Study title: A phase III multicentre open study to assess the safety of a flavoured alternative propellant (HFA-227) formulation of Nedocromil sodium 4 mg metered-dose inhaler and FISONAIR holding chamber, 4 times daily for one year in children with asthma
Type of medicine: Medicines containing chemical active substances | |||||
Therapeutic area: Respiratory Tract Diseases | |||||
Brands: Please see report | |||||
MAH holders: Please see report | |||||
Assessment: | |||||
Active substance: NEDOCROMIL | |||||
ATC code: S01GX04 | |||||
Document link: Nedocromil-Study 2.pdf | |||||
Document date: 2013-05-13 | |||||
Study number: CR 2520 | |||||
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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