欧盟HMA药品数据库（European Union HMA Authorisation of Medicines DataBase）
MR编号NL/H/5552/001
药品名称Edicot-Opto 3.35 mg/ml eye drops, solution in single-dose container
活性成分
    • hydrocortisone sodium phosphate 3.35 mg/ml
剂型Eye drops, solution in single-dose container
上市许可持有人Uni-Pharma Kleon Tsetis Pharmaceutical Laboratories S.A. 14th km National Road 1, Building B Kifisia 145 64 Greece
参考成员国 - 产品名称Netherlands (NL)
Edicot-Opto 3,35 mg/ml oogdruppels, oplossing
互认成员国 - 产品名称
    • Greece (GR)
    • Cyprus (CY)
      Edicot-Opto 3.35 mg/ml eye drops, solution in single-dose container
    • Denmark (DK)
    • Finland (FI)
    • Sweden (SE)
许可日期2023/10/18
最近更新日期2023/10/26
药物ATC编码
    • S01BA02 hydrocortisone
申请类型
  • TypeLevel1：Known Active Substance
  • TypeLevel2：Initial Application
  • TypeLevel3：Bibliographic Art 10 a 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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