欧盟HMA药品数据库（European Union HMA Authorisation of Medicines DataBase）
MR编号DE/H/2020/005
药品名称Palexia retard
活性成分
    • tapentadol hydrochloride 116.48 mg
剂型Prolonged-release tablet
上市许可持有人Grünenthal GmbH Zieglerstrasse 6 D- 52078 Aachen Germany
参考成员国 - 产品名称Germany (DE)
Palexia long 100 mg Retardtabletten
互认成员国 - 产品名称
    • Croatia (HR)
      Palexia retard 100 mg tablete s produljenim oslobađanjem
    • Denmark (DK)
    • Belgium (BE)
    • Luxembourg (LU)
    • United Kingdom (Northern Ireland) (XI)
    • Ireland (IE)
    • Spain (ES)
    • Portugal (PT)
    • Italy (IT)
    • Greece (GR)
    • Sweden (SE)
    • Norway (NO)
    • Poland (PL)
    • Cyprus (CY)
      PALEXIA R100mg PR TABS
    • Czechia (CZ)
      Palexia® retard 100 mg tablety s prodlouženým uvolňováním
    • Slovakia (SK)
      Palexia
    • Slovenia (SI)
    • Netherlands (NL)
    • Austria (AT)
许可日期2010/08/10
最近更新日期2024/09/19
药物ATC编码
    • N02AX06 tapentadol
申请类型
  • TypeLevel1：New Active Substance
  • TypeLevel2：Additional Strength/Form
  • TypeLevel3：Full Dossier Art 8.3(i) Dir 2001/83/EC
  • TypeLevel4：Chemical Substance
  • TypeLevel5：Prescription Only
附件文件下载
市场状态Positive
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