Is Lamivudine registered with the SFDA?

The SFDA human drug list (edition 4-2026, as published by the Council of Health Insurance) lists 6 valid registrations of Lamivudine, including EPIVIR 10 MG \ ML ORAL SOLUTION (10 mg/ml, Oral solution, SAR 89.65); EPIVIR 150MG F.C TABLET (150 mg, Film-coated tablet, SAR 336.30); HEPIX 100MG F-C TABLETS (100 mg, Film-coated tablet, SAR 283.45); TABIVIR 150MG F-C TABLETS (150 mg, Film-coated tablet, SAR 283.45); TABIVIR 300MG F-C TABLETS (300 mg, Film-coated tablet, SAR 283.45).

Is Lamivudine approved by the US FDA?

Drugs@FDA lists 23 application product lines for Lamivudine, including EPIVIR (Prescription); EPIVIR (Prescription); LAMIVUDINE (Prescription); LAMIVUDINE (Prescription); LAMIVUDINE (Prescription).

Is Lamivudine authorised in the European Union?

EMA lists 4 centrally authorised medicines containing Lamivudine: Epivir, Zeffix, Lamivudine Teva, Lamivudine Teva Pharma B.V..

Is Lamivudine on the WHO Model List of Essential Medicines?

Yes — 6.4.2.1. Antiretrovirals > Nucleoside/Nucleotide reverse transcriptase inhibitors (core list): Human immunodeficiency virus disease without mention of tuberculosis or malaria, clinical stage unspecified.

Are there safety signals or safety updates for Lamivudine?

EMA PRAC: 2 entries; US FDA: 14 entries (latest 2026-09-29).

Active substance

Lamivudine

SFDA 8
US FDA 23
EMA 4
Health Canada 9
US price lines 3
NHS prices 4
WHO EML 1
Safety 16

Open in the medicines table

SFDA Saudi Arabia — SFDA human drug list

Trade name	Strength	Form · route	Pack	Public price	Type	Company	Status
EPIVIR 10 MG \ ML ORAL SOLUTION	10 mg/ml	Oral solution · Oral use	1 Bottle	SAR 89.65	NCE · Prescription	Glaxo Saudi Arabia Ltd.	Valid
EPIVIR 150MG F.C TABLET	150 mg	Film-coated tablet · Oral use	60 Blister	SAR 336.30	Generic · Prescription	Glaxo Saudi Arabia Ltd.	Valid
HEPIX 100MG F-C TABLETS	100 mg	Film-coated tablet · Oral use	30 Blister	SAR 283.45	Generic · Prescription	Tabuk Pharmaceutical Manufacturing Company	Valid
TABIVIR 150MG F-C TABLETS	150 mg	Film-coated tablet · Oral use	30 Blister	SAR 283.45	Generic · Prescription	Tabuk Pharmaceutical Manufacturing Company	Valid
TABIVIR 300MG F-C TABLETS	300 mg	Film-coated tablet · Oral use	30 Blister	SAR 283.45	Generic · Prescription	Tabuk Pharmaceutical Manufacturing Company	Valid
ZEFFIX	100 mg	Film-coated tablet · Oral use	28 Blister	SAR 303.70	NCE · Prescription	GLAXO SAUDI ARABIA	Valid
ZEFFIX	100 mg	Film-coated tablet · Oral use	28 Blister	SAR 404.95	NCE · Prescription	GLAXOWELLCOME	Withdrawn by MAH · Not Marketed
ZEFFIX 5MG\ML ORAL SOLUTION	5 mg/ml	Oral solution · Oral use	1 Bottle	SAR 77.20	NCE · Prescription	Glaxo Saudi Arabia Ltd.	Withdrawn by MAH · Not Marketed

Indications — CHI Daman Drug Formulary

BURKITT`S LYMPHOMA-HBV PROPHYLAXIS; CASTLEMAN DISEASE; CHRONIC LYMPHOCYTIC LEUKEMIA (CLL)-HBV PROPHYLAXIS; DIFFUSE LARGE B-CELL LYMPHOMA (DLBCL)-HBV PROPHYLAXIS; FOLLICULAR LYMPHOMA-HBV PROPHYLAXIS; HEPATITIS B; HODGKIN'S LYMPHOMA-HBV PROPHYLAXIS; HUMAN IMMUNODEFICIENCY VIRUS; MANTLE CELL LYMPHOMA-HBV PROPHYLAXIS; MARGINAL ZONE LYMPHOMA-HBV PROPHYLAXIS; PEDIATRIC B-CELL LYMPHOMA-HBV PROPHYLAXIS

US FDA United States — FDA approvals (Drugs@FDA)

