Study title: Clinical investigator’s report (pediatrics).
Type of medicine: Medicines containing chemical active substances | |||||
Therapeutic area: Respiratory Tract Diseases | |||||
Brands: Please see report, Please see report | |||||
MAH holders: Please see report, Please see report | |||||
Assessment: | |||||
Active substance: PHOLCODINE | |||||
ATC code: R05DA08 | |||||
Document link: Pholcodine_STUDY_640.6.003_Lajouanine.xls | |||||
Document date: 2013-05-08 | |||||
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) |
- | - | - | Y | - |