欧盟HMA药品数据库（European Union HMA Authorisation of Medicines DataBase）
MR编号NL/H/6049/001
药品名称Macitentan CF 10 mg, film-coated tablets
活性成分
    • Macitentan 10.0 mg
剂型Film-coated tablet
上市许可持有人Centrafarm B.V. Van de Reijtstraat 31 E 4814 NE Breda The Netherlands
参考成员国 - 产品名称Netherlands (NL)
Macitentan CF 10 mg, filmomhulde tablette
互认成员国 - 产品名称
    • Norway (NO)
      Macitentan STADA
    • Slovakia (SK)
    • Iceland (IS)
    • Romania (RO)
    • Luxembourg (LU)
    • Hungary (HU)
    • Belgium (BE)
      Macitentan EG 10 mg filmomhulde tabletten
    • Poland (PL)
      Macitentan Stada
    • Finland (FI)
    • Germany (DE)
      Macitentan STADA 10 mg Filmtabletten
    • Sweden (SE)
    • Italy (IT)
    • Portugal (PT)
    • Spain (ES)
    • Austria (AT)
    • Malta (MT)
      Macitentan Clonmel 10 mg film coated tablet
    • Ireland (IE)
    • Denmark (DK)
      Macitentan STADA
许可日期2025/07/04
最近更新日期2025/09/08
药物ATC编码
    • C02KX04 macitentan
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
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市场状态Positive
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