HEPSERA

This brand name is authorized in United States. It is also authorized in Austria, Brazil, Canada, Cyprus, Estonia, Finland, France, Hong Kong SAR China, Ireland, Israel, Japan, Lithuania, Netherlands, Poland, Romania, Singapore, Spain, UK.

Active ingredients

The drug HEPSERA contains one active pharmaceutical ingredient (API):

1	Adefovir dipivoxil UNII U6Q8Z01514 - ADEFOVIR DIPIVOXIL
	Adefovir dipivoxil is an oral prodrug of adefovir, an acyclic nucleotide phosphonate analogue of adenosine monophosphate, which is actively transported into mammalian cells where it is converted by host enzymes to adefovir diphosphate. Adefovir diphosphate inhibits viral polymerases by competing for direct binding with the natural substrate (deoxyadenosine triphosphate) and, after incorporation into viral DNA, causes DNA chain termination.
	Read more about Adefovir dipivoxil

Medication package inserts

Below package inserts are available for further reading:

Document	Type	Information Source
Hepsera 10 mg tablets	MPI, EU: SmPC	Medicines & Healthcare Products Regulatory Agency (GB)
HEPSERA Tablet	MPI, EU: SmPC	European Medicines Agency (EU)

Medicine classification

This drug has been classified in the anatomical therapeutic chemical (ATC) classification system as follows:

ATC Group		Classification
J05AF08	Adefovir dipivoxil	J Antiinfectives for systemic use → J05 Antivirals for systemic use → J05A Direct acting antivirals → J05AF Nucleoside and nucleotide reverse transcriptase inhibitors
Discover more medicines within J05AF08

Authorization and marketing

This drug has been assigned below unique identifiers within the countries it is being marketed:

Country	Identification scheme	Identifier(s)
BR	Câmara de Regulação do Mercado de Medicamentos	510610001115217
CA	Health Products and Food Branch	02247823
EE	Ravimiamet	1203073, 1295760
ES	Centro de información online de medicamentos de la AEMPS	03251001
FI	Lääkealan turvallisuus- ja kehittämiskeskus	014510
FR	Base de données publique des médicaments	60954219
GB	Medicines & Healthcare Products Regulatory Agency	78426
HK	Department of Health Drug Office	65358
IE	Health Products Regulatory Authority	88503
IL	מִשְׂרַד הַבְּרִיאוּת	4714
JP	医薬品医療機器総合機構	6250026F1020
LT	Valstybinė vaistų kontrolės tarnyba	1028725, 1028726, 1075653
NL	Z-Index G-Standaard, PRK	70629
PL	Rejestru Produktów Leczniczych	100127602
RO	Agenția Națională a Medicamentului și a Dispozitivelor Medicale	W64757001, W64757002
SG	Health Sciences Authority	12341P
US	FDA, National Drug Code	61958-0501