欧盟HMA药品数据库(European Union HMA Authorisation of Medicines DataBase)
MR编号DE/H/2021/004
药品名称Tapentadol Libra-Pharm retard 50 mg Retardtabletten
活性成分
    • tapentadol hydrochloride 58.24 mg
剂型Prolonged-release tablet
上市许可持有人Libra-Pharm GmbH Zieglerstr. 6 52078 Aachen Germany
参考成员国 - 产品名称Germany (DE)
Yantil retard; 50 mg
互认成员国 - 产品名称
    • Portugal (PT)
    • United Kingdom (Northern Ireland) (XI)
    • Austria (AT)
    • Spain (ES)
    • Italy (IT)
许可日期2010/08/10
最近更新日期2024/11/13
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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