LYSODREN Tablet Ref.[9129] Active ingredients: Mitotane

Source: European Medicines Agency (EU)  Revision Year: 2020  Publisher: HRA Pharma Rare Diseases, 200 avenue de Paris, 92320, CHATILLON, France

Product name and form

Lysodren 500 mg tablets.

Pharmaceutical Form

Tablet.

White, biconvex, round, scored tablets.

They are bisected on one side and impressed “BL” over “L1” on the other side.

Qualitative and quantitative composition

Each tablet contains 500 mg of mitotane.

For the full list of excipients, see section 6.1.

Active Ingredient Description
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.

List of Excipients

Maize starch
Microcrystalline cellulose (E460)
Macrogol 3350
Silica colloidal anhydrous

Pack sizes and marketing

Square opaque white HDPE bottle having a thread on the mouth containing 100 tablets.

Pack size of 1 bottle.

Marketing authorization holder

HRA Pharma Rare Diseases, 200 avenue de Paris, 92320, CHATILLON, France

Marketing authorization dates and numbers

EU/1/04/273/001

Date of first authorisation: 28 April 2004
Date of last renewal: 28 April 2009

Drugs

Drug Countries
LYSODREN Austria, Canada, Cyprus, Estonia, Spain, Finland, France, Croatia, Ireland, Israel, Italy, Lithuania, Netherlands, Poland, Romania, United Kingdom, United States

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