Source: European Medicines Agency (EU) Revision Year: 2021 Publisher: Janssen-Cilag International NV, Turnhoutseweg 30, B-2340, Beerse, Belgium
Dacogen 50 mg powder for concentrate for solution for infusion.
| Pharmaceutical Form |
|---|
|
Powder for concentrate for solution for infusion (powder for infusion). White to almost white lyophilized powder. |
Each vial of powder for concentrate for solution for infusion contains 50 mg decitabine.
After reconstitution with 10 ml of water for injections, each ml of concentrate contains 5 mg of decitabine.
Excipients with known effect: Each vial contains 0.29 mmol sodium (E524).
For the full list of excipients, see section 6.1.
| Active Ingredient | Description | |
|---|---|---|
| Decitabine |
Decitabine is a cytidine deoxynucleoside analogue that selectively inhibits DNA methyltransferases at low doses, resulting in gene promoter hypomethylation that can result in reactivation of tumour suppressor genes, induction of cellular differentiation or cellular senescence followed by programmed cell death. |
| List of Excipients |
|---|
|
Potassium dihydrogen phosphate (E340) |
20 ml clear colourless Type I glass vial sealed with a butyl rubber stopper and an aluminium seal with plastic flip-off cap containing 50 mg decitabine.
Pack size: 1 vial.
Janssen-Cilag International NV, Turnhoutseweg 30, B-2340, Beerse, Belgium
EU/1/12/792/001
Date of first authorisation: 20 September 2012
Date of latest renewal: 22 May 2017
| Drug | Countries | |
|---|---|---|
| DACOGEN | Austria, Brazil, Cyprus, Estonia, Spain, Finland, Hong Kong, Croatia, Ireland, Israel, Lithuania, Netherlands, Poland, Romania, Turkey, United Kingdom, United States, South Africa |
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