CRYSVITA

This brand name is authorized in United States. It is also authorized in Austria, Brazil, Canada, Croatia, Estonia, Finland, France, Hong Kong SAR China, Ireland, Israel, Japan, Lithuania, Netherlands, Poland, Romania, Spain, UK.

Active ingredients

The drug CRYSVITA contains one active pharmaceutical ingredient (API):

1	Burosumab UNII G9WJT6RD29 - BUROSUMAB
	Burosumab is a recombinant human monoclonal antibody (IgG1) that binds to and inhibits the activity of fibroblast growth factor 23 (FGF23). By inhibiting FGF23, burosumab increases tubular reabsorption of phosphate from the kidney and increases serum concentration of 1,25 dihydroxy-Vitamin D.
	Read more about Burosumab

Medication package inserts

Below package inserts are available for further reading:

Document	Type	Information Source
CRYSVITA Solution for injection	MPI, EU: SmPC	European Medicines Agency (EU)
CRYSVITA Solution for injection	MPI, US: SPL/PLR	FDA, National Drug Code (US)

Medicine classification

This drug has been classified in the anatomical therapeutic chemical (ATC) classification system as follows:

ATC Group		Classification
M05BX05		M Musculo-skeletal system → M05 Drugs for treatment of bone diseases → M05B Drugs affecting bone structure and mineralization → M05BX Other drugs affecting bone structure and mineralization
Discover more medicines within M05BX05

Authorization and marketing

This drug has been assigned below unique identifiers within the countries it is being marketed:

Country	Identification scheme	Identifier(s)
BR	Câmara de Regulação do Mercado de Medicamentos	597321080000217, 597321080000317, 597321080000417
CA	Health Products and Food Branch	02483629, 02483637, 02483645
EE	Ravimiamet	1765672, 1765683, 1765694
ES	Centro de información online de medicamentos de la AEMPS	1171262001, 1171262002, 1171262003
FI	Lääkealan turvallisuus- ja kehittämiskeskus	089121, 429792, 589244
FR	Base de données publique des médicaments	60215018, 66071126, 67649597
GB	Medicines & Healthcare Products Regulatory Agency	358208, 358212, 358216
HK	Department of Health Drug Office	66641, 66642, 66643
IL	מִשְׂרַד הַבְּרִיאוּת	8296, 8753, 8875
JP	医薬品医療機器総合機構	3999452A1024, 3999452A2020, 3999452A3027
LT	Valstybinė vaistų kontrolės tarnyba	1085106, 1085107, 1085108
NL	Z-Index G-Standaard, PRK	151092, 151106, 151114
PL	Rejestru Produktów Leczniczych	100402623, 100402630, 100402646
RO	Agenția Națională a Medicamentului și a Dispozitivelor Medicale	W65286001, W65287001, W65288001
US	FDA, National Drug Code	69794-102, 69794-203, 69794-304