EU/3/04/260: Orphan designation for the treatment of alpha-mannosidosis
Recombinant human alpha-Mannosidase (velmanase alfa)
Table of contents
Overview
This medicine is now known as velmanase alfa.
On 26 January 2005, orphan designation (EU/3/04/260) was granted by the European Commission to Zymenex A/S, Denmark, for recombinant human α-mannosidase for the treatment of α-mannosidosis.
The sponsorship was transferred to Chiesi Farmaceutici S.p.A., Italy, in January 2015.
Recombinant human α-mannosidase has been authorised in the EU as Lamzede since 23 March 2018.
Key facts
Active substance |
Recombinant human alpha-Mannosidase (velmanase alfa)
|
Intended use |
Treatment of alpha-mannosidosis
|
Orphan designation status |
Positive
|
EU designation number |
EU/3/04/260
|
Date of designation |
26/01/2005
|
Sponsor |
Chiesi Farmaceutici S.p.A. |
Review of designation
The Committee for Orphan Medicinal Products reviewed the orphan designation of Lamzede at the time of marketing authorisation, and confirmed that the orphan designation should be maintained.
More information is available in the
orphan medicine assessment report
.
Patients' organisations
For contact details of patients’ organisations whose activities are targeted at rare diseases, see:
Orphanet, a database containing information on rare diseases, which includes a directory of patients’ organisations registered in Europe.
European Organisation for Rare Diseases (EURORDIS), a non-governmental alliance of patient organisations and individuals active in the field of rare diseases.
EU register of orphan medicines
The list of medicines that have received an orphan designation in the EU is available on the European Commission's website: