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欧盟CHMP建议批准默沙东Noxafil静脉注射液

来源:生物谷 2014-07-31 09:39

2014年7月30日讯 /生物谷BIOON/ --默沙东(Merck & Co)7月30日宣布,欧洲药品管理局(EMA)人用医药产品委员会(CHMP)已建议批准Noxafil(posaconazole,泊沙康唑)静脉注射剂(intravenous,IV),该药是一种新配方的Noxafil。

Noxafil是一种新型三唑类抗真菌药。此前,Noxafil肠溶片和Noxafil口服混悬液已获欧盟委员会(EC)批准。

在美国,Noxafil的适应症为用于因免疫功能严重低下而具有高风险的侵袭性曲霉菌和念珠菌感染的患者,如患有移植物抗宿主病(GVHD)的造血干细胞移植(HSCT)受者,或那些因化疗导致长期的中性粒细胞减少(低白细胞计数)的恶性血液病患者。Noxafil缓释片和口服混悬液适用于13岁及以上患者,Noxafil静脉注射液适用于18岁及以上患者。(生物谷Bioon.com)

英文原文:CHMP Issues Positive Opinion for Intravenous (IV) Formulation of Merck’s NOXAFIL® (posaconazole)

Wednesday, July 30, 2014 8:00 am EDT
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WHITEHOUSE STATION, N.J., July 30, 2014 – Merck (NYSE: MRK), known as MSD outside the United States and Canada, today announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has adopted a positive opinion recommending approval of a new, investigational intravenous (IV) formulation of NOXAFIL® (posaconazole).

The CHMP positive opinion will be reviewed by the European Commission which, should they affirm the CHMP opinion, will grant a centralized marketing authorization with unified labeling that is valid in the 28 countries that are members of the European Union, as well as European Economic Area members, Iceland, Liechtenstein and Norway.

The European Commission previously granted centralized marketing authorization for NOXAFIL gastro-resistant tablets and NOXAFIL oral suspension.

NOXAFIL in the U.S.

In the U.S., NOXAFIL is indicated for the prophylaxis of invasive Aspergillus and Candida infections in patients who are at high risk of developing these infections due to being severely immunocompromised, such as hematopoietic stem cell transplant (HSCT) recipients with graft-versus-host disease (GVHD) or those with hematologic malignancies with prolonged neutropenia (low white blood cell counts) from chemotherapy. NOXAFIL injection is indicated in patients 18 years of age and older. NOXAFIL delayed-release tablets and oral suspension are indicated in patients 13 years of age and older.

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