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11月欧盟批准新药及制剂
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11月英国批准新药
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Botulinum A toxin (Botox)
A型肉毒杆菌素
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Idiopathic overactive bladder
特发性膀胱过动症
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Certolizumab pegol (Cimzia)
赛妥珠单抗
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Severe active axial spondyloarthritis
重度中轴型脊柱关节炎
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Colestilan (BindRen)
考来替兰
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Hyperphosphataemia in dialysed adults with chronic kidney disease
成年慢性肾脏病透析患者高磷血症
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Dapoxetine (Priligy)
达帕西汀
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Premature ejaculation
早泄
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Ipilimumab (Yervoy)
伊匹单抗
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Malignant melanoma, advanced – first-line
晚期恶性黑色素瘤（一线用药）
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Lubiprostone (Amitiza)
鲁比前列酮
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Chronic idiopathic constipation
慢性特发性便秘
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11月欧盟批准新药
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Anakinra (Kineret)
阿那白滞素
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Cryopyrin-associated periodic syndromes in adults and children
周期性综合症
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Aripiprazole (Abilify Maintena)
阿立哌唑长效制剂（一月给药一次）
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Schizophrenia
精神分裂症
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Canagliflozin (Invokana)
坎格列嗪
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Type 2 diabetes mellitus in adults
成人2型糖尿病
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Elvitegravir (Vitekta)
埃替拉韦
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HIV-1 infection in adults
成人HIV-1感染
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Fluticasone furoate + vilanterol trifenatate
(Relvar Ellipta)
糠酸氟替卡松+三氟甲磺酸维兰特罗
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Asthma / Chronic obstructive pulmonary disease
哮喘、COPD
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Radium-223 chloride (Xofigo)
氯化镭
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Bone metastases in patients with castration-resistant prostate cancer
去势抵抗性前列腺癌骨转移患者
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Trastuzumab emtansine (Kadcyla)
曲妥珠单抗
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Breast cancer, metastatic HER2-positive – second- and third-line
HER2阳性转移性乳腺癌
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11月欧盟持审评积极意见新药
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Cholic acid (Orphacol)
胆酸
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Inborn errors of primary bile acid synthesis
先天性胆酸综合症
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Dapagliflozin + metformin (Xigduo)
达帕格列净+二甲双胍
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Type 2 diabetes mellitus in adults
成人2型糖尿病
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Delamanid (Deltyba)
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Tuberculosis, pulmonary multidrug-resistant in adults
耐药性肺结核
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Dolutegravir (Tivicay)
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HIV-1 infection in adults and adolescents from age 12 years
HIV-1感染
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Paclitaxel albumin-bound (Abraxane)
紫杉醇白蛋白
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Pancreatic adenocarcinoma, metastatic
转移性胰腺癌（一线用药）
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Sofosbuvir (Sovaldi)
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Hepatitis C infection in adults
丙肝
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11月欧盟申请上市新药
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Aclidinium bromide + formoterol fumarate
阿地溴铵+福莫特罗
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Chronic obstructive pulmonary disease
COPD
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Aflibercept (Eylea)
阿柏西普
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Diabetic macular oedema
糖尿病黄斑水肿
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Balugrastim
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Chemotherapy-induced neutropenia
嗜中性白血球减少症
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Factor IX, recombinant (Rixubis)
凝血因子IX
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Haemophilia B
B型血友病
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Faldaprevir
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Hepatitis C, in patients who are co-infected with HIV
HIV/HCV合并感染
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Fibrinogen + thrombin (Fibrocaps)
纤维蛋白原+凝血酶
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Intrasurgical haemorrhage
局部止血
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Posaconazole (Noxafil)
泊沙康唑
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Fungal infections
真菌感染
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Tiotropium bromide (Spiriva)
噻托溴铵
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Asthma in adults
哮喘
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其他
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Daclatasvir
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Hepatitis C infection
丙肝
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Fedratinib
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Myelofibrosis – development discontinued
骨髓纤维化-终止开发
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Masitinib (Masican)
马赛替尼
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Gastrointestinal stromal tumours, imatinib-resistant – negative opinion
对伊马替尼耐药的胃肠道间质瘤-不看好
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