欧盟HMA药品数据库(European Union HMA Authorisation of Medicines DataBase)
MR编号
SE/H/2158/001
药品名称
Efavirenz/Emtricitabine/Tenofovir disoproxil Zentiva k.s.
活性成分
Efavirenz 600.0 mg
Emtricitabine 200.0 mg
Tenofovir disoproxil fumarate 300.0 mg
剂型
Film-coated tablet
上市许可持有人
Zentiva k.s., Czechia
参考成员国 - 产品名称
Sweden (SE)
互认成员国 - 产品名称
Germany (DE)
Efavirenz/Emtricitabin/Tenofovirdisoproxil Zentiva 600 mg/200 mg/245 mg Filmtabletten
Denmark (DK)
Efavirenz/Emtricitabine/Tenofovir disoproxil "Zentiva k.s."
France (FR)
Italy (IT)
Estonia (EE)
Romania (RO)
许可日期
2024/12/04
最近更新日期
2024/12/13
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
附件文件下载
Final PL
|
Final PL
Final SPC
|
Final SPC
市场状态
Positive
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