欧盟HMA药品数据库(European Union HMA Authorisation of Medicines DataBase)
MR编号AT/H/0959/002
药品名称Risperidon Pulver und Lösungsmittel zur Herstellung einer Depot-Injektionssuspension
活性成分
    • Risperidone 37.5 mg
剂型Powder and solvent for prolonged-release suspension for injection
上市许可持有人Teva B.V. Swensweg 5 2031GA Haarlem Netherlands
参考成员国 - 产品名称Austria (AT)
Risperidon ratiopharm 37,5 mg Pulver und Lösungsmittel zur Herstellung einer Depot-Injektionssuspension
互认成员国 - 产品名称
    • Germany (DE)
      Risperidon-ratiopharm 37,5 mg Pulver und Lösungsmittel zur Herstellung einer Depot-Injektionssuspension
    • Denmark (DK)
    • Belgium (BE)
      Risperidone Teva 37,5 mg Poeder en oplosmiddel voor suspensie voor injectie met verlengde afgifte
    • Netherlands (NL)
    • Luxembourg (LU)
    • Iceland (IS)
      Risperidone Teva GmbH
    • France (FR)
    • Spain (ES)
    • Portugal (PT)
    • Italy (IT)
    • Sweden (SE)
    • Norway (NO)
      Risperidone Teva GmbH
    • Finland (FI)
    • Poland (PL)
    • Lithuania (LT)
      Risperidone Teva 37,5 mg milteliai ir tirpiklis pailginto atpalaidavimo injekcinei suspensijai
    • Hungary (HU)
    • Bulgaria (BG)
      Speridan
    • Romania (RO)
      Risperidonă Teva 37,5 mg pulbere și solvent pentru suspensie injectabilă cu eliberare prelungită
许可日期2020/10/14
最近更新日期2025/01/14
药物ATC编码
    • N05AX08 risperidone
申请类型
  • TypeLevel1:Abridged
  • TypeLevel2:Initial Application
  • TypeLevel3:Generic Art 10.1 and 10.2 Dir 2001/83/EC
  • TypeLevel4:Chemical Substance
  • TypeLevel5:Prescription Only
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市场状态Positive
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