| MR编号 | NL/H/3492/001 |
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| 药品名称 | Proalta |
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| 活性成分 | - acetylsalicylic acid 100.0 mg
- atorvastatin calcium trihydrate 20.0 mg
- PERINDOPRIL ARGININE 5.0 mg
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| 剂型 | Capsule, hard |
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| 上市许可持有人 | Les Laboratoires Servier
50 rue Carnot
92284 Suresnes Cedex
France |
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| 参考成员国 - 产品名称 | Netherlands (NL) |
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| 互认成员国 - 产品名称 | - Austria (AT)
- Belgium (BE)
- Bulgaria (BG)
Proalta 20 mg/ 5 mg/ 100 mg hard capsules - Cyprus (CY)
- Czechia (CZ)
PROALTA 20mg/5mg/100mg tvrdá tobolka - Germany (DE)
Proalta 20 mg/5 mg/100 mg Hartkapseln - Greece (GR)
PROALTOR® - Finland (FI)
- France (FR)
- Croatia (HR)
- Hungary (HU)
- Italy (IT)
- Ireland (IE)
- Lithuania (LT)
PROALTA 20mg/5mg/100mg kietosios kapsulės - Luxembourg (LU)
- Latvia (LV)
- Malta (MT)
Proalta 20mg/5mg/100mg hard capsules - Portugal (PT)
- Romania (RO)
- Slovenia (SI)
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| 许可日期 | 2017/10/03 |
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| 最近更新日期 | 2018/02/22 |
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| 药物ATC编码 | - C10BX Lipid modifying agents in combination with other drugs
| 申请类型 | - TypeLevel1：Known Active Substance
- TypeLevel2：Initial Application
- TypeLevel3：Full Dossier Art 8.3(i) 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| 市场状态 | Withdrawn（注：已撤市） 撤市原因：1.The company decided to withdraw the application.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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