EU/3/19/2155

About

On 24 April 2019, orphan designation (EU/3/19/2155) was granted by the European Commission to IQVIA RDS Ireland Limited, Ireland, for human culture expanded autologous mesenchymal stromal cells (also known as lenzumestrocel) for the treatment of amyotrophic lateral sclerosis.

Key facts

Active substance
Human culture expanded autologous mesenchymal stromal cells
Disease / condition
Treatment of amyotrophic lateral sclerosis
Date of first decision
24/04/2019
Outcome
Positive
EU designation number
EU/3/19/2155

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

IQVIA RDS Ireland Limited
Estuary House
East Point Business Park
Fairview
Dublin 3
Ireland
Tel. +353 1 819 51 00
E-mail: kelly.theel@iqvia.com

Patients' organisations

For contact details of patients’ organisations whose activities are targeted at rare diseases, see:

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