CRYSVITA Solution for injection (2020)
Active ingredients: Burosumab
Product Name and Form
CRYSVITA 10 mg solution for injection.
CRYSVITA 20 mg solution for injection.
CRYSVITA 30 mg solution for injection.
Solution for injection (injection).
Clear to slightly opalescent, colourless to pale brownish-yellowish solution.
Qualitative and Quantitative Composition
CRYSVITA 10 mg solution for injection: Each vial contains 10 mg of burosumab in 1 ml solution.
CRYSVITA 20 mg solution for injection: Each vial contains 20 mg of burosumab in 1 ml solution.
CRYSVITA 30 mg solution for injection: Each vial contains 30 mg of burosumab in 1 ml solution.
Burosumab is a recombinant human monoclonal IgG1 antibody for FGF23 and is produced by recombinant DNA technology using Chinese hamster ovary (CHO) mammalian cell culture.
Excipient with known effect: Each vial contains 45.91 mg sorbitol.
For the full list of excipients, see section 6.1.
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.
Hydrochloric acid, 10% (for pH adjustment)
Water for injections
Pack sizes and Marketing
Clear glass vial with butyl rubber stopper, and aluminium seal.
Pack size of one vial.
Kyowa Kirin Holdings B.V., Bloemlaan 2, 2132NP Hoofddorp, The Netherlands, +31 (0) 237200822, email@example.com
Date of first authorisation: 19 February 2018