Study title: PLACEBO-CONTROLLED, DOSE-FINDING, SINGLE-CENTRE, DOUBLE-BLIND, WITHIN-PATIENT TRIAL OF DIFFERENT DOSES OF INHALED FORMOTEROL DRY POWDER (6, 12, 24 UG) AND 400 UG INHALED SALBUTAMOL DRY POWDER IN CHILDREN WITH REVERSIBLE OBSTRUCTIVE AIRWAYS DISEASE
Type of medicine: Medicines containing chemical active substances | |||||
Therapeutic area: Respiratory Tract Diseases | |||||
Brands: | |||||
MAH holders: Please see report, Please see report | |||||
Assessment: | |||||
Active substance: FORMOTEROL | |||||
ATC code: R03AC13 | |||||
Document link: FOR258 DP-PD6 Art45 listing 2011.xls | |||||
Document date: 2011-11-22 | |||||
Study number: DP/PD6 | |||||
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) |
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