Source: European Medicines Agency (EU) Revision Year: 2022 Publisher: Helsinn Birex Pharmaceuticals Ltd., Damastown, Mulhuddart, Dublin 15, Ireland
Ledaga 160 micrograms/g gel.
| Pharmaceutical Form |
|---|
|
Gel. Clear, colourless gel. |
Each gram of gel contains chlormethine hydrochloride equivalent to 160 micrograms of chlormethine.
Excipients with known effect: Each tube contains 10.5 grams of propylene glycol and 6 micrograms of butylhydroxytoluene.
For the full list of excipients, see section 6.1.
| Active Ingredient | Description | |
|---|---|---|
| Chlormethine |
Chlormethine is a bifunctional alkylating agent that inhibits rapidly proliferating cells. It works by binding to DNA, crosslinking two strands and preventing cell duplication. It binds to the N7 nitrogen on the DNA base guanine. It has been derivatized into the estrogen analogue estramustine phosphate, used to treat prostate cancer. |
| List of Excipients |
|---|
|
Diethylene glycol monoethyl ether |
Ledaga is provided in a white aluminium tube with an inner lacquer and an aluminium seal and a white polypropylene screw cap. Each tube contains 60 g of gel.
Helsinn Birex Pharmaceuticals Ltd., Damastown, Mulhuddart, Dublin 15, Ireland
EU/1/16/1171/001
Date of first authorisation: 3 March 2017
| Drug | Countries | |
|---|---|---|
| LEDAGA | Austria, Estonia, Finland, France, Croatia, Ireland, Israel, Italy, Lithuania, Netherlands, Poland, United Kingdom |
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