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Juluca

50/25 milligram(s) Film-coated tablet

ViiV Healthcare BVEU/1/18/1282/001-002

Main Information

Trade NameJuluca
Active SubstancesDolutegravir
Rilpivirine hydrochloride
Sodium starch glycolate ep
Iron oxide yellow (E172)
Strength50/25 milligram(s)
Dosage FormFilm-coated tablet
Licence HolderViiV Healthcare BV
Licence NumberEU/1/18/1282/001-002

Group Information

ATC CodeJ05AR21 Dolutegravir and Rilpivirine

Status

Authorised/WithdrawnAuthorised
Licence Issued16/05/2018
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 StatusUnknown

Documents

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