This is a summary of the European public assessment report (EPAR) for Empliciti. It explains how the Agency assessed the medicine to recommend its authorisation in the EU and its conditions of use. It is not intended to provide practical advice on how to use Empliciti.
For practical information about using Empliciti, patients should read the package leaflet or contact their doctor or pharmacist.
Empliciti : EPAR - Summary for the public (PDF/96.06 KB)
First published: 19/05/2016
Last updated: 19/05/2016
Empliciti : EPAR - Risk-management-plan summary (PDF/215.13 KB) (updated)
First published: 25/01/2016
Last updated: 18/09/2019
|Agency product number||
|International non-proprietary name (INN) or common name||
|Therapeutic area (MeSH)||
|Anatomical therapeutic chemical (ATC) code||
Bristol-Myers Squibb Pharma EEIG
|Date of issue of marketing authorisation valid throughout the European Union||
23/08/2019 Empliciti - EMEA/H/C/003967 - II/0012
- Annex I - Summary of product characteristics
- Annex IIA - Manufacturing-authorisation holder responsible for batch release
- Annex IIB - Conditions of the marketing authorisation
- Annex IIIA - Labelling
- Annex IIIB - Package leaflet
Please note that the size of the above document can exceed 50 pages.
You are therefore advised to be selective about which sections or pages you wish to print.
Empliciti is indicated in combination with lenalidomide and dexamethasone for the treatment of multiple myeloma in adult patients who have received at least one prior therapy (see sections 4.2 and 5.1).