| MR编号 | NL/H/5261/001 |
|---|
| 药品名称 | Icatibant Xiromed 30 mg oplossing voor injectie, in voorgevulde spuit |
|---|
| 活性成分 | - Icatibant acetate 10.0 mg
|
|---|
| 剂型 | Solution for injection in pre-filled syringe |
|---|
| 上市许可持有人 | Medical Valley Invest AB
Bradgardsvagen 28
Hollviken 23632
Skane Lan
Sweden |
|---|
| 参考成员国 - 产品名称 | Netherlands (NL) Icatibant Xiromed 30 mg oplossing voor injectie, in voorgevulde spuit |
|---|
| 互认成员国 - 产品名称 | - Poland (PL)
Icatibant Medical Valley - Germany (DE)
Icatibant AXiromed 30 mg Injektionslösung in einer Fertigspritze - Denmark (DK)
- Iceland (IS)
Icatibant Medical Valley 30 mg stungulyf, lausn í áfylltri sprautu - Spain (ES)
- Sweden (SE)
- Norway (NO)
Icatibant Medical Valley
|
|---|
| 许可日期 | 2021/12/20 |
|---|
| 最近更新日期 | 2025/03/05 |
|---|
| 药物ATC编码 | | 申请类型 | - TypeLevel1：Abridged
- TypeLevel2：Multiple (Copy) Application
- TypeLevel3：Generic Art 10.1 and 10.2 Dir 2001/83/EC
- TypeLevel4：Chemical Substance
- TypeLevel5：Prescription Only
|
|---|
| 附件文件下载 | |
|---|
| 市场状态 | Positive |
|---|
|
|---|