Study title: Safety profile of the combination ipratropium bromide (20 mcg)/fenoterol hydrobromide (50 mcg) 2 puffs t.i.d. delivered by an MDI aerosol formulated with CFC propellants compared to an MDI formulation with the propellant HFA 134a, in pediatric patients in asthma
Type of medicine: Medicines containing chemical active substances | |||||
Therapeutic area: Respiratory Tract Diseases [C08] | |||||
Brands: Please see report | |||||
MAH holders: Please see report | |||||
Assessment: | |||||
Active substance: IPRATROPIUM AND FENOTEROL | |||||
ATC code: | |||||
Document link: Fenoterol hydrobromide_U84-0885_synopsis.pdf | |||||
Document date: 2011-09-15 | |||||
Study number: U84-0885 | |||||
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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