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REZOLSTA

800/150 milligram(s) Film-coated tablet

Janssen-Cilag International NVEU/1/14/967/001

Main Information

Trade NameREZOLSTA
Active SubstancesDarunavir
Cobicistat
Strength800/150 milligram(s)
Dosage FormFilm-coated tablet
Licence HolderJanssen-Cilag International NV
Licence NumberEU/1/14/967/001

Group Information

ATC CodeJ05AR Antivirals for treatment of HIV infections, combinations
J05AR14 darunavir and cobiscistat

Status

Authorised/WithdrawnAuthorised
Licence Issued19/11/2014
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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