Is Entecavir registered with the SFDA?

The SFDA human drug list (edition 4-2026, as published by the Council of Health Insurance) lists 16 valid registrations of Entecavir, including ARVIDA 0.5 mg Tablet (0.5 mg, Tablet, SAR 1352.55); Adacter (0.5 mg, Film-coated tablet, SAR 374.75); ELIVE (0.5 mg, Film-coated tablet, SAR 1352.55); ELIVE (1 mg, Film-coated tablet, SAR 1387.10); ENTAVIR 0.5 mg Film Coated Tablet (0.5 mg, Film-coated tablet, SAR 1352.55).

Is Entecavir approved by the US FDA?

Drugs@FDA lists 20 application product lines for Entecavir, including BARACLUDE (Prescription); BARACLUDE (Prescription); ENTECAVIR (Prescription); ENTECAVIR (Prescription); ENTECAVIR (Prescription).

Is Entecavir authorised in the European Union?

EMA lists 3 centrally authorised medicines containing Entecavir: Baraclude, Entecavir Viatris (previously Entecavir Mylan), Entecavir Accord.

Is Entecavir on the WHO Model List of Essential Medicines?

Yes — 6.4.4.1.1. Medicines for hepatitis B > Nucleoside/Nucleotide reverse transcriptase inhibitors (core list): Chronic hepatitis B.

Are there safety signals or safety updates for Entecavir?

US FDA: 2 entries (latest 2019-11-06).

Active substance

Entecavir

SFDA 24
US FDA 20
EMA 3
Health Canada 10
US price lines 3
NHS prices 3
WHO EML 1
Safety 2

Open in the medicines table

SFDA Saudi Arabia — SFDA human drug list

Trade name	Strength	Form · route	Pack	Public price	Type	Company	Status
ARVIDA 0.5 mg Tablet	0.5 mg	Tablet · Oral use	30 Bottle	SAR 1352.55	Generic · Prescription	APOTEX INC. (SIGNET SITE)	Valid
Adacter	0.5 mg	Film-coated tablet · Oral use	30 Blister	SAR 374.75	Generic · Prescription	HEXAL AG	Valid
ELIVE	0.5 mg	Film-coated tablet · Oral use	30 Blister	SAR 1352.55	Generic · Prescription	AJA PHARMACEUTICAL INDUSTRIES	Valid
ELIVE	1 mg	Film-coated tablet · Oral use	30 Blister	SAR 1387.10	Generic · Prescription	AJA PHARMACEUTICAL INDUSTRIES	Valid
ENTAVIR 0.5 mg Film Coated Tablet	0.5 mg	Film-coated tablet · Oral use	30 Blister	SAR 1352.55	Generic · Prescription	DAMMAM PHARMA	Valid
ENTAVIR 1 mg Film Coated Tablet	1 mg	Film-coated tablet · Oral use	30 Blister	SAR 1387.10	Generic · Prescription	DAMMAM PHARMA	Valid
Etvab	0.5 mg	Film-coated tablet · Oral use	30 Blister	SAR 1079.00	Generic · Prescription	Med City Pharma	Valid
Etvab	1 mg	Film-coated tablet · Oral use	30 Blister	SAR 1106.55	Generic · Prescription	Med City Pharma	Valid
HEPATAB 0.5 mg film-coated tablet	0.5 mg	Film-coated tablet · Oral use	30 Tablet Container	SAR 1669.85	Generic · Prescription	Tabuk Pharmaceutical Manufacturing Company	Valid
HEPATAB 1 mg film-coated tablet	1 mg	Film-coated tablet · Oral use	30 Tablet Container	SAR 1712.50	Generic · Prescription	Tabuk Pharmaceutical Manufacturing Company	Valid
HEPAVIR 0.5 mg film-coated tablet	0.5 mg	Film-coated tablet · Oral use	30 Blister	SAR 1502.85	Generic · Prescription	SPIMACO ADDWAEIH	Valid
HEPAVIR 1 mg film-coated tablet	1 mg	Film-coated tablet · Oral use	30 Blister	SAR 1541.25	Generic · Prescription	SPIMACO ADDWAEIH	Valid
Kavira	0.5 mg	Film-coated tablet · Oral use	30 Blister	SAR 402.45	Generic · Prescription	Jazeera Pharmaceutical Industries (JPI)	Valid
Kavira	1 mg	Film-coated tablet · Oral use	30 Blister	SAR 462.40	Generic · Prescription	Jazeera Pharmaceutical Industries (JPI)	Valid
TECABEN	1 mg	Film-coated tablet · Oral use	30 Blister	SAR 1387.10	Generic · Prescription	Saudi Amarox	Valid
TECABEN	0.5 mg	Film-coated tablet · Oral use	30 Blister	SAR 1352.55	Generic · Prescription	Saudi Amarox	Valid
BARACLUDE 0.5MG F.C. TABLETS	0.5 mg	Film-coated tablet · Oral use	30 Tablet Container	SAR 2055.20	NCE · Prescription	BRISTOL-MYERS SQUIBB	Withdrawn by MAH · Not Marketed
BARACLUDE 0.5MG F.C. TABLETS	0.5 mg	Film-coated tablet · Oral use	30 Tablet Container	SAR 2055.20	NCE · Prescription	BRISTOL-MYERS SQUIBB	Withdrawn by MAH · Not Marketed
BARACLUDE 1MG F.C. TABLETS	1 mg	Film-coated tablet · Oral use	30 Blister	SAR 2107.70	NCE · Prescription	BRISTOL-MYERS SQUIBB	Withdrawn by MAH · Not Marketed
BARACLUDE 1MG F.C. TABLETS	1 mg	Film-coated tablet · Oral use	30 Blister	SAR 2107.70	NCE · Prescription	BRISTOL-MYERS SQUIBB	Withdrawn by MAH · Not Marketed
ENVICA 0.5MG F.C.TABLET	0.5 mg	Film-coated tablet · Oral use	30 Blister	SAR 402.45	Generic · Prescription	SAJA-SAUDI ARABIAN JAPANESE PHARMACEUTICAL CO	Withdrawn by regulatory authority · Not Marketed
ENVICA 1MG F.C.TABLET	1 mg	Film-coated tablet · Oral use	30 Blister	SAR 462.40	Generic · Prescription	SAJA-SAUDI ARABIAN JAPANESE PHARMACEUTICAL CO	Withdrawn by regulatory authority · Not Marketed
VIRCAN 0.5 mg Film Coted Tablet	0.5 mg	Film-coated tablet · Oral use	30 Blister	SAR 1217.30	Generic · Prescription	PHARMASCIENCE INC.	Withdrawn by MAH · Not Marketed
VIRCAN 1 mg Film Coted Tablet	1 mg	Film-coated tablet · Oral use	30 Blister	SAR 1387.10	Generic · Prescription	PHARMASCIENCE INC.	Withdrawn by MAH · Not Marketed

