| 商品名称 | Flebogamma DIF (previously Flebogammadif) |
|---|
| 适用类别 | Human |
|---|
| 治疗领域 | Mucocutaneous Lymph Node Syndrome;Guillain-Barre Syndrome;Bone Marrow Transplantation;Purpura, Thrombocytopenic, Idiopathic;Immunologic Deficiency Syndromes |
|---|
| 通用名/非专利名称 | human normal immunoglobulin |
|---|
| 活性成分 | human normal immunoglobulin |
|---|
| 产品号 | EMEA/H/C/000781 |
|---|
| 患者安全信息 | No |
|---|
| 许可状态 | Authorised |
|---|
| ATC编码 | J06BA02 |
|---|
| 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 | 2007/07/23 |
|---|
| 上市许可开发者/申请人/持有人 | Instituto Grifols S.A. |
|---|
| 人用药物治疗学分组 | Immune sera and immunoglobulins |
|---|
| 兽用药物治疗学分组 | |
|---|
| 欧盟委员会决定日期 | 2023/10/30 |
|---|
| 修订号 | 19 |
|---|
| 治疗适应症 | Replacement therapy in adults, children and adolescents (0-18 years) in: primary immunodeficiency syndromes with impaired antibody production; hypogammaglobulinaemia and recurrent bacterial infections in patients with chronic lymphocytic luekaemia, in whom prophylactic antibiotics have failed; hypogammaglobulinaemia and recurrent bacterial infections in plateau-phase-multiple-myeloma patients who failed to respond to pneumococcal immunisation; hypogammaglobulinaemia in patients after allogenic haematopoietic-stem-cell transplantation (HSCT); congenital AIDS with recurrent bacterial infections. Immunomodulation in adults, children and adolescents (0-18 years) in: primary immune thrombocytopenia (ITP), in patients at high risk of bleeding or prior to surgery to correct the platelet count; Guillain Barré syndrome; Kawasaki disease. |
|---|
| 适用物种 | |
|---|
| 兽用药物ATC编码 | |
|---|
| 首次发布日期 | 2017/06/29 |
|---|
| 最后更新日期 | 2024/01/11 |
|---|
| 产品说明书 | https://www.ema.europa.eu/en/documents/product-information/flebogamma-dif-epar-product-information_en.pdf |
|---|
| 公共评估报告 | https://www.ema.europa.eu/en/medicines/human/EPAR/flebogamma-dif |
|---|