欧盟HMA药品数据库（European Union HMA Authorisation of Medicines DataBase）
MR编号
PT/H/1616/001
药品名称
Emtricitabina + Tenofovir Zentiva
活性成分
Emtricitabine 200.0 mg
Tenofovir 300.0 mg
剂型
Film-coated tablet
上市许可持有人
Sanofi - Produtos Farmacêuticos, Lda.
参考成员国 - 产品名称
Portugal (PT)
互认成员国 - 产品名称
Czechia (CZ)
Germany (DE)
Emtricitabin/Tenofovirdisoproxilfumarat Zentiva 200 mg/245 mg Filmtabletten
United Kingdom (Northern Ireland) (XI)
France (FR)
Estonia (EE)
EMTRICITABINE/TENOFOVIR ZENTIVA
许可日期
2017/03/08
最近更新日期
2025/08/15
药物ATC编码
J05AR03 tenofovir disoproxil and emtricitabine
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 Product Information
|
EMTRICITABINE_TENOFOVIR DISOPROXIL FUMARATE_200_245mg_fct_EN_PT_H_1616_001_IT 12_2024_cl
Date of last change:2025/08/15
Final SPC
|
EMTRICITABINE_TENOFOVIR DISOPROXIL FUMARATE_200_245mg_fct_EN_PT_H_1616_001_PSUSA 202402_240328_tr_2_
Date of last change:2025/03/06
PubAR Summary
|
605102_20170608_PAR_GBB
Date of last change:2024/09/06
市场状态
Positive
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European Union HMA Authorisation of Medicines DataBase