EU/3/16/1799: Orphan designation for the treatment of tenosynovial giant cell tumour, localised and diffuse type

Cabiralizumab

Overview

On 12 December 2016, orphan designation (EU/3/16/1799) was granted by the European Commission to Albany Regulatory Consulting Ltd, United Kingdom, for cabiralizumab for the treatment of tenosynovial giant cell tumour, localised and diffuse type.

The sponsorship was transferred to TMC Pharma Services Ltd, United Kingdom, in November 2017.

The sponsorship was transferred to TMC Pharma (EU) Limited, Ireland in November 2019. 

Please note that this product was withdrawn from the Union Register of orphan medicinal products in July 2020 on request of the Sponsor.

Key facts

Active substance
Cabiralizumab
Intended use
Treatment of tenosynovial giant cell tumour, localised and diffuse type
Orphan designation status
Withdrawn
EU designation number
EU/3/16/1799
Date of designation
12/12/2016
Sponsor

TMC Pharma (EU) Limited 
Durands Court 45
7a Parnell Street
Waterford
Co. Waterford
X91 P381
Ireland
Tel. +353 1 901 5595
E-mail: info@tmcpharma.com

Review of designation

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

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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