Source: European Medicines Agency (EU) Revision Year: 2018 Publisher: LEO Pharma A/S, Industriparken 55, DK-2750, Ballerup, Denmark
Kyntheum 210 mg solution for injection in pre-filled syringe.
| Pharmaceutical Form |
|---|
|
Solution for injection (injection). The solution is clear to slightly opalescent, colourless to slightly yellow and free from particles. |
Each pre-filled syringe contains 210 mg brodalumab in 1.5 ml solution. 1 ml solution contains 140 mg brodalumab.
Brodalumab is a recombinant human monoclonal antibody produced in Chinese Hamster Ovary (CHO) cells.
For the full list of excipients, see section 6.1.
| Active Ingredient | Description | |
|---|---|---|
| Brodalumab |
Brodalumab is a recombinant fully human monoclonal immunoglobulin IgG2 antibody that binds with high affinity to human IL-17RA and blocks the biological activities of the pro-inflammatory cytokines IL-17A, IL-17F, IL-17A/F heterodimer and IL-25, resulting in inhibition of the inflammation and clinical symptoms associated with psoriasis. |
| List of Excipients |
|---|
|
Proline |
1.5 ml solution in a type I glass pre-filled syringe with stainless steel 27G x ½" needle, covered with an elastomeric needle cap.
Kyntheum is available in unit packs containing 2 pre-filled syringes and in multipacks containing 6 (3 packs of 2) pre-filled syringes.
Not all pack sizes may be marketed.
LEO Pharma A/S, Industriparken 55, DK-2750, Ballerup, Denmark
EU/1/16/1155/001
EU/1/16/1155/002
Date of first authorisation: 17 July 2017
| Drug | Countries | |
|---|---|---|
| KYNTHEUM | Austria, Estonia, Spain, Finland, France, Croatia, Ireland, Italy, Lithuania, Netherlands, Poland, United Kingdom |
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