欧盟HMA药品数据库（European Union HMA Authorisation of Medicines DataBase）
MR编号DE/H/2020/013
药品名称PALEXIA 1 mg/ml Injektionslösung
活性成分
    • TAPENTADOL HYDROCHLORIDE 2.33 mg
剂型Solution for injection
上市许可持有人Grünenthal GmbH Zieglerstr. 6 D-52078 Aachen Germany
参考成员国 - 产品名称Germany (DE)
PALEXIA 1 mg/ml Injektionslösung
互认成员国 - 产品名称
    • Austria (AT)
    • Belgium (BE)
    • Bulgaria (BG)
      Palexia
    • Cyprus (CY)
      PALEXIA 1MG/ML SOL FOR INJ
    • Croatia (HR)
    • Czechia (CZ)
      PALEXIA®
    • Denmark (DK)
    • Estonia (EE)
    • Finland (FI)
    • France (FR)
    • Greece (GR)
    • Hungary (HU)
    • Iceland (IS)
    • Ireland (IE)
    • Italy (IT)
    • Latvia (LV)
    • Lithuania (LT)
      Palexia 1 mg/ml injekcinis tirpalas
    • Luxembourg (LU)
    • Malta (MT)
    • Netherlands (NL)
    • Norway (NO)
    • Poland (PL)
      Palexia
    • Portugal (PT)
    • Romania (RO)
    • Slovenia (SI)
    • Slovakia (SK)
    • Sweden (SE)
    • United Kingdom (GB)
    • Spain (ES)
许可日期2018/08/21
最近更新日期2019/05/06
药物ATC编码
    • N02AX06 tapentadol
申请类型
  • TypeLevel1：Abridged
  • 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Withdrawn（注：已撤市）
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