Please note that this product (marketed as Sarclisa) was withdrawn from the Union Register of orphan medicinal products in April 2020 upon request of the marketing authorisation holder at the time of the granting of a marketing authorisation.
This medicine is now known as isatuximab.
On 29 April 2014, orphan designation (EU/3/14/1268) was granted by the European Commission to Sanofi-Aventis Groupe, France, for humanised monoclonal antibody against CD38 for the treatment of plasma cell myeloma.
Humanised monoclonal antibody against CD38 for the treatment of plasma cell myeloma (isatuximab)
|Disease / condition||
Treatment of plasma cell myeloma
|Date of first decision||
|EU designation number||
Review of designation
The sponsor formally requested the withdrawal of the orphan designation prior to the Committee’s final opinion. More information is available in the withdrawal assessment report – orphan maintenance .
Sponsor's contact details
For contact details of patients’ organisations whose activities are targeted at rare diseases, see:
European Organisation for Rare Diseases (EURORDIS), a non-governmental alliance of patient organisations and individuals active in the field of rare diseases.
Orphanet, a database containing information on rare diseases, which includes a directory of patients’ organisations registered in Europe.