Source: European Medicines Agency (EU) Revision Year: 2020 Publisher: Roche Registration GmbH, Emil-Barell-Strasse 1, 79639, Grenzach-Wyhlen, Germany
Gazyvaro 1,000 mg concentrate for solution for infusion.
| Pharmaceutical Form |
|---|
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Concentrate for solution for infusion. Clear, colourless to slightly brownish liquid. |
One vial of 40 mL concentrate contains 1,000 mg obinutuzumab, corresponding to a concentration before dilution of 25 mg/mL.
Obinutuzumab is a Type II humanised anti-CD20 monoclonal antibody of the IgG1 subclass derived by humanisation of the parental B-Ly1 mouse antibody and produced in the Chinese Hamster Ovary cell line by recombinant DNA technology.
For the full list of excipients, see section 6.1.
| Active Ingredient | Description | |
|---|---|---|
| Obinutuzumab |
Obinutuzumab is a recombinant monoclonal humanised and glycoengineered Type II anti-CD20 antibody of the IgG1 isotype. It specifically targets the extracellular loop of the CD20 transmembrane antigen on the surface of non-malignant and malignant pre-B and mature B-lymphocytes. Glycoengineering of the Fc part of obinutuzumab results in higher affinity for FcγRIII receptors on immune effector cells such as natural killer cells, macrophages and monocytes as compared to non-glycoengineered antibodies. |
| List of Excipients |
|---|
|
Histidine |
40 mL concentrate in a 50 mL vial (clear Type I glass) with stopper (butyl rubber). Pack size of 1 vial.
Roche Registration GmbH, Emil-Barell-Strasse 1, 79639, Grenzach-Wyhlen, Germany
EU/1/14/937/001
Date of first authorisation: 23 July 2014
Date of latest renewal: 02 April 2019
| Drug | Countries | |
|---|---|---|
| GAZYVARO | Austria, Cyprus, Estonia, Spain, Finland, France, Croatia, Ireland, Italy, Lithuania, Netherlands, Poland, Romania, Tunisia, United Kingdom |
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