Study title: A 12-Month Study to Assess the Safety and Efficacy of Meridia® (sibutramine hydrochloride monohydrate) 10 and 15 mg in Obese Adolescents
Type of medicine: Medicines containing chemical active substances | |||||
Therapeutic area: Nutritional and Metabolic Diseases | |||||
Brands: Please see report | |||||
MAH holders: Please see report, Please see report | |||||
Assessment: | |||||
Active substance: SIBUTRAMINE | |||||
ATC code: | |||||
Document link: Sibutramine-SB238.pdf | |||||
Document date: 2011-10-14 | |||||
Study number: SB238 | |||||
EudraCT number: | |||||
Scope of study: CLINICAL | |||||
Population of study subjects: | Preterm newborn Infants | Newborn infants (1 to 27 days) | Infants and toddlers (28 days to 24 months) | Children (2 to 11 years) | Adolescents (12 to 18 years) |
- | - | - | - | Y |