EU/3/19/2151

About

On 1 April 2019, orphan designation (EU/3/19/2151) was granted by the European Commission to Voisin Consulting S.A.R.L., France, for marzeptacog alfa (activated) (also known as MarzAA) for the treatment of haemophilia B.

The sponsorship was transferred to Regintel Limited, Ireland, in October 2019.

Key facts

Active substance
Marzeptacog alfa (activated)
Disease / condition
Treatment of haemophilia B
Date of first decision
01/04/2019
Outcome
Positive
EU designation number
EU/3/19/2151

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

RegIntel Limited
Templetown
Carlingford A91 T923
County Louth
Ireland
Tel. +353 4293 76740
E-mail: bmartin@regintel.com

Patients' organisations

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

How useful was this page?

Add your rating