Source: European Medicines Agency (EU) Revision Year: 2020 Publisher: HRA Pharma Rare Diseases, 200 avenue de Paris, 92320, CHATILLON, France
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. |
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 |
Square opaque white HDPE bottle having a thread on the mouth containing 100 tablets.
Pack size of 1 bottle.
HRA Pharma Rare Diseases, 200 avenue de Paris, 92320, CHATILLON, France
EU/1/04/273/001
Date of first authorisation: 28 April 2004
Date of last renewal: 28 April 2009
| Drug | Countries | |
|---|---|---|
| LYSODREN | Austria, Canada, Cyprus, Estonia, Spain, Finland, France, Ireland, Israel, Lithuania, Netherlands, Poland, Romania, United Kingdom, United States |
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