| 商品名称 | Procomvax |
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| 适用类别 | Human |
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| 治疗领域 | Hepatitis B;Meningitis, Haemophilus;Immunization |
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| 通用名/非专利名称 | haemophilus B conjugate (meningococcal protein conjugate) and hepatitis B (recombinant) vaccine |
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| 活性成分 | polyribosylribitol phosphate from Haemophilus influenzae type b as PRP-OMPC;outer membrane protein complex of Neisseria meningitidis (outer membrane protein complex of the B11 strain of Neisseria meningitidis subgroup B);adsorbed hepatitis B surface antigen produced in recombinant yeast cells (Saccharomyces cerevisiae) |
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| 产品号 | EMEA/H/C/000231 |
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| 患者安全信息 | No |
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| 许可状态 | Expired |
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| ATC编码 | J07CA |
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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 | 1999/05/07 |
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| 上市许可开发者/申请人/持有人 | Sanofi Pasteur MSD, SNC |
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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 | 2007/12/11 |
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| 修订号 | 9 |
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| 治疗适应症 | PROCOMVAX is indicated for vaccination against invasive disease caused by Haemophilus influenzae type b and against infection caused by all known subtypes of hepatitis B virus in infants 6 weeks to 15 months of age. |
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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 | 2007/12/11 |
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| 最后更新日期 | 2009/07/29 |
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| 产品说明书 | https://www.ema.europa.eu/en/documents/product-information/procomvax-epar-product-information_en.pdf |
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| 公共评估报告 | https://www.ema.europa.eu/en/medicines/human/EPAR/procomvax |
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