ORSERDU

This brand name is authorized in Austria, Estonia, France, Croatia, Ireland, Italy, Lithuania, United States

Active ingredients

The drug ORSERDU contains one active pharmaceutical ingredient (API):

1 Elacestrant UNII FM6A2627A8 - ELACESTRANT

Elacestrant, a tetrahydronaphthalene compound, is a potent, selective and orally active estrogen receptor-α (ERα) antagonist and degrader. Elacestrant inhibits the estradiol-dependent and independent growth of ERα-positive breast cancer cells, including models harbouring estrogen receptor 1 (ESR1) gene mutations. Read about Elacestrant

Medication package inserts

Below package inserts are available for further reading:

Title	Information Source	Document Type
ORSERDU Film-coated tablet	European Medicines Agency (EU)	MPI, EU: SmPC
ORSERDU Film-coated tablet	FDA, National Drug Code (US)	MPI, US: SPL/PLR

Medicine classification

This drug has been classified in the anatomical therapeutic chemical (ATC) classification system as follows:

ATC code	Group title	Classification
L02BA	Anti-estrogens	L Antineoplastic and immunomodulating agents → L02 Endocrine therapy → L02B Hormone antagonists and related agents
Discover more medicines within L02BA

Authorization and marketing

This drug has been assigned below unique identifiers within the countries it is being marketed:

Country	Identification scheme	Identifier(s)
Country: EE	Ravimiamet	Identifier(s): 3044708, 3044719
Country: FR	Base de données publique des médicaments	Identifier(s): 67179699, 69242739
Country: IT	Agenzia del Farmaco	Identifier(s): 050896012, 050896024
Country: LT	Valstybinė vaistų kontrolės tarnyba	Identifier(s): 1097798, 1097799
Country: US	FDA, National Drug Code	Identifier(s): 72187-0101, 72187-0102