| 商品名称 | Silgard |
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| 适用类别 | Human |
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| 治疗领域 | Papillomavirus Infections;Uterine Cervical Dysplasia;Condylomata Acuminata;Immunization |
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| 通用名/非专利名称 | human papillomavirus vaccine [types 6, 11, 16, 18] (recombinant, adsorbed) |
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| 活性成分 | human papillomavirus type 6 L1 protein;human papillomavirus type 11 L1 protein;human papillomavirus type 16 L1 protein;human papillomavirus type 18 L1 protein |
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| 产品号 | EMEA/H/C/000732 |
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| 患者安全信息 | No |
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| 许可状态 | Withdrawn |
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| ATC编码 | J07BM01 |
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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 | 2006/09/19 |
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| 上市许可开发者/申请人/持有人 | Merck Sharp Dohme Ltd |
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| 人用药物治疗学分组 | Vaccines |
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| 兽用药物治疗学分组 | |
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| 欧盟委员会决定日期 | 2019/02/18 |
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| 修订号 | 33 |
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| 治疗适应症 | Silgard is a vaccine for use from the age of 9 years for the prevention of: premalignant genital lesions (cervical, vulvar and vaginal), premalignant anal lesions, cervical cancers and anal cancers causally related to certain oncogenic Human Papillomavirus (HPV) types; genital warts (condyloma acuminata) causally related to specific HPV types. See sections 4.4 and 5.1 for important information on the data that support this indication. The use of Silgard 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 | 2018/05/17 |
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| 最后更新日期 | 2019/04/02 |
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| 产品说明书 | https://www.ema.europa.eu/en/documents/product-information/silgard-epar-product-information_en.pdf |
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| 公共评估报告 | https://www.ema.europa.eu/en/medicines/human/EPAR/silgard |
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