Pegloticase: withdrawal of its EU marketing authorisation is welcome

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Pegloticase: withdrawal of its EU marketing authorisation is welcome

机译：Pegloticase：欢迎撤回其欧盟上市许可

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In June 2016, the European Commission withdrew the marketing authorisation for the injectable urate-lowering drug pegloticase (Krystexxa0) at the request of the pharmaceutical company for "commercial reasons" (1,2). In France, Krystexxa0 was available in hospitals for patients who had already been receiving the drug through an "ATU nominative", a temporary compassionate use programme in which a drug is used to treat a specific patient at the request of and under the responsibility of the prescribing physician (3). According to the French Health Products Agency (ANSM), "Krystexxa will no longer be eligible for authorisation by the French drug regulatory agency for temporary compassionate use" our translation (2).

机译：2016 年 6 月，欧盟委员会应制药公司的要求，出于“商业原因”撤回了可注射降尿酸药物聚乙二醇酶（Krystexxa0）的上市许可（1,2）。在法国，Krystexxa0 在医院可供已经通过“ATU nominative”接受该药物的患者使用，这是一种临时同情使用计划，其中药物用于治疗特定患者应处方医生的要求并在处方医生的责任下（3）。根据法国保健品管理局（ANSM）的说法，“Krystexxa 将不再有资格获得法国药品监管机构的临时同情使用授权”[我们的翻译] （2）。

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《Prescrire international》 |2017年第180期|71-71|共1页
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Pegloticase: withdrawal of its EU marketing authorisation is welcome

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