欧盟HMA药品数据库(European Union HMA Authorisation of Medicines DataBase)
MR编号DK/H/2439/001
药品名称Mydrane
活性成分
    • Lidocaine hydrochloride 10.0 mg/ml
    • Phenylephrine hydrochloride 3.1 mg/ml
    • Tropicamide 0.2 mg/ml
剂型Solution for injection
上市许可持有人Laboratoires Thea 12, rue Louis Bleriot 63017 Clermont-Ferrand Cedex 2 France Change of RMS during validation, former RMS SE/H/1351/001/DC
参考成员国 - 产品名称Denmark (DK)
MYDRANE
互认成员国 - 产品名称
    • Germany (DE)
      Mydrane
    • Belgium (BE)
      Mydrane 0,2 mg/ml + 3,1 mg/ml + 10 mg/ml, solution Injectable
    • Netherlands (NL)
      MYDRANE 10/3.1/0.2 mg/ml, oplossing voor injectie
    • Luxembourg (LU)
    • Iceland (IS)
      MYDRANE 0,2 mg/ml + 3,1 mg/ml + 10 mg/ml Stungulyf, lausn
    • Ireland (IE)
    • Austria (AT)
    • France (FR)
    • Spain (ES)
    • Portugal (PT)
    • Italy (IT)
    • Greece (GR)
      MYDRANE
    • Sweden (SE)
      MYDRANE
    • Norway (NO)
    • Finland (FI)
    • Poland (PL)
      Mydrane
    • Bulgaria (BG)
      Mydrane
    • Cyprus (CY)
      MYDRANE SOL FOR INJECTION
    • Czechia (CZ)
      Mydrane 0,2 mg/ml + 3,1 mg/ml + 10 mg/ml
    • Romania (RO)
      MYDRANE 0,2 mg/ml+3,1 mg/ml+10 mg/ml soluție injectabilă
    • United Kingdom (Northern Ireland) (XI)
    • Slovakia (SK)
      MYDRANE 0,2 mg/ml + 3,1 mg/ml + 10 mg/ml injekčný roztok
    • Slovenia (SI)
    • Croatia (HR)
      Mydrane 0,2 mg/ml + 3,1 mg/ml + 10 mg/ml otopina za injekciju
许可日期2015/07/02
最近更新日期2025/01/02
药物ATC编码
    • S01FA56 tropicamide, combinations
申请类型
  • TypeLevel1:Known Active Substance
  • TypeLevel2:Initial Application
  • TypeLevel3:Fixed combination Art 10b Dir 2001/83/EC
  • TypeLevel4:Chemical Substance
  • TypeLevel5:Prescription Only
附件文件下载
市场状态Positive
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