Indications — CHI Daman Drug Formulary

ANTIMICROBIAL PROPHYLAXIS IN CANCER PATIENTS; CASTLEMAN DISEASE

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

Product	Strength	Form · route	Applicant	Status	First approved
BARACLUDE	0.5MG; 1MG	tablet · oral	BRISTOL MYERS SQUIBB	Prescription	29 Mar 2005
BARACLUDE	0.05MG/ML	solution · oral	BRISTOL MYERS SQUIBB	Prescription	29 Mar 2005
ENTECAVIR	0.5MG; 1MG	tablet · oral	HETERO LABS LTD V	Prescription	21 Aug 2015
ENTECAVIR	0.5MG; 1MG	tablet · oral	AUROBINDO PHARMA	Prescription	26 Aug 2015
ENTECAVIR	0.5MG; 1MG	tablet · oral	AMNEAL PHARMS	Prescription	12 Nov 2015
ENTECAVIR	0.5MG; 1MG	tablet · oral	CIPLA	Prescription	6 Dec 2016
ENTECAVIR	0.5MG; 1MG	tablet · oral	ZYDUS PHARMS	Prescription	23 Jun 2017
ENTECAVIR	0.5MG; 1MG	tablet · oral	BRIGHTGENE	Prescription	25 Sep 2019
ENTECAVIR	0.5MG; 1MG	tablet · oral	YUNG SHIN PHARM	Prescription	10 Nov 2021
ENTECAVIR	0.5MG; 1MG	tablet · oral	CONBA USA	Prescription	23 Dec 2024
ENTECAVIR	0.5MG; 1MG	tablet · oral	TEVA PHARMS USA	Discontinued	26 Aug 2014
ENTECAVIR	0.5MG; 1MG	tablet · oral	CHARTWELL RX	Discontinued	23 Nov 2016
ENTECAVIR	0.5MG; 1MG	tablet · oral	CHARTWELL RX	Discontinued	11 May 2017
ENTECAVIR	0.5MG; 1MG	tablet · oral	ACCORD HLTHCARE	Discontinued	25 Aug 2017
ENTECAVIR	0.5MG; 1MG	tablet · oral	PRINSTON INC	Discontinued	10 Oct 2017
ENTECAVIR	0.5MG; 1MG	tablet · oral	BRECKENRIDGE	Discontinued	15 Mar 2018
ENTECAVIR	0.5MG; 1MG	tablet · oral	RISING	Discontinued	26 Mar 2019
ENTECAVIR	0.5MG; 1MG	tablet · oral	YAOPHARMA CO LTD	Discontinued	4 Nov 2019
ENTECAVIR	0.5MG; 1MG	tablet · oral	SUNSHINE	Discontinued	20 May 2020
ENTECAVIR	0.5MG; 1MG	tablet · oral	PHARMADAX	Discontinued	10 Aug 2020

EMA European Union — centrally authorised medicines

Baraclude Bristol-Myers Squibb Pharma EEIG · Authorised · authorised 26 Jun 2006 · ATC J05AF10

Therapeutic indication (EMA)

Baraclude is indicated for the treatment of chronic hepatitis B virus (HBV) infection in adults with: compensated liver disease and evidence of active viral replication, persistently elevated serum alanine aminotransferase (ALT) levels and histological evidence of active inflammation and/or fibrosis; decompensated liver disease. For both compensated and decompensated liver disease, this indication is based on clinical trial data in nucleoside naive patients with HBeAg positive and HBeAg negative HBV infection. With respect to patients with lamivudine-refractory hepatitis B.

