| MR编号 | SE/H/1214/001 |
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| 药品名称 | Orest Easyhaler |
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| 活性成分 | - budesonide 80.0 µg/inhalation
- formoterol fumarate 4.5 µg/inhalation
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| 剂型 | Inhalation powder |
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| 上市许可持有人 | Orion Corporation
Finland |
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| 参考成员国 - 产品名称 | Sweden (SE) |
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| 互认成员国 - 产品名称 | - Austria (AT)
- Cyprus (CY)
OREST EASYHALER INHALATION PWD - Germany (DE)
Orest Easyhaler 80/ 4,5 µg, Pulver zur Inhalation - Greece (GR)
OREST® EASYHALER - Spain (ES)
- France (FR)
- Italy (IT)
- Luxembourg (LU)
- Malta (MT)
Orest Easyhaler - Netherlands (NL)
- Poland (PL)
- Portugal (PT)
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| 许可日期 | 2014/03/06 |
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| 最近更新日期 | 2016/11/08 |
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| 药物ATC编码 | - R03AK07 formoterol and budesonide
| 申请类型 | - TypeLevel1：Abridged
- TypeLevel2：Multiple (Copy) Application
- TypeLevel3：Other Generic application Art 10.3 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| 市场状态 | Withdrawn（注：已撤市） 撤市原因：1.The company decided to withdraw the application.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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