| 商品名称 | Kauliv |
|---|---|
| 适用类别 | Human |
| 治疗领域 | Osteoporosis; Osteoporosis, Postmenopausal |
| 通用名/非专利名称 | teriparatide |
| 活性成分 | teriparatide |
| 产品号 | EMEA/H/C/004932 |
| 患者安全信息 | no |
| 授权状态 | Authorised |
| ATC编码 | H05AA02 |
| 是否额外监管 | yes |
| 是否仿制药 | no |
| 是否生物类似药 | yes |
| 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 |
| 批准上市日期 | 2023/01/12 |
| 上市许可持有人/公司名称 | Strides Pharma (Cyprus) Limited |
| 人用药物治疗分组 | Calcium homeostasis |
| 审评意见发布日期 | 2022/11/10 |
| 决定日期 | 2023/11/10 |
| 修订号 | 1 |
| 适应症 | Kauliv is indicated in adults., , Treatment of osteoporosis in postmenopausal women and in men at increased risk of fracture (see section 5.1). In postmenopausal women, a significant reduction in the incidence of vertebral and non-vertebral fractures but not hip fractures has been demonstrated., , Treatment of osteoporosis associated with sustained systemic glucocorticoid therapy in women and men at increased risk for fracture (see section 5.1)., |
| 首次发布日期 | 2022/07/18 |
| 修订日期 | 2023/11/20 |
| 产品信息 | https://www.ema.europa.eu/en/documents/product-information/kauliv-epar-product-information_en.pdf |
| 公共评估报告 | https://www.ema.europa.eu/en/medicines/human/EPAR/kauliv |