| MR编号 | AT/H/0177/003 |
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| 药品名称 | Immunine 1200 I.E. - Pulver und Lösungsmittel zur Herstellung einer Injektionslösung |
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| 活性成分 | - Human coagulation factor IX 1200.0 IE
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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) Immunine 1200 I.E. Pulver und Lösungsmittel zur Herstellung einer Injektionslösung |
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| 互认成员国 - 产品名称 | - Germany (DE)
PEI.H.03595.03.1 - Spain (ES)
- Italy (IT)
- Greece (GR)
- Sweden (SE)
- Norway (NO)
- Poland (PL)
IMMUNINE 1200 IU - Latvia (LV)
- Lithuania (LT)
IMMUNINE Baxter 1200 TV milteliai ir tirpiklis injekciniam/ infuziniam tirpalui - Estonia (EE)
Immunine - Bulgaria (BG)
- Czechia (CZ)
- Romania (RO)
Immunine 1200 UI, pulbere si solvent pentru solutie injectabila/ perfuzabila - Slovakia (SK)
IMMUNINE 1200 IU - Portugal (PT)
- Slovenia (SI)
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| 许可日期 | 2007/10/22 |
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| 最近更新日期 | 2025/08/04 |
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| 药物ATC编码 | - B02BD04 coagulation factor IX
| 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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