Study title:
McLane J A*, Liss C, Leach E, Eberhardt D R, Bryce G F, Khoo K-C, Final Study Report / Open label extension of Protocol NR15645 to evaluate the efficacy and safety of a second course of Accutane for severe recalcitrant nodular acne in pediatric patients experiencing recurrence between 36 and 72 weeks of previous isotretinoin treatment
Type of medicine: Medicines containing chemical active substances
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Therapeutic area: Skin and Connective Tissue Diseases [C17]
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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 link:
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Document date:
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Study number: 1004100 |
EudraCT number:
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Scope of study: Clinical |
Population of study subjects:
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Preterm newborn Infants
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Newborn infants
(1 to 27 days)
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Infants and toddlers
(28 days to 24 months)
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Children
(2 to 11 years)
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Adolescents
(12 to 18 years)
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-
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-
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-
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Y
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-
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