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欧盟和美国分别批准替莫唑胺静脉注射剂上市
作者:网络来源 时间:2009-04-01 点击:1266 来源:网络来源
<P class=MsoNormal style="MARGIN: 2.5pt 0cm 2.5pt 0.05pt; TEXT-INDENT: 21pt; LINE-HEIGHT: 20pt; TEXT-ALIGN: left; mso-line-height-rule: exactly; mso-pagination: widow-orphan; mso-char-indent-count: 2.0" align=left><FONT size=3><?xml:namespace prefix = st1 ns = "urn:schemas-microsoft-com:office:smarttags" /><st1:chsdate w:st="on" IsROCDate="False" IsLunarDate="False" Day="17" Month="2" Year="2009"><SPAN lang=EN-US style="COLOR: black; mso-bidi-font-size: 10.5pt; mso-font-kerning: 0pt; mso-bidi-font-weight: bold"><FONT face="Times New Roman">2009</FONT></SPAN><SPAN style="COLOR: black; FONT-FAMILY: 宋体; mso-bidi-font-size: 10.5pt; mso-font-kerning: 0pt; mso-bidi-font-weight: bold; mso-ascii-font-family: ’Times New Roman’; mso-hansi-font-family: ’Times New Roman’">年</SPAN><SPAN lang=EN-US style="COLOR: black; mso-bidi-font-size: 10.5pt; mso-font-kerning: 0pt; mso-bidi-font-weight: bold"><FONT face="Times New Roman">2</FONT></SPAN><SPAN style="COLOR: black; FONT-FAMILY: 宋体; mso-bidi-font-size: 10.5pt; mso-font-kerning: 0pt; mso-bidi-font-weight: bold; mso-ascii-font-family: ’Times New Roman’; mso-hansi-font-family: ’Times New Roman’">月</SPAN><SPAN lang=EN-US style="COLOR: black; mso-bidi-font-size: 10.5pt; mso-font-kerning: 0pt; mso-bidi-font-weight: bold"><FONT face="Times New Roman">17</FONT></SPAN><SPAN style="COLOR: black; FONT-FAMILY: 宋体; mso-bidi-font-size: 10.5pt; mso-font-kerning: 0pt; mso-bidi-font-weight: bold; mso-ascii-font-family: ’Times New Roman’; mso-hansi-font-family: ’Times New Roman’">日</SPAN></st1:chsdate><SPAN style="COLOR: black; FONT-FAMILY: 宋体; mso-bidi-font-size: 10.5pt; mso-font-kerning: 0pt; mso-bidi-font-weight: bold; mso-ascii-font-family: ’Times New Roman’; mso-hansi-font-family: ’Times New Roman’">和</SPAN><SPAN lang=EN-US style="COLOR: black; mso-bidi-font-size: 10.5pt; mso-font-kerning: 0pt; mso-bidi-font-weight: bold"><FONT face="Times New Roman">27</FONT></SPAN><SPAN style="COLOR: black; FONT-FAMILY: 宋体; mso-bidi-font-size: 10.5pt; mso-font-kerning: 0pt; mso-bidi-font-weight: bold; mso-ascii-font-family: ’Times New Roman’; mso-hansi-font-family: ’Times New Roman’">日,欧盟和美国分别批准</SPAN><SPAN style="COLOR: #333333; FONT-FAMILY: 宋体; mso-bidi-font-size: 10.5pt; mso-font-kerning: 0pt; mso-bidi-font-weight: bold; mso-ascii-font-family: ’Times New Roman’; mso-hansi-font-family: ’Times New Roman’">先灵葆雅公司的</SPAN><SPAN style="COLOR: black; FONT-FAMILY: 宋体; mso-bidi-font-size: 10.5pt; mso-font-kerning: 0pt; mso-ascii-font-family: ’Times New Roman’; mso-hansi-font-family: ’Times New Roman’">替莫唑胺<SPAN style="mso-bidi-font-weight: bold"><FONT face=宋体>静脉注射剂</FONT></SPAN>(</SPAN><SPAN lang=EN-US style="COLOR: black; mso-bidi-font-size: 10.5pt; mso-font-kerning: 0pt"><FONT face="Times New Roman">temozolomide</FONT></SPAN><SPAN style="COLOR: black; FONT-FAMILY: 宋体; mso-bidi-font-size: 10.5pt; mso-font-kerning: 0pt; mso-ascii-font-family: ’Times New Roman’; mso-hansi-font-family: ’Times New Roman’">)<FONT face=宋体><SPAN style="mso-bidi-font-weight: bold">上市,欧盟还批准袋装</SPAN>替莫唑胺<SPAN style="mso-bidi-font-weight: bold">口服</SPAN>胶囊<SPAN style="mso-bidi-font-weight: bold">上市。