RUXIENCE Concentrate for solution for infusion Ref.[10654] Active ingredients: Rituximab

Source: European Medicines Agency (EU)  Revision Year: 2020  Publisher: Pfizer Europe MA EEIG, Boulevard de la Plaine 17, 1050 Bruxelles, Belgium

Product name and form

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.

Qualitative and quantitative composition

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
L-histidine hydrochloride monohydrate
Disodium edetate
Polysorbate 80 (E433)
Sucrose
Water for injection

Pack sizes and marketing

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.

Marketing authorization holder

Pfizer Europe MA EEIG, Boulevard de la Plaine 17, 1050 Bruxelles, Belgium

Marketing authorization dates and numbers

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

Drugs

Drug Countries
RUXIENCE Austria, Brazil, Canada, Estonia, Spain, Finland, France, Ireland, Israel, Lithuania, Netherlands, New Zealand, Poland, Romania, Turkey, United Kingdom, United States

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