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山度士的争议事件

以下收录公开来源中与该品牌相关的争议事件。列出一条并不表示过错已经证实。

返回词条共 2 条

  1. 2020

    Astellas 就专利侵权起诉多家制药公司

    提起诉讼

    Astellas Pharma Inc. 及关联原告在特拉华州起诉 21 家制药公司，指称其拟推出的 Myrbetriq 仿制药将侵犯 '780 专利。原告请求法院给予救济；相关内容属于诉状中的指称。

    来源摘录

    • At the District Court of Delaware on Tuesday, Astellas Pharma Inc. (API), Astellas Ireland Co. Ltd. (AICL), and Astellas Pharma Global Development (APGD) filed a complaint against 21 pharmaceutical companies alleging patent infringement.
    • The defendants are as follows: Sandoz Inc., Actavis Elizabeth LLC, Actavis LLC, Teva Pharmaceuticals USA Inc., Apotex Inc., Apotex Corp., Aurobindo Pharma Ltd., Aurobindo Pharma USA Inc., Aurolife Pharma LLC, Sawai Pharmaceutical Co. Ltd., Sawai USA Inc., Prinston Pharmaceutical Inc., Zhejiang Huahai Pharmaceutical Co. Ltd., Huahai US Inc., Solco Healthcare US LLC, Windlas Healthcare Pvt. Ltd., Windlas Biotech Ltd., Zydus Pharmaceuticals (USA) Inc., Cadila Healthcare Ltd. (doing business as Zydus Cadila), Lupin Ltd., and Lupin Pharmaceuticals, Inc.
    • The patent in question, deemed the ’780 patent, corresponds to APGD’s Myrbetriq extended-release tablets, containing active ingredient mirabegron, which is used to treat overactive bladder.
    来源

  2. 2019

    Sandoz因NDMA污染召回雷尼替丁胶囊

    宣布召回

    Sandoz Inc.在美国自愿将所有未过期数量和批次的雷尼替丁盐酸盐胶囊召回至消费者层级。此次召回是在确认该产品批次中的NDMA污染超过FDA设定水平后进行的。公司表示，截至当时未收到相关不良事件报告。

    Sandoz Inc.在确认其雷尼替丁盐酸盐胶囊批次中的NDMA污染超过FDA设定水平后，在美国自愿将所有未过期数量和批次的产品召回至消费者层级。公司表示，截至当时未收到相关不良事件报告。

    品牌回应

    • 召回 — Sandoz Inc.

      Sandoz Inc. is voluntarily recalling all quantities and lots within expiry of Ranitidine Hydrochloride Capsules in the US to the consumer level because of confirmed contamination with N-Nitrosodimethylamine (NDMA) above levels established by the FDA in batches of Sandoz Ranitidine Hydrochloride Capsules.

    来源摘录

    • Sandoz Inc. is voluntarily recalling all quantities and lots within expiry of Ranitidine Hydrochloride Capsules in the US to the consumer level because of confirmed contamination with N-Nitrosodimethylamine (NDMA) above levels established by the FDA in batches of Sandoz Ranitidine Hydrochloride Capsules.
    来源