| MR编号 | NL/H/3778/001 |
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| 药品名称 | Remurel 40 mg/ml solution for injection, pre-filled syringe |
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| 活性成分 | - glatiramer acetate 40.0 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 | Alvogen IPCO S.a.r.l.
5 Rue Heienhaff
L-1736 Senningerberg
Luxembourg |
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| 参考成员国 - 产品名称 | Netherlands (NL) |
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| 互认成员国 - 产品名称 | - Iceland (IS)
Remurel 40 mg/ml stungulyf, lausn í áfylltri sprautu - Poland (PL)
Remurel - Latvia (LV)
Remurel 40 mg/ml šķīdums injekcijām pilnšļircē - Lithuania (LT)
Remurel 40 mg/ml injekcinis tirpalas užpildytame švirkšte - Estonia (EE)
REMUREL - Hungary (HU)
REMUREL 40 mg/ml oldatos injekció előretöltött fecskendőben - Bulgaria (BG)
Remurel - Czechia (CZ)
Remurel - Romania (RO)
REMUREL 40 mg/ml soluţie injectabilă în seringă preumplută - Slovakia (SK)
- Slovenia (SI)
- Croatia (HR)
Remurel 40 mg/ml otopina za injekciju, u napunjenoj štrcaljki
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| 许可日期 | 2017/10/03 |
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| 最近更新日期 | 2024/03/08 |
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| 药物ATC编码 | - L03AX13 glatiramer acetate
| 申请类型 | - TypeLevel1：Abridged
- TypeLevel2：Multiple (Copy) 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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