Voxzogo

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vosoritide

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

Overview

Voxzogo is a medicine for treating achondroplasia in patients aged 2 years and older whose bones are still growing.

Achondroplasia is an inherited disease caused by a mutation (change) in a gene called fibroblast growth-factor receptor 3 (FGFR3). The mutation affects growth of almost all bones in the body including the skull, spine, arms and legs resulting in very short stature with a characteristic appearance.

Achondroplasia is rare, and Voxzogo was designated an ‘orphan medicine’ (a medicine used in rare diseases) on 24 January 2013. Further information on the orphan designation can be found here: ema.europa.eu/medicines/human/orphan-designations/EU3121094.

Voxzogo contains the active substance vosoritide.

This EPAR was last updated on 06/09/2023

Authorisation details

Product details
Name
Voxzogo
Agency product number
EMEA/H/C/005475
Active substance
Vosoritide
International non-proprietary name (INN) or common name
vosoritide
Therapeutic area (MeSH)
Achondroplasia
Anatomical therapeutic chemical (ATC) code
M05BX
Additional monitoringAdditional 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.

OrphanOrphan

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
BioMarin International Limited
Revision
3
Date of issue of marketing authorisation valid throughout the European Union
26/08/2021
Contact address

Shanbally
Ringaskiddy
County Cork
P43 R298
Ireland

Product information

01/09/2023 Voxzogo - EMEA/H/C/005475 - IB/0011

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Select ‘available languages’ to access the language you need.

 

Product information documents contain:

You can find product information documents for centrally authorised human medicines on this website. For centrally authorised veterinary medicines authorised or updated from February 2022, see the Veterinary Medicines Information website.

Pharmacotherapeutic group

Drugs for treatment of bone diseases

Therapeutic indication

Voxzogo is indicated for the treatment of achondroplasia in patients 2 years of age and older whose epiphyses are not closed. The diagnosis of achondroplasia should be confirmed by appropriate genetic testing.

Assessment history

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