Study title: Efficacy of Ambroxol (Surbronc) in acute respiratory exacerbation in cystic fibrosis.
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: AMBROXOL | |||||
ATC code: R05CB06 | |||||
Document link: Ambroxol Hydrochloride_U92-0170_Synopsis.pdf | |||||
Document date: 2011-09-07 | |||||
Study number: U92-0170 | |||||
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) |
- | - | - | Y | - |