Source: European Medicines Agency (EU) Revision Year: 2019 Publisher: Sanofi-aventis groupe, 54, rue La Boรฉtie, 75008 Paris, France
Kevzara 150 mg solution for injection in pre-filled syringe.
Kevzara 150 mg solution for injection in pre-filled pen.
Kevzara 200 mg solution for injection in pre-filled syringe.
Kevzara 200 mg solution for injection in pre-filled pen.
| Pharmaceutical Form |
|---|
|
Solution for injection (injection). Clear, colourless to pale yellow sterile solution of approximately pH 6.0. |
150 mg solution for injection:
Each single-dose pre-filled syringe contains 150 mg sarilumab in 1.14 ml solution (131.6 mg/ml).
Each single-dose pre-filled pen contains 150 mg sarilumab in 1.14 ml solution (131.6 mg/ml).
200 mg solution for injection:
Each single-dose pre-filled syringe contains 200 mg sarilumab in 1.14 ml solution (175 mg/ml).
Each single-dose pre-filled pen contains 200 mg sarilumab in 1.14 ml solution (175 mg/ml).
Sarilumab is a human monoclonal antibody selective for the interleukin-6 (IL-6) receptor, 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-6Rฮฑ), 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 |
|---|
|
Histidine |
All presentations contain a 1.14 ml solution in a syringe (type 1 glass) equipped with a stainless steel staked needle and an elastomer plunger stopper.
Pre-filled syringe 150 mg: The single-use pre-filled syringe has a styrene-butadiene elastomer needle cap and is equipped with a white polystyrene plunger rod and a light-orange polypropylene finger flange.
Pre-filled syringe 200 mg: The single-use pre-filled syringe has a styrene-butadiene elastomer needle cap and is equipped with a white polystyrene plunger rod and a dark-orange polypropylene finger flange.
Pre-filled pen 150 mg: The syringe components are pre-assembled into a single-use pre-filled pen with a yellow needle cover and light-orange cap.
Pre-filled pen 200 mg: The syringe components are pre-assembled into a single-use pre-filled pen with a yellow needle cover and dark-orange cap.
Pack sizes:
Not all pack sizes may be marketed.
Sanofi-aventis groupe, 54, rue La Boรฉtie, 75008 Paris, France
EU/1/17/1196/001
EU/1/17/1196/002
EU/1/17/1196/003
EU/1/17/1196/004
EU/1/17/1196/005
EU/1/17/1196/006
EU/1/17/1196/007
EU/1/17/1196/008
EU/1/17/1196/009
EU/1/17/1196/010
EU/1/17/1196/011
EU/1/17/1196/012
Date of first authorisation: 23 June 2017
| 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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