Empliciti
elotuzumab
Table of contents
Overview
Empliciti is a medicine for treating multiple myeloma (a cancer of the bone marrow). It is used together with two other medicines (lenalidomide and dexamethasone) and is given to adults who have received at least one previous cancer treatment.
Empliciti is also used together with the medicines pomalidomide and dexamethasone to treat multiple myeloma that was previously treated with at least two other treatments but the cancer had come back. Patients’ previous treatment should have included the multiple myeloma medicines lenalidomide and a class of medicines called proteasome inhibitors (e.g. bortezomib, carfilzomib and ixazomib).
Empliciti contains the active substance elotuzumab.
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List item
Empliciti : EPAR - Medicine overview (PDF/71.5 KB)
First published: 19/05/2016
Last updated: 24/10/2019
EMA/463919/2019 -
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List item
Empliciti : EPAR - Risk-management-plan summary (PDF/215.13 KB)
First published: 25/01/2016
Last updated: 18/09/2019
Authorisation details
Product details | |
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Name |
Empliciti
|
Agency product number |
EMEA/H/C/003967
|
Active substance |
Elotuzumab
|
International non-proprietary name (INN) or common name |
elotuzumab
|
Therapeutic area (MeSH) |
Multiple Myeloma
|
Anatomical therapeutic chemical (ATC) code |
L01FX08
|
Accelerated assessment |
This medicine had an accelerated assessment. This means that it is a medicine of major interest for public health, so its timeframe for review was 150 evaluation days rather than 210. For more information, see Accelerated assessment. |
Publication details | |
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Marketing-authorisation holder |
Bristol-Myers Squibb Pharma EEIG
|
Revision |
12
|
Date of issue of marketing authorisation valid throughout the European Union |
11/05/2016
|
Contact address |
Plaza 254 |
Product information
01/06/2023 Empliciti - EMEA/H/C/003967 - IB/0035
This medicine’s product information is available in all official EU languages.
Select ‘available languages’ to access the language you need.
Product information documents contain:
- summary of product characteristics (annex I);
- manufacturing authorisation holder responsible for batch release (annex IIA);
- conditions of the marketing authorisation (annex IIB);
- labelling (annex IIIA);
- package leaflet (annex IIIB).
You can find product information documents for centrally authorised human medicines on this website. For centrally authorised veterinary medicines authorised or updated from February 2022, see the Veterinary Medicines Information website.
Pharmacotherapeutic group
Antineoplastic agents
Therapeutic indication
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).