欧盟HMA药品数据库（European Union HMA Authorisation of Medicines DataBase）
MR编号SE/H/1376/001
药品名称Pramipexol Sigillata
活性成分
    • pramipexole dihydrochloride 0.26 mg
剂型Prolonged-release tablet
上市许可持有人Sigillata Limited Suite 23, Park Royal House, 23 Park Royal Rd, London, NW10 7JH, United Kingdom
参考成员国 - 产品名称Sweden (SE)
互认成员国 - 产品名称
    许可日期2015/05/26
    最近更新日期2015/09/01
    药物ATC编码
      • N04BC05 pramipexole
    申请类型
    • TypeLevel1：Abridged
    • TypeLevel2：Multiple (Copy) Application
    • TypeLevel3：Generic Art 10.1 and 10.2 Dir 2001/83/EC
    • 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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