Study title: Rapport d'etude: evaluation des concentrations bronchiques de colistine apres administration en aerosol, a la posologie de 1 MUI 2 fois par jour et de la tolerance de cette voie d'administration chez des patients atteints de mucoviscidose.
Type of medicine: Medicines containing chemical active substances | |||||
Therapeutic area: Digestive System Diseases | |||||
Brands: Please see report | |||||
MAH holders: Please see report, Please see report | |||||
Assessment: | |||||
Active substance: COLISTIN | |||||
ATC code: J01XB01 | |||||
Document link: Colistimethate sodium STUDY SAF-133.xls | |||||
Document date: 2013-03-05 | |||||
Study number: NL 30262 | |||||
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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