ACTIVE SUBSTANCE / INN

EFAVIRENZ;EMTRICITABINE;TENOFOVIR DISOPROXIL

Brand name(s): Atripla, Efavirenz/Emtricitabine/Tenofovir disoproxil Krka, Efavirenz/Emtricitabine/Tenofovir disoproxil Mylan, Efavirenz/Emtricitabine/Tenofovir disoproxil Zentiva
EMA LISTED
WITHDRAWN
AUTHORISED
HIV Infections
ACTIVE SUBSTANCE
Efavirenz;Emtricitabine;Tenofovir Disoproxil
REGULATORS
EMA
SPONSORS / MAH
Mylan Pharmaceuticals Limited, Gilead Sciences Ireland UC, Zentiva k.s.
TOTAL APPLICATIONS
4
EMA AUTHORISATIONS
PRODUCT NAMEHOLDERSTATUSDATEINDICATION
Efavirenz/Emtricitabine/Tenofovir disoproxil MylanMylan Pharmaceuticals LimitedAuthorised05/09/2017HIV Infections
Efavirenz/Emtricitabine/Tenofovir disoproxil ZentivaZentiva k.s.Authorised17/07/2017HIV Infections
Efavirenz/Emtricitabine/Tenofovir disoproxil KrkaKRKA, d.d., Novo mestoAuthorised08/02/2018HIV Infections
AtriplaGilead Sciences Ireland UCWithdrawn13/12/2007HIV Infections

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