Is Adefovir dipivoxil registered with the SFDA?

The SFDA human drug list (edition 4-2026, as published by the Council of Health Insurance) lists 0 valid registrations of Adefovir dipivoxil.

Is Adefovir dipivoxil approved by the US FDA?

Drugs@FDA lists 3 application product lines for Adefovir dipivoxil, including ADEFOVIR DIPIVOXIL (Prescription); ADEFOVIR DIPIVOXIL (Prescription); HEPSERA (Discontinued).

Is Adefovir dipivoxil authorised in the European Union?

EMA lists 0 centrally authorised medicines containing Adefovir dipivoxil.

Are there safety signals or safety updates for Adefovir dipivoxil?

US FDA: 1 entry (latest 2018-12-28).

Active substance

Adefovir dipivoxil

SFDA 2
US FDA 3
EMA 1
US price lines 1
Safety 1

Open in the medicines table

SFDA Saudi Arabia — SFDA human drug list

Trade name	Strength	Form · route	Pack	Public price	Type	Company	Status
HEPSERA 10MG TABLET	10 mg	Tablet · Oral use	30 Blister	SAR 1871.95	NCE · Prescription	GLAXO SAUDI ARABIA	Withdrawn by MAH · Not Marketed
HEPSERA 10MG TABLET	10 mg	Tablet · Oral use	30 Blister	SAR 2367.35	NCE · Prescription	GLAXOSMITHKLINE (GSK)	Withdrawn by MAH · Not Marketed

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

Product	Strength	Form · route	Applicant	Status	First approved
ADEFOVIR DIPIVOXIL	10MG	tablet · oral	SIGMAPHARM LABS LLC	Prescription	29 Aug 2013
ADEFOVIR DIPIVOXIL	10MG	tablet · oral	APOTEX	Prescription	6 Jul 2018
HEPSERA	10MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	tablet · oral	GILEAD	Discontinued	20 Sep 2002

EMA European Union — centrally authorised medicines

Hepsera Gilead Sciences Ireland UC · Withdrawn · authorised 6 Mar 2003 · ATC J05AF08

Therapeutic indication (EMA)

Hepsera 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 fibrosis. Initiation of Hepsera treatment should only be considered when the use of an alternative antiviral agent with a higher genetic barrier to resistance is not available or appropriate (see section 5.1); decompensated liver disease in combination with a second agent without cross-resistance to Hepsera.

Prices — United States and England

Source	Product as listed	Price	Unit / pack	Date
US NADAC	ADEFOVIR DIPIVOXIL 10 MG TAB	$21.73128	per EA	19 Aug 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.

Safety signals and safety-related labeling changes

US FDA 28 Dec 2018 HEPSERA — safety-related labeling change
Labeling sections changed: Warnings and Precautions; Drug Interactions; Use in Specific Populations; Patient Counseling Information / Patient Information / Medication Guide

All safety entries for adefovir dipivoxil →

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.