| MR编号 | NL/H/5941/002 |
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| 药品名称 | Sacubitril/Valsartan 49 mg/51 mg Film-coated tablet |
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| 活性成分 | - Sacubitril sodium 49.0 mg
- Valsartan disodium 51.0 mg
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| 剂型 | Film-coated tablet |
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| 上市许可持有人 | Teva Nederland B.V.
Swensweg 5
2031 GA Haarlem The Netherlands |
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| 参考成员国 - 产品名称 | Netherlands (NL) |
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| 互认成员国 - 产品名称 | - Spain (ES)
- Slovakia (SK)
Sacubitril/Valsartan Teva 49mg/51mg filmom obalené tablety - Italy (IT)
- Sweden (SE)
- Norway (NO)
- Germany (DE)
Sacubitril/Valsartan-ratiopharm 49 mg/51 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 49mg/51mg plėvele dengtos tabletės - Iceland (IS)
- Estonia (EE)
- Ireland (IE)
- Hungary (HU)
- Austria (AT)
- Czechia (CZ)
Sakubitril/Valsartan Teva - France (FR)
- Romania (RO)
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| 许可日期 | 2025/06/13 |
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| 最近更新日期 | 2025/07/22 |
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| 药物ATC编码 | - C09DX04 valsartan and sacubitril
| 申请类型 | - TypeLevel1：Abridged
- TypeLevel2：Additional Strength/Form
- TypeLevel3：Generic Art 10.1 and 10.2 Dir 2001/83/EC
- TypeLevel4：Chemical Substance
- TypeLevel5：Prescription Only
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| 附件文件下载 | |
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| 市场状态 | Positive |
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