| MR编号 | DE/H/0213/001 |
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| 药品名称 | Octanine F 500 |
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| 活性成分 | - blood coagulation factor IX 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 | Octapharma GmbH
Elisabeth-Selbert-Str. 11
D40764 Langenfeld
Germany |
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| 参考成员国 - 产品名称 | Germany (DE) Octanine F 500 |
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| 互认成员国 - 产品名称 | - Denmark (DK)
- Austria (AT)
Octanine F 100 I.E./ml Pulver und Lösungsmittel zur Herstellung einer Injektionslösung - Spain (ES)
- Portugal (PT)
- Italy (IT)
- Sweden (SE)
- Norway (NO)
- Poland (PL)
- Latvia (LV)
- Lithuania (LT)
octanine 500TV milteliai ir tirpiklis injekciniam tirpalui - Estonia (EE)
OCTANINE - Hungary (HU)
OCTANINE 500 NE por és oldószer oldatos injekcióhoz - Bulgaria (BG)
- Cyprus (CY)
- Czechia (CZ)
- Romania (RO)
OCTANINE F 500 UI pulbere şi solvent pentru soluţie perfuzabilă - Slovakia (SK)
- Slovenia (SI)
- Malta (MT)
- Belgium (BE)
- France (FR)
- Finland (FI)
- Luxembourg (LU)
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| 许可日期 | 2002/01/02 |
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| 最近更新日期 | 2024/04/05 |
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| 药物ATC编码 | - B02BD04 coagulation factor IX
| 申请类型 | - TypeLevel1：New Active Substance
- TypeLevel2：Initial Application
- TypeLevel3：Full Dossier Article 4.8 Di 65/65
- 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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