Study title: Summary of the efficacy and safety and safety of salmeterol 50mcg and fluticasone propionate 100mcg administered in Diskus Dry Powder Inhaler twice daily in steroid experienced children with reversible airways obstruction
Type of medicine: Medicines containing chemical active substances | |||||
Therapeutic area: Respiratory Tract Diseases [C08] | |||||
Brands: Please see report | |||||
MAH holders: Please see report, Please see report | |||||
Assessment: | |||||
Active substance: FLUTICASONE AND SALMETEROL | |||||
ATC code: | |||||
Document link: Fluticasone-Propionate-Sameterol-SAM40121-ICHE3.pdf | |||||
Document date: 2011-09-30 | |||||
Study number: SAM40121 | |||||
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 | - |