Source: European Medicines Agency (EU) Revision Year: 2024 Publisher: Kyowa Kirin Holdings B.V., Bloemlaan 2, 2132NP Hoofddorp, The Netherlands, +31 (0) 237200822, medinfo@kyowakirin.com
CRYSVITA 10 mg solution for injection.
CRYSVITA 20 mg solution for injection.
CRYSVITA 30 mg solution for injection.
CRYSVITA 10 mg solution for injection in pre-filled syringe.
CRYSVITA 20 mg solution for injection in pre-filled syringe.
CRYSVITA 30 mg solution for injection in pre-filled syringe.
| Pharmaceutical Form |
|---|
|
Solution for injection (injection). Clear to slightly opalescent, colourless to pale brownish-yellowish solution. |
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.
CRYSVITA 10 mg solution for injection in pre-filled syringe:
Each pre-filled syringe contains 10 mg of burosumab in 0.33 ml solution.
CRYSVITA 20 mg solution for injection in pre-filled syringe:
Each pre-filled syringe contains 20 mg of burosumab in 0.67 ml solution.
CRYSVITA 30 mg solution for injection in pre-filled syringe:
Each pre-filled syringe 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.
Each 10 mg pre-filled syringe contains 15.30 mg sorbitol.
Each 20 mg pre-filled syringe contains 30.61 mg sorbitol.
Each 30 mg pre-filled syringe contains 45.91 mg sorbitol.
For the full list of excipients, see section 6.1.
| Active Ingredient | Description | |
|---|---|---|
| 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. |
| List of Excipients |
|---|
|
L-histidine |
CRYSVITA solution for injection in vials:
Clear glass vial with butyl rubber stopper, and aluminium seal.
Pack size of one vial
CRYSVITA solution for injection in pre-filled syringe:
Clear type I glass syringe with a staked stainless steel needle. The syringe is closed by a rigid polypropylene and elastomer needle shield and a fluoropolymer-laminated bromobutyl rubber plunger stopper.
The different strengths of the medicinal product can be identified by a different coloured plunger rod: 10 mg (blue), 20 mg (red), and 30 mg (green).
Pack size of one pre-filled syringe.
Kyowa Kirin Holdings B.V., Bloemlaan 2, 2132NP Hoofddorp, The Netherlands, +31 (0) 237200822, medinfo@kyowakirin.com
EU/1/17/1262/001
EU/1/17/1262/002
EU/1/17/1262/003
EU/1/17/1262/004
EU/1/17/1262/005
EU/1/17/1262/006
Date of first authorisation: 19 February 2018
Date of latest renewal: 21 February 2022
| Drug | Countries | |
|---|---|---|
| CRYSVITA | Austria, Brazil, Canada, Estonia, Spain, Finland, France, Hong Kong, Croatia, Ireland, Israel, Japan, Lithuania, Netherlands, Poland, Romania, United Kingdom, United States |
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