LYSODREN

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

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 more about Mitotane

Medication package inserts

Below package inserts are available for further reading:

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

Medicine classification

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

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