Study title: Wirksamkeit und Vertraeglichkeit von Rytmonorm 10 mg, Dragees, bei Kindern - Ergebnisse einer multizentrischen Studie - (Efficacy and safety of Rytmonorm 10 mg sugar-coated tablets in children - Results of a multicentre study -)
Type of medicine: Medicines containing chemical active substances | |||||
Therapeutic area: Cardiovascular Diseases | |||||
Brands: Please see report, Please see report, Please see report | |||||
MAH holders: Please see report, Please see report, Please see report | |||||
Assessment: | |||||
Active substance: PROPAFENONE | |||||
ATC code: | |||||
Document link: propafenone-m03681.pdf | |||||
Document date: 2013-07-25 | |||||
Study number: MPF/K8306 | |||||
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 | - |