Voxzogo
vosoritide
Table of contents
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.
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Voxzogo : EPAR - Medicine overview (PDF/110.57 KB)
First published: 09/09/2021
EMA/373903/2021 -
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Voxzogo : EPAR - Risk management plan summary (PDF/157.29 KB)
First published: 09/09/2021
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 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. |
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 |
BioMarin International Limited
|
Revision |
3
|
Date of issue of marketing authorisation valid throughout the European Union |
26/08/2021
|
Contact address |
Shanbally |
Product information
01/09/2023 Voxzogo - EMEA/H/C/005475 - IB/0011
This medicine’s product information is available in all official EU languages.
Select ‘available languages’ to access the language you need.
Product information documents contain:
- summary of product characteristics (annex I);
- manufacturing authorisation holder responsible for batch release (annex IIA);
- conditions of the marketing authorisation (annex IIB);
- labelling (annex IIIA);
- package leaflet (annex IIIB).
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.