Mepsevii
vestronidase alfa
Table of contents
Overview
Mepsevii is a medicine to treat mucopolysaccharidosis type VII (MPS VII, also known as Sly syndrome), an inherited disease caused by a lack of an enzyme needed to break down complex carbohydrates known as glycosaminoglycans (GAGs).
The disease leads to build up of GAGs in the body, which causes a wide range of problems, including joint stiffness, short stature, enlarged liver and spleen, hearing loss, cataract and delays in development.
MPS VII is rare, and Mepsevii was designated an ‘orphan medicine’ (a medicine used in rare diseases) on 21 March 2012.
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Mepsevii : EPAR - Medicine overview (PDF/113.24 KB)
First published: 28/08/2018
Last updated: 13/10/2020
EMA/435402/2020 -
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Mepsevii : EPAR - Risk-management-plan summary (PDF/100.61 KB)
Adopted
First published: 28/08/2018
Last updated: 28/08/2018
Authorisation details
Product details | |
---|---|
Name |
Mepsevii
|
Agency product number |
EMEA/H/C/004438
|
Active substance |
vestronidase alfa
|
International non-proprietary name (INN) or common name |
vestronidase alfa
|
Therapeutic area (MeSH) |
Mucopolysaccharidosis VII
|
Anatomical therapeutic chemical (ATC) code |
A16AB18
|
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 |
Ultragenyx Germany GmbH
|
Revision |
5
|
Date of issue of marketing authorisation valid throughout the European Union |
23/08/2018
|
Contact address |
Product information
24/09/2020 Mepsevii - EMEA/H/C/004438 - IAIN/0018
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
Therapeutic indication
Mepsevii is indicated for the treatment of non-neurological manifestations of Mucopolysaccharidosis VII (MPS VII; Sly syndrome).