| MR编号 | DE/H/0471/003 |
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| 药品名称 | Wilate 500 |
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| 活性成分 | - blood coagulation factor VIII and human von Willebrand factor in combination 500.0 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 | Octapharma GmbH
Elisabeth-Selbert-Str. 11
40764 Langenfeld
Germany |
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| 参考成员国 - 产品名称 | Germany (DE) Wilate 500 |
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| 互认成员国 - 产品名称 | - France (FR)
- Malta (MT)
- Croatia (HR)
- Denmark (DK)
- Belgium (BE)
- Netherlands (NL)
- Luxembourg (LU)
- United Kingdom (Northern Ireland) (XI)
- Ireland (IE)
- Austria (AT)
Wilate 500 I.E. FVIII und 500 I.E. VWF Pulver und Lösungsmittel zur Herstellung einer Injektionslösu - Spain (ES)
- Portugal (PT)
- Italy (IT)
- Sweden (SE)
- Norway (NO)
- Finland (FI)
- Poland (PL)
Wilate 500 - Latvia (LV)
- Lithuania (LT)
Wilate 500 TV/500 TV milteliai ir tirpiklis injekciniam tirpalui - Estonia (EE)
WILATE 500 - Hungary (HU)
WILATE 500 NE/500 NE por és oldószer oldatos injekcióhoz - Bulgaria (BG)
- Cyprus (CY)
WILATE 500 PWD AND SOLVENT FOR SOL FOR INJECTION - Czechia (CZ)
Wilate 500 - Romania (RO)
WILATE 500 UI FVIII / 500 UI FVW pulbere şi solvent pentru soluţie injectabilă - Slovakia (SK)
- Slovenia (SI)
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| 许可日期 | 2011/11/11 |
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| 最近更新日期 | 2025/08/14 |
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| 药物ATC编码 | - B02BD06 von Willebrand factor and coagulation factor VIII 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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