MR编号 | NL/H/3492/004 |
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药品名称 | Proalta |
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活性成分 | - ACETYL SALICYLIC ACID 100.0 mg
- atorvastatin calcium trihydrate 40.0 mg
- PERINDOPRIL ARGININE 10.0 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 | - Portugal (PT)
- Malta (MT)
Proalta 40mg/10mg/100mg hard capsules - Latvia (LV)
- Luxembourg (LU)
- Lithuania (LT)
PROALTA 40mg/10mg/100mg kietosios kapsulės - Ireland (IE)
- Italy (IT)
- Austria (AT)
- Belgium (BE)
- Cyprus (CY)
- Czechia (CZ)
PROALTA 40mg/10mg/100mg tvrdá tobolka - Germany (DE)
Proalta 40 mg/10 mg/100 mg Hartkapseln - Hungary (HU)
- Croatia (HR)
- France (FR)
- Finland (FI)
- Greece (GR)
PROALTOR® - Slovenia (SI)
- Romania (RO)
- Bulgaria (BG)
Proalta 40 mg/ 10 mg/ 100 mg hard capsules
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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
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申请类型 | - TypeLevel1:Known Active Substance
- TypeLevel2:Additional Strength/Form
- 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市场状态 | Withdrawn(注:已撤市) 撤市原因:1.The company decided to withdraw the application.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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