Lamzede
velmanase alfa
Table of contents
Overview
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.
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List item
Lamzede : EPAR - Summary for the public (PDF/77.45 KB)
First published: 10/04/2018
Last updated: 10/04/2018
EMA/67223/2018 -
List item
Lamzede : EPAR - Risk-management-plan summary (PDF/154.26 KB)
First published: 24/08/2020
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 | |
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Marketing-authorisation holder |
Chiesi Farmaceutici S.p.A.
|
Revision |
3
|
Date of issue of marketing authorisation valid throughout the European Union |
23/03/2018
|
Contact address |
Via Palermo 26/A |
Product information
29/10/2020 Lamzede - EMEA/H/C/003922 - N/0016
Contents
- Annex I - Summary of product characteristics
- Annex IIA - Manufacturing-authorisation holder responsible for batch release
- Annex IIB - Conditions of the marketing authorisation
- Annex IIIA - Labelling
- Annex IIIB - Package leaflet
Please note that the size of the above document can exceed 50 pages.
You are therefore advised to be selective about which sections or pages you wish to print.
Pharmacotherapeutic group
Other alimentary tract and metabolism products
Therapeutic indication
Treatment of non-neurological manifestations in patients with mild to moderate alpha-mannosidosis.