期刊文献+

加拿大和美国分别批准戈利木单抗注射剂上市 被引量:2

下载PDF
导出
摘要 2009年4月,加拿大在全球率先批准先灵葆雅公司的戈利木单抗注射剂(golimumab,Simponi)上市,其为一月1次用皮下注射制剂,可用于中度至重度活动性类风湿关节炎、活动性银屑病性关节炎和强直性脊柱炎等治疗。加拿大还批准本品与甲氨蝶呤联用以减少中度至重度成年活动性类风湿关节炎患者的症状,单用或与甲氨蝶呤联用以减少中度至重度成年活动性银屑病关节炎患者的症状,单用或与甲氨蝶呤联用以减少不能采用常规药物治疗的成年强直性脊柱炎患者的症状。本品是迄今批准的首个可同时治疗上述3种类型疾病的药物。FDA随后也批准了一月1次用本品50mg注射剂上市。
出处 《世界临床药物》 CAS 2009年第6期333-333,共1页 World Clinical Drug
  • 相关文献

同被引文献29

  • 1孙丽霞.类风湿性关节炎治疗药——阿达木单抗(adalimumab)[J].世界临床药物,2005,26(4):251-251. 被引量:4
  • 2欧盟批准阿达木单抗治疗强直性脊柱炎[J].世界临床药物,2006,27(8):452-452. 被引量:1
  • 3范鸣.抗TNF抗体产品Certolizumab Pegol[J].药学进展,2006,30(8):381-382. 被引量:1
  • 4HUTAS G. Golimumab, a fully human monoclonal antibody against TNFalpha[J]. Curr Opin Mol Ther, 2008,10 (4) : 393 - 406.
  • 5KAVANAUGH A, MCINNES I, MEASE P, et al. Golimumab, a new human tumor necrosis factor alpha antibody, administered every four weeks as a subcutaneous injection in psoriatic arthritis: twenty-four-week efficacy and safety results of a randomized, placebo-controlled study [J]. Arthritis Rheum, 2009,60 ( 4 ) : 976 - 986.
  • 6ZHUANG Y, XU Z, FREDERICK B, et al. Golimumab pharmacokinetics after repeated subcutaneous and intravenous administrations in patients with rheumatoid arthritis and the effect of concomitant methotrexate: an open-label, randomized study [J] . cu? Ther, 2012 ,34( I) :77 - 90.
  • 7ZHOU H, JANG H, FLEISCHMANN RM, et al. Pharmacokinetics and safety of golimumab, a fully human anti-TNF-alpha monoclonal antibody, in subjects with rheumatoid arthritis [J]. J Clin Pharmacal, 2007, 47 (3) :383 - 396.
  • 8XU ZH, LEE H, VU T, et al. Population pharmacokinetics of golimumab, an anti-tumor necrosis factor-alpha human monoclonal antibody, in patients with psoriatic arthritis [J]. J Clin Pharmacal, 2009,49(9) :1056 -1070.
  • 9LING J, LYN S, XU Z, et al. Lack of racial differences in the pharmacokinetics of subcutaneous golimumab in healthy Japanese and Caucasian male subjects [J]. J Clin Pharmacol, 2010,50 (7) :792 - 802.
  • 10MAL VERN PA. Centoeor Ortho Biotech Inc. ; SIMPONI? ( golimumab) [S]. 2013.

引证文献2

二级引证文献10

相关作者

内容加载中请稍等...

相关机构

内容加载中请稍等...

相关主题

内容加载中请稍等...

浏览历史

内容加载中请稍等...
;
使用帮助 返回顶部