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 |
|---|
|
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 |
© All content on this website, including data entry, data processing, decision support tools, "RxReasoner" logo and graphics, is the intellectual property of RxReasoner and is protected by copyright laws. Unauthorized reproduction or distribution of any part of this content without explicit written permission from RxReasoner is strictly prohibited. Any third-party content used on this site is acknowledged and utilized under fair use principles.