MR编号 | SE/H/2153/005 |
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药品名称 | Rivaroxaban STADA |
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活性成分 | - RIVAROXABAN 15.0 mg
- RIVAROXABAN 20.0 mg
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剂型 | Film-coated tablet |
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上市许可持有人 | STADA Arzneimittel AG, Germany |
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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 | - Netherlands (NL)
Rivaroxaban CF 15 mg + 20 mg, filmomhulde tabletten - Lithuania (LT)
Rivaroxaban STADA 15 mg plėvele dengtos tabletės Rivaroxaban STADA 20 mg plėvele dengtos tabletės - Luxembourg (LU)
- Estonia (EE)
- Iceland (IS)
- Hungary (HU)
Rivaroxaban STADA 15 mg filmtabletta + Rivaroxaban STADA 20 mg filmtabletta - Ireland (IE)
- Romania (RO)
Rivaroxaban STADA 15mg+20mg comprimate filmate - Austria (AT)
- France (FR)
- Spain (ES)
- Portugal (PT)
- Greece (GR)
- Germany (DE)
Rivaroxaban AL Starterpackung 15 mg und 20 mg Filmtabletten - Norway (NO)
- Denmark (DK)
- Finland (FI)
- Belgium (BE)
Rivaroxaban EG 15 mg filmomhulde tabletten + 20 mg filmomhulde tabletten - Latvia (LV)
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许可日期 | 2022/09/14 |
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最近更新日期 | 2024/08/30 |
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药物ATC编码 | 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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