| MR编号 | SE/H/1213/001 |
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| 药品名称 | Bufomix 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)
- Belgium (BE)
Bufomix Easyhaler - Bulgaria (BG)
Bufomyx Easyhaler - Czechia (CZ)
Bufomix Easyhaler - Germany (DE)
Bufomix Easyhaler 80/ 4,5 µg, Pulver zur Inhalation - Cyprus (CY)
BUFOMIX EASYHALER INHALATION PWD - Denmark (DK)
- Estonia (EE)
BUFOMIX EASYHALER - Greece (GR)
BUFOMIX® EASYHALER - Spain (ES)
- Finland (FI)
- France (FR)
- Hungary (HU)
- Ireland (IE)
- Iceland (IS)
- Italy (IT)
- Lithuania (LT)
- Luxembourg (LU)
Bufomix Easyhaler 320 mcg / 9 mcg Poudre pour inhalation - Latvia (LV)
- Malta (MT)
Bufomix Easyhaler - Netherlands (NL)
- Norway (NO)
- Poland (PL)
- Portugal (PT)
- Romania (RO)
Bufomix Easyhaler 80 micrograme/ 4.5 micrograme pulbere de inhalat - Slovenia (SI)
- Slovakia (SK)
Bufomix Easyhaler - United Kingdom (GB)
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| 许可日期 | 2014/03/06 |
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| 最近更新日期 | 2015/09/03 |
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| 药物ATC编码 | - R03AK07 formoterol and budesonide
| 申请类型 | - TypeLevel1：Abridged
- TypeLevel2：Initial 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| 市场状态 | Withdrawn（注：已撤市） 撤市原因：1.The company decided to withdraw the application.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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