欧盟HMA药品数据库(European Union HMA Authorisation of Medicines DataBase)
MR编号PT/H/1955/001
药品名称Efavirenz + Emtricitabina + Tenofovir Generis
活性成分
    • efavirenz 600.0 mg
    • emtricitabine 200.0 mg
    • tenofovir 245.0 mg
剂型Film-coated tablet
上市许可持有人Generis Farmacêutica, S.A.
参考成员国 - 产品名称Portugal (PT)
互认成员国 - 产品名称
    • Germany (DE)
      Efavirenz/Emtricitabin/Tenofovirdisoproxil PUREN 600 mg/200 mg/245 mg Filmtabletten
    • Belgium (BE)
      Efavirenz/Emtricitabine/Tenofovir disoproxil AB 600 mg - 200 mg - 245 mg filmomhulde tabletten
    • Netherlands (NL)
      Efavirenz/Emtricitabine/Tenofovirdisoproxil Aurobindo 600 mg/200 mg/245 mg, filmomhulde tabletten
    • France (FR)
    • Spain (ES)
    • Italy (IT)
    • Poland (PL)
      Efavirenz/Emtricitabine/Tenofovir disoproxil Aurovitas
许可日期2019/12/11
最近更新日期2024/04/15
药物ATC编码
    • J05AR06 emtricitabine, tenofovir disoproxil and efavirenz
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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