MR编号 | DE/H/0481/002 |
---|
药品名称 | Berinert 1500 |
---|
活性成分 | - C1-esterase inhibitor human 1500.0 IU
|
---|
剂型 | Powder and solvent for solution for injection |
---|
上市许可持有人 | CSL Behring GmbH
Emil-von-Behring-Str. 76
35041 Marburg, Germany |
---|
参考成员国 - 产品名称 | Germany (DE) Berinert 1500 |
---|
互认成员国 - 产品名称 | - Italy (IT)
- Luxembourg (LU)
- United Kingdom (Northern Ireland) (XI)
- Belgium (BE)
Berinert® 1500 eenheden poeder en oplosmiddel voor oplossing voor injectie of infusie - Denmark (DK)
- Netherlands (NL)
- Croatia (HR)
Berinert 1500 IU prašak i otapalo za otopinu za injekciju - Estonia (EE)
BERINERT IV - Lithuania (LT)
Human C1-esterase inhibitor CSL Behring 1500 TV milteliai ir tirpiklis injekciniam tirpalui - Malta (MT)
Berinert 1500IU Powder and solvent for solution for injection - Ireland (IE)
- Czechia (CZ)
- Iceland (IS)
- Slovenia (SI)
- Slovakia (SK)
Berinert 1500 - Romania (RO)
Berinert 1500 1500 UI pulbere si solvent pentru soluţie injectabilă - Cyprus (CY)
- Bulgaria (BG)
- Hungary (HU)
BERINERT 1500 NE por és oldószer oldatos injekcióhoz - Poland (PL)
- Finland (FI)
- Norway (NO)
- Sweden (SE)
50666 - Greece (GR)
BERINERT - Austria (AT)
- Portugal (PT)
- Spain (ES)
- France (FR)
|
---|
许可日期 | 2014/12/23 |
---|
最近更新日期 | 2025/01/13 |
---|
药物ATC编码 | - B06AC01 c1-inhibitor, plasma derived
|
---|
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
|
---|
附件文件下载 | |
---|
市场状态 | Positive |
---|