| 商品名称 | ImmunoGam |
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| 适用类别 | Human |
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| 治疗领域 | Immunization, Passive;Hepatitis B |
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| 通用名/非专利名称 | human hepatitis B immunoglobulin |
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| 活性成分 | human hepatitis B immunoglobulin |
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| 产品号 | EMEA/H/C/001055 |
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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| 许可状态 | Withdrawn |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 | J06BB04 |
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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 | 2010/03/16 |
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| 上市许可开发者/申请人/持有人 | Cangene Europe Limited |
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| 人用药物治疗学分组 | Specific immunoglobulins |
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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 | 2010/09/06 |
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| 修订号 | |
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| 治疗适应症 | Immunoprophylaxis of Hepatitis B - In case of accidental exposure in non-immunised subjects (including persons whose vaccination isincomplete or status unknown). - In haemodialysed patients, until vaccination has become effective. - In the newborn of a hepatitis B virus carrier-mother. - In subjects who did not show an immune response (no measurable hepatitis B antibodies) after vaccination and for whom a continuous prevention is necessary due to the continuous risk of being infected with hepatitis B. Consideration should also be given to other official guidance on the appropriate use of human hepatitis B immunoglobulin for intramuscular use. |
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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 | 2010/09/06 |
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| 最后更新日期 | 2011/01/26 |
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| 产品说明书 | https://www.ema.europa.eu/en/documents/product-information/immunogam-epar-product-information_en.pdf |
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| 公共评估报告 | https://www.ema.europa.eu/en/medicines/human/EPAR/immunogam |
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