Empliciti

RSS

elotuzumab

Authorised
This medicine is authorised for use in the European Union.

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.

This EPAR was last updated on 14/11/2019

Authorisation details

Product details
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
L01XC
Accelerated assessmentAccelerated 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.

Additional monitoringAdditional monitoring

This medicine is under additional monitoring, meaning that it is monitored even more intensively than other medicines. For more information, see Medicines under additional monitoring.

Publication details
Marketing-authorisation holder
Bristol-Myers Squibb Pharma EEIG
Revision
6
Date of issue of marketing authorisation valid throughout the European Union
11/05/2016
Contact address

Plaza 254
Blanchardstown Corporate Park 2
Dublin 15
D15 T867
Ireland

Product information

26/09/2019 Empliciti - EMEA/H/C/003967 - II/0018

Contents

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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).

Assessment history

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