Please note that this product (marketed as Sarclisa) was withdrawn from the Union Register of orphan medicinal products in April 2020 upon request of the marketing authorisation holder at the time of the granting of a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.

Key facts

Active substance
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 Committee for Orphan Medicinal Products reviewed the orphan designation of Sarclisa at the time of marketing authorisation.

The sponsor formally requested the withdrawal of the orphan designation prior to the Committee’s final opinion. More information is available in the PDF iconwithdrawal assessment report – orphan maintenance .

Sponsor's contact details

Sanofi-Aventis Groupe
54 rue de la Boétie
75008 Paris
Tel. +33 153 774 000
Fax +33 153 774 133

Patients' organisations

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.

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