Study title: Children’s Advil ® Cold & Sinus Suspension Multiple-Dose Safety Study in Children 2 to <12 Years Old
Type of medicine: Medicines containing chemical active substances | |||||
Therapeutic area: Pathological Conditions, Signs and Symptoms [C23] | |||||
Brands: Please see report, Please see report, Please see report, Please see report | |||||
MAH holders: Please see report, Please see report | |||||
Assessment: | |||||
Active substance: IBUPROFEN AND PSEUDOEPHEDRINE | |||||
ATC code: | |||||
Document link: Ibuprofen and Pseudoephedrine Clinical Trial Summaries.pdf | |||||
Document date: 2013-07-25 | |||||
Study number: AQ-99-03 | |||||
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) |
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