| MR编号 | DE/H/5021/001 |
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| 药品名称 | Crusia 10.000 IE (100 mg)/1 ml Injektionslösung in einer Fertigspritze |
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| 活性成分 | - enoxaparin sodium 10000.0 IU
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| 剂型 | Solution for injection in prefilled syringe |
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| 上市许可持有人 | Laboratorios Farmaceuticos Rovi, S.A.
C/Julian Camarillo, 35
E-28037 Madrid
Spain |
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| 参考成员国 - 产品名称 | Germany (DE) Crusia 100 mg (10,000 IU/ml) solution for injection in pre-filled syringe |
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| 互认成员国 - 产品名称 | - Denmark (DK)
Crusia - Belgium (BE)
Teuro 2.000 IE (20 mg)/0,2 ml oplossing voor injectie in een voorgevulde spuit - Netherlands (NL)
Crusia 10.000 I.E. (100 mg)/1 mL oplossing voor injectie in een voorgevulde spuit - Luxembourg (LU)
- United Kingdom (Northern Ireland) (XI)
- Ireland (IE)
- Austria (AT)
Crusia 10.000 I.E. (100 mg)/1 ml Injektionslösung in einer Fertigspritze - France (FR)
- Portugal (PT)
- Italy (IT)
- Greece (GR)
CRUSIA - Sweden (SE)
- Norway (NO)
Crusia - Finland (FI)
- Poland (PL)
- Latvia (LV)
Crusia 10000 SV (100 mg) /1 ml šķīdums injekcijām pilnšļircē - Estonia (EE)
CRUSIA - Hungary (HU)
CRUSIA 10000 NE (100 mg)/1 ml oldatos injekció előretöltött fecskendőben - Bulgaria (BG)
Crusia - Czechia (CZ)
Crusia - Romania (RO)
Crusia 10000 UI (100 mg)/1,0 ml soluţie injectabilă în seringă preumplută - Slovakia (SK)
Crusia 10 000 IU (100 mg)/1 ml - Slovenia (SI)
Teuro 10.000 i.e. (100 mg)/1 ml raztopina za injiciranje v napolnjeni injekcijski brizgi - Croatia (HR)
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| 许可日期 | 2017/02/24 |
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| 最近更新日期 | 2024/04/19 |
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| 药物ATC编码 | | 申请类型 | - TypeLevel1：Abridged
- TypeLevel2：Initial Application
- TypeLevel3：Similar biological Art 10.4 Dir 2001/83/EC
- TypeLevel4：Biological: Other
- 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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