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MechanismFibrinogen stimulants |
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Inactive Indication- |
Drug Highest PhaseApproved |
First Approval Ctry. / Loc.CN |
First Approval Date09 Jul 2020 |
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Inactive Indication- |
Drug Highest PhaseApproved |
First Approval Ctry. / Loc.KR |
First Approval Date09 Jan 2012 |
评价人纤维蛋白原在先天性纤维蛋白原减少或缺乏症患者中的有效性和安全性的上市后临床研究
[Translation] Post-marketing clinical study to evaluate the efficacy and safety of human fibrinogen in patients with congenital fibrinogen deficiency or deficiency
1)通过单次给药的简易PK研究,探索本品的部分关键药代动力学(PK)特征,为本品用量计算提供依据;
2)评价本品在上市后治疗先天性纤维蛋白原减少或缺乏症患者的有效性和安全性。
[Translation] 1) Through a simple PK study of a single dose, explore some key pharmacokinetic (PK) characteristics of this product to provide a basis for the dosage calculation of this product;
2) Evaluate the efficacy and safety of this product in the treatment of patients with congenital fibrinogen deficiency or deficiency after marketing.
评价静注人免疫球蛋白(pH4)治疗原发免疫性血小板减少症有效性和安全性的临床研究
[Translation] Clinical study to evaluate the efficacy and safety of intravenous human immunoglobulin (pH4) in the treatment of primary immune thrombocytopenia
以原生产工艺静注人免疫球蛋白(pH4)对照,评价静注人免疫球蛋白(pH4)治疗原发免疫性血小板减少症的有效性和安全性。
[Translation] To evaluate the efficacy and safety of intravenous human immunoglobulin (pH4) in the treatment of primary immune thrombocytopenia, using the original production process of intravenous human immunoglobulin (pH4) as a control.
100 Clinical Results associated with Green Cross China Biological Products Co., Ltd.
0 Patents (Medical) associated with Green Cross China Biological Products Co., Ltd.
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100 Translational Medicine associated with Green Cross China Biological Products Co., Ltd.