HEPSERA

This brand name is authorized in Austria, Brazil, Canada, Cyprus, Estonia, Spain, Finland, France, Hong Kong, Ireland, Israel, Japan, Lithuania, Netherlands, Poland, Romania, Singapore, United Kingdom, United States

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 about Adefovir dipivoxil

Medication package inserts

Below package inserts are available for further reading:

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

Medicine classification

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

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

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