EU/3/19/2222

About

On 13 November 2019, orphan designation EU/3/19/2222 was granted by the European Commission to Real Regulatory Limited, Ireland, for chimeric fibril-reactive IgG1k monoclonal antibody 11-1F4 (also known as NSC-711516 and CAEL-101) for the treatment of AL amyloidosis.

Key facts

Active substance
Chimeric fibril-reactive IgG1k monoclonal antibody 11-1F4
Disease / condition
Treatment of AL amyloidosis
Date of first decision
13/11/2019
Outcome
Positive
EU designation number
EU/3/19/2222

Review of designation

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

Sponsor's contact details

Real Regulatory Limited
Unit 9A, Plato Business Park
Damastown
Dublin 15
D15 PA4C
Ireland
Tel: +353 (1) 882 9702
E-mail: Info@realregulatory.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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