Study title: Open, 12-month, follow-up of a 3-month, comparative, multi-centre, double-blind trial to assess the long-term tolerability and efficacy of formoterol 12 ug dry powder capsules in children with reversible obstructive airways diseases
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-PD2F Art45 listing 2011.xls | |||||
Document date: 2011-11-22 | |||||
Study number: DP/PD2F | |||||
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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