| MR编号 | HU/H/0435/001 |
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| 药品名称 | Etoxib/Etoriax/Roticox (Etoricoxib KRKA) 30 mg film-coated tablet |
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| 活性成分 | |
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| 剂型 | Film-coated tablet |
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| 上市许可持有人 | Krka d.d.
Smarjeska cesta 6
8501 Novo mesto
Slovenia |
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| 参考成员国 - 产品名称 | Hungary (HU) ROTICOX 30 mg filmtabletta |
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| 互认成员国 - 产品名称 | - Germany (DE)
Etoriax 30 mg Filmtabletten - Denmark (DK)
- Belgium (BE)
Etoricoxib Krka 30 mg filmomhulde tabletten - Iceland (IS)
Etoricoxib Krka 30 mg filmuhúðuð tafla - United Kingdom (Northern Ireland) (XI)
- Ireland (IE)
- Spain (ES)
- Sweden (SE)
- Norway (NO)
- Finland (FI)
- Poland (PL)
Roticox - Latvia (LV)
Bericox 30 mg apvalkotās tabletes - Lithuania (LT)
Bericox 30 mg plėvele dengtos tabletės - Estonia (EE)
ETOXIB - Bulgaria (BG)
Etoxib - Czechia (CZ)
Roticox 30 mg - Romania (RO)
ROTICOX 30 mg comprimate filmate - Slovakia (SK)
Roticox 30 mg - Slovenia (SI)
- Croatia (HR)
Etoxib 30 mg filmom obložene tablete
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| 许可日期 | 2016/09/13 |
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| 最近更新日期 | 2024/04/18 |
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| 药物ATC编码 | | 申请类型 | - TypeLevel1：Abridged
- 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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