MR编号 | DE/H/0481/001 |
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药品名称 | Berinert 500 |
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活性成分 | - C1-esterase inhibitor human 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 | 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) 294.00.00 |
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互认成员国 - 产品名称 | - Iceland (IS)
- Netherlands (NL)
- Ireland (IE)
- Lithuania (LT)
Human C1-esterase inhibitor CSL Behring 500 TV milteliai ir tirpiklis injekciniam ar infuziniam tirpalui - Estonia (EE)
BERINERT IV - Malta (MT)
Berinert 500IU Powder and solvent for solution for injection/infusion - Croatia (HR)
Berinert 500 IU prašak i otapalo za otopinu za injekciju/infuziju - Norway (NO)
- Denmark (DK)
- Belgium (BE)
- Luxembourg (LU)
- United Kingdom (Northern Ireland) (XI)
- Austria (AT)
Berinert 500 Einheiten Pulver & Lösungsmittel zur Herstellung einer Injektions-oder Infusionslösung - France (FR)
- Spain (ES)
- Italy (IT)
- Greece (GR)
- Sweden (SE)
- Finland (FI)
- Poland (PL)
Berinert - Hungary (HU)
BERINERT 500 Egység por és oldószer oldatos injekcióhoz vagy infúzióhoz - Bulgaria (BG)
- Cyprus (CY)
- Czechia (CZ)
- Romania (RO)
BERINERT P, 500 unităţi, pulbere şi solvent pentru soluţie injectabilă/perfuzabilă - Slovakia (SK)
- Slovenia (SI)
- Portugal (PT)
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许可日期 | 2008/12/11 |
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最近更新日期 | 2025/01/13 |
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药物ATC编码 | - B06AC01 c1-inhibitor, plasma derived
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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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