Ulipristal 5 mg: marketing authorisation suspended in the European Union

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Ulipristal 5 mg: marketing authorisation suspended in the European Union

机译：ulipristal 5毫克：销售授权暂停在欧盟

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Ulipristal is a progesterone receptor antagonist and partial agonist. It was authorised in 2012 for patients with uterine fibroids at a dose of 5 mg per day under the brand name Esmya° (1). Esmya's marketing authorisation was suspended in the European Union in March 2020 due to a new case of serious hepatitis reported in a 54-year-old patient who had been taking ulipristal for 2 months and had no other identified hepatic risk factors.The patient's liver injury continued to worsen after discontinuation, and she underwent liver transplantation 59 days after taking her last dose (2).

机译：Ulipristal是一种孕酮受体拮抗剂和部分激动剂。该药于2012年被授权用于子宫肌瘤患者，剂量为每天5毫克，商标为Esmya°（1）。2020年3月，由于一名54岁的患者报告了一例新的严重肝炎病例，Esmya在欧盟的营销授权被暂停，该患者服用ulipristal已有2个月，没有其他确定的肝脏风险因素。患者的肝损伤在停药后继续恶化，在服用最后一剂后59天，她接受了肝移植（2）。

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《Prescrire international》 |2020年第218期|共1页
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正文语种 eng
中图分类药学;
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Ulipristal 5 mg: marketing authorisation suspended in the European Union

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