| MR编号 | SE/H/2315/001 |
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| 药品名称 | Dabigatran Etexilate Viatris |
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| 活性成分 | - Dabigatran etexilate mesilate 75.0 mg
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| 剂型 | Capsule, hard |
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| 上市许可持有人 | Viatris Limited, Ireland |
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| 参考成员国 - 产品名称 | Sweden (SE) |
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| 互认成员国 - 产品名称 | - Greece (GR)
- Slovakia (SK)
- Germany (DE)
Dabigatranetexilat Vale 75 mg Hartkapseln - Norway (NO)
- Slovenia (SI)
- Denmark (DK)
Dabigatran Etexilate Viatris - Finland (FI)
- Malta (MT)
Dabigatran Etexilate Vale 75mg hard capsules - Belgium (BE)
- Poland (PL)
Dabigatran Etexilate Vale - Croatia (HR)
- Netherlands (NL)
- Latvia (LV)
- Luxembourg (LU)
- Lithuania (LT)
Dabigatran etexilate Vale 75 mg kietosios kapsulės - Iceland (IS)
- Estonia (EE)
- Austria (AT)
- Hungary (HU)
- France (FR)
- Bulgaria (BG)
Dabigatran etexilate Vale - Spain (ES)
- Cyprus (CY)
Dabigatran Etexilate Vale 75 mg Kαψάκιο, σκληρό - Portugal (PT)
- Czechia (CZ)
Dabigatran Etexilate Vale - Italy (IT)
- Romania (RO)
Dabigatran Etexilat Vale 75 mg capsule
|
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| 许可日期 | 2023/12/21 |
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| 最近更新日期 | 2025/02/05 |
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| 药物ATC编码 | - B01AE07 dabigatran etexilate
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| 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
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| 附件文件下载 | |
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| 市场状态 | Positive |
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