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This medicinal product is subject to additional monitoring. Healthcare professionals are asked to report any suspected adverse reactions. See section 4. Isotretinoin should only be prescribed by or under the supervision of physicians with expertise in the use of systemic retinoids for the treatment of severe acne and a full understanding of the risks of isotretinoin therapy and monitoring requirements. Isotretinoin is not indicated for the treatment of prepubertal acne and is not recommended in patients less than 12 years of age due to a lack of data on efficacy and safety. Isotretinoin therapy should be started at a dose of 0.

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