欧盟HMA药品数据库（European Union HMA Authorisation of Medicines DataBase）
MR编号DE/H/1743/001
药品名称Plenaxis, powder for suspension for injection, 100 mg
活性成分
    • abarelix 100.0 mg
剂型Powder for suspension for injection
上市许可持有人**SWITCHED to UK/H/4879/001** SEP - Speciality European Pharma Ltd., Gregory Fryer Associates Ltd., UK
参考成员国 - 产品名称Germany (DE)
Plenaxis
互认成员国 - 产品名称
    • Denmark (DK)
    • Belgium (BE)
    • Netherlands (NL)
    • Luxembourg (LU)
    • United Kingdom (Northern Ireland) (XI)
    • Austria (AT)
      Plenaxis 100 mg Pulver und Lösungsmittel zur Herstellung einer Injektionssuspension
    • France (FR)
    • Sweden (SE)
      Plenaxis
    • Norway (NO)
许可日期2010/08/04
最近更新日期2013/01/03
药物ATC编码
    • L02BX01 abarelix
申请类型
  • TypeLevel1：Known Active Substance
  • TypeLevel2：Initial Application
  • TypeLevel3：Full Dossier Art 8.3(i) Dir 2001/83/EC
  • TypeLevel4：Chemical Substance
  • TypeLevel5：Prescription Only
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    市场状态Positive
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