EMPLICITI Powder for concentrate for solution for infusion Ref.[8967] Active ingredients: Elotuzumab

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

Product name and form

Empliciti 300 mg powder for concentrate for solution for infusion.

Empliciti 400 mg powder for concentrate for solution for infusion.

Pharmaceutical Form

Powder for concentrate for solution for infusion (powder for concentrate).

The powder is white to off white whole or fragmented cake.

Qualitative and quantitative composition

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
Sodium citrate
Citric acid monohydrate
Polysorbate 80

Pack sizes and marketing

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.

Marketing authorization holder

Bristol-Myers Squibb Pharma EEIG, Plaza 254, Blanchardstown Corporate Park 2, Dublin 15, D15 T867, Ireland

Marketing authorization dates and numbers

EU/1/16/1088/001-002

Date of first authorisation: 11 May 2016

Drugs

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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