EU/3/20/2370 : Orphan designation for the treatment of hepatocellular carcinoma

Tremelimumab

Overview

Please note that this product was withdrawn from the Union Register of orphan medicinal products in December 2022 on request of the Sponsor.

On 9 December 2020, orphan designation EU/3/20/2370 was granted by the European Commission to AstraZeneca AB, Sweden, for tremelimumab for the treatment of hepatocellular carcinoma.

Key facts

Active substance
Tremelimumab
Intended use
Treatment of hepatocellular carcinoma
Orphan designation status
Withdrawn
EU designation number
EU/3/20/2370
Date of designation
09/12/2020
Sponsor

AstraZeneca AB
151 85
Södertälje
Sweden
Tel.+46 8 553 24400
E-mail: EMA-Fax@astrazeneca.com

Review of designation

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

Update history

DateUpdate
December 2022Product withdrawn from the Union Register of orphan medicinal products on request of the Sponsor.

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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