LYSODREN

This brand name is authorized in Austria, Canada, Cyprus, Estonia, Spain, Finland, France, Croatia, Ireland, Israel, Italy, Lithuania, Netherlands, Poland, Romania, United Kingdom, United States

Active ingredients

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

1 Mitotane UNII 78E4J5IB5J - MITOTANE

Mitotane is an adrenal cytotoxic active substance, although it can apparently also cause adrenal inhibition without cellular destruction. Available data suggest that mitotane modifies the peripheral metabolism of steroids and that it also directly suppresses the adrenal cortex. The administration of mitotane alters the extra-adrenal metabolism of cortisol in humans, leading to a reduction in measurable 17-hydroxy corticosteroids, even though plasma levels of corticosteroids do not fall. Read about Mitotane

Medication package inserts

Below package inserts are available for further reading:

Title	Information Source	Document Type
LYSODREN Tablet	European Medicines Agency (EU)	MPI, EU: SmPC

Medicine classification

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

ATC code	Group title	Classification
L01XX23	Mitotane	L Antineoplastic and immunomodulating agents → L01 Antineoplastic agents → L01X Other antineoplastic agents → L01XX Other antineoplastic agents
Discover more medicines within L01XX23

Authorization and marketing

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

Country	Identification scheme	Identifier(s)
Country: CA	Health Products and Food Branch	Identifier(s): 00463221
Country: EE	Ravimiamet	Identifier(s): 1208461, 1735972, 1849765
Country: ES	Centro de información online de medicamentos de la AEMPS	Identifier(s): 04273001
Country: FI	Lääkealan turvallisuus- ja kehittämiskeskus	Identifier(s): 020282
Country: FR	Base de données publique des médicaments	Identifier(s): 66435544
Country: GB	Medicines & Healthcare Products Regulatory Agency	Identifier(s): 94674
Country: IL	מִשְׂרַד הַבְּרִיאוּת	Identifier(s): 20099
Country: IT	Agenzia del Farmaco	Identifier(s): 036560011
Country: LT	Valstybinė vaistų kontrolės tarnyba	Identifier(s): 1029634
Country: NL	Z-Index G-Standaard, PRK	Identifier(s): 37818
Country: PL	Rejestru Produktów Leczniczych	Identifier(s): 100111570
Country: RO	Agenția Națională a Medicamentului și a Dispozitivelor Medicale	Identifier(s): W66770001
Country: US	FDA, National Drug Code	Identifier(s): 0015-3080, 76336-080