| 商品名称 | HyQvia |
|---|
| 适用类别 | Human |
|---|
| 治疗领域 | Immunologic Deficiency Syndromes;Polyradiculoneuropathy;Polyradiculoneuropathy, Chronic Inflammatory Demyelinating |
|---|
| 通用名/非专利名称 | human normal immunoglobulin |
|---|
| 活性成分 | human normal immunoglobulin |
|---|
| 产品号 | EMEA/H/C/002491 |
|---|
| 患者安全信息 | No |
|---|
| 许可状态 | Authorised |
|---|
| ATC编码 | J06BA01 |
|---|
| 是否额外监管 | No |
|---|
| 是否仿制药或hybrid药物 | No |
|---|
| 是否生物类似药 | No |
|---|
| 是否附条件批准 | No |
|---|
| 是否特殊情形 | No |
|---|
| 是否加速审评 | No |
|---|
| 是否罕用药 | No |
|---|
| 上市许可日期 | 2013/05/16 |
|---|
| 上市许可开发者/申请人/持有人 | Baxalta Innovations GmbH |
|---|
| 人用药物治疗学分组 | Immune sera and immunoglobulins |
|---|
| 兽用药物治疗学分组 | |
|---|
| 审评意见日期 | 2013/03/21 |
|---|
| 欧盟委员会决定日期 | 2025/04/03 |
|---|
| 修订号 | 24 |
|---|
| 治疗适应症 | Replacement therapy in adults, children and adolescents (0-18 years) in: Primary immunodeficiency syndromes with impaired antibody production. Secondary immunodeficiencies (SID) in patients who suffer from severe or recurrent infections, ineffective antimicrobial treatment and either proven specific antibody failure (PSAF)* or serum IgG level of < 4 g/L. *PSAF = failure to mount at least a 2-fold rise in IgG antibody titre to pneumococcal polysaccharide and polypeptide antigen vaccines. Immunomodulatory therapy in adults, children and adolescents (0 to 18 years) in: Chronic inflammatory demyelinating polyneuropathy (CIDP) as maintenance therapy after stabilization with IVIg. |
|---|
| 适用物种 | |
|---|
| 兽用药物ATC编码 | |
|---|
| 首次发布日期 | 2018/07/26 |
|---|
| 最后更新日期 | 2025/05/27 |
|---|
| 产品说明书 | https://www.ema.europa.eu/en/documents/product-information/hyqvia-epar-product-information_en.pdf |
|---|
| 公共评估报告 | https://www.ema.europa.eu/en/medicines/human/EPAR/hyqvia |
|---|