欧盟HMA药品数据库（European Union HMA Authorisation of Medicines DataBase）
MR编号PT/H/1773/001
药品名称Diclofenac NTC
活性成分
    • diclofenac 1.0 mg/ml
剂型Eye drop solution in single dose containers
上市许可持有人NTC, Srl
参考成员国 - 产品名称Portugal (PT)
互认成员国 - 产品名称
    许可日期2018/06/20
    最近更新日期2018/07/13
    药物ATC编码
      • S01BC03 diclofenac
    申请类型
    • TypeLevel1：Abridged
    • TypeLevel2：Initial Application
    • TypeLevel3：Other Generic application Art 10.3 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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