欧盟HMA药品数据库(European Union HMA Authorisation of Medicines DataBase)
MR编号EE/H/0187/001
药品名称Aclexa
活性成分
    • celecoxib 100.0 mg
剂型Capsule, hard
上市许可持有人KRKA, d.d., Novo mesto Šmarješka cesta 6, 8501 Novo mesto Slovenia
参考成员国 - 产品名称Estonia (EE)
ACLEXA
互认成员国 - 产品名称
    • Malta (MT)
      MA982/00901
    • Germany (DE)
      ACLEXA 100 mg Hartkapseln
    • Denmark (DK)
    • Belgium (BE)
      Celecoxib KRKA 100 mg harde capsules
    • Netherlands (NL)
    • United Kingdom (Northern Ireland) (XI)
    • Ireland (IE)
    • France (FR)
    • Portugal (PT)
    • Italy (IT)
    • Sweden (SE)
    • Finland (FI)
    • Poland (PL)
    • Lithuania (LT)
      Aclexa 100 mg kietosios kapsulės
    • Hungary (HU)
      ACLEXA 100 mg kemény kapszula
    • Bulgaria (BG)
      Aclexa
    • Czechia (CZ)
      ACLEXA 100 mg tvrdé tobolky
    • Romania (RO)
      ACLEXA 100 mg, capsule
    • Slovakia (SK)
      Aclexa 100 mg tvrdé kapsuly
    • Slovenia (SI)
      Aclexa 100 mg trde kapsule
许可日期2013/11/07
最近更新日期2023/04/03
药物ATC编码
    • M01AH01 celecoxib
申请类型
  • TypeLevel1:Abridged
  • TypeLevel2:Initial Application
  • TypeLevel3:Generic Art 10.1 and 10.2 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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