欧盟HMA药品数据库(European Union HMA Authorisation of Medicines DataBase)
MR编号DE/H/0363/004
药品名称Salofalk Granu-Stix 1,5 g magensaftresistentes Retardgranulat
活性成分
    • Mesalazine 1.5 g
剂型Gastro-resistant prolonged release granules
上市许可持有人Dr. Falk Pharma GmbH Leinenweberstrasse 5 79108 Freiburg im Breisgau Germany
参考成员国 - 产品名称Germany (DE)
互认成员国 - 产品名称
    • Ireland (IE)
    • Poland (PL)
    • Latvia (LV)
      Salofalk 1,5 g zarnās šķīstošās ilgstošās darbības granulas
    • Hungary (HU)
      SALOFALK 1,5 g gyomornedv-ellenálló retard granulátum
    • Czechia (CZ)
      Salofalk 1,5g gastro-resistant prolonged-release granules
    • Slovakia (SK)
    • Slovenia (SI)
    • Italy (IT)
    • France (FR)
    • United Kingdom (Northern Ireland) (XI)
    • Lithuania (LT)
    • Denmark (DK)
    • Belgium (BE)
    • Netherlands (NL)
    • Luxembourg (LU)
    • Austria (AT)
      Mesagran 1500 mg magensaftresistentes Retardgranulat
    • Spain (ES)
    • Portugal (PT)
    • Greece (GR)
    • Sweden (SE)
    • Norway (NO)
    • Finland (FI)
    • Cyprus (CY)
      Salofalk 1.5 g prolonged-release granules
许可日期2008/05/26
最近更新日期2025/02/12
药物ATC编码
    • A07EC02 mesalazine
申请类型
  • TypeLevel1:Line Extension
  • TypeLevel2:Initial Application
  • TypeLevel3:Full Dossier Art 8.3(i) Dir 2001/83/EC
  • TypeLevel4:Chemical Substance
  • TypeLevel5:Prescription Only
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市场状态Positive
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