Source: European Medicines Agency (EU) Revision Year: 2019 Publisher: Celgene Europe B.V., Winthontlaan 6 N, 3526 KV Utrecht, Netherlands
Vidaza 25 mg/mL powder for suspension for injection.
| Pharmaceutical Form |
|---|
|
Powder for suspension for injection. White lyophilised powder. |
Each vial contains 100 mg azacitidine. After reconstitution, each mL of suspension contains 25 mg azacitidine.
For the full list of excipients, see section 6.1.
| Active Ingredient |
|---|
|
Azacitidine is believed to exert its antineoplastic effects by multiple mechanisms including cytotoxicity on abnormal haematopoietic cells in the bone marrow and hypomethylation of DNA. The cytotoxic effects of azacitidine may result from multiple mechanisms, including inhibition of DNA, RNA and protein synthesis, incorporation into RNA and DNA, and activation of DNA damage pathways. |
| List of Excipients |
|---|
|
Mannitol (E421) |
Colourless type I glass vial sealed with butyl elastomeric stopper and aluminium seal with polypropylene plastic button, containing 100 mg of azacitidine.
Pack size: 1 vial.
Celgene Europe B.V., Winthontlaan 6 N, 3526 KV Utrecht, Netherlands
EU/1/08/488/001
Date of first authorisation: 17 December 2008
Date of latest renewal: 13 November 2013
| Drug | Countries | |
|---|---|---|
| VIDAZA | Austria, Australia, Brazil, Canada, Cyprus, Ecuador, Estonia, Spain, Finland, France, Hong Kong, Ireland, Israel, Japan, Lithuania, Mexico, Netherlands, New Zealand, Poland, Romania, Singapore, Tunisia, Turkey, United Kingdom, United States, South Africa |
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