维莫德吉硬胶囊Erivedge capsules 150mg(vismodegib)

药店国别： 产地国家：英国 处方药：是 所属类别： 150毫克/胶囊 28胶囊/瓶 包装规格： 150毫克/胶囊 28胶囊/瓶 计价单位：瓶 生产厂家中文参考译名： 生产厂家英文名：Roche 原产地英文商品名：Erivedge hard capsules 150mg/cap 28Caps/bottle 原产地英文药品名：vismodegib 中文参考商品译名：Erivedge硬胶囊 150毫克/胶囊 28胶囊/瓶 中文参考药品译名：维莫德吉

简介

Erivedge(vismodegib hard capsules)商品名：Erivedge 通用名：vismodegib生产商：罗氏的基因技术公司(Genentech)Erivedge(vismodegib)是一种具有选择性Hedgehog信号通路的新型口服类药物。由罗氏(Roche)的基因技术公司生产 药品介绍 欧盟委员会(EC)已授予Erivedge(vismodegib)有条件批准(conditionalapproval)，用于不适宜手术或放疗治疗的有症状转移性基底细胞癌(BCC)或局部晚期BCC成人患者的治疗。 该项批准，使Erivedge成为欧盟首个获批用于这一严重危机生命的皮肤癌的药物。有条件批准授予具有积极效益/风险评估的产品，以满足一种严重未获满足的医疗需求，将带来重大的公共卫生利益。根据有条件批准的规定，罗氏将提供目前正在开展的全球安全性研究中有关Erivedge治疗晚期BCC的额外数据。2012年1月，FDA通过优先审查程序批准了Erivedge，成为美国首个获批用于晚期BCC治疗的药物，专门用于已经不能开刀或化疗治疗的局部晚期基底细胞癌或癌变已扩散至身体其他器官的BCC患者的治疗。 Erivedge已获瑞士、澳大利亚、以色列、韩国、墨西哥、厄瓜多尔批准。目前，罗氏正积极与多国的监管机构密切合作，确保Erivedge能尽快上市。基底细胞癌是最常见的皮肤癌之一，它源于皮肤表层，患者同时不会感到疼痛。对于经常暴露在阳光下或是紫外线照射的皮肤病发的几率最大。

英文版说明书

ERIVEDGE™ (EH-rih-vej)(vismodegib)capsuleRead this Medication Guide beforeyou start taking ERIVEDGE and each time you get a refill. There may be newinformation. This Medication Guide does not take the place of talking with yourhealthcare provider about your medical condition or your treatment.What is themost important information I should know about ERIVEDGE?ERIVEDGE can cause yourbaby to die before it is born (be stillborn) or cause your baby to have severebirth defects.For females who can become pregnant:•You should talk with yourhealthcare provider about the risks of ERIVEDGE to your unborn child.•Yourhealthcare provider should do a pregnancy test within 7 days before you starttaking ERIVEDGE to find out if you are pregnant.•In order to avoid pregnancy,you should start using highly effective birth control before you start ERIVEDGE,and continue to use highly effective birth control during treatment, and for 7months after your last dose of ERIVEDGE. Talk with your healthcare providerabout what birth control method is right for you during this time.•Talk to yourhealthcare provider right away if you have unprotected sex or if you think thatyour birth control has failed.•Tell your healthcare provider right away if youbecome pregnant or think that you may be pregnant.For males:•You should alwaysuse a condom with a spermicide, even if you have had a vasectomy, during sexwith female partners while you are taking ERIVEDGE and for 2 months after yourlast dose to protect your female partner from being exposed to ERIVEDGE.•Tellyour healthcare provider right away if your partner becomes pregnant or thinksshe is pregnant while you are taking ERIVEDGE.Exposure to ERIVEDGE duringpregnancy:If you think that you or your female partner may have been exposed toERIVEDGE during pregnancy, talk to your healthcare provider right away. Pregnantwomen are encouraged to participate in a program that collects information aboutexposure to ERIVEDGE during pregnancy, and the effects on the mother and herunborn child. This program is called the ERIVEDGE pregnancy pharmacovigilanceprogram. You may participate in this program by calling the Genentech AdverseEvent Line at