| MR编号 | NL/H/5941/001 |
|---|
| 药品名称 | Sacubitril/Valsartan 24 mg/26 mg Film-coated tablet |
|---|
| 活性成分 | - Sacubitril sodium 24.0 mg
- Valsartan disodium 26.0 mg
|
|---|
| 剂型 | Film-coated tablet |
|---|
| 上市许可持有人 | Teva Nederland B.V.
Swensweg 5
2031 GA Haarlem The Netherlands |
|---|
| 参考成员国 - 产品名称 | Netherlands (NL) |
|---|
| 互认成员国 - 产品名称 | - Sweden (SE)
- Norway (NO)
- Germany (DE)
Sacubitril/Valsartan-ratiopharm 24 mg/26 mg Filmtabletten - Finland (FI)
- Denmark (DK)
Sacubitril/Valsartan Teva - Poland (PL)
Sacubitril + Valsartan Teva - Belgium (BE)
- Latvia (LV)
- Luxembourg (LU)
- Lithuania (LT)
Sacubitril/Valsartan Teva 24mg/26mg plėvele dengtos tabletės - Iceland (IS)
- Estonia (EE)
- Ireland (IE)
- Hungary (HU)
- Austria (AT)
- Czechia (CZ)
Sakubitril/Valsartan Teva - France (FR)
- Romania (RO)
- Spain (ES)
- Slovakia (SK)
Sacubitril/Valsartan Teva 24mg/26mg filmom obalené tablety - Italy (IT)
|
|---|
| 许可日期 | 2025/06/13 |
|---|
| 最近更新日期 | 2025/07/22 |
|---|
| 药物ATC编码 | - C09DX04 valsartan and sacubitril
| 申请类型 | - TypeLevel1：Abridged
- TypeLevel2：Initial 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 |
|---|
|
|---|