</SPAN>替莫唑胺在欧洲上市的<SPAN style="mso-bidi-font-weight: bold">商品名为</SPAN></FONT></SPAN><SPAN lang=EN-US style="COLOR: black; mso-bidi-font-size: 10.5pt; mso-font-kerning: 0pt; mso-bidi-font-weight: bold"><FONT face="Times New Roman">Temodal</FONT></SPAN><SPAN style="COLOR: black; FONT-FAMILY: 宋体; mso-bidi-font-size: 10.5pt; mso-font-kerning: 0pt; mso-bidi-font-weight: bold; mso-ascii-font-family: ’Times New Roman’; mso-hansi-font-family: ’Times New Roman’">,在美国为</SPAN><SPAN lang=EN-US style="COLOR: black; mso-bidi-font-size: 10.5pt; mso-font-kerning: 0pt; mso-bidi-font-weight: bold"><FONT face="Times New Roman">Temodar</FONT></SPAN><SPAN style="COLOR: black; FONT-FAMILY: 宋体; mso-bidi-font-size: 10.5pt; mso-font-kerning: 0pt; mso-bidi-font-weight: bold; mso-ascii-font-family: ’Times New Roman’; mso-hansi-font-family: ’Times New Roman’">。新品获准上市大大地方便了患者治疗。本品剂量规格(注射剂):</SPAN><SPAN style="COLOR: black; FONT-FAMILY: 宋体; mso-bidi-font-size: 10.5pt; mso-font-kerning: 0pt; mso-ascii-font-family: ’Times New Roman’; mso-hansi-font-family: ’Times New Roman’">替莫唑胺</SPAN><SPAN lang=EN-US style="COLOR: black; mso-bidi-font-size: 10.5pt; mso-font-kerning: 0pt"><FONT face="Times New Roman"> 100 mg/</FONT></SPAN><SPAN style="COLOR: black; FONT-FAMILY: 宋体; mso-bidi-font-size: 10.5pt; mso-font-kerning: 0pt; mso-ascii-font-family: ’Times New Roman’; mso-hansi-font-family: ’Times New Roman’">瓶;(欧洲的胶囊):替莫唑胺</SPAN><SPAN lang=EN-US style="COLOR: black; mso-bidi-font-size: 10.5pt; mso-font-kerning: 0pt"><FONT face="Times New Roman"> 5 mg/</FONT></SPAN><SPAN style="COLOR: black; FONT-FAMILY: 宋体; mso-bidi-font-size: 10.5pt; mso-font-kerning: 0pt; mso-ascii-font-family: ’Times New Roman’; mso-hansi-font-family: ’Times New Roman’">粒、</SPAN><SPAN lang=EN-US style="COLOR: black; mso-bidi-font-size: 10.5pt; mso-font-kerning: 0pt"><FONT face="Times New Roman">20 mg/</FONT></SPAN><SPAN style="COLOR: black; FONT-FAMILY: 宋体; mso-bidi-font-size: 10.5pt; mso-font-kerning: 0pt; mso-ascii-font-family: ’Times New Roman’; mso-hansi-font-family: ’Times New Roman’">粒、</SPAN><SPAN lang=EN-US style="COLOR: black; mso-bidi-font-size: 10.5pt; mso-font-kerning: 0pt"><FONT face="Times New Roman">100 mg/</FONT></SPAN><SPAN style="COLOR: black; FONT-FAMILY: 宋体; mso-bidi-font-size: 10.5pt; mso-font-kerning: 0pt; mso-ascii-font-family: ’Times New Roman’; mso-hansi-font-family: ’Times New Roman’">粒、</SPAN><SPAN lang=EN-US style="COLOR: black; mso-bidi-font-size: 