Kyntheum LEO Pharma A/S · Authorised · authorised 17 Jul 2017 · ATC L04AC12
Therapeutic indication (EMA)
Kyntheum is indicated for the treatment of moderate to severe plaque psoriasis in adult patients who are candidates for systemic therapy.
Active substance
Brodalumab
- US FDA 1
- EMA 1
- Health Canada 1
- Safety 2
US FDA United States — FDA approvals (Drugs@FDA)
| Product | Strength | Form · route | Applicant | Status | First approved |
|---|---|---|---|---|---|
| SILIQ | 210MG/1.5ML | injectable · injection | VALEANT LUXEMBOURG | Prescription | 15 Feb 2017 |
EMA European Union — centrally authorised medicines
Canada Canada — marketed products (Health Canada)
| Brand | DIN | Strength | Form · route | Company |
|---|---|---|---|---|
| SILIQ | 02473623 | 210 MG / 1.5 ML | SOLUTION · SUBCUTANEOUS | BAUSCH HEALTH, CANADA INC. |
Safety signals and safety-related labeling changes
- EMA PRAC 5 Jun 2025 PRAC signal: Pyoderma gangrenosum
Action for MAH: update of the product information: Yes - EMA PRAC 10 Apr 2025 PRAC signal: Pyoderma gangrenosum
Action for MAH: update of the product information: No
Values as published by each source: SFDA human drug list (4-2026, as published by the Council of Health Insurance; indications from the CHI Daman Drug Formulary), Drugs@FDA, EMA medicines data, Health Canada Drug Product Database (Open Government Licence – Canada), CMS NADAC, NHS Drug Tariff Part VIIIA (NHSBSA Copyright, Open Government Licence v3.0), WHO Model List of Essential Medicines (CC BY 3.0 IGO; regrouped by active substance, not created by WHO), EMA PRAC, US FDA safety-related labeling changes and MHRA Drug Safety Update (Open Government Licence v3.0). Sources and reuse. Not a substitute for the official registers or the product information.