| MR编号 | SE/H/1323/001 |
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| 药品名称 | Salmeterol/Fluticasone Sandoz |
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| 活性成分 | - fluticasone propionate 250.0 µg/dose
- salmeterol xinafoate 50.0 µg/dose
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| 剂型 | Inhalation powder, pre-dispensed |
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| 上市许可持有人 | Sandoz A/S
Edvard Thomsens Vej 14 DK-2300 Kobenhavn S
Denmark |
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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 | - Germany (DE)
AirFluSal Forspiro 250 / 50 Mikrogramm einzeldosiertes Pulver zur Inhalation - Belgium (BE)
- Bulgaria (BG)
AirFluSal Forspiro - Hungary (HU)
- Luxembourg (LU)
- Romania (RO)
AirFluSal® Forspiro® 250 micrograme/50 micrograme, pulbere unidoză de inhalat
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| 许可日期 | 2013/12/03 |
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| 最近更新日期 | 2015/09/02 |
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| 药物ATC编码 | - R03AK06 salmeterol and fluticasone
| 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| 市场状态 | Withdrawn（注：已撤市） 撤市原因：1.The company decided to withdraw the application.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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