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800/150 milligram(s) Film-coated tablet

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

Main Information

Active SubstancesDarunavir
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


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


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