菲律宾宣布暂停Dengvaxia的批准,对赛诺菲公司象征性的处以2000美元的罚款

2018-01-07 MedSci MedSci原创

据路透社报道,在菲律宾的赛诺菲(Sanofi)的Dengvaxia的所有骚乱和愤怒中,该国目前只暂停了疫苗的审批,并对制药商处以2000美元的罚款。这一决定于去年12月29日向赛诺菲·巴斯德(Sanofi Pasteur)提交,并将Dengvaxia的营销授权搁置一年。赛诺菲在一份发给FiercePharma的声明中说,卫生部的停职并不是针对产品的质量,而是"与所谓的不符合上市后要求有关"。赛诺菲

据路透社报道,在菲律宾的赛诺菲(Sanofi)的Dengvaxia的所有骚乱和愤怒中,该国目前只暂停了疫苗的审批,并对制药商处以2000美元的罚款。这一决定于去年12月29日向赛诺菲·巴斯德(Sanofi Pasteur)提交,并将Dengvaxia的营销授权搁置一年。赛诺菲在一份发给FiercePharma的声明中说,卫生部的停职并不是针对产品的质量,而是"与所谓的不符合上市后要求有关"。赛诺菲驳斥了它不符合要求的说法,强调它已经根据国际和菲律宾法律进行了批准后的药物警戒活动。赛诺菲11月底发布分析报告显示,登革热疫苗可能对未曾接触过病毒的人造成更严重的反应,菲律宾卫生当局立即停止了免疫接种计划。该公司在一份声明中表示:"赛诺菲巴斯德将继续与菲律宾FDA保持完全透明的合作,并承诺遵守菲律宾的法律和法规。"目前的处罚并没有涉及政府对陷入困境的疫苗的采购过程,这实际上是调查对象和一个民事请愿书,要求对政府官员和赛诺菲高管进行刑事指控。如果发现任何不当行为,可能还会受到更严厉的惩罚。该国一些人指责赛诺菲与上届政府合谋,以获得一项7000万美元的大规模免疫计划迅速获得批准,一些人对该疫苗的安

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    2018-04-17 zhouqu_8
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    2018-01-07 1e0e5697m83(暂无匿称)

    henhao

    0

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    2018-01-07 183****7028

    学习

    0

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  5. [GetPortalCommentsPageByObjectIdResponse(id=2081432, encodeId=5f18208143236, content=<a href='/topic/show?id=57406e8506' target=_blank style='color:#2F92EE;'>#Eng#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=19, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=6785, encryptionId=57406e8506, topicName=Eng)], attachment=null, authenticateStatus=null, createdAvatar=https://wx.qlogo.cn/mmopen/aLGWoFXAyMbIu3qymFOyheQLjPSX3OUs5GmkyBlcCOwTPIeq3why9NGibxxUqYo6hcx8qZLHZFgNPnBK1yzWeOFpyg2OnWOt0/0, createdBy=fa4716, createdName=zhouqu_8, createdTime=Tue Apr 17 18:52:00 CST 2018, time=2018-04-17, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=276385, encodeId=79222e6385f8, content=henhao, beContent=null, objectType=article, channel=null, level=null, likeNumber=53, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=https://wx.qlogo.cn/mmopen/mStl88fu4NcXNhUvfhzd2VdicMnaLeK2Im5gKx4Ucxd8Bwu6S7RG0uILBFQx5HTW2bU4VricDYlQqN20ibASSMYAeGrZrrTpy2Q/0, createdBy=b10c1938054, createdName=1e0e5697m83(暂无匿称), createdTime=Sun Jan 07 14:16:00 CST 2018, time=2018-01-07, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=276335, encodeId=0f0b2e63352d, content=学习, beContent=null, objectType=article, channel=null, level=null, likeNumber=37, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=https://wx.qlogo.cn/mmopen/vi_32/iaAVWEsIJUkA1ITy3uL0lhHUhyaJibWgFtH4KbJuaLbY2WUK33jgCFyoZ8Eqx7eE7hCuZhytc1C5GRrfjVXN8lYg/0, createdBy=fcb82149579, createdName=183****7028, createdTime=Sun Jan 07 11:26:07 CST 2018, time=2018-01-07, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=276328, encodeId=ceb32e632815, content=学, beContent=null, objectType=article, channel=null, level=null, likeNumber=30, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=https://wx.qlogo.cn/mmopen/mStl88fu4NfDEeydJz0GlP8O0ngrUX6AYCXFic0XDOOAyeQicIqnOd4TrWSwiagJrsFNYuWC1Uc6iavbS1hWt9xtZAhAqLGHqZyl/0, createdBy=42891977006, createdName=1e17414fm02(暂无匿称), createdTime=Sun Jan 07 10:12:53 CST 2018, time=2018-01-07, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=276325, encodeId=098a2e6325c5, content=优质资源.共同学习, beContent=null, objectType=article, channel=null, level=null, likeNumber=46, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=https://wx.qlogo.cn/mmopen/oLAjfB7s1ib06iaV3D9Tg5K0LqDY57Aia0TOQByoJhNt3icm4sfukp500hLH6RHOpFdV01NbECtAV7s0qKpQPibyRukQAwAmqJU3X/0, createdBy=f91f1928792, createdName=九九消寒, createdTime=Sun Jan 07 09:52:48 CST 2018, time=2018-01-07, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=276304, encodeId=c1ec2e630429, content=阅, beContent=null, objectType=article, channel=null, level=null, likeNumber=38, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=https://wx.qlogo.cn/mmopen/vi_32/fhZdOu27e88Voqh19n8eF8cLplo8L4nicKtH0WnE3KFELXns5XDu8rsiceK2HHDZc2SEStia5VV3Pia2QLMVqlWbHw/0, createdBy=6e012139475, createdName=神功盖世, createdTime=Sun Jan 07 09:16:26 CST 2018, time=2018-01-07, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=276297, encodeId=76e52e629781, content=学习谢谢分享, beContent=null, objectType=article, channel=null, level=null, likeNumber=17, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=https://wx.qlogo.cn/mmopen/mStl88fu4Nd44v3xHnnictn9UpctwtH62EPQ59TMdI9lnqHMgQ16nH7GmGCfpzicsHgjibYVk6vwSpXrC86gMibRkoaIzf5HwSz7/0, createdBy=78cc1691107, createdName=龙胆草, createdTime=Sun Jan 07 09:14:32 CST 2018, time=2018-01-07, status=1, ipAttribution=)]
    2018-01-07 九九消寒

    优质资源.共同学习

    0

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    2018-01-07 神功盖世

    0

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    2018-01-07 龙胆草

    学习谢谢分享

    0