MR编号 | DE/H/3944/001 |
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药品名称 | Dotagraf 0,5 mmol/ml Injektionslösung |
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活性成分 | - Gadoteric acid 279.32 mg/ml
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剂型 | Solution for injection |
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上市许可持有人 | Jenapharm GmbH & Co. KG
Otto-Schott-Str. 15
07745 Jena
Germany |
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参考成员国 - 产品名称 | Germany (DE) Gadoteric acid Sanochemia (single use) Injektionslösung |
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互认成员国 - 产品名称 | - Denmark (DK)
- Netherlands (NL)
- Luxembourg (LU)
- Ireland (IE)
- Portugal (PT)
- Greece (GR)
DOTAGRAF - Sweden (SE)
- Poland (PL)
- Latvia (LV)
Dotagraf 0,5 mmol/ml šķīdums injekcijām - Lithuania (LT)
Dotagraf 0,5 mmol/ml injekcinis tirpalas - Cyprus (CY)
- Estonia (EE)
DOTAGRAF - Croatia (HR)
- Hungary (HU)
DOTAGRAF 0,5 mmol/ml oldatos injekció, egyadagos - Malta (MT)
- Romania (RO)
DOTAGRAF 0,5 mmol/ml soluţie injectabilă în flacon unidoză - Slovenia (SI)
- Bulgaria (BG)
- Belgium (BE)
Dotagraph 0,5 mmol/ml oplossing voor injectie - Spain (ES)
- Italy (IT)
- Iceland (IS)
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许可日期 | 2015/06/03 |
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最近更新日期 | 2025/02/13 |
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药物ATC编码 | |
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申请类型 | - TypeLevel1:Abridged
- TypeLevel2:Initial Application
- TypeLevel3:Generic Art 10.1 and 10.2 Dir 2001/83/EC
- TypeLevel4:Chemical Substance
- 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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