SFDA Saudi Arabia — SFDA human drug list
| Trade name | Strength | Form · route | Pack | Public price | Type | Company | Status |
|---|
| TREMFYA 100 MG/ML | 100 mg/ml | Solution for injection · Subcutaneous use | 1 Pre-filled syringe | SAR 9265.60 | Biological · Prescription | JANSSEN-CILAG | Valid |
| Tremfya | 10 mg/ml | Concentrate for solution for infusion · Intravenous use | 1 Vial | SAR 12030.30 | Biological · Prescription | Janssen Cilag AG | Valid |
| Tremfya | 100 mg/ml | Solution for injection in pre-filled syringe · Subcutaneous use | 1 Pre-filled syringe | SAR 11118.70 | Biological · Prescription | Janssen Cilag AG | Valid |
Indications — CHI Daman Drug Formulary
CROHN'S DISEASE; PSORIASIS; PSORIATIC ARTHRITIS; ULCERATIVE COLITIS
US FDA United States — FDA approvals (Drugs@FDA)
| Product | Strength | Form · route | Applicant | Status | First approved |
|---|
| TREMFYA | 100MG/ML | injectable · injection | JANSSEN BIOTECH | Prescription | 13 Jul 2017 |
EMA European Union — centrally authorised medicines
Tremfya Janssen-Cilag International NV · Authorised · authorised 10 Nov 2017 · ATC L04AC
Therapeutic indication (EMA)
Adult plaque psoriasisTremfya is indicated for the treatment of moderate to severe plaque psoriasis in adults who are candidates for systemic therapy. Paediatric plaque psoriasisTremfya is indicated for the treatment of moderate to severe plaque psoriasis in children and adolescents from the age of 6 years who are candidates for systemic therapy. Psoriatic arthritisTremfya, alone or in combination with methotrexate (MTX), is indicated for the treatment of active psoriatic arthritis in adult patients who have had an inadequate response or who have been intolerant to a prior disease-modifying antirheumatic drug (DMARD) therapy.Ulcerative colitisTremfya is indicated for the treatment of adult patients with moderately to severely active ulcerative colitis who have had an inadequate response, lost response, or were intolerant to either conventional therapy, or a biologic treatment.Crohn’s diseaseTremfya is indicated for the treatment of adult patients with moderately to severely active Crohn’s disease who have had an inadequate response, lost response, or were intolerant to either conventional therapy or a biologic treatment.
Canada Canada — marketed products (Health Canada)
| Brand | DIN | Strength | Form · route | Company |
|---|
| TREMFYA | 02469758 | 100 MG / 1 ML | SOLUTION · SUBCUTANEOUS | JANSSEN INC |
| TREMFYA | 02559145 | 200 MG / 2 ML | SOLUTION · SUBCUTANEOUS | JANSSEN INC |
| TREMFYA | 02566877 | 100 MG / ML | SOLUTION · SUBCUTANEOUS | JANSSEN INC |
| TREMFYA I.V. | 02559153 | 200 MG / 20 ML | SOLUTION · INTRAVENOUS | JANSSEN INC |
| TREMFYA ONE-PRESS | 02487314 | 100 MG / 1 ML | SOLUTION · SUBCUTANEOUS | JANSSEN INC |
Prices — United States and England
| Source | Product as listed | Price | Unit / pack | Date |
|---|
| US NADAC | TREMFYA 100 MG/ML ONE-PRESS | $14743.71813 | per ML | 23 Sep 2026 |
| US NADAC | TREMFYA 100 MG/ML PEN | $14620.06917 | per ML | 23 Sep 2026 |
| US NADAC | TREMFYA 100 MG/ML SYRINGE | $14728.90533 | per ML | 23 Sep 2026 |
| US NADAC | TREMFYA 200 MG/2 ML PEN | $7321.65571 | per ML | 23 Sep 2026 |
NADAC: average price US retail pharmacies pay to buy the medicine. NHS Drug Tariff Part VIIIA: basic price reimbursed to pharmacies in England and Wales.
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.