Product	Strength	Form · route	Applicant	Status	First approved
EPIVIR	150MG; 300MG	tablet · oral	VIIV HLTHCARE	Prescription	17 Nov 1995
EPIVIR	10MG/ML	solution · oral	VIIV HLTHCARE	Prescription	17 Nov 1995
LAMIVUDINE	150MG; 300MG	tablet · oral	APOTEX	Prescription	2 Dec 2011
LAMIVUDINE	100MG	tablet · oral	APOTEX	Prescription	2 Jan 2014
LAMIVUDINE	100MG	tablet · oral	HETERO LABS LTD V	Prescription	2 Jan 2014
LAMIVUDINE	150MG; 300MG	tablet · oral	HETERO LABS LTD V	Prescription	6 Jan 2014
LAMIVUDINE	10MG/ML	solution · oral	CHARTWELL MOLECULAR	Prescription	31 Oct 2014
LAMIVUDINE	150MG; 300MG	tablet · oral	AUROBINDO PHARMA	Prescription	21 Nov 2016
LAMIVUDINE	10MG/ML	solution · oral	AUROBINDO PHARMA	Prescription	21 Nov 2016
LAMIVUDINE	150MG; 300MG	tablet · oral	SOMERSET THERAPS LLC	Prescription	21 Nov 2016
LAMIVUDINE	150MG; 300MG	tablet · oral	CIPLA	Prescription	3 Mar 2017
LAMIVUDINE	150MG; 300MG	tablet · oral	STRIDES PHARMA	Prescription	19 Apr 2018
LAMIVUDINE	100MG	tablet · oral	ANNORA	Prescription	21 Mar 2019
LAMIVUDINE	150MG; 300MG	tablet · oral	MACLEODS PHARMS	Prescription	1 May 2019
LAMIVUDINE	10MG/ML	solution · oral	HETERO LABS LTD III	Prescription	6 Oct 2023
EPIVIR-HBV	100MG	tablet · oral	GLAXOSMITHKLINE	Discontinued	8 Dec 1998
EPIVIR-HBV	5MG/ML	solution · oral	GLAXOSMITHKLINE	Discontinued	8 Dec 1998
LAMIVUDINE	150MG; 300MG	tablet · oral	AUROBINDO PHARMA LTD	Discontinued	17 Nov 2011
LAMIVUDINE	150MG; 300MG	tablet · oral	LUPIN	Discontinued	18 Dec 2014
LAMIVUDINE	100MG	tablet · oral	AUROBINDO PHARMA USA	Discontinued	31 Dec 2014
LAMIVUDINE	150MG; 300MG	tablet · oral	NATCO	Discontinued	4 Mar 2016
LAMIVUDINE	150MG	tablet · oral	BRECKENRIDGE	Discontinued	21 Nov 2016
LAMIVUDINE	150MG; 300MG	tablet · oral	PHARMOBEDIENT	Discontinued	5 Mar 2019

EMA European Union — centrally authorised medicines

Epivir ViiV Healthcare BV · Authorised · authorised 8 Aug 1996 · ATC J05AF05

Therapeutic indication (EMA)

Epivir is indicated as part of antiretroviral combination therapy for the treatment of human-immunodeficiency-virus (HIV)-infected adults and children.

Zeffix GlaxoSmithKline Trading Services Limited · Authorised · authorised 29 Jul 1999 · ATC J05AF05

Therapeutic indication (EMA)

Zeffix is indicated for the treatment of chronic hepatitis B in adults with: compensated liver disease with evidence of active viral replication, persistently elevated serum alanine aminotransferase (ALT) levels and histological evidence of active liver inflammation and / or fibrosis. Initiation of lamivudine treatment should only be considered when the use of an alternative antiviral agent with a higher genetic barrier is not available or appropriate; decompensated liver disease in combination with a second agent without cross-resistance to lamivudine.

Lamivudine Teva Teva B.V. · Authorised · authorised 23 Oct 2009 · ATC J05AF05

Therapeutic indication (EMA)

Lamivudine Teva is indicated for the treatment of chronic hepatitis B in adults with: compensated liver disease with evidence of active viral replication, persistently elevated serum alanine aminotransferase (ALT) levels and histological evidence of active liver inflammation and / or fibrosis. Initiation of lamivudine treatment should only be considered when the use of an alternative antiviral agent with a higher genetic barrier is not available or appropriate (see in section 5.1).

Lamivudine Teva Pharma B.V. Teva B.V. · Authorised · authorised 10 Dec 2009 · ATC J05AF05

Therapeutic indication (EMA)

Lamivudine Teva Pharma B.V. is indicated as part of antiretroviral combination therapy for the treatment of human-immunodeficiency-virus (HIV)-infected adults and children.

