Study title: A Multi-Center, Open-Label Study to Evaluate Omeprazole for the Treatment of Gastrointestinal Symptoms Associated with Acid-Related Disorders in Pediatric Subjects (Ages 2 through 16 years, Inclusive), 9 August 2000
Type of medicine: Medicines containing chemical active substances | |||||
Therapeutic area: Digestive System Diseases [C06] | |||||
Brands: Please see report, Please see report | |||||
MAH holders: Please see report, Please see report | |||||
Assessment: | |||||
Active substance: OMEPRAZOLE | |||||
ATC code: A02BC01 | |||||
Document link: | |||||
Document date: | |||||
Study number: 214 | |||||
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 |