| MR编号 | DE/H/1948/001 |
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| 药品名称 | Panzyga |
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| 活性成分 | - IMMUNGLOBULIN 100.0 mg/ml
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| 剂型 | Intravenous infusion |
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| 上市许可持有人 | Octapharma GmbH
Elisabeth-Selbert-Str. 11
40764 Langenfeld
Germany |
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| 参考成员国 - 产品名称 | Germany (DE) Panzyga |
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| 互认成员国 - 产品名称 | - Denmark (DK)
- Belgium (BE)
Panzyga 100 mg/ml solution pour perfusion - Netherlands (NL)
Panzyga 100 mg/ml oplossing voor infusie - Luxembourg (LU)
- Iceland (IS)
Panzyga 100 mg/ml Innrennslislyf, lausn - United Kingdom (Northern Ireland) (XI)
- Ireland (IE)
- Austria (AT)
Panzyga 100 mg/ml Infusionslösung - France (FR)
- Spain (ES)
- Portugal (PT)
- Italy (IT)
- Sweden (SE)
- Norway (NO)
Panzyga - Finland (FI)
- Latvia (LV)
Panzyga 100 mg/ml šķīdums infūzijām - Lithuania (LT)
Panzyga 100 mg/ml infuzinis tirpalas - Estonia (EE)
PANZYGA - Hungary (HU)
PANZYGA 100 mg/ml oldatos infúzió - Bulgaria (BG)
- Czechia (CZ)
Panzyga® - Romania (RO)
- Slovakia (SK)
- Slovenia (SI)
- Malta (MT)
Panzyga - Croatia (HR)
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| 许可日期 | 2016/02/04 |
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| 最近更新日期 | 2024/11/30 |
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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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