EU/3/20/2331: Orphan designation for the treatment of multiple myeloma



Please note that this product (marketed as marketed as Tecvayli) was withdrawn from the Union Register of orphan medicinal products in month & year upon request of the marketing authorisation holder at the time of the granting of a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
Intended use
Treatment of multiple myeloma
Orphan designation status
EU designation number
Date of designation

Turnhoutseweg 30
2340 Beerse Antwerp
Tel: +353857446696

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 PDF icon withdrawal assessment report – orphan maintenance .

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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