| MR编号 | DE/H/0470/001 |
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| 药品名称 | Intratect |
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| 活性成分 | - human normal immunoglobulin 50.0 mg/ml
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| 剂型 | Solution for infusion |
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| 上市许可持有人 | Biotest Pharma GmbH
Postfach 10 20 40
D- 63266 Dreieich
Germany |
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| 参考成员国 - 产品名称 | Germany (DE) Intratect To CMS: Procedere requires finalisation of IA/27, started on 26.11.14 |
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| 互认成员国 - 产品名称 | - Cyprus (CY)
INTRATECT SOL FOR INFUSION - Slovenia (SI)
- United Kingdom (Northern Ireland) (XI)
- Greece (GR)
- Poland (PL)
- Hungary (HU)
INTRATECT 50 g/l oldatos infúzió - Italy (IT)
- Austria (AT)
Intratect 50 g/l Infusionslösung - Ireland (IE)
- France (FR)
- Netherlands (NL)
- Belgium (BE)
- Finland (FI)
- Portugal (PT)
- Spain (ES)
- Denmark (DK)
- Malta (MT)
Intratect - Romania (RO)
Intratect 50 g/l, solutie perfuzabila - Czechia (CZ)
Intratect - Bulgaria (BG)
- Sweden (SE)
- Croatia (HR)
- Norway (NO)
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| 许可日期 | 2005/09/26 |
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| 最近更新日期 | 2024/04/05 |
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| 药物ATC编码 | - J06BA02 immunoglobulins, normal human, for intravascular adm.
| 申请类型 | - TypeLevel1：New Active Substance
- TypeLevel2：Initial Application
- TypeLevel3：Full Dossier [Article 8.3(i)]
- 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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