Source: European Medicines Agency (EU) Revision Year: 2020 Publisher: Genzyme Europe B.V., Paasheuvelweg 25, 1105 BP, Amsterdam, The Netherlands
Mozobil 20 mg/ml solution for injection.
| Pharmaceutical Form |
|---|
|
Solution for injection. Clear, colourless to pale yellow solution, with a pH of 6.0-7.5 and an osmolality of 260-320 mOsm/kg. |
One ml of solution contains 20 mg plerixafor.
Each vial contains 24 mg plerixafor in 1.2 ml solution.
Excipients with known effect: Each ml contains approximately 5 mg (0.2 mmol) of sodium.
For the full list of excipients, see section 6.1.
| Active Ingredient | Description | |
|---|---|---|
| Plerixafor |
Plerixafor induces leukocytosis and elevations in circulating haematopoietic progenitor cell levels due to a disruption of CXCR4 binding to its cognate ligand, known as CXCL12, resulting in the appearance of both mature and pluripotent cells in the systemic circulation. CD34+ cells mobilised by plerixafor are functional and capable of engraftment with long-term repopulating capacity. |
| List of Excipients |
|---|
|
Sodium chloride |
Clear type I glass 2 ml vial with a chlorobutyl/butyl rubber stopper and aluminium seal with a plastic flip-off cap. Each vial contains 1.2 ml solution.
Pack size of 1 vial.
Genzyme Europe B.V., Paasheuvelweg 25, 1105 BP, Amsterdam, The Netherlands
EU/1/09/537/001
Date of first authorisation: 31 July 2009
Date of latest renewal: 11 April 2014
| Drug | Countries | |
|---|---|---|
| MOZOBIL | Austria, Australia, Brazil, Canada, Cyprus, Estonia, Spain, Finland, France, Hong Kong, Croatia, Ireland, Israel, Italy, Japan, Lithuania, Netherlands, New Zealand, Romania, Singapore, Turkey, United Kingdom, United States, South Africa |
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