ACTIVE SUBSTANCE / INN

INSULIN DEGLUDEC

Brand name(s): RYZODEG 70/30, Tresiba, TRESIBA, XULTOPHY 100/3.6

FDA LISTED

EMA LISTED

PRESCRIPTION

DISCONTINUED

AUTHORISED

BLA203314

BLA208583

ACTIVE SUBSTANCE

Insulin Degludec

REGULATORS

FDA · EMA

SPONSORS / MAH

Novo Nordisk A/S, NOVO

TOTAL APPLICATIONS

FDA APPLICATIONS (DRUGS@FDA)

BRAND NAME	APPLICATION	SPONSOR	STATUS
TRESIBA	BLA203314	NOVO	Prescription
XULTOPHY 100/3.6	BLA208583	NOVO	Prescription
RYZODEG 70/30	BLA203313	NOVO	Discontinued

EMA AUTHORISATIONS

PRODUCT NAME	HOLDER	STATUS	DATE	INDICATION
Tresiba	Novo Nordisk A/S	Authorised	20/01/2013	Diabetes Mellitus

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