| 商品名称 | Gardasil 9 |
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| 适用类别 | Human |
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| 治疗领域 | Condylomata Acuminata;Papillomavirus Infections;Immunization;Uterine Cervical Dysplasia |
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| 通用名/非专利名称 | human papillomavirus 9-valent vaccine (recombinant, adsorbed) |
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| 活性成分 | human papillomavirus vaccine [types 6, 11, 16, 18, 31, 33, 45, 52, 58] (recombinant, adsorbed) |
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| 产品号 | EMEA/H/C/003852 |
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| 患者安全信息 | No |
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| 许可状态 | Authorised |
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| ATC编码 | J07BM03 |
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| 是否额外监管 | No |
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| 是否仿制药或hybrid药物 | No |
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| 是否生物类似药 | No |
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| 是否附条件批准 | No |
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| 是否特殊情形 | No |
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| 是否加速审评 | No |
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| 是否罕用药 | No |
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| 上市许可日期 | 2015/06/10 |
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| 上市许可开发者/申请人/持有人 | Merck Sharp & Dohme B.V. |
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| 人用药物治疗学分组 | Papillomavirus vaccines |
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| 兽用药物治疗学分组 | |
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| 审评意见日期 | 2015/03/25 |
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| 欧盟委员会决定日期 | 2025/10/09 |
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| 修订号 | 28 |
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| 治疗适应症 | Gardasil 9 is indicated for active immunisation of individuals from the age of 9 years against the following HPV diseases: Premalignant lesions and cancers affecting the cervix, vulva, vagina and anus caused by vaccine HPV types Genital warts (Condyloma acuminata) caused by specific HPV types. See sections 4.4 and 5.1 for important information on the data that support these indications. The use of Gardasil 9 should be in accordance with official recommendations. |
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| 适用物种 | |
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| 兽用药物ATC编码 | |
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| 首次发布日期 | 2018/07/26 |
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| 最后更新日期 | 2025/10/09 |
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| 产品说明书 | https://www.ema.europa.eu/en/documents/product-information/gardasil-9-epar-product-information_en.pdf |
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| 公共评估报告 | https://www.ema.europa.eu/en/medicines/human/EPAR/gardasil-9 |
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