欧盟HMA药品数据库（European Union HMA Authorisation of Medicines DataBase）
MR编号IT/H/0025/008
药品名称SAIZEN
活性成分
    • Somatropin 8.0 mg/ml
剂型Solution for injection
上市许可持有人Merck Serono S.p.A. Via Casilina, 125 00176 - Rome Italy
参考成员国 - 产品名称Italy (IT)
互认成员国 - 产品名称
    • Luxembourg (LU)
    • Romania (RO)
      Saizen 8 mg/ml soluție injectabilă
    • Belgium (BE)
    • Germany (DE)
      Saizen LQ 8 mg/ml Injektionslösung
    • Iceland (IS)
    • United Kingdom (Northern Ireland) (XI)
    • Ireland (IE)
    • Austria (AT)
      Saizen 8 mg/ml Injektionslösung
    • France (FR)
    • Spain (ES)
    • Portugal (PT)
    • Greece (GR)
    • Sweden (SE)
    • Norway (NO)
    • Finland (FI)
    • Latvia (LV)
    • Estonia (EE)
      SAIZEN 8 MG/ML
    • Czechia (CZ)
      Saizen LQ 8 mg/ml injekční roztok
    • Hungary (HU)
      SAIZEN 8 mg/ml oldatos injekció
    • Slovakia (SK)
      Saizen LQ 8 mg/ml injekčný roztok
许可日期2010/10/29
最近更新日期2024/11/04
药物ATC编码
    • H01AC01 somatropin
申请类型
  • TypeLevel1：Line Extension
  • TypeLevel2：Additional Strength/Form
  • TypeLevel3：Full Dossier Art 8.3(i) Dir 2001/83/EC
  • TypeLevel4：Biological: Other
  • TypeLevel5：Prescription Only
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    市场状态Positive
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