| MR编号 | UK/H/6498/001 |
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| 药品名称 | Salmeterol/Fluticasone APC 50 microgram / 100 microgram / dose inhalation powder, pre-dispensed |
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| 活性成分 | - fluticasone propionate 100.0 µg
- salmeterol xinafoate 50.0 µg
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| 剂型 | Inhalation powder, pre-dispensed |
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| 上市许可持有人 | APC Instytut Sp. z o.o.
Al. Jerozolimskie 146C
Warszawa
02-305
Poland |
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| 参考成员国 - 产品名称 | United Kingdom (GB) |
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| 互认成员国 - 产品名称 | - Italy (IT)
- Netherlands (NL)
Salmeterol/Fluticasone APC 50 microgram/100 microgram/dosis inhalatiepoeder, voorverdeeld - Ireland (IE)
- Malta (MT)
- Luxembourg (LU)
Salmex, 50 mcg / 1 Dose + 100 mcg / 1 Dose, Poudre pour inhalation en récipient unidose - Czechia (CZ)
Salmeterol/Fluticasone APC 50 mikrogramů/100 mikrogramů dávkovaný prášek k inhalaci - Romania (RO)
- Slovakia (SK)
Salmeterol/ Flutikazón APC 50 mikrogramov/100 mikrogramov
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| 许可日期 | 2018/09/25 |
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| 最近更新日期 | 2019/07/19 |
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| 药物ATC编码 | - R03AK06 salmeterol and fluticasone
| 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| 市场状态 | Withdrawn（注：已撤市） 撤市原因：1.The company decided to withdraw the application.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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