MR编号 | DE/H/0481/003 |
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药品名称 | Berinert 2000 |
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活性成分 | - C1-esterase inhibitor 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 GmbH
Emil-von-Behring Str. 76
D-35041 Marburg
Germany |
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参考成员国 - 产品名称 | Germany (DE) Berinert 2000 |
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互认成员国 - 产品名称 | - Lithuania (LT)
Human C1-esterase inhibitor CSL Behring 2000 TV milteliai ir tirpiklis injekciniam tirpalui - Denmark (DK)
- Belgium (BE)
Berinert 2000 eenheden poeder en oplosmiddel voor oplossing voor injectie - Luxembourg (LU)
- United Kingdom (Northern Ireland) (XI)
- Austria (AT)
- France (FR)
- Spain (ES)
- Portugal (PT)
- Italy (IT)
- Estonia (EE)
BERINERT SC - Greece (GR)
BERINERT - Sweden (SE)
- Norway (NO)
- Finland (FI)
- Poland (PL)
- Hungary (HU)
BERINERT 2000 NE por és oldószer oldatos injekcióhoz - Bulgaria (BG)
- Cyprus (CY)
BERINERT 2000IU PDR AND SOLV FOR SOL FOR INJ - Czechia (CZ)
Berinert 2000 IU - Romania (RO)
Berinert 2000 2000 UI pulbere si solvent pentru soluţie injectabilă - Iceland (IS)
- Slovakia (SK)
Berinert 2000 IU - Slovenia (SI)
- Malta (MT)
- Croatia (HR)
Berinert 2000 IU prašak i otapalo za otopinu za injekciju - Netherlands (NL)
- Ireland (IE)
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许可日期 | 2017/12/22 |
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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: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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