| MR编号 | DE/H/0477/003 |
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| 药品名称 | Beriplex P/N 1000 |
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| 活性成分 | - blood coagulation factors II, VII, IX, X in combination (Prothrombin complex) 1000.0 IU
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| 剂型 | Powder and solvent for solution for injection |
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| 上市许可持有人 | CSL Behring GmbH
Emil-von-Behring Str. 76
35041 Marburg
Germany |
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| 参考成员国 - 产品名称 | Germany (DE) Beriplex P/N 1000 |
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| 互认成员国 - 产品名称 | - Belgium (BE)
Confidex® 1000 I.E. poeder en oplosmiddel voor oplossing voor injectie - Netherlands (NL)
- Luxembourg (LU)
- United Kingdom (Northern Ireland) (XI)
- Austria (AT)
- France (FR)
- Spain (ES)
- Italy (IT)
- Greece (GR)
- Sweden (SE)
48261 - Norway (NO)
- Finland (FI)
- Poland (PL)
Beriplex P/N 1000 - Hungary (HU)
BERIPLEX P/N 1000 por és oldószer oldatos injekcióhoz - Cyprus (CY)
- Denmark (DK)
- Bulgaria (BG)
- Czechia (CZ)
Beriplex P/N 1000 - Ireland (IE)
- Romania (RO)
Beriplex P/N 1000 UI pulbere și solvent pentru soluție injectabilă - Croatia (HR)
- Malta (MT)
- Slovenia (SI)
- Slovakia (SK)
- Portugal (PT)
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| 许可日期 | 2012/12/27 |
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| 最近更新日期 | 2024/04/12 |
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| 药物ATC编码 | - B02BD01 coagulation factor IX, II, VII and X in combination
| 申请类型 | - TypeLevel1：Known Active Substance
- TypeLevel2：Additional Strength/Form
- 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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