labeling Information Database - Detail
FDA Home
Pediatrics
New Pediatric Labeling Information Database
Detail
-
Please note:
JavaScript must be enabled for this application to work properly.
Check your settings
if you are unsure if your JavaScript is enabled.
Pediatric Labeling Date:
08/29/2018
Trade Name:
JIVI
Generic Name or Proper Name (*):
Antihemophilic Factor (Recombinant), PEGylated-aucl*
Indications Studied:
Use in previously treated adults and adolescents (12 years of age and older) with hemophilia A (congenital Factor VIII deficiency) for: on demand treatment and control of bleeding episodes; perioperative management of bleeding; and routine prophylaxis to reduce the frequency of bleeding episodes
Label Changes Summary:
See Package Insert for new information on biologics
Product Labeling:
Labeling
PREA(P):
P
Sponsor:
Bayer HealthCare, Inc.
NNPS:
FALSE
Therapeutic Category:
Antihemophilic Factor
-
-