Lamzede

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velmanase alfa

Authorised
This medicine is authorised for use in the European Union.

Overview

An overview of Lamzede and why it is authorised in the EU

Lamzede is a medicine used for patients with mild to moderate alpha-mannosidosis. It is used for treating effects of the disease that do not involve the brain (non-neurological effects).

Alpha-mannosidosis is an inherited disease with features that include learning disability, difficulty controlling movement, deafness, speaking difficulty, frequent infections, enlarged liver and spleen, bone abnormalities, and muscle pain and weakness.

Lamzede contains the active substance velmanase alfa.

Alpha-mannosidosis is rare, and Lamzede was designated an ‘orphan medicine’ (a medicine used in rare diseases) on 26 January 2005.

This EPAR was last updated on 05/12/2018

Authorisation details

Product details
Name
Lamzede
Agency product number
EMEA/H/C/003922
Active substance
velmanase alfa
International non-proprietary name (INN) or common name
velmanase alfa
Therapeutic area (MeSH)
alpha-Mannosidosis
Anatomical therapeutic chemical (ATC) code
A16AB15
Additional monitoring

This medicine is under additional monitoring, meaning that it is monitored even more intensively than other medicines. For more information, see Medicines under additional monitoring.

Exceptional circumstances

This medicine was authorised under exceptional circumstances, because the applicant was unable to provide comprehensive data on the efficacy and safety of the medicine under normal conditions of use. This can happen because the condition to be treated is rare or because collection of full information is not possible or is unethical. For more information, see Pre-authorisation guidance.

Orphan

This medicine was designated an orphan medicine. This means that it was developed for use against a rare, life-threatening or chronically debilitating condition or, for economic reasons, it would be unlikely to have been developed without incentives. For more information, see Orphan designation.

Publication details
Marketing-authorisation holder
Chiesi Farmaceutici S.p.A.
Revision
1
Date of issue of marketing authorisation valid throughout the European Union
23/03/2018
Contact address
Via Palermo 26/A
43122 Parma
Italy

Product information

20/11/2018 Lamzede - EMEA/H/C/003922 - N/0002

Contents

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Pharmacotherapeutic group

Other alimentary tract and metabolism products

Therapeutic indication

Treatment of non-neurological manifestations in patients with mild to moderate alpha-mannosidosis.

Assessment history

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