EU/3/15/1593

About

On 14 December 2015, orphan designation (EU/3/15/1593) was granted by the European Commission to Janssen-Cilag International N.V., Belgium, for imetelstat sodium for the treatment of myelofibrosis.

The sponsorship was transferred to Parexel International GmbH, Germany, in August 2019.

Key facts

Active substance
Imetelstat sodium
Disease / condition
Treatment of myelofibrosis
Date of first decision
14/12/2015
Outcome
Positive
EU designation number
EU/3/15/1593

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

Parexel International GmbH
Spandauer Damm 130
Charlottenburg
14050 Berlin
Germany
E-mail: ivan.tommasini@parexel.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.

How useful was this page?

Add your rating
Average
2 ratings