Study title: Ondovik M S*, Eberhardt D R, Liss C, Khoo K-C, Clinical Study Report (Protocol NR 15806): Evaluation of the pharmacokinetics and safety of Accutane in pediatric and adult patients with severe recalcitrant nodular acne
Type of medicine: Medicines containing chemical active substances | |||||
Therapeutic area: Skin and Connective Tissue Diseases [C17] | |||||
Brands: Please see report, Please see report, Please see report, Please see report, Please see report, Please see report | |||||
MAH holders: Please see report, Please see report | |||||
Assessment: | |||||
Active substance: ISOTRETINOIN | |||||
ATC code: D10BA01 | |||||
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Document date: | |||||
Study number: 1004587 | |||||
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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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