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EFAVIRENZ/EMTRICITABINE/TENOFOVIR DISOPROXIL KRKA



Krka, d.d., Novo mestoEU/1/17/1263/001-002

Main Information

Trade NameEFAVIRENZ/EMTRICITABINE/TENOFOVIR DISOPROXIL KRKA
Active SubstancesEFAVIRENZ
EMTRICITABINE
TENOFOVIR DISOPROXIL SUCCINATE
Dosage FormFilm-coated tablet
Licence HolderKrka, d.d., Novo mesto
Licence NumberEU/1/17/1263/001-002

Group Information

ATC CodeJ05AR06 emtricitabine, tenofovir disoproxil and efavirenz

Status

License statusAuthorised
Licence Issued08/02/2018
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 Status

Documents

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