EU/3/12/1034

About

This medicine is now known as crizanlizumab.

On 9 August 2012, orphan designation (EU/3/12/1034) was granted by the European Commission to Quintiles Ireland Ltd, Ireland, for humanised monoclonal antibody against P-selectin for the treatment of sickle-cell disease.

The sponsorship was transferred to Novartis Europharm Limited, United Kingdom, in March 2017 and subsequently to Novartis Europharm Limited, Ireland, in May 2018.

The medicinal product has been authorised in the EU as Adakveo since 28 October 2020.

Key facts

Active substance
Humanised monoclonal antibody against P-selectin (crizanlizumab)
Disease / condition
Treatment of sickle cell disease
Date of first decision
09/08/2012
Outcome
Positive
EU designation number
EU/3/12/1034

Review of designation

The Committee for Orphan Medicinal Products reviewed the orphan designation of Humanised monoclonal antibody against P-selectin at the time of marketing authorisation, and confirmed that the orphan designation should be maintained.

More information is available in the PDF icon orphan medicine assessment report .

Sponsor's contact details

Novartis Europharm Limited
Vista Building
Elm Park
Merrion Road
Dublin 4
Tel. +41 61 324 11 11 (Switzerland)
E-mail: orphan.enquiries@novartis.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.

Related content

How useful was this page?

Add your rating