| 商品名称 | Protopic |
|---|---|
| 适用类别 | Human |
| 治疗领域 | Dermatitis, Atopic |
| 通用名/非专利名称 | tacrolimus |
| 活性成分 | tacrolimus |
| 产品号 | EMEA/H/C/000374 |
| 患者安全信息 | No |
| 许可状态 | Authorised |
| ATC编码 | D11AH01 |
| 是否额外监管 | Nei |
| 是否仿制药或hybrid药物 | Nei |
| 是否生物类似药 | Nei |
| 是否附条件批准 | Nei |
| 是否特殊情形 | Nei |
| 是否加速审评 | Nei |
| 是否罕用药 | Nei |
| 上市许可日期 | 2002/02/27 |
| 上市许可开发者/申请人/持有人 | LEO Pharma A/S |
| 人用药物治疗学分组 | Other dermatological preparations |
| 兽用药物治疗学分组 | |
| 欧盟委员会决定日期 | 2025/12/02 |
| 修订号 | 29 |
| 治疗适应症 | Flare treatment Adults and adolescents (16 years of age and above) Treatment of moderate to severe atopic dermatitis in adults who are not adequately responsive to or are intolerant of conventional therapies such as topical corticosteroids. Children (two years of age and above) Treatment of moderate to severe atopic dermatitis in children (two years of age and above) who failed to respond adequately to conventional therapies such as topical corticosteroids. Maintenance treatment Maintenance treatment of moderate to severe atopic dermatitis for the prevention of flares and the prolongation of flare-free intervals in patients experiencing a high frequency of disease exacerbations (i.e. occurring four or more times per year) who have had an initial response to a maximum of six weeks treatment of twice daily tacrolimus ointment (lesions cleared, almost cleared or mildly affected). |
| 适用物种 | |
| 兽用药物ATC编码 | |
| 首次发布日期 | 2018/06/30 |
| 最后更新日期 | 2025/12/03 |
| 产品说明书 | https://www.ema.europa.eu/en/documents/product-information/protopic-epar-product-information_en.pdf |
| 公共评估报告 | https://www.ema.europa.eu/en/medicines/human/EPAR/protopic |