Sarclisa

RSS

isatuximab

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

Overview

Sarclisa is a cancer medicine used to treat multiple myeloma (a cancer of the bone marrow). It is given:

  • together with the medicines pomalidomide and dexamethasone to treat adults who have received at least two previous treatments for their cancer, including lenalidomide and a proteasome inhibitor, and whose cancer has worsened since receiving the last treatment;
  • together with the medicines carfilzomib and dexamethasone to treat adults who have received at least one previous treatment.

Multiple myeloma is rare, and Sarclisa was designated an ‘orphan medicine’ (a medicine used in rare diseases) on 29 April 2014. Further information on the orphan designation (EU/3/14/1268) is available.

Sarclisa contains the active substance isatuximab.

This EPAR was last updated on 18/01/2023

Authorisation details

Product details
Name
Sarclisa
Agency product number
EMEA/H/C/004977
Active substance
Isatuximab
International non-proprietary name (INN) or common name
isatuximab
Therapeutic area (MeSH)
Multiple Myeloma
Anatomical therapeutic chemical (ATC) code
L01XC38
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
Sanofi Winthrop Industrie
Revision
6
Date of issue of marketing authorisation valid throughout the European Union
30/05/2020
Contact address

82 Avenue Raspail
94250 Gentilly
France

Product information

20/12/2022 Sarclisa - EMEA/H/C/004977 - T/0019

Other EU languages available icon 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:

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

Sarclisa is indicated: 

  • in combination with pomalidomide and dexamethasone, for the treatment of adult patients with relapsed and refractory multiple myeloma (MM) who have received at least two prior therapies including lenalidomide and a proteasome inhibitor (PI) and have demonstrated disease progression on the last therapy.
  • in combination with carfilzomib and dexamethasone, for the treatment of adult patients with multiple myeloma who have received at least one prior therapy (see section 5.1).

Assessment history

Changes since initial authorisation of medicine

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