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EMA Product

Mepsevii

Product approved by European Medicines Agency (EU)

Basic Information

Mepsevii

Regulatory Information

EMEA/H/C/004438

Authorised

August 23, 2018

April 26, 2018

8

June 28, 2024

Company Information

Germany

Rahel-Hirsch-Str. 10 10557 Berlin

Ultragenyx Germany GmbH

Drug Classification

Orphan MedicineAdditional MonitoringExceptional Circumstances

Active Substances Detail

Detailed Information

Therapeutic Indication

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

Overview Summary

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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