Mepsevii

RSS

vestronidase alfa

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

Overview

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

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.

This EPAR was last updated on 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
Marketing-authorisation holder
Ultragenyx Germany GmbH
Revision
0
Date of issue of marketing authorisation valid throughout the European Union
22/08/2018
Contact address
Stadtquartier Friedrichstrasse 191
10117 Berlin
Germany

Product information

23/08/2018 Mepsevii - EMEA/H/C/004438 -

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

Enzymes

Therapeutic indication

Mepsevii is indicated for the treatment of non-neurological manifestations of Mucopolysaccharidosis VII (MPS VII; Sly syndrome).

Assessment history

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