| MR编号 | DE/H/0479/001 |
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| 药品名称 | Octagam 10% |
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| 活性成分 | - Human normal immunoglobulin 100.0 mg/ml
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| 剂型 | Solution for infusion |
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| 上市许可持有人 | Octapharma GmbH
Elisabeth-Selbert-Str. 11
40764 Langenfeld (Rheinland)
Germany |
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| 参考成员国 - 产品名称 | Germany (DE) Octagam 10% |
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| 互认成员国 - 产品名称 | - Denmark (DK)
- Luxembourg (LU)
- United Kingdom (Northern Ireland) (XI)
- Austria (AT)
Octagam 100 mg/ml Infusionslösung - Portugal (PT)
- Sweden (SE)
Octagam - Norway (NO)
- Estonia (EE)
OCTAGAM 10% - Hungary (HU)
OCTAGAM 100 mg/ml oldatos infúzió - Belgium (BE)
- Spain (ES)
- France (FR)
- Iceland (IS)
- Netherlands (NL)
Octagam 10%, oplossing voor infusie - Bulgaria (BG)
- Cyprus (CY)
OCTAGAM 10% INTRAVENOUS INFUSION - Finland (FI)
- Italy (IT)
- Lithuania (LT)
Octagam 10% infuzinis tirpalas - Latvia (LV)
- Poland (PL)
Octagam 10% - Czechia (CZ)
Octagam 10% - Malta (MT)
- Romania (RO)
Octagam 10 % solutie perfuzabila - Slovenia (SI)
- Slovakia (SK)
Octagam 10% - Greece (GR)
OCTAGAM
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| 许可日期 | 2008/04/20 |
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| 最近更新日期 | 2025/01/24 |
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| 药物ATC编码 | - J06BA02 immunoglobulins, normal human, for intravascular adm.
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| 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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