EU/3/12/1083

About

This medicine is now known as otlertuzumab.

On 6 December 2012, orphan designation (EU/3/12/1083) was granted by the European Commission to Emergent Product Development UK Limited, United Kingdom, for humanised single-chain monoclonal antibody against CD37 for the treatment chronic lymphocytic leukaemia.

The sponsorship was transferred to Aptevo Europe Limited, United Kingdom, in March 2017.

The sponsorship was transferred to Global Regulatory Ltd, United Kingdom, in July 2018.

The sponsorship was transferred to Voisin Consulting S.A.R.L., France, in January 2019.

Key facts

Active substance
Humanised single-chain monoclonal antibody against CD37 (otlertuzumab)
Disease / condition
Treatment chronic lymphocytic leukaemia
Date of first decision
06/12/2012
Outcome
Positive
EU designation number
EU/3/12/1083

Review of designation

The Committee for Orphan Medicinal Products reviews the orphan designation of a product if it is approved for marketing authorisation.

Sponsor's contact details

Voisin Consulting S.A.R.L.
64 Avenue Pierre Grenier
92100 Boulogne-Billancourt
France
Tel. +33 1413 18300
E-mail: orphan@voisinconsulting.com

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;

How useful was this page?

Add your rating