欧盟HMA药品数据库（European Union HMA Authorisation of Medicines DataBase）
MR编号DE/H/2020/001
药品名称Palexia Akutschmerz 50 mg Filmtabletten
活性成分
    • Tapentadol hydrochloride 58.24 mg
剂型Film-coated 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 50 mg Filmtabletten
互认成员国 - 产品名称
    • Croatia (HR)
      Palexia 50 mg filmom obložene tablete
    • Denmark (DK)
      Palexia
    • Belgium (BE)
    • Luxembourg (LU)
    • United Kingdom (Northern Ireland) (XI)
    • Ireland (IE)
    • Netherlands (NL)
    • Spain (ES)
    • Austria (AT)
      Donepezil STADA 5 mg Filmtabletten
    • Portugal (PT)
    • Italy (IT)
    • Greece (GR)
    • Sweden (SE)
    • Norway (NO)
    • Poland (PL)
    • Cyprus (CY)
      PALEXIA 50mg FC TABS
    • Czechia (CZ)
      Palexia® 50 mg potahované tablety
    • Slovakia (SK)
      Palexia 50 mg filmom obalené tablety
    • Slovenia (SI)
许可日期2010/08/10
最近更新日期2025/01/27
药物ATC编码
    • N02AX06 tapentadol
申请类型
  • TypeLevel1：New 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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