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
Pediatric Studies Characteristics - Detail
FDA Home
Pediatrics
Pediatric Studies Characteristics
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.
Approval Date:
08/28/2009
Trade Name:
Valcyte
Generic or Proper Name (*):
valganciclovir
Indications Studied:
Prevention of cytomegalovirus (CMV) disease in pediatric kidney and heart transplant patients e 4 months of age
Therapeutic Category:
Antiviral
Ages Studied:
6 months - 16 years
Study #:
2
Study Type:
Safety/Pharmacokinetic
Study Design:
Open Label/Traditional Pharmacokinetic
No Patients:
20
No Centers:
1
No Countries:
1
BPCA(B), PREA(P):
B, P
Asian:
0
Black:
2
Other:
0
White:
18
Native Hawaiian or Pacific Islander:
0
American Indian/Alaska Native:
0
Hispanic/Latino:
0
Non-Hispanic/Non Latino:
0
-
-