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Off-label prescriptions for atopic dermatitis in Europe

机译：欧洲特应性皮炎的标签外处方

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Moderate-to-severe forms of atopic dermatitis (AD) have a substantial impact on the quality of life of patients and their relatives, carrying a significant socioeconomic burden. They often require a systemic therapy, and ciclosporine A (CsA) is the only medicinal product approved for this indication in a limited number of European countries. However, due to the safety profile of CsA and its approval conditions, this treatment can only be prescribed for a limited period of time. Thus, moderate-to-severe forms of AD represent a significant unmet medical need and are subject to off-label prescriptions. Besides giving some insights into the approval procedures for medicinal products in the European Union, this short review is aimed to provide some relevant background information for off-label prescription in AD. It also provides a clinical algorithm for the off-label prescription of systemic immunosuppressants in AD, discusses the apparent dilemma between approval and guidelines, and finally suggests practical rules to be considered in the context of off-label prescription.
机译：中度至重度的特应性皮炎（AD）对患者及其亲属的生活质量具有重大影响，并带来巨大的社会经济负担。他们经常需要系统治疗，而环孢霉素A（CsA）是在少数欧洲国家/地区中唯一批准用于该适应症的药物。但是，由于CsA的安全性及其批准条件，只能在有限的时间内开这种治疗方法。因此，中度至重度形式的AD代表了严重的未满足的医疗需求，并需遵循非处方处方。除了对欧盟的药品批准程序提供一些见识之外，本篇简短的评论旨在为AD中的非标签处方提供一些相关的背景信息。它还提供了针对AD中全身免疫抑制剂的标签外处方的临床算法，讨论了批准和指南之间的明显难题，最后提出了在标签外处方中要考虑的实用规则。

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