| MR编号 | DE/H/0464/002 |
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| 药品名称 | Octaplex 1000 |
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| 活性成分 | - blood coagulation factors II, VII, IX, X in combination (Prothrombin complex) 1000.0 IU
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| 剂型 | Powder and solvent for solution for infusion |
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| 上市许可持有人 | Octapharma GmbH
Elisabeth-Selbert-Str. 11
40764 Langenfeld
Germany |
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| 参考成员国 - 产品名称 | Germany (DE) Octaplex 1000 |
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| 互认成员国 - 产品名称 | - Cyprus (CY)
Octaplex 1000 IU powder and solvent for solution for infusion - Denmark (DK)
- Belgium (BE)
Octaplex 1000 UI poudre et solvant pour solution pour perfusion - Netherlands (NL)
Octaplex 1000 IE, poeder en oplosmiddel voor oplossing voor infusie - Luxembourg (LU)
- Iceland (IS)
Octaplex 1000 a.e. Innrennslisstofn og leysir, lausn - United Kingdom (Northern Ireland) (XI)
- Ireland (IE)
- Austria (AT)
Octaplex 1000 I.E. Pulver und Lösungsmittel zur Herstellung einer Infusionslösung - France (FR)
- Spain (ES)
- Portugal (PT)
- Italy (IT)
- Sweden (SE)
- Norway (NO)
- Finland (FI)
- Poland (PL)
Octaplex - Latvia (LV)
Octaplex 1000 SV pulveris un šķīdinātājs infūziju šķīduma pagatavošanai - Lithuania (LT)
OCTAPLEX 1000 TV milteliai ir tirpiklis infuziniam tirpalui - Estonia (EE)
OCTAPLEX - Hungary (HU)
OCTAPLEX 1000 NE por és oldószer oldatos infúzióhoz - Bulgaria (BG)
- Czechia (CZ)
Ocplex 1000 IU - Romania (RO)
PRONATIV 1000 UI, pulbere şi solvent pentru soluţie perfuzabilă - Slovakia (SK)
- Slovenia (SI)
- Malta (MT)
Octaplex 1000 IU powder and solvent for solution for infusion
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| 许可日期 | 2015/07/16 |
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| 最近更新日期 | 2024/04/12 |
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| 药物ATC编码 | - B02BD01 coagulation factor IX, II, VII and X in combination
| 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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