BARACLUDE

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

Active ingredients

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

1	Entecavir UNII 5968Y6H45M - ENTECAVIR
	Entecavir, a guanosine nucleoside analogue with activity against HBV polymerase, is efficiently phosphorylated to the active triphosphate (TP) form, which has an intracellular half-life of 15 hours. By competing with the natural substrate deoxyguanosine TP, entecavir-TP functionally inhibits the 3 activities of the viral polymerase: (1) priming of the HBV polymerase, (2) reverse transcription of the negative strand DNA from the pregenomic messenger RNA, and (3) synthesis of the positive strand HBV DNA.
	Read more about Entecavir

Medication package inserts

Below package inserts are available for further reading:

Document	Type	Information Source
BARACLUDE Film-coated 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
J05AF10	Entecavir	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 J05AF10

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	505107601111213
CA	Health Products and Food Branch	02282224
DE	Bundesinstitut für Arzneimittel und Medizinprodukte	04492968, 04493117, 05012864, 05480826, 05541261, 05541278, 05896797, 05988536, 05988542, 06434538, 07349906, 10318163, 10318186, 10532838, 10532844, 10744405, 10833244, 10833250, 10917372, 11000954, 11046896, 11344866, 12740682, 12740699, 13421619, 15896752
EE	Ravimiamet	1247509, 1247510, 1247521, 1397437, 1397460
ES	Centro de información online de medicamentos de la AEMPS	06343003, 06343004
FI	Lääkealan turvallisuus- ja kehittämiskeskus	025102, 025368, 058515
FR	Base de données publique des médicaments	62048799, 62066808, 69469719
GB	Medicines & Healthcare Products Regulatory Agency	107402, 107405, 146056
HK	Department of Health Drug Office	55152, 55153
IE	Health Products Regulatory Authority	88700, 88732, 88733, 89000, 89049
IT	Agenzia del Farmaco	037221076, 037221088
JP	医薬品医療機器総合機構	6250029F1024
LT	Valstybinė vaistų kontrolės tarnyba	1027697, 1027698, 1027699, 1027700, 1027701, 1056119, 1056120
MX	Comisión Federal para la Protección contra Riesgos Sanitarios	521M2005
NL	Z-Index G-Standaard, PRK	81388, 81396
NZ	Medicines and Medical Devices Safety Authority	11970, 11971
PL	Rejestru Produktów Leczniczych	100163319, 100163325, 100163331
RO	Agenția Națională a Medicamentului și a Dispozitivelor Medicale	W65556001, W65556002, W65556003, W65557001, W65557002, W65557003
SG	Health Sciences Authority	13165P, 13167P
TN	Direction de la Pharmacie et du Médicament	11033011H, 11033012H
TR	İlaç ve Tıbbi Cihaz Kurumu	8699726093100, 8699726093308
US	FDA, National Drug Code	0003-1611, 0003-1612, 0003-1614