SPC, UK: Vidaza 25 mg/ml powder for suspension for injection (2012)

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 suspension contains 25 mg azacitidine.

For a full list of excipients, see section 6.1.

List of excipients

Mannitol (E421)

Pack sizes and Marketing

Colourless type I 30 ml glass vial sealed with butyl elastomeric stopper and aluminium seal with polypropylene plastic button.

Pack size: 1 vial of 100 mg azacitidine.

Marketing authorization holder
Authorization dates

Celgene Europe Ltd
1 Longwalk Road
Stockley Park
Uxbridge
UB11 1DB
United Kingdom

17/12/2008

Marketing authorization number:

EU/1/08/488/001