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.
Treatment of diffuse large B-cell lymphoma
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Review of designation
Documents related to this orphan designation evaluation
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: