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2000年以来FDA批准的新放射性药物

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1. 2000年以来FDA批准的新放射性药物
序号 药品名称 活性成分 适应症 批准日期  申请机构
1 NETSPOT Gallium dotatate Ga-68 A diagnostic imaging agent to detect rare neuroendocrine tumors 2016-6-1 AAA USA INC
2 Axumin Fluciclovine F-18 A new diagnostic imaging agent to detect recurrent prostate cancer 2016-5-27 BLUE EARTH
3 Neuraceq Florbetaben F-18 For Positron EmissionTomography (PET) imaging of the brain 2014-3-19 PIRAMAL IMAGING
4 Vizamyl Flutemetamol F-18 A radioactive diagnostic drug for use with positron emission tomography (PET) imaging of the brain in adults being evaluated for Alzheimer's disease (AD) and dementia. 2013-10-25 GE HEALTHCARE
5 Xofigo Radium Ra-223 dichloride To treat men with symptomatic late-stage (metastatic) castration-resistant prostate cancer that has spread to bones but not to other organs. 2013-5-15 BAYER HLTHCARE
6 Lymphoseek kit Technetium Tc-99m tilmanocept A radioactive diagnostic imaging agent that helps doctors locate lymph nodes in patients with breast cancer or melanoma who are undergoing surgery to remove tumor-draining lymph nodes. 2013-3-13 NAVIDEA BIOPHARMS
7 Choline C 11 Injection Choline C-11 A Positron Emission Tomography (PET) imaging agent used to help detect recurrent prostate cancer. 2012-9-12 MCPRF
8 Amyvid Florbetapir F-18 Used as a radioactive diagnostic agent for Positron Emission Tomography (PET) imaging of the brain to estimate β-amyloid neuritic plaque density in adult patients with cognitive impairment who are bei 2012-4-6 AVID RADIOPHARMS INC
9 Datscan Ioflupane i-123 An imaging drug used to assist in the evaluation of adult patients with suspected Parkinsonian syndromes (PS). 2011-1-14 GE HLTHCARE INC
10 Adreview Iobenguane sulfate I-123 PROVIDES FOR THE DETECTION OF PRIMARY OR METASTATIC PHEOCHROMOCYTOMAS. 2008-9-19 GE HEALTHCARE
11 Ammonia N 13 Ammonia N-13 Provides for the treatment as a radioactive diagnostic agent for Positron Emission Tomography (PET), for diagnostic PET imaging of the myocardium under rest or pharmacologic stress conditions to evalu 2007-8-23 FEINSTEIN
12 NeutroSpec Technetium 99m Tc fanolesomab NeutroSpec is indicated for scintigraphic imaging of patients with equivocal signs and symptoms of appendicitis who are five years of age or older. 2004-7-2 Palatin Technologies Inc.
 
 
2.  2000年以来CFDA批准的新放射性药物
序号 国产药品名称 批准文号 生产单位
1 碘[131I]美妥昔单抗注射液 S20060064 成都华神生物技术有限责任公司
2 碘[131I]肿瘤细胞核人鼠嵌合单克隆抗体注射液 S20060061 上海美恩生物技术有限公司
3 氟[18F]脱氧葡糖注射液 H20050441 原子高科股份有限公司
4 碘[125I]密封籽源 H20045969 原子高科股份有限公司
5 氯化锶[89Sr]注射液 H20041312 上海原子科兴药业有限公司
6 来昔决南钐[153Sm]注射液 H20010679 原子高科股份有限公司
7 锝[99Tc]亚甲基二膦酸盐注射液 H20000218 成都云克药业有限责任公司
 
 

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