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Efavirenz/Emtricitabine/Tenofovir disoproxil Zentiva



Zentiva k.s.EU/1/17/1210/001

Main Information

Trade NameEfavirenz/Emtricitabine/Tenofovir disoproxil Zentiva
Active SubstancesTenofovir disoproxil phosphate
Efavirenz
Emtricitabine
Dosage FormFilm-coated tablet
Licence HolderZentiva k.s.
Licence NumberEU/1/17/1210/001

Group Information

ATC CodeJ05AR Antivirals for treatment of HIV infections, combinations
J05AR06 emtricitabine, tenofovir disoproxil and efavirenz

Status

License statusAuthorised
Licence Issued17/07/2017
Legal statusProduct subject to prescription which may not be renewed (A)
Supply StatusSupply through pharmacies only
Advertising StatusAdvertising to healthcare professionals only
Conditions of LicenceMedicinal product subject to restricted medical prescription (See Annex I: Summary of Product Characteristics, section 4.2)
Marketing StatusUnknown

Documents

Summary of Product CharacteristicsSearch EMA website
Package LeafletSearch EMA website
Public Assessment ReportSearch EMA website
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