欧盟HMA药品数据库(European Union HMA Authorisation of Medicines DataBase)
MR编号DE/H/4857/001
药品名称Agomelatin AbZ 25 mg Filmtabletten
活性成分
    • agomelatine 25.0 mg
剂型Film-coated tablet
上市许可持有人AbZ-Pharma GmbH - Geschäftsanschrift - Graf-Arco-Str. 3 D-89079 Ulm
参考成员国 - 产品名称Germany (DE)
2198737
互认成员国 - 产品名称
    • Denmark (DK)
    • Netherlands (NL)
    • United Kingdom (Northern Ireland) (XI)
    • Spain (ES)
    • Portugal (PT)
    • Sweden (SE)
    • Finland (FI)
    • Lithuania (LT)
      Agomelatine Teva 25 mg plėvele dengtos tabletės
    • Hungary (HU)
      AGOMELATIN TEVA 25 mg filmtabletta
    • Czechia (CZ)
      Agomelatine Teva
    • Slovakia (SK)
      Agomelatín Teva
许可日期2018/05/11
最近更新日期2023/01/18
药物ATC编码
    • N06AX22 agomelatine
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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