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Gilead Sciences公司已就其用于慢性乙型肝炎(HBV)治疗的抗病毒药阿德福韦酯(adefovir dipivoxil)10mg向美国和欧盟提出了新药申请。在美国,公司申请了6个月的优先审查权,在欧洲,将以法国和丹麦为参照国按统一批准程序进行。
Gilead Sciences has filed a new drug application with the United States and the European Union for its adefovir dipivoxil 10 mg for the treatment of chronic hepatitis B (HBV). In the United States, the company applied for a six-month priority of review, in Europe, France and Denmark will be the reference country under a uniform approval process.