| MR编号 | AT/H/0373/001 |
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| 药品名称 | Prothromplex TOTAL 600 I.E. |
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| 活性成分 | - blood coagulation factors II, VII, IX, X in combination (Prothrombin complex) 600.0 IU/20 ml
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| 剂型 | Powder and solvent for solution for injection |
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| 上市许可持有人 | Baxter AG
Industriestraße 67
A-1221 Vienna |
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| 参考成员国 - 产品名称 | Austria (AT) Prothromplex TOTAL 600 I.E. Pulver und Lösungsmittel zur Herstellung einer Injektionslösung |
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| 互认成员国 - 产品名称 | - Germany (DE)
Prothromplex TOTAL 600 I.E. - Denmark (DK)
- Belgium (BE)
- Luxembourg (LU)
- Netherlands (NL)
- United Kingdom (Northern Ireland) (XI)
- Greece (GR)
PROTHROMPLEX TOTAL - Spain (ES)
- Ireland (IE)
- Italy (IT)
- Portugal (PT)
- Bulgaria (BG)
- Czechia (CZ)
Prothromplex Total NF - Estonia (EE)
PROTHROMPLEX TOTAL - Hungary (HU)
PROTHROMPLEX TOTAL 600 NE por és oldószer oldatos injekcióhoz - Lithuania (LT)
Prothromplex 600 TV milteliai ir tirpiklis injekciniam tirpalui - Latvia (LV)
Prothromplex 600 SV pulveris un šķīdinātājs injekciju šķīduma pagatavošanai - Malta (MT)
Prothromplex Total 600 IU powder and solvent for solution for injection - Poland (PL)
- Romania (RO)
Prothromplex TOTAL 600 UI pulbere şi solvent pentru soluţie injectabilă - Slovenia (SI)
- Norway (NO)
- Slovakia (SK)
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| 许可日期 | 2010/06/15 |
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| 最近更新日期 | 2023/12/21 |
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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：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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