EPCLUSA

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

Active ingredients

The drug EPCLUSA contains a combination of these active pharmaceutical ingredients (APIs):

1 Sofosbuvir UNII WJ6CA3ZU8B - SOFOSBUVIR

Sofosbuvir is a pan-genotypic inhibitor of the HCV NS5B RNA-dependent RNA polymerase, which is essential for viral replication. Sofosbuvir is a nucleotide prodrug that undergoes intracellular metabolism to form the pharmacologically active uridine analog triphosphate (GS-461203), which can be incorporated into HCV RNA by the NS5B polymerase and acts as a chain terminator. Read about Sofosbuvir

2 Velpatasvir UNII KCU0C7RS7Z - VELPATASVIR

Velpatasvir is a HCV inhibitor targeting the HCV NS5A protein, which is essential for both RNA replication and the assembly of HCV virions. In vitro resistance selection and cross-resistance studies indicate velpatasvir targets NS5A as its mode of action. Read about Velpatasvir

Medication package inserts

Below package inserts are available for further reading:

Title	Information Source	Document Type
EPCLUSA Film-coated tablet	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
J05AP55		J Antiinfectives for systemic use → J05 Antivirals for systemic use → J05A Direct acting antivirals → J05AP Antivirals for treatment of HCV infections
Discover more medicines within J05AP55

Authorization and marketing

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

Country	Identification scheme	Identifier(s)
Country: AU	Pharmaceutical Benefits Scheme	Identifier(s): 11144M, 11145N, 11147Q
Country: BR	Câmara de Regