Study title: A phase II, single-centre, open-label pharmacokinetic and pharmacodynamic study of lansoprazole 30mg/1.73m2 in children aged 18 days to 14 years who required anti-secretory treatment
Type of medicine: Medicines containing chemical active substances | |||||
Therapeutic area: Digestive System Diseases | |||||
Brands: Please see report | |||||
MAH holders: Please see report | |||||
Assessment: | |||||
Active substance: LANSOPRAZOLE | |||||
ATC code: A02BC03 | |||||
Document link: Lansoprazole_FH-93-749-54 Synopsis _EC430__English.pdf | |||||
Document date: 2011-10-14 | |||||
Study number: FH/93/749/54 | |||||
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 | Y | Y | Y |