10.5pt; mso-font-kerning: 0pt"><FONT face="Times New Roman">140 mg/</FONT></SPAN><SPAN style="COLOR: black; FONT-FAMILY: 宋体; mso-bidi-font-size: 10.5pt; mso-font-kerning: 0pt; mso-ascii-font-family: ’Times New Roman’; mso-hansi-font-family: ’Times New Roman’">粒、</SPAN><SPAN lang=EN-US style="COLOR: black; mso-bidi-font-size: 10.5pt; mso-font-kerning: 0pt"><FONT face="Times New Roman">180 mg/</FONT></SPAN><SPAN style="COLOR: black; FONT-FAMILY: 宋体; mso-bidi-font-size: 10.5pt; mso-font-kerning: 0pt; mso-ascii-font-family: ’Times New Roman’; mso-hansi-font-family: ’Times New Roman’">粒、</SPAN><SPAN lang=EN-US style="COLOR: black; mso-bidi-font-size: 10.5pt; mso-font-kerning: 0pt"><FONT face="Times New Roman">250 mg/</FONT></SPAN><SPAN style="COLOR: black; FONT-FAMILY: 宋体; mso-bidi-font-size: 10.5pt; mso-font-kerning: 0pt; mso-ascii-font-family: ’Times New Roman’; mso-hansi-font-family: ’Times New Roman’">粒。</SPAN><FONT face="Times New Roman"><SPAN style="COLOR: black; mso-bidi-font-size: 10.5pt; mso-font-kerning: 0pt; mso-bidi-font-weight: bold"> </SPAN><SPAN lang=EN-US style="COLOR: #333333; mso-bidi-font-size: 10.5pt; mso-font-kerning: 0pt"><?xml:namespace prefix = o ns = "urn:schemas-microsoft-com:office:office" /><o:p></o:p></SPAN></FONT></FONT></P><BR> <P class=MsoNormal style="MARGIN: 2.5pt 0cm 2.5pt 0.05pt; TEXT-INDENT: 21pt; LINE-HEIGHT: 20pt; TEXT-ALIGN: left; mso-line-height-rule: exactly; mso-pagination: widow-orphan; mso-char-indent-count: 2.0" align=left><FONT size=3><SPAN style="COLOR: black; FONT-FAMILY: 宋体; mso-bidi-font-size: 10.5pt; mso-font-kerning: 0pt; mso-ascii-font-family: ’Times New Roman’; mso-hansi-font-family: ’Times New Roman’">替莫唑胺在欧盟获准<FONT face=宋体><SPAN style="mso-bidi-font-weight: bold">先</SPAN>与放疗联合治疗<SPAN style="mso-bidi-font-weight: bold">而后单一治疗新</SPAN>诊断的多形性成胶质细胞瘤、常规药物治疗后复发或加重的多形性成胶质细胞瘤等恶性胶质瘤。替莫唑胺在美国获准用于成人<SPAN style="mso-bidi-font-weight: bold">先</SPAN></FONT>与放疗联合治疗<SPAN style="mso-bidi-font-weight: bold"><FONT face=宋体>而后维持治疗新</FONT></SPAN>诊断的多形性成胶质细胞瘤、难治愈的多形性成胶质细胞瘤(采用亚硝基脲和丙卡巴肼给药方案病情仍加重)。</SPAN><SPAN style="COLOR: black; mso-bidi-font-size: 10.5pt; mso-font-kerning: 0pt"><FONT face="Times New Roman"> </FONT></SPAN></FONT></P> <P class=MsoNormal style="MARGIN: 2.5pt 0cm 2.5pt 0.05pt; TEXT-INDENT: 21pt; LINE-HEIGHT: 20pt; TEXT-ALIGN: left; mso-line-height-rule: exactly; mso-pagination: widow-orphan; mso-char-indent-count: 2.0" align=left><FONT size=3><SPAN style="COLOR: black; mso-bidi-font-size: 10.5pt; mso-font-kerning: 0pt"><FONT face="Times New Roman">(数据<FONT size=3><SPAN style="FONT-FAMILY: 宋体; mso-ascii-font-family: ’Times New Roman’; mso-hansi-font-family: ’Times New Roman’">来源:中国医药数字图书馆网站</SPAN><SPAN lang=EN-US><FONT face="Times New Roman">&nbsp;)</FONT></SPAN></FONT></FONT></SPAN></FONT></P>
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