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ACTIVE SUBSTANCE / INN

PRETOMANID

Brand name(s): Dovprela (previously Pretomanid FGK), PRETOMANID
FDA LISTED
EMA LISTED
PRESCRIPTION
AUTHORISED
Tuberculosis, Multidrug-Resistant
NDA212862
ACTIVE SUBSTANCE
Pretomanid
REGULATORS
FDA · EMA
SPONSORS / MAH
Mylan IRE Healthcare Limited, MYLAN IRELAND LTD
TOTAL APPLICATIONS
2
FDA APPLICATIONS (DRUGS@FDA)
BRAND NAMEAPPLICATIONSPONSORSTATUS
PRETOMANIDNDA212862MYLAN IRELAND LTDPrescription
EMA AUTHORISATIONS
PRODUCT NAMEHOLDERSTATUSDATEINDICATION
Dovprela (previously Pretomanid FGK)Mylan IRE Healthcare LimitedAuthorised31/07/2020Tuberculosis, Multidrug-Resistant

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