欧盟HMA药品数据库(European Union HMA Authorisation of Medicines DataBase)
MR编号UK/H/6725/007
药品名称Methylphenidate Hydrochloride 60mg Prolonged-release capsule, hard
活性成分
    • Methylphenidate hydrochloride 60.0 mg
剂型Prolonged-release capsule, hard
上市许可持有人Mundipharma Gesellschaft m.b.H. Apollogasse 16-18 Vienna 1070 Austria
参考成员国 - 产品名称United Kingdom (UK)
Methylphenidate Hydrochloride 60mg Prolonged-release capsule, hard
互认成员国 - 产品名称
    • Austria (AT)
    • Czech Republic (CZ)
      Biphentin
    • Denmark (DK)
      Biphentin
    • Finland (FI)
    • France (FR)
    • Germany (DE)
      Biphentin 60 mg Hartkapseln , retadiert
    • Iceland (IS)
    • Ireland (IE)
    • Italy (IT)
    • Netherlands (NL)
    • Norway (NO)
    • Poland (PL)
      Biphentin
    • Spain (ES)
    • Sweden (SE)
许可日期2018/12/13
最近更新日期2019/03/06
药物ATC编码
    • N06BA04 methylphenidate
申请类型
  • TypeLevel1:Abridged
  • TypeLevel2:Initial Application
  • TypeLevel3:Full Dossier
  • TypeLevel4:Chemical Substance
  • TypeLevel5:Prescription Only
附件文件下载
    市场状态Withdrawn(注:已撤市)
    撤市原因:1.The company decided to withdraw the application. At the time of withdrawal, the MS considered that the data provided did not allow to conclude on a positive benefit-risk balance as major objections were raised.
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