| MR编号 | DK/H/3057/002 |
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| 药品名称 | Olmesartan/Amlodipine/HCTZ "Krka" |
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| 活性成分 | - Amlodipine besilate 5.0 mg
- Hydrochlorothiazide besilate 12.5 mg
- Olmesartan medoxomil 40.0 mg
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| 剂型 | Film-coated tablet |
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| 上市许可持有人 | KRKA d.d. Novo mesto
Smarjeska cesta 6
8501 Novo Mesto Slovenia |
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| 参考成员国 - 产品名称 | Denmark (DK) Olmesartan/Amlodipine/HCTZ "Krka" |
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| 互认成员国 - 产品名称 | - Germany (DE)
OlmeAmlo HCT 40 mg/5 mg/12,5 mg Filmtabletten - Belgium (BE)
Olmesartan/Amlodipine/HCTZ Krka 40 mg/5 mg/12,5 mg filmomhulde tabletten - Ireland (IE)
- Spain (ES)
- Portugal (PT)
- Greece (GR)
- Latvia (LV)
Olsitri 40 mg/5 mg/12,5 mg apvalkotās tabletes - Lithuania (LT)
Olsitri 40 mg/5 mg/12,5 mg plėvele dengtos tabletės - Estonia (EE)
OLSITRI - Slovenia (SI)
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| 许可日期 | 2020/04/29 |
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| 最近更新日期 | 2025/09/28 |
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| 药物ATC编码 | - C09DX Angiotensin II receptor blockers (ARBs), other combinations
- C09D ANGIOTENSIN II RECEPTOR BLOCKERS (ARBs), COMBINATIONS
- C09 AGENTS ACTING ON THE RENIN-ANGIOTENSIN SYSTEM
- C09DX03 olmesartan medoxomil, amlodipine and hydrochlorothiazide
- C CARDIOVASCULAR SYSTEM
| 申请类型 | - TypeLevel1：Abridged
- TypeLevel2：Additional Strength/Form
- TypeLevel3：Generic Art 10.1 and 10.2 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 | Positive |
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