MR编号 | DE/H/0483/004 |
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药品名称 | Beriate 2000 |
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活性成分 | - blood coagulation factor VIII human 2000.0 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
Emil-von-Behring Str. 76
35041 Marburg |
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参考成员国 - 产品名称 | Germany (DE) Beriate 2000 |
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互认成员国 - 产品名称 | - Austria (AT)
Beriate 200 I.E./ml Pulver und Lösungsmittel zur Herstellung einer Injektions- oder Infusionslösung - Italy (IT)
- Latvia (LV)
Beriate 2000 SV pulveris un šķīdinātājs injekciju vai infūziju šķīduma pagatavošanai - Portugal (PT)
- Poland (PL)
Beriate 2000 - Bulgaria (BG)
- Czechia (CZ)
Beriate® 2000 IU - Hungary (HU)
BERIATE 200 NE/ml por és oldószer oldatos injekcióhoz vagy infúzióhoz - Romania (RO)
Beriate 2000 pulbere şi solvent pentru soluţie injectabilă/perfuzabilă - Croatia (HR)
Beriate 2000 IU prašak i otapalo za otopinu za injekciju ili infuziju - Slovenia (SI)
- Slovakia (SK)
Beriate 2000 - Lithuania (LT)
Beriate 2000 TV milteliai ir tirpiklis injekciniam ar infuziniam tirpalui - Estonia (EE)
- Malta (MT)
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许可日期 | 2012/11/16 |
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最近更新日期 | 2025/01/13 |
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药物ATC编码 | - B02BD02 coagulation factor VIII
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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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