SFDA Saudi Arabia — SFDA human drug list
| Trade name | Strength | Form · route | Pack | Public price | Type | Company | Status |
|---|
| BENLYSTA 120MG POWDER FOR SOLUTION FOR INFUSION | 120 mg | Powder for concentrate for solution for infusion · Intravenous use | 1 Vial | SAR 452.70 | Biological · Prescription | Glaxo Saudi Arabia Ltd | Valid |
| BENLYSTA 400MG POWDER FOR SOLUTION FOR INFUSION | 400 mg | Powder for concentrate for solution for infusion · Intravenous use | 1 Vial | SAR 1509.10 | Biological · Prescription | Glaxo Saudi Arabia Ltd | Valid |
| Benlysta | 200 mg | Solution for injection · Subcutaneous use | 4 Automatic Injection Device | SAR 3531.99 | Biological · Prescription | Glaxo Saudi Arabia Ltd | Valid |
Indications — CHI Daman Drug Formulary
SJOGREN'S SYNDROME; SYSTEMIC LUPUS ERYTHEMATOSUS
US FDA United States — FDA approvals (Drugs@FDA)
| Product | Strength | Form · route | Applicant | Status | First approved |
|---|
| BENLYSTA | 120MG; 400MG | injectable · injection | HUMAN GENOME SCIENCES INC. | Prescription | 9 Mar 2011 |
| BENLYSTA | 200MG/ML | injectable · injection | GLAXOSMITHKLINE LLC | Prescription | 20 Jul 2017 |
EMA European Union — centrally authorised medicines
Benlysta GlaxoSmithKline (Ireland) Limited · Authorised · authorised 13 Jul 2011 · ATC L04AG04
Therapeutic indication (EMA)
Benlysta is indicated as add-on therapy in patients aged 5 years and older with active, autoantibody-positive systemic lupus erythematosus (SLE) with a high degree of disease activity (e.g., positive anti‑dsDNA and low complement) despite standard therapy. Benlysta is indicated in combination with background immunosuppressive therapies for the treatment of adult patients with active lupus nephritis. Benlysta is indicated as add-on therapy in adult patients with active, autoantibody-positive systemic lupus erythematosus (SLE) with a high degree of disease activity (e.g., positive anti dsDNA and low complement) despite standard therapy.
Canada Canada — marketed products (Health Canada)
| Brand | DIN | Strength | Form · route | Company |
|---|
| BENLYSTA | 02370050 | 120 MG / VIAL | POWDER FOR SOLUTION · INTRAVENOUS | GLAXOSMITHKLINE INC |
| BENLYSTA | 02370069 | 400 MG / VIAL | POWDER FOR SOLUTION · INTRAVENOUS | GLAXOSMITHKLINE INC |
| BENLYSTA | 02470489 | 200 MG / 1 ML | SOLUTION · SUBCUTANEOUS | GLAXOSMITHKLINE INC |
Safety signals and safety-related labeling changes
- US FDA 21 Aug 2026 BENLYSTA — safety-related labeling change
Labeling sections changed: Contraindications; Warnings and Precautions; Adverse Reactions; Drug Interactions; Use in Specific Populations; Patient Counseling Information / Patient Information / Medication Guide - US FDA 21 Aug 2026 BENLYSTA — safety-related labeling change
Labeling sections changed: Contraindications; Warnings and Precautions; Adverse Reactions; Drug Interactions; Use in Specific Populations; Patient Counseling Information / Patient Information / Medication Guide - MHRA 16 Apr 2019 Belimumab (Benlysta▼): increased risk of serious psychiatric events seen in clinical trials
Clinical trials, including interim findings from a randomised trial, show an increased risk of depression, suicidal ideation or behaviour, or self-injury in patients with systemic lupus erythematosus receiving belimumab compared with those receiving placebo in addition to standard therapy. Assess patients for these risks before the start of treatment with belimumab and advise them to promptly seek medical attention if they develop new or worsening depression, suicidal ideation or thoughts about injuring themselves. - EMA PRAC 15 Mar 2019 PRAC signal: Lupus nephritis
Action for MAH: update of the product information: No - EMA PRAC 4 Oct 2018 PRAC signal: Lupus nephritis
Action for MAH: update of the product information: No - EMA PRAC 12 Apr 2018 PRAC signal: Lupus nephritis
Action for MAH: update of the product information: No
All safety entries for belimumab →
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.