Canada Canada — marketed products (Health Canada)

Brand	DIN	Strength	Form · route	Company
3TC	02192683	150 MG	TABLET · ORAL	VIIV HEALTHCARE ULC
3TC	02192691	10 MG / ML	SOLUTION · ORAL	VIIV HEALTHCARE ULC
3TC	02247825	300 MG	TABLET · ORAL	VIIV HEALTHCARE ULC
APO-LAMIVUDINE	02369052	150 MG	TABLET · ORAL	APOTEX INC
APO-LAMIVUDINE	02369060	300 MG	TABLET · ORAL	APOTEX INC
APO-LAMIVUDINE HBV	02393239	100 MG	TABLET · ORAL	APOTEX INC
JAMP LAMIVUDINE	02507110	150 MG	TABLET · ORAL	JAMP PHARMA CORPORATION
JAMP LAMIVUDINE	02507129	300 MG	TABLET · ORAL	JAMP PHARMA CORPORATION
JAMP LAMIVUDINE HBV	02512467	100 MG	TABLET · ORAL	JAMP PHARMA CORPORATION

Prices — United States and England

Source	Product as listed	Price	Unit / pack	Date
US NADAC	LAMIVUDINE 10 MG/ML ORAL SOLN	$0.21763	per ML	22 Jul 2026
US NADAC	LAMIVUDINE 150 MG TABLET	$0.48868	per EA	23 Sep 2026
US NADAC	LAMIVUDINE 300 MG TABLET	$1.40117	per EA	23 Sep 2026
NHS Drug Tariff	Lamivudine 100mg tablets	£78.09	28 tablet	1 Oct 2026
NHS Drug Tariff	Lamivudine 150mg tablets	£143.32	60 tablet	1 Oct 2026
NHS Drug Tariff	Lamivudine 300mg tablets	£157.51	30 tablet	1 Oct 2026
NHS Drug Tariff	Lamivudine 50mg/5ml oral solution	£39.01	240 ml	1 Oct 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)

6.4.2.1. Antiretrovirals > Nucleoside/Nucleotide reverse transcriptase inhibitors · core
Human immunodeficiency virus disease without mention of tuberculosis or malaria, clinical stage unspecified
Oral > Liquid: 50 mg per 5 mL (EMLc) | Oral > Solid: 150 mg tablet (EML)

Safety signals and safety-related labeling changes

US FDA 29 Sep 2026 DELSTRIGO — safety-related labeling change
Labeling sections changed: Warnings and Precautions; Adverse Reactions; 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 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
US FDA 22 Dec 2021 EPIVIR-HBV — safety-related labeling change
Labeling sections changed: Boxed Warning; Warnings and Precautions; Adverse Reactions; Drug Interactions; Use in Specific Populations; Patient Counseling Information / Patient Information / Medication Guide
US FDA 22 Dec 2021 EPIVIR-HBV — safety-related labeling change
Labeling sections changed: Boxed Warning; Warnings and Precautions; Adverse Reactions; Drug Interactions; Use in Specific Populations; Patient Counseling Information / Patient Information / Medication Guide
US FDA 10 Dec 2021 EPZICOM — safety-related labeling change
Labeling sections changed: Boxed Warning; Warnings and Precautions; Drug Interactions; Use in Specific Populations; Patient Counseling Information / Patient Information / Medication Guide
US FDA 17 Feb 2021 TRIZIVIR — safety-related labeling change
Labeling sections changed: Boxed Warning; Warnings and Precautions; Adverse Reactions; Drug Interactions; Use in Specific Populations; Patient Counseling Information / Patient Information / Medication Guide
US FDA 29 Oct 2019 SYMFI — safety-related labeling change
Labeling sections changed: Warnings and Precautions; Adverse Reactions; Use in Specific Populations; Patient Counseling Information / Patient Information / Medication Guide
US FDA 29 Oct 2019 SYMFI LO — safety-related labeling change
Labeling sections changed: Warnings and Precautions; Adverse Reactions; Use in Specific Populations; Patient Counseling Information / Patient Information / Medication Guide
US FDA 29 Oct 2019 TEMIXYS — safety-related labeling change
Labeling sections changed: Warnings and Precautions; Adverse Reactions; Use in Specific Populations; Patient Counseling Information / Patient Information / Medication Guide
US FDA 10 May 2019 COMBIVIR — safety-related labeling change
Labeling sections changed: Boxed Warning; Warnings and Precautions; Adverse Reactions; Drug Interactions; Use in Specific Populations; Patient Counseling Information / Patient Information / Medication Guide
EMA PRAC 12 Jul 2018 PRAC signal: Autoimmune hepatitis
Action for MAH: update of the product information: Yes
US FDA 27 Apr 2018 EPIVIR — safety-related labeling change
Labeling sections changed: Warnings and Precautions; Use in Specific Populations; Patient Counseling Information / Patient Information / Medication Guide
US FDA 27 Apr 2018 EPIVIR — safety-related labeling change
Labeling sections changed: Warnings and Precautions; Use in Specific Populations; Patient Counseling Information / Patient Information / Medication Guide

All safety entries for lamivudine →

Combinations containing Lamivudine

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.