ACTIVE SUBSTANCE / INN

SEMAGLUTIDE

Brand name(s): Rybelsus, WEGOVY, Wegovy, Ozempic, RYBELSUS, OZEMPIC, Kayshild

FDA LISTED

EMA LISTED

PRESCRIPTION

DISCONTINUED

AUTHORISED

NDA218316

Obesity;Overweight

ACTIVE SUBSTANCE

Semaglutide

REGULATORS

FDA · EMA

SPONSORS / MAH

Novo Nordisk A/S, NOVO, NOVO NORDISK INC

TOTAL APPLICATIONS

FDA APPLICATIONS (DRUGS@FDA)

BRAND NAME	APPLICATION	SPONSOR	STATUS
RYBELSUS	NDA213182	NOVO NORDISK INC	Prescription
OZEMPIC	NDA209637	NOVO	Prescription
OZEMPIC	NDA209637	NOVO	Discontinued
WEGOVY	NDA218316	NOVO	Prescription

EMA AUTHORISATIONS

PRODUCT NAME	HOLDER	STATUS	DATE	INDICATION
Ozempic	Novo Nordisk A/S	Authorised	08/02/2018	Diabetes Mellitus
Wegovy	Novo Nordisk A/S	Authorised	06/01/2022	Obesity;Overweight
Kayshild	Novo Nordisk A/S	Opinion		Non-alcoholic Fatty Liver Disease;Liver Cirrhosis
Rybelsus	Novo Nordisk A/S	Authorised	03/04/2020	Diabetes Mellitus, Type 2

FULL INTELLIGENCE ON SEMAGLUTIDE