EU/3/03/137: Orphan designation for the treatment of follicular lymphoma


Table of contents


Please note that this product was withdrawn from the Community Register of designated Orphan Medicinal Products in March 2015 on request of the Sponsor.

On 14 February 2003, orphan designation (EU/3/03/137) was granted by the European Commission to Amersham plc, U.K., for tositumomab for the treatment of follicular lymphoma.

The sponsorship was transferred to GlaxoSmithKline Research & Development Limited, United Kingdom, in August 2005.

For a list of the administrative updates to this public summary of opinion please refer to the PDF document below.

Key facts

Active substance
Intended use
Treatment of follicular lymphoma
Orphan designation status
EU designation number
Date of designation
GlaxoSmithKline Research & Development Ltd
1-3 Iron Bridge Road
Stockley Park West
Middlesex UB11 1BT
United Kingdom
Tel. +44 (0)20 8990 3879
Fax +44 (0)20 8990 3511

Documents related to this orphan designation evaluation

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.

EU register of orphan medicines

The list of medicines that have received an orphan designation in the EU is available on the European Commission's website:

How useful was this page?

Add your rating