Study title: A twelve-month, double-blind, between-patient, placebo-controlled trial comparing the safety, tolerability and efficacy of 12 ug and 25 ug twice daily formoterol dry powder capsules for inhalation delivered by a single -dose inhaler (aeroliser) in childre
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: R03A C13 | |||||
Document link: FOR258 2702049 Art45 listing 2011.xls | |||||
Document date: 2011-11-22 | |||||
Study number: CFOR2582702049 | |||||
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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