MR编号 | DE/H/1942/001 |
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药品名称 | Cluvot 250 |
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活性成分 | - blood coagulation factor XIII human 250.0 U
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剂型 | Powder and solvent for solution for infusion |
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上市许可持有人 | CSL Behring GmbH
Emil-von-Behring-Str. 76
35041 Marburg |
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参考成员国 - 产品名称 | Germany (DE) Cluvot 250 |
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互认成员国 - 产品名称 | - Denmark (DK)
- Belgium (BE)
Cluvot® 250 IE Poeder en oplosmiddel voor oplossing voor injectie/infusie - Netherlands (NL)
- Spain (ES)
- Portugal (PT)
- Italy (IT)
- Greece (GR)
CLUVOT - Sweden (SE)
- Norway (NO)
Cluvot - Finland (FI)
- Poland (PL)
Cluvot 250 - Luxembourg (LU)
- Hungary (HU)
CLUVOT 250 NE por és oldószer oldatos injekcióhoz vagy infúzióhoz - Bulgaria (BG)
- Romania (RO)
Cluvot® 250 pulbere si solvent pentru solutie injectabila - Malta (MT)
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许可日期 | 2014/02/11 |
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最近更新日期 | 2025/01/13 |
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药物ATC编码 | - B02BD07 coagulation factor XIII
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申请类型 | - TypeLevel1:Known Active Substance
- TypeLevel2:Initial Application
- TypeLevel3:Full Dossier Art 8.3(i) Dir 2001/83/EC
- TypeLevel4:Biological: Blood Product
- 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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