Source: European Medicines Agency (EU) Revision Year: 2020 Publisher: Pfizer Europe MA EEIG, Boulevard de la Plaine 17, 1050 Bruxelles, Belgium
Ruxience 100 mg concentrate for solution for infusion.
Ruxience 500 mg concentrate for solution for infusion.
| Pharmaceutical Form |
|---|
|
Concentrate for solution for infusion (sterile concentrate). Clear to slightly opalescent, colourless to pale brownish-yellow liquid. |
Ruxience 100 mg concentrate for solution for infusion: Each mL contains 10 mg of rituximab. Each 10 mL vial contains 100 mg of rituximab.
Ruxience 500 mg concentrate for solution for infusion: Each mL contains 10 mg of rituximab. Each 50 mL vial contains 500 mg of rituximab.
Rituximab is a genetically engineered chimeric mouse/human monoclonal antibody representing a glycosylated immunoglobulin with human IgG1 constant regions and murine light-chain and heavy-chain variable region sequences. The antibody is produced by mammalian (Chinese hamster ovary) cell suspension culture and purified by affinity chromatography and ion exchange, including specific viral inactivation and removal procedures.
Excipient with known effect: This medicinal product contains less than 1 mmol sodium (23 mg) per dose.
For the full list of excipients, see section 6.1.
| Active Ingredient | Description | |
|---|---|---|
| Rituximab |
Rituximab binds specifically to the transmembrane antigen, CD20, a non-glycosylated phosphoprotein, located on pre-B and mature B lymphocytes. The antigen is expressed on >95% of all B cell non-Hodgkin’s lymphomas. |
| List of Excipients |
|---|
|
L-histidine |
Ruxience 100 mg concentrate for solution for infusion: Clear Type I glass vials with chlorobutyl rubber stopper containing 100 mg of rituximab in 10 mL. Pack of 1 vial.
Ruxience 500 mg concentrate for solution for infusion: Clear Type I glass vials with chlorobutyl rubber stopper containing 500 mg of rituximab in 50 mL. Pack of 1 vial.
Pfizer Europe MA EEIG, Boulevard de la Plaine 17, 1050 Bruxelles, Belgium
Ruxience 100 mg concentrate for solution for infusion: EU/1/20/1431/001
Ruxience 500 mg concentrate for solution for infusion: EU/1/20/1431/002
Date of first authorisation: 01 April 2020
| Drug | Countries | |
|---|---|---|
| RUXIENCE | Austria, Brazil, Canada, Estonia, Spain, Finland, France, Croatia, Ireland, Israel, Italy, Lithuania, Netherlands, New Zealand, Poland, Romania, Turkey, United Kingdom, United States |
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