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ACTIVE SUBSTANCE / INN

RILPIVIRINE

Brand name(s): EMTRICITABINE; RILPIVIRINE; TENOFOVIR ALAFENAMIDE, RILPIVIRINE, Edurant, CABENUVA KIT, Rekambys, DOLUTEGRAVIR; RILPIVIRINE
FDA LISTED
EMA LISTED
PRESCRIPTION
AUTHORISED
NONE (TENTATIVE APPROVAL)
ANDA213120
HIV Infections
ACTIVE SUBSTANCE
Rilpivirine
REGULATORS
FDA · EMA
SPONSORS / MAH
Janssen-Cilag International NV, LUPIN LTD, Janssen-Cilag International N.V.   
TOTAL APPLICATIONS
6
FDA APPLICATIONS (DRUGS@FDA)
BRAND NAMEAPPLICATIONSPONSORSTATUS
RILPIVIRINEANDA218798SOMERSET THERAPS LLCNone (Tentative Approval)
DOLUTEGRAVIR; RILPIVIRINEANDA213120LUPIN LTDNone (Tentative Approval)
EMTRICITABINE; RILPIVIRINE; TENOFOVIR ALAFENAMIDEANDA214058CIPLA LIMITEDNone (Tentative Approval)
CABENUVA KITNDA212888VIIV HLTHCAREPrescription
EMA AUTHORISATIONS
PRODUCT NAMEHOLDERSTATUSDATEINDICATION
RekambysJanssen-Cilag International NVAuthorised17/12/2020HIV Infections
EdurantJanssen-Cilag International N.V.   Authorised28/11/2011HIV Infections

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