| MR编号 | DE/H/0478/002 |
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| 药品名称 | Haemoctin SDH 500 |
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| 活性成分 | - blood coagulation factor VIII 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 | Biotest Pharma GmbH
Landsteiner Str. 5
D-63303 Dreieich
Germany |
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| 参考成员国 - 产品名称 | Germany (DE) Haemoctin SDH 500 |
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| 互认成员国 - 产品名称 | - United Kingdom (Northern Ireland) (XI)
- Italy (IT)
- Austria (AT)
Haemoctin SDH 50 I.E./ml Pulver und Lösungsmittel zur Herstellung einer Injektionslösung - Greece (GR)
- Poland (PL)
Haemoctin 500 - Hungary (HU)
HAEMOCTIN 500 NE por és oldószer oldatos injekcióhoz - Bulgaria (BG)
- Czechia (CZ)
- Romania (RO)
Haemoctin SDH 500, pulbere şi solvent pentru soluţie injectabilă - Malta (MT)
- Spain (ES)
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| 许可日期 | 2008/03/18 |
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| 最近更新日期 | 2024/04/17 |
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| 药物ATC编码 | - B02BD02 coagulation factor VIII
| 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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