| MR编号 | SE/H/1562/003 |
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| 药品名称 | Clariscan |
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| 活性成分 | - gadoteric acid 0.5 mmol/ml
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| 剂型 | Solution for injection |
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| 上市许可持有人 | GE Healthcare AS
Nydalen
Norway |
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| 参考成员国 - 产品名称 | Sweden (SE) Clariscan |
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| 互认成员国 - 产品名称 | - Austria (AT)
- Belgium (BE)
- Croatia (HR)
- Denmark (DK)
- Estonia (EE)
- Finland (FI)
- Germany (DE)
Clariscan 0,5 mmol/mL, Injektionslösung - Hungary (HU)
- Iceland (IS)
- Ireland (IE)
- Italy (IT)
- Lithuania (LT)
Clariscan 0,5 mmol/ml injekcinis tirpalas - Latvia (LV)
- Luxembourg (LU)
- Netherlands (NL)
- Norway (NO)
- Poland (PL)
- Portugal (PT)
- Romania (RO)
- Spain (ES)
- United Kingdom (GB)
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| 许可日期 | 2019/05/22 |
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| 最近更新日期 | 2022/09/29 |
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| 药物ATC编码 | | 申请类型 | - TypeLevel1：Line Extension
- TypeLevel2：Additional Strength/Form
- 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| 市场状态 | Withdrawn（注：已撤市） 撤市原因：1.The company decided to withdraw the application. At the time of withdrawal, the MS considered that the data provided did not allow to conclude on a positive benefit-risk balance as major objections were raised. |
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