欧盟HMA药品数据库（European Union HMA Authorisation of Medicines DataBase）
MR编号IT/H/0413/001
药品名称SOFACOR
活性成分
    • Hydrocortisone sodium phosphate 3.35 mg/ml
剂型Eye drop solution in single dose containers
上市许可持有人Laboratoires THEA_12 rue Louis Blériot – 63017 Clermont-Ferrand cedex 2-France
参考成员国 - 产品名称Italy (IT)
互认成员国 - 产品名称
    • Germany (DE)
      Softacort 3,35 mg/ml Augentropfen
    • Denmark (DK)
      Softacort
    • Belgium (BE)
      Softacor 3,35 mg/ml collyre en solution en récipient unidose
    • Netherlands (NL)
    • Luxembourg (LU)
    • Iceland (IS)
      Softacort 3,35 mg/ml augndropar, lausn í stakskammtaíláti
    • United Kingdom (Northern Ireland) (XI)
    • Ireland (IE)
    • Austria (AT)
      Softacort 3,35 mg/ml Augentropfen, Lösung im Einzeldosisbehältnis
    • France (FR)
    • Spain (ES)
    • Portugal (PT)
    • Greece (GR)
    • Sweden (SE)
    • Norway (NO)
    • Finland (FI)
      Softacort 3,35 mg/ml silmätipat, liuos, kerta-annospakkaus
    • Poland (PL)
      SOFTACORT
    • Bulgaria (BG)
      Softacort
    • Cyprus (CY)
      SOFTACORT 3,35 mg/ml
    • Czechia (CZ)
      Softacort 3.35 mg/ml
    • Romania (RO)
    • Slovakia (SK)
      SOFTACORT
    • Slovenia (SI)
      Softacort 3,35 mg/ml kapljice za oko, raztopina v enoodmernem vsebniku
    • Croatia (HR)
      Softacort 3,35 mg/ml kapi za oko, otopina u jednodoznom spremniku
    • Hungary (HU)
      SOFTACORT 3,35 mg/ml oldatos szemcsepp egyadagos tartályban
许可日期2017/03/14
最近更新日期2024/10/25
药物ATC编码
    • S SENSORY ORGANS
    • S01 OPHTHALMOLOGICALS
    • S01BA02 hydrocortisone
    • S01BA Corticosteroids, plain
    • S01B ANTIINFLAMMATORY AGENTS
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Positive
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