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Odefsey

200mg/25mg/25 milligram(s) Film-coated tablet

Gilead Sciences Ireland UCEU/1/16/1112/001-002

Main Information

Trade NameOdefsey
Active SubstancesEmtricitabine
Rilpivirine
Tenofovir alafenamide
Strength200mg/25mg/25 milligram(s)
Dosage FormFilm-coated tablet
Licence HolderGilead Sciences Ireland UC
Licence NumberEU/1/16/1112/001-002

Group Information

ATC CodeJ05AR Antivirals for treatment of HIV infections, combinations
J05AR19 ZZZ emtricitabine, tenofovir alafenamide and rilpivirine

Status

Authorised/WithdrawnAuthorised
Licence Issued
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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