Is Dolutegravir registered with the SFDA?

The SFDA human drug list (edition 4-2026, as published by the Council of Health Insurance) lists 2 valid registrations of Dolutegravir, including Dolutegravir Eva (50 mg, Film-coated tablet, SAR 1568.00); TIVICAY 50 mg Tablet (50 mg, Film-coated tablet, SAR 1680.00).

Is Dolutegravir approved by the US FDA?

Drugs@FDA lists 4 application product lines for Dolutegravir, including TIVICAY (Prescription); TIVICAY PD (Prescription); DOLUTEGRAVIR (Prescription); TIVICAY (Discontinued).

Is Dolutegravir authorised in the European Union?

EMA lists 1 centrally authorised medicine containing Dolutegravir: Tivicay.

Is Dolutegravir on the WHO Model List of Essential Medicines?

Yes — 6.4.2.4. Antiretrovirals > Integrase inhibitors (core list): Human immunodeficiency virus disease without mention of tuberculosis or malaria, clinical stage unspecified.

Are there safety signals or safety updates for Dolutegravir?

EMA PRAC: 6 entries; US FDA: 6 entries; MHRA: 2 entries (latest 2026-08-25).

Active substance

Dolutegravir

SFDA 2
US FDA 4
EMA 1
Health Canada 3
US price lines 1
WHO EML 1
Safety 14

Open in the medicines table

SFDA Saudi Arabia — SFDA human drug list

Trade name	Strength	Form · route	Pack	Public price	Type	Company	Status
Dolutegravir Eva	50 mg	Film-coated tablet · Oral use	30 Blister	SAR 1568.00	Generic · Prescription	Eva pharma for Industry	Valid
TIVICAY 50 mg Tablet	50 mg	Film-coated tablet · Oral use	30 Tablet Container	SAR 1680.00	NCE · Prescription	Glaxo Saudi Arabia Ltd.	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
TIVICAY	EQ 50MG BASE	tablet · oral	VIIV HLTHCARE	Prescription	12 Aug 2013
TIVICAY PD	EQ 5MG BASE	tablet, for suspension · oral	VIIV HLTHCARE	Prescription	12 Jun 2020
DOLUTEGRAVIR	5MG; 10MG	film · oral	LAURUS GENERICS INC	Prescription
TIVICAY	EQ 10MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons; EQ 25MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	tablet · oral	VIIV HLTHCARE	Discontinued	12 Aug 2013

EMA European Union — centrally authorised medicines

Tivicay ViiV Healthcare BV · Authorised · authorised 16 Jan 2014 · ATC J05AX12

Therapeutic indication (EMA)

Tivicay is indicated in combination with other anti-retroviral medicinal products for the treatment of Human Immunodeficiency Virus (HIV) infected adults, adolescents and children of at least 6 years of age or older and weighing at least 14 kg. Tivicay is indicated in combination with other anti-retroviral medicinal products for the treatment of Human Immunodeficiency Virus (HIV) infected adults, adolescents and children of at least 4 weeks of age or older and weighing at least 3 kg.

Canada Canada — marketed products (Health Canada)

Brand	DIN	Strength	Form · route	Company
PMS-DOLUTEGRAVIR	02556782	50 MG	TABLET · ORAL	PHARMASCIENCE INC
TIVICAY	02414945	50 MG	TABLET · ORAL	VIIV HEALTHCARE ULC
TIVICAY	02511517	5 MG	TABLET FOR SUSPENSION · ORAL	VIIV HEALTHCARE ULC

Prices — United States and England

Source	Product as listed	Price	Unit / pack	Date
US NADAC	TIVICAY 50 MG TABLET	$77.63562	per EA	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.

WHO WHO Model List of Essential Medicines (2025)

6.4.2.4. Antiretrovirals > Integrase inhibitors · core
Human immunodeficiency virus disease without mention of tuberculosis or malaria, clinical stage unspecified
Oral > Solid: 50 mg tablet; 10 mg tablet (dispersible, scored) (EMLc)

Safety signals and safety-related labeling changes

US FDA 25 Aug 2026 TIVICAY — 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 25 Aug 2026 TIVICAY PD — 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 28 Oct 2025 TRIUMEQ — safety-related labeling change
Labeling sections changed: Boxed Warning; Contraindications; Warnings and Precautions; Adverse Reactions; Drug Interactions; Use in Specific Populations; Patient Counseling Information / Patient Information / Medication Guide
US FDA 28 Oct 2025 JULUCA — 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 28 Oct 2025 DOVATO — 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 28 Oct 2025 TRIUMEQ PD — safety-related labeling change
Labeling sections changed: Adverse Reactions; Drug Interactions; Use in Specific Populations; Patient Counseling Information / Patient Information / Medication Guide
MHRA 22 Oct 2020 Dolutegravir (Tivicay▼, Triumeq▼, Juluca▼): updated advice on increased risk of neural tube defects
Updated safety recommendations have been issued as part of the European review evaluating cases of neural tube defects in babies born to mothers who became pregnant while taking the HIV medicine dolutegravir. Evidence collected as more women have given birth while on dolutegravir treatment shows a smaller increased risk than previously thought, almost comparable to other HIV drugs. The previous restrictions against use in pregnancy are no longer in place – inform women of the potential risk of neural tube defects with dolutegravir and discuss the benefits and risks of continuing treatment if a woman plans pregnancy.
EMA PRAC 17 Jan 2019 PRAC signal: Evaluation of preliminary data from an observational study on birth outcomes in human immunodeficiency virus (HIV)-infected women
Action for MAH: update of the product information: No
EMA PRAC 4 Oct 2018 PRAC signal: Evaluation of preliminary data from an observational study on birth outcomes in human immunodeficiency virus (HIV)-infected women
Action for MAH: update of the product information: Yes
EMA PRAC 12 Jul 2018 PRAC signal: Autoimmune hepatitis
Action for MAH: update of the product information: Yes
MHRA 22 Jun 2018 Dolutegravir (Tivicay▼, Triumeq▼, Juluca▼): signal of increased risk of neural tube defects; do not prescribe to women seeking to become pregnant; exclude pregnancy before initiation and advise use of effective contraception
New safety recommendations have been issued while an EU review evaluates cases of neural tube defects in babies born to mothers who became pregnant while taking the HIV medicine dolutegravir.
EMA PRAC 14 Jun 2018 PRAC signal: Evaluation of preliminary data from an observational study on birth outcomes in human immunodeficiency virus (HIV)-infected women
Action for MAH: update of the product information: No
EMA PRAC 17 May 2018 PRAC signal: Evaluation of preliminary data from an observational study on birth outcomes in human immunodeficiency virus (HIV)-infected women
Action for MAH: update of the product information: No
EMA PRAC 8 Mar 2018 PRAC signal: Autoimmune hepatitis
Action for MAH: update of the product information: No

All safety entries for dolutegravir →

Combinations containing Dolutegravir

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.