Entecavir Viatris (previously Entecavir Mylan) Viatris Limited · Authorised · authorised 18 Sep 2017 · ATC J05AF10

Therapeutic indication (EMA)

Entecavir Viatris is indicated for the treatment of chronic hepatitis B virus (HBV) infection in adults with: compensated liver disease and evidence of active viral replication, persistently elevated serum alanine aminotransferase (ALT) levels and histological evidence of active inflammation and/or fibrosis. decompensated liver disease. For both compensated and decompensated liver disease, this indication is based on clinical trial data in nucleoside naive patients with HBeAg positive and HBeAg negative HBV infection. With respect to patients with lamivudine-refractory hepatitis B.Entecavir Viatris is also indicated for the treatment of chronic HBV infection in nucleoside naive paediatric patients from 2 to <18 years of age with compensated liver disease who have evidence of active viral replication and persistently elevated serum ALT levels, or histological evidence of moderate to severe inflammation and/or fibrosis. With respect to the decision to initiate treatment in paediatric patients.

Entecavir Accord Accord Healthcare S.L.U. · Authorised · authorised 25 Sep 2017 · ATC J05AF10

Therapeutic indication (EMA)

Entecavir Accord is indicated for the treatment of chronic hepatitis B virus (HBV) infection in adults with: compensated liver disease and evidence of active viral replication, persistently elevated serum alanine aminotransferase (ALT) levels and histological evidence of active inflammation and/or fibrosis. decompensated liver disease. For both compensated and decompensated liver disease, this indication is based on clinical trial data in nucleoside naive patients with HBeAg positive and HBeAg negative HBV infection. With respect to patients with lamivudine-refractory hepatitis B. Entecavir Accord is also indicated for the treatment of chronic HBV infection in nucleoside naive paediatric patients from 2 to <18 years of age with compensated liver disease who have evidence of active viral replication and persistently elevated serum ALT levels, or histological evidence of moderate to severe inflammation and/or fibrosis. With respect to the decision to initiate treatment in paediatric patients.

Canada Canada — marketed products (Health Canada)

Brand	DIN	Strength	Form · route	Company
ACCEL-ENTECAVIR	02479907	0.5 MG	TABLET · ORAL	ACCEL PHARMA INC
APO-ENTECAVIR	02396955	0.5 MG	TABLET · ORAL	APOTEX INC
AURO-ENTECAVIR	02448777	0.5 MG	TABLET · ORAL	AURO PHARMA INC
BARACLUDE	02282224	0.5 MG	TABLET · ORAL	BRISTOL-MYERS SQUIBB CANADA
ENTECAVIR	02527154	0.5 MG	TABLET · ORAL	SANIS HEALTH INC
ENTECAVIR TABLETS	02453797	0.5 MG	TABLET · ORAL	STRIDES PHARMA CANADA INC
JAMP ENTECAVIR	02467232	0.5 MG	TABLET · ORAL	JAMP PHARMA CORPORATION
MINT-ENTECAVIR	02485907	0.5 MG	TABLET · ORAL	MINT PHARMACEUTICALS INC
PMS-ENTECAVIR	02430576	0.5 MG	TABLET · ORAL	PHARMASCIENCE INC
PMS-ENTECAVIR	02430584	1 MG	TABLET · ORAL	PHARMASCIENCE INC

Prices — United States and England

Source	Product as listed	Price	Unit / pack	Date
US NADAC	BARACLUDE 0.5 MG TABLET	$44.18654	per EA	19 Nov 2025
US NADAC	ENTECAVIR 0.5 MG TABLET	$0.21857	per EA	23 Sep 2026
US NADAC	ENTECAVIR 1 MG TABLET	$0.36844	per EA	23 Sep 2026
NHS Drug Tariff	Entecavir 1mg tablets	£363.26	30 tablet	1 Oct 2026
NHS Drug Tariff	Entecavir 500microgram tablets	£363.26	30 tablet	1 Oct 2026
NHS Drug Tariff	Entecavir 50micrograms/ml oral solution sugar free	£423.80	210 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)

6.4.4.1.1. Medicines for hepatitis B > Nucleoside/Nucleotide reverse transcriptase inhibitors · core
Chronic hepatitis B
Oral > Liquid: 0.05 mg per mL | Oral > Solid: 0.5 mg; 1 mg

Safety signals and safety-related labeling changes

US FDA 6 Nov 2019 BARACLUDE — safety-related labeling change
Labeling sections changed: Adverse Reactions; Use in Specific Populations; Patient Counseling Information / Patient Information / Medication Guide
US FDA 6 Nov 2019 BARACLUDE — safety-related labeling change
Labeling sections changed: Adverse Reactions; Use in Specific Populations; Patient Counseling Information / Patient Information / Medication Guide

All safety entries for entecavir →

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.