| MR编号 | DE/H/3941/001 |
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| 药品名称 | mito-extra 40 mg Pulver und Lösungsmittel zur Herstellung einer Lösung zur intravesikalen Anwendung |
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| 活性成分 | |
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| 剂型 | Powder and solvent for intravesical solution |
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| 上市许可持有人 | Medac Gesellschaft für klinische Spezialpräparate m.b.H.
Theaterstr. 6
DE-22880 Wedel
Germany |
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| 参考成员国 - 产品名称 | Germany (DE) Mitomycin 40 mg Pulver zur Herstellung einer Lösung zur intravesikalen Anwendung |
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| 互认成员国 - 产品名称 | - Denmark (DK)
- Netherlands (NL)
Mitomycin 40 mg, poeder en oplossing voor intravesicaal gebruik - Iceland (IS)
Mitomycin medac 40 mg duft og leysir fyrir þvagblöðrulausn - Ireland (IE)
- Austria (AT)
- Portugal (PT)
- Italy (IT)
- Sweden (SE)
- Norway (NO)
Mitomycin medac - Finland (FI)
- Poland (PL)
Mitomycin PharmaLex - Latvia (LV)
Mitomycin medac 40 mg pulveris un šķīdinātājs intravezikāli lietojama šķīduma pagatavošanai - Lithuania (LT)
Mitomycin medac 40 mg milteliai ir tirpiklis šlapimo pūslės tirpalui - Estonia (EE)
MITOMYCIN MEDAC - Slovakia (SK)
- Slovenia (SI)
- United Kingdom (Northern Ireland) (XI)
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| 许可日期 | 2015/10/28 |
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| 最近更新日期 | 2025/01/16 |
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| 药物ATC编码 | |
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| 申请类型 | - TypeLevel1：Abridged
- TypeLevel2：Initial Application
- TypeLevel3：Generic Art 10.1 and 10.2 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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