EU/3/16/1799

About

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Please note that this product was withdrawn from the Union Register of orphan medicinal products in July 2020 on request of the Sponsor.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
Disease / condition
Treatment of tenosynovial giant cell tumour, localised and diffuse type
Date of first decision
12/12/2016
Outcome
Withdrawn
EU designation number
EU/3/16/1799

Review of designation

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

Sponsor's contact details

TMC Pharma (EU) Limited
The Black Church
St. Mary's Place
Dublin D07 P4AX
Ireland
Tel. +353 76 670 5745
E-mail: info@tmcpharma.com

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.

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