EU/3/20/2331: Orphan designation for the treatment of multiple myeloma
Teclistamab
Table of contents
Overview
Please note that this product (marketed as marketed as Tecvayli) was withdrawn from the Union Register of orphan medicinal products in month & year upon request of the marketing authorisation holder at the time of the granting of a marketing authorisation.
On 19 October 2020, orphan designation EU/3/20/2331 was granted by the European Commission to Janssen-Cilag International N.V, Belgium, for teclistamab for the treatment of multiple myeloma.
Key facts
Active substance |
Teclistamab
|
Intended use |
Treatment of multiple myeloma
|
Orphan designation status |
Withdrawn
|
EU designation number |
EU/3/20/2331
|
Date of designation |
19/07/2022
|
Sponsor |
Turnhoutseweg 30 |
Review of designation
The Committee for Orphan Medicinal Products reviewed the orphan designation of product at the time of marketing authorisation.
The sponsor formally requested the withdrawal of the orphan designation prior to the Committee’s final opinion. More information is available in the
withdrawal assessment report – orphan maintenance
.
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: