| MR编号 | DE/H/4903/001 |
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| 药品名称 | Cutaquig |
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| 活性成分 | - Human normal immunoglobulin 165.0 mg/ml
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| 剂型 | Solution for injection |
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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) Cutaquig |
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| 互认成员国 - 产品名称 | - Denmark (DK)
Cutaquig - Belgium (BE)
Cutaquig 165 mg/ml solution injectable - Netherlands (NL)
CUTAQUIG 165 mg/ml, oplossing voor injectie - Luxembourg (LU)
- Iceland (IS)
- United Kingdom (Northern Ireland) (XI)
- Ireland (IE)
- Austria (AT)
CUTAQUIG 165 mg/ml Injektionslösung - France (FR)
- Spain (ES)
- Portugal (PT)
- Italy (IT)
- Sweden (SE)
- Norway (NO)
Cutaquig - Finland (FI)
- Poland (PL)
CUTAQUIG - Latvia (LV)
Cutaquig 165 mg/ml šķīdums injekcijām - Lithuania (LT)
- - Estonia (EE)
CUTAQUIG - Hungary (HU)
CUTAQUIG 165 mg/ml oldatos injekció - Bulgaria (BG)
- Czechia (CZ)
CUTAQUIG 165 mg/ml, injekční roztok - Romania (RO)
- Slovakia (SK)
Cutaquig 165 mg/ml injekčný roztok - Slovenia (SI)
- Malta (MT)
- Croatia (HR)
Cutaquig 165 mg/ml otopina za injekciju
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| 许可日期 | 2019/02/03 |
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| 最近更新日期 | 2025/07/23 |
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| 药物ATC编码 | - J06BA01 immunoglobulins, normal human, for extravascular adm.
| 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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