Source: European Medicines Agency (EU) Revision Year: 2025 Publisher: Sanofi Winthrop Industrie, 82 avenue Raspail, 94250 Gentilly, France
Kevzara 175 mg/ml solution for injection.
| Pharmaceutical Form |
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Solution for injection (injection). Clear, colourless to pale yellow sterile solution of approximately pH 6.0. Kevzara 175 mg/ml solution for injection: 306-371 mmol/kg. |
Kevzara 175 mg/ml solution for injection: Each vial contains 270 mg sarilumab in 1.54 ml solution (175 mg/ml).
Sarilumab is a human monoclonal antibody produced in Chinese Hamster Ovary cells by recombinant DNA technology.
For the full list of excipients see section 6.1.
| Active Ingredient | Description | |
|---|---|---|
| Sarilumab |
Sarilumab is a human monoclonal antibody (IgG1 subtype) that specifically binds to both soluble and membrane-bound IL-6 receptors (IL-6Rα), and inhibits IL-6-mediated signalling which involves ubiquitous signal-transducing glycoprotein 130 (gp130) and the Signal Transducer and Activator of Transcription-3 (STAT-3). In functional human cell-based assays, sarilumab was able to block the IL-6 signalling pathway, measured as STAT-3 inhibition, only in the presence of IL-6. |
| List of Excipients |
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Histidine |
Kevzara 175 mg/ml solution for injection:
The vial (type 1 glass) containing 1.54 ml solution is closed with ETFE-coated bromobutyl stoppers and crimped with an aluminium seal with a flip-off cap.
Pack sizes:
Not all pack sizes may be marketed.
Sanofi Winthrop Industrie, 82 avenue Raspail, 94250 Gentilly, France
EU/1/17/1196/013
Date of first authorisation: 23 June 2017
Date of latest renewal: 25 April 2022
| Drug | Countries | |
|---|---|---|
| KEVZARA | Austria, Canada, Estonia, Spain, Finland, France, Hong Kong, Croatia, Ireland, Israel, Italy, Japan, Lithuania, Netherlands, Poland, Singapore, United Kingdom, United States |
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