BARACLUDE

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

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 about Entecavir

Medication package inserts

Below package inserts are available for further reading:

Title	Information Source	Document Type
BARACLUDE Film-coated tablets	European Medicines Agency (EU)	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
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)
Country: BR	Câmara de Regulação do Mercado de Medicamentos	Identifier(s): 505107601111213
Country: CA	Health Products and Food Branch	Identifier(s): 02282224
Country: DE	Bundesinstitut für Arzneimittel und Medizinprodukte	Identifier(s): 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
Country: EE	Ravimiamet	Identifier(s): 1247509, 1247510, 1247521, 1397437, 1397460
Country: ES	Centro de información online de medicamentos de la AEMPS	Identifier(s): 06343003, 06343004
Country: FI	Lääkealan turvallisuus- ja kehittämiskeskus	Identifier(s): 025102, 025368, 058515
Country: FR	Base de données publique des médicaments	Identifier(s): 62048799, 62066808, 69469719
Country: GB	Medicines & Healthcare Products Regulatory Agency	Identifier(s): 107402, 107405, 146056
Country: HK	Department of Health Drug Office	Identifier(s): 55152, 55153
Country: IE	Health Products Regulatory Authority	Identifier(s): 88700, 88732, 88733, 89000, 89049
Country: IT	Agenzia del Farmaco	Identifier(s): 037221076, 037221088
Country: JP	医薬品医療機器総合機構	Identifier(s): 6250029F1024
Country: LT	Valstybinė vaistų kontrolės tarnyba	Identifier(s): 1027697, 1027698, 1027699, 1027700, 1027701, 1056119, 1056120
Country: MX	Comisión Federal para la Protección contra Riesgos Sanitarios	Identifier(s): 521M2005
Country: NL	Z-Index G-Standaard, PRK	Identifier(s): 81388, 81396
Country: NZ	Medicines and Medical Devices Safety Authority	Identifier(s): 11970, 11971
Country: PL	Rejestru Produktów Leczniczych	Identifier(s): 100163319, 100163325, 100163331
Country: RO	Agenția Națională a Medicamentului și a Dispozitivelor Medicale	Identifier(s): W65556001, W65556002, W65556003, W65557001, W65557002, W65557003
Country: SG	Health Sciences Authority	Identifier(s): 13165P, 13167P
Country: TN	Direction de la Pharmacie et du Médicament	Identifier(s): 11033011H, 11033012H
Country: TR	İlaç ve Tıbbi Cihaz Kurumu	Identifier(s): 8699726093100, 8699726093308
Country: US	FDA, National Drug Code	Identifier(s): 0003-1611, 0003-1612, 0003-1614