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ACTIVE SUBSTANCE / INN

LETERMOVIR

Brand name(s): LETERMOVIR, PREVYMIS, Prevymis
FDA LISTED
EMA LISTED
PRESCRIPTION
AUTHORISED
NONE (TENTATIVE APPROVAL)
NDA209939
ANDA216799
ACTIVE SUBSTANCE
Letermovir
REGULATORS
FDA · EMA
SPONSORS / MAH
ZYDUS PHARMS USA INC, MERCK SHARP DOHME, Merck Sharp & Dohme B.V.
TOTAL APPLICATIONS
3
FDA APPLICATIONS (DRUGS@FDA)
BRAND NAMEAPPLICATIONSPONSORSTATUS
PREVYMISNDA209939MERCK SHARP DOHMEPrescription
LETERMOVIRANDA216799ZYDUS PHARMS USA INCNone (Tentative Approval)
EMA AUTHORISATIONS
PRODUCT NAMEHOLDERSTATUSDATEINDICATION
PrevymisMerck Sharp & Dohme B.V.Authorised08/01/2018Cytomegalovirus Infections

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