| MR编号 | NL/H/3712/001 |
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| 药品名称 | Grinterol (ursodeoxycholic acid) |
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| 活性成分 | - Ursodeoxycholic acid 250.0 mg
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| 剂型 | Capsule, hard |
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| 上市许可持有人 | AS Grindeks
Krustpils iela 53
Riga
LV 1057 Latvia |
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| 参考成员国 - 产品名称 | Netherlands (NL) Grinterol |
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| 互认成员国 - 产品名称 | - Austria (AT)
- Bulgaria (BG)
Ursogrix - France (FR)
- Greece (GR)
- Hungary (HU)
URZODEZOXIKOLSAV GRINDEKS 250 mg kemény kapszula - Ireland (IE)
- Spain (ES)
- Romania (RO)
- Slovakia (SK)
- Belgium (BE)
Ursogrix 250 mg harde capsules - United Kingdom (Northern Ireland) (XI)
- Portugal (PT)
- Poland (PL)
Ursoxyn - Latvia (LV)
Ursogrix 250 mg cietās kapsulas - Lithuania (LT)
URSOGRIX 250 mg kietosios kapsulės - Estonia (EE)
URSOGRIX - Czechia (CZ)
URSOGRIX 250 MG TVRDÉ TOBOLKY - Denmark (DK)
- Croatia (HR)
- Sweden (SE)
URSOGRIX
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| 许可日期 | 2016/12/21 |
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| 最近更新日期 | 2025/03/17 |
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| 药物ATC编码 | - A05AA02 ursodeoxycholic acid
| 申请类型 | - TypeLevel1：Known Active Substance
- TypeLevel2：Initial Application
- 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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