| MR编号 | DE/H/5020/001 |
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| 药品名称 | Enoxaparin Becat 10.000 IE (100 mg)/1 ml Injektionslösung in einer Fertigspritze |
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| 活性成分 | - Enoxaparin sodium 10000.0 IU/1.0 ml
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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
28037 Madrid
Spain |
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| 参考成员国 - 产品名称 | Germany (DE) Enoxaparin Becat 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)
Enoxaparin "Becat" - Belgium (BE)
Enoxaparine Becat 2.000 IE (20 mg)/0,2 ml oplossing voor injectie in een voorgevulde spuit - Netherlands (NL)
Enoxaparine Becat 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)
Enoxaparin Becat 10.000 IE (100 mg)/1 ml Injektionslösung in einer Fertigspritze - France (FR)
- Spain (ES)
- Portugal (PT)
- Italy (IT)
- Greece (GR)
ENOXAPARIN/ROVI - Sweden (SE)
- Norway (NO)
Enoxaparin Becat - Finland (FI)
- Poland (PL)
- Latvia (LV)
- Estonia (EE)
LOSMINA - Hungary (HU)
LOSMINA 10000 NE (100 mg)/1 ml oldatos injekció előretöltött fecskendőben - Bulgaria (BG)
Losmina - Czechia (CZ)
Losmina - Romania (RO)
Losmina 10000 UI (100 mg)/1,0 ml soluţie injectabilă în seringă preumplută - Slovakia (SK)
Losmina 10 000 IU (100 mg)/1 ml - Slovenia (SI)
Enoksaparin Rovi 10.000 i.e. (100 mg)/1 mL raztopina za injiciranje v napolnjeni injekcijski brizgi - Croatia (HR)
Losmina 10000 IU (100 mg)/1 ml otopina za injekciju u napunjenoj štrcaljki
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| 许可日期 | 2017/02/24 |
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| 最近更新日期 | 2024/11/19 |
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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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