| MR编号 | DE/H/0470/002 |
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| 药品名称 | Intratect 100 g/l |
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| 活性成分 | - human normal immunoglobulin 100.0 g/l
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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 100 g/l: 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 | - Denmark (DK)
- Belgium (BE)
- Netherlands (NL)
- United Kingdom (Northern Ireland) (XI)
- Ireland (IE)
- Austria (AT)
- Spain (ES)
- Portugal (PT)
- Italy (IT)
- Greece (GR)
- Sweden (SE)
- Norway (NO)
- Poland (PL)
- Hungary (HU)
- Bulgaria (BG)
- Cyprus (CY)
- Czechia (CZ)
- Romania (RO)
- Slovenia (SI)
- Malta (MT)
- Croatia (HR)
- Finland (FI)
- France (FR)
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| 许可日期 | 2012/10/24 |
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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：Known Active Substance
- TypeLevel2：Additional Strength/Form
- TypeLevel3：Full Dossier Art 8.3(i) Dir 2001/83/EC
- TypeLevel4：Biological: Other
- 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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