MR编号 | ES/H/0626/001 |
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药品名称 | Amiodarone Accord 300 mg/ml solution for injection/infusion in pre-filled syringe |
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活性成分 | - Amiodarone hydrochloride 30.0 mg/ml
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剂型 | Solution for injection/infusion in pre-filled syringe |
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上市许可持有人 | ACCORD HEALTHCARE, S.L.U
Moll de Barcelona s/n. World Trade Center. Edifici Est 6ª planta
Barcelona SPAIN |
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参考成员国 - 产品名称 | Spain (ES) |
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互认成员国 - 产品名称 | - Germany (DE)
Amiodaron 300 mg Lösung zur Injektion/Infusion in einer Fertigspritze - Portugal (PT)
- Italy (IT)
- Norway (NO)
Amiodarone Accord - Czechia (CZ)
Amiodarone Accord 300 mg injekční/infuzní roztok v předplněné injekční stříkačce - Romania (RO)
Amiodarona Accord 300 mg soluție injectabilă / perfuzabilă în seringă preumplută
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许可日期 | 2020/10/06 |
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最近更新日期 | 2024/10/01 |
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药物ATC编码 | |
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申请类型 | - TypeLevel1:Abridged
- 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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