Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

New Pediatric Labeling Information Database - Detail
  • Print
  • Share
  • E-mail
-
 
Pediatric Labeling Date:  01/10/2008
 
Trade Name:  Alvesco Inhalation Aerosol, 80 mcg & 160 mcg
 
Generic Name or Proper Name (*):  ciclesonide
 
Indications Studied:  Treatment of asthma in patients 12 years of age and older.
 
Label Changes Summary:  Not indicated for children under the age of 12 years Five clinical studies evaluated safety in children 12 years of age and older Safety and effectiveness have not been established in children under 12 years of age Waiver of studies in children 0 to less than 6 months of age due to too few patients with the disease New dosage form
 
Product Labeling:  Labeling  Opens a new window
 
PREA(P):  P
 
Sponsor:  Nycomed US Inc.
 
NNPS:  FALSE'
 
Therapeutic Category:  Antiasthmatic
 
-
-