SFDA Saudi Arabia — SFDA human drug list
| Trade name | Strength | Form · route | Pack | Public price | Type | Company | Status |
|---|
| SUNLENCA | 300 mg | Film-coated tablet · Oral use | 4 Blister | SAR 12201.60 | NCE · Prescription | Gilead Sciences, Inc | Valid |
| SUNLENCA | 300 mg | Film-coated tablet · Oral use | 5 Blister | SAR 15252.00 | NCE · Prescription | Gilead Sciences, Inc | Valid |
| SUNLENCA 463.5 mg per 1.5 ml | 309 mg/ml | Solution for injection · Subcutaneous use | 2 Vial | SAR 90250.85 | NCE · Prescription | Gilead Sciences, Inc | Valid |
Indications — CHI Daman Drug Formulary
HUMAN IMMUNODEFICIENCY VIRUS
US FDA United States — FDA approvals (Drugs@FDA)
| Product | Strength | Form · route | Applicant | Status | First approved |
|---|
| SUNLENCA | EQ 463.5MG BASE/1.5ML (EQ 309MG BASE/ML) | solution · subcutaneous | GILEAD SCIENCES INC | Prescription | 22 Dec 2022 |
| SUNLENCA | EQ 300MG BASE | tablet · oral | GILEAD SCIENCES INC | Prescription | 22 Dec 2022 |
| YEZTUGO | EQ 463.5MG BASE/1.5ML (EQ 309MG BASE/ML); 463.5MG/1.5ML(309MG/ML) | solution · subcutaneous | GILEAD SCIENCES INC | Prescription | 18 Jun 2025 |
| YEZTUGO | EQ 300MG BASE | tablet · oral | GILEAD SCIENCES INC | Prescription | 18 Jun 2025 |
EMA European Union — centrally authorised medicines
Sunlenca Gilead Sciences Ireland Unlimited Company · Authorised · authorised 17 Aug 2022 · ATC J05AX
Therapeutic indication (EMA)
Sunlenca injection, in combination with other antiretroviral(s), is indicated for the treatment of adults with multidrug resistant HIV 1 infection for whom it is otherwise not possible to construct a suppressive anti viral regimen (see sections 4.2 and 5.1). Sunlenca tablet, in combination with other antiretroviral(s), is indicated for the treatment of adults with multidrug resistant HIV 1 infection for whom it is otherwise not possible to construct a suppressive anti viral regimen, for oral loading prior to administration of long-acting lenacapavir injection (see sections 4.2 and 5.1).
Yeytuo Gilead Sciences Ireland Unlimited Company · Authorised · authorised 25 Aug 2025 · ATC J05AX31
Therapeutic indication (EMA)
Yeytuo tablet is indicated in combination with safer sex practices for pre-exposure prophylaxis (PrEP) to reduce the risk of sexually acquired HIV-1 infection in adults and adolescents with increased HIV 1 acquisition risk, weighing at least 35 kg for: oral loading oral bridging (see sections 4.2, 4.4 and 5.1)
Canada Canada — marketed products (Health Canada)
| Brand | DIN | Strength | Form · route | Company |
|---|
| SUNLENCA | 02532468 | 300 MG | TABLET · ORAL | GILEAD SCIENCES CANADA INC |
| SUNLENCA | 02532476 | 309 MG / ML | SOLUTION · SUBCUTANEOUS | GILEAD SCIENCES CANADA INC |
Safety signals and safety-related labeling changes
- US FDA 27 Aug 2026 SUNLENCA — safety-related labeling change
Labeling sections changed: Warnings and Precautions; Adverse Reactions; Drug Interactions; Use in Specific Populations; Patient Counseling Information / Patient Information / Medication Guide - US FDA 27 Aug 2026 SUNLENCA — safety-related labeling change
Labeling sections changed: Warnings and Precautions; Adverse Reactions; Drug Interactions; Use in Specific Populations; Patient Counseling Information / Patient Information / Medication Guide
All safety entries for lenacapavir →
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.