Study title: Placebo controlled, randomised, double-blind, parallel-group, multicentre clinical trial in patients; Duration: Treatment was 14 consecutive days;Medication: Sachets containing 2.5 g lactitol or 2.5 g placebo. Report Zy 15060 BG-95-F7
Type of medicine: Medicines containing chemical active substances | |||||
Therapeutic area: | |||||
Brands: Please see report | |||||
MAH holders: Please see report | |||||
Assessment: | |||||
Active substance: Lactitol | |||||
ATC code: | |||||
Document link: 2011_EMAspreadsheet_Importal_Report Zy 15060 BG-95-F7.xls | |||||
Document date: 2013-10-03 | |||||
Study number: | |||||
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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