VIDAZA Powder for suspension for injection Ref.[6341] Active ingredients: Azacitidine

Source: European Medicines Agency (EU) Revision Year: 2019 Publisher: Celgene Europe B.V., Winthontlaan 6 N, 3526 KV Utrecht, Netherlands

Product name and form

Vidaza 25 mg/mL powder for suspension for injection.

Pharmaceutical Form
Powder for suspension for injection. White lyophilised powder.

Qualitative and quantitative composition

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	Description
Azacitidine	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)

Pack sizes and marketing

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.

Marketing authorization holder

Celgene Europe B.V., Winthontlaan 6 N, 3526 KV Utrecht, Netherlands

Marketing authorization dates and numbers

EU/1/08/488/001

Date of first authorisation: 17 December 2008
Date of latest renewal: 13 November 2013

Drugs

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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