Study title: Randomized, open-label, cross-over study comparing the efficacy and tolerance of Creon® Forte and Cotazym S Forte® in children and young adults with cystic fibrosis
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: Pancreatin | |||||
ATC code: A09AA02 | |||||
Document link: Pancreatin-K224-5010.pdf | |||||
Document date: 2011-10-19 | |||||
Study number: K.224.5010 | |||||
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 |