EU/3/04/260: Orphan designation for the treatment of alpha-mannosidosis

Recombinant human alpha-Mannosidase (velmanase alfa)


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
EU designation number
Date of designation

Chiesi Farmaceutici S.p.A.
Via Palermo 26/A
43122 Parma
Tel. +39 0521 279793
Fax +39 0521 774120

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 PDF icon orphan medicine assessment report .

Documents related to this orphan designation evaluation

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:

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