欧盟HMA药品数据库（European Union HMA Authorisation of Medicines DataBase）
MR编号DE/H/6636/001
药品名称Polithera Peritonealdialyselösung Icodextrin 7,5 g/l Natriumchlorid 5,4 g/l Natrium-S-Lactat-Lösung 9,0 g/l Calciumchlorid-Dihydrat 0,257 g/l Magnesiumchlorid-Hexahydrat 0,051 g/l
活性成分
    • calcium chloride dihydrate 0.26 g/l
    • icodextrin 75.0 g/l
    • magnesium chloride hexahydrate 0.05 g/l
    • sodium chloride 5.4 g/l
    • sodium lactate anhydrous 4.5 g/l
剂型Solution for peritoneal dialysis
上市许可持有人VIVISOL Srl Via Gerolamo Borgazzi 27 20900 MONZA Italy
参考成员国 - 产品名称Germany (DE)
IcoCore 7.5%
互认成员国 - 产品名称
    • Sweden (SE)
    • Poland (PL)
      Polithera 7.5%, Solution for peritoneal dialysis
    • Romania (RO)
    • United Kingdom (Northern Ireland) (XI)
    • Denmark (DK)
    • Belgium (BE)
    • Netherlands (NL)
    • Austria (AT)
    • Spain (ES)
    • Italy (IT)
许可日期2022/12/08
最近更新日期2024/07/26
药物ATC编码
    • B05DA Isotonic solutions
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
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市场状态Positive
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