This medicine is authorised for use in the European Union.


Crysvita is a medicine used for the treatment of X-linked hypophosphataemia, a hereditary disorder characterised by low levels of phosphate in the blood (hypophosphataemia). Phosphate is essential to build bones and teeth and to maintain their strength, so patients may develop rickets and other bone deformities and growth problems. Crysvita can be used to treat children and adolescents between 1 and 17 years of age when signs of bone disease are seen on X-rays, and in adults.

Crysvita is also used to treat osteomalacia (softening and weakening of the bones) caused by phosphaturic mesenchymal tumours. This type of tumour produces hormones, particularly a substance called fibroblast growth factor 23 (FGF23), which cause the body to lose phosphate. Crysvita is used in patients from 1 year of age, when the tumour cannot be located or removed by surgery.

Crysvita contains the active substance burosumab.

These diseases are rare, and Crysvita was designated an ‘orphan medicine’ (a medicine used in rare diseases). Further information on the orphan designations can be found on the European Medicines Agency’s website (X-linked hypophosphataemia: 15 October 2014; phosphaturic mesenchymal tumour: 16 April 2018).

This EPAR was last updated on 08/11/2022

Authorisation details

Product details
Agency product number
Active substance
International non-proprietary name (INN) or common name
Therapeutic area (MeSH)
  • Hypophosphatemia, Familial
  • Hypophosphatemic Rickets, X-Linked Dominant
  • Osteomalacia
Anatomical therapeutic chemical (ATC) code
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.


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
Kyowa Kirin Holdings B.V.
Date of issue of marketing authorisation valid throughout the European Union
Contact address

Bloemlaan 2
2132NP Hoofddorp
The Netherlands

Product information

21/09/2022 Crysvita - EMEA/H/C/004275 - IA/0028

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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

Crysvita is indicated for the treatment of X-linked hypophosphataemia, in children and adolescents aged 1 to 17 years with radiographic evidence of bone disease, and in adults.

Crysvita is indicated for the treatment of FGF23-related hypophosphataemia in tumour-induced osteomalacia associated with phosphaturic mesenchymal tumours that cannot be curatively resected or localised in children and adolescents aged 1 to 17 years and in adults.

Assessment history

Changes since initial authorisation of medicine

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