Source: European Medicines Agency (EU) Revision Year: 2019 Publisher: Bristol-Myers Squibb Pharma EEIG, Plaza 254, Blanchardstown Corporate Park 2, Dublin 15, D15 T867, Ireland
Empliciti 300 mg powder for concentrate for solution for infusion.
Empliciti 400 mg powder for concentrate for solution for infusion.
| Pharmaceutical Form |
|---|
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Powder for concentrate for solution for infusion (powder for concentrate). The powder is white to off white whole or fragmented cake. |
Empliciti 300 mg powder for concentrate for solution for infusion: Each vial contains 300 mg elotuzumab*.
Empliciti 400 mg powder for concentrate for solution for infusion: Each vial contains 400 mg elotuzumab.
After reconstitution, each mL of concentrate contains 25 mg elotuzumab.
* Elotuzumab is produced in NS0 cells by recombinant DNA technology.
For the full list of excipients, see section 6.1.
| Active Ingredient | Description | |
|---|---|---|
| Elotuzumab |
Elotuzumab is an immunostimulatory humanised, IgG1 monoclonal antibody that specifically targets the SLAMF7 (signaling lymphocyte activation molecule family member 7) protein. Elotuzumab directly activates natural killer cells through both the SLAMF7 pathway and Fc receptors enhancing anti-myeloma activity in vitro. Elotuzumab also targets SLAMF7 on myeloma cells and through interactions with Fc receptors on specific immune cells, promotes the killing of myeloma cells through NK cell-mediated antibody-dependent cellular cytotoxicity (ADCC) and macrophage-mediated antibody-dependant cellular phagocytosis (ADCP). |
| List of Excipients |
|---|
|
Sucrose |
20 ml Type I glass vial, closed with a grey butyl stopper and sealed with aluminium crimp seal with a polypropylene flip off button, containing either 300 mg or 400 mg elotuzumab. The flip-off seal button colour is ivory for the 300 mg presentation and blue for the 400 mg presentation. Pack size of 1 vial.
Bristol-Myers Squibb Pharma EEIG, Plaza 254, Blanchardstown Corporate Park 2, Dublin 15, D15 T867, Ireland
EU/1/16/1088/001-002
Date of first authorisation: 11 May 2016
| Drug | Countries | |
|---|---|---|
| EMPLICITI | Austria, Brazil, Estonia, Spain, Finland, Hong Kong, Croatia, Ireland, Israel, Japan, Lithuania, Netherlands, Poland, United Kingdom, United States |
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