| MR编号 | NL/H/3211/001 |
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| 药品名称 | Brabio 20 mg/ml solution for injection,
pre-filled syringe |
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| 活性成分 | - Glatiramer acetate 20.0 mg/ml
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| 剂型 | Solution for injection in prefilled syringe |
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| 上市许可持有人 | Synthon BV
Microweg 22
Nijmegen
The Netherlands |
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| 参考成员国 - 产品名称 | Netherlands (NL) Brabio 20 mg/ml, oplossing voor injectie in een voorgevulde spuit |
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| 互认成员国 - 产品名称 | - Denmark (DK)
Copemyl - Iceland (IS)
- United Kingdom (Northern Ireland) (XI)
- Ireland (IE)
- Greece (GR)
BRABIO (ex GLATIRAMER ACETATE/ACTAVIS) - Sweden (SE)
- Norway (NO)
Brabio - Finland (FI)
- Poland (PL)
- Latvia (LV)
Remurel 20 mg/ml šķīdums injekcijām pilnšļircē - Lithuania (LT)
Remurel 20 mg/ml injekcinis tirpalas užpildytame švirkšte - Estonia (EE)
REMUREL - Hungary (HU)
REMUREL 20 mg/ml oldatos injekció előretöltött fecskendőben - Bulgaria (BG)
Remurel - Cyprus (CY)
- Czechia (CZ)
BRABIO 20 MG/ML INJEKČNÍ ROZTOK V PŘEDPLNĚNÉ INJEKČNÍ STŘÍKAČCE - Romania (RO)
- Slovakia (SK)
Brabio 20 mg/ml - Slovenia (SI)
- Croatia (HR)
Remurel 20 mg/ml otopina za injekciju u napunjenoj štrcaljki
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| 许可日期 | 2016/03/11 |
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| 最近更新日期 | 2025/04/18 |
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| 药物ATC编码 | - L03AX13 glatiramer acetate
| 申请类型 | - TypeLevel1：Known Active Substance
- TypeLevel2：Initial Application
- TypeLevel3：Other Generic application Art 10.3 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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