欧盟HMA药品数据库（European Union HMA Authorisation of Medicines DataBase）
MR编号DE/H/3941/001
药品名称mito-extra 40 mg Pulver und Lösungsmittel zur Herstellung einer Lösung zur intravesikalen Anwendung
活性成分
    • mitomycin 40.0 mg
剂型Powder and solvent for intravesical solution
上市许可持有人Medac Gesellschaft für klinische Spezialpräparate m.b.H. Theaterstr. 6 DE-22880 Wedel Germany
参考成员国 - 产品名称Germany (DE)
Mitomycin 40 mg Pulver zur Herstellung einer Lösung zur intravesikalen Anwendung
互认成员国 - 产品名称
    • Denmark (DK)
    • Belgium (BE)
      Mitomycin medac, 40 mg, poeder en oplosmiddel voor oplossing voor intravesicaal gebruik
    • 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)
许可日期2015/10/28
最近更新日期2024/02/15
药物ATC编码
    • L01DC03 mitomycin
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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市场状态Positive
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