Study title: A multicentre open label multiple dose study to determine the safety and tolerability of ibuprofen suspension in the treatment of mild to moderate pain of various etiologies in children.
Type of medicine: Medicines containing chemical active substances | |||||
Therapeutic area: Anesthesia and Analgesia [E03] | |||||
Brands: Please see report | |||||
MAH holders: Please see report, Please see report, Please see report, Please see report | |||||
Assessment: | |||||
Active substance: IBUPROFEN | |||||
ATC code: | |||||
Document link: Ibuprofen-BPI-320.pdf | |||||
Document date: 2011-09-29 | |||||
Study number: BPI320 | |||||
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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