EU/3/18/2013: Orphan designation for the treatment of diffuse large B-cell lymphoma

polatuzumab vedotin

Overview

On 16 April 2018, orphan designation (EU/3/18/2013) was granted by the European Commission to Roche Registration Limited, United Kingdom, for polatuzumab vedotin for the treatment of diffuse large B-cell lymphoma.

The sponsorship was transferred to Roche Registration GmbH., Germany, in July 2018.

Polatuzumab vedotin has been authorised in the EU as Polivy since 16 January 2020.

The medicinal product has been authorised in the EU as Polivy since 24 May 2022.

Key facts

Active substance
polatuzumab vedotin
Intended use
Treatment of diffuse large B-cell lymphoma
Orphan designation status
Positive
EU designation number
EU/3/18/2013
Date of designation
16/04/2018
Sponsor

Roche Registration GmbH
Emil-Barell-Strasse 1
Grenzach
79639 Grenzach-Wyhlen Baden-Wuerttemberg
Germany
Tel. +49 (0) 7624 142892
E-mail: global.eu_regulatory_office@roche.com

Review of designation

The Committee for Orphan Medicinal Products reviewed the orphan designation of Polivy at the time of marketing authorisation, and confirmed that the orphan designation should be maintained.

More information is available in the orphan medicine assessment report.

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:

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