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KYNTHEUM Solution for injection (2018)

Active ingredients: Brodalumab

Product Name and Form

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.

Qualitative and Quantitative Composition

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.

Chemical substance
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
Glutamate
Polysorbate 20
Water for injections

Pack sizes and Marketing

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.

Marketing authorization holder
Authorization dates

LEO Pharma A/S, Industriparken 55, DK-2750, Ballerup, Denmark

Date of first authorisation: 17 July 2017

Marketing authorization number:

EU/1/16/1155/001
EU/1/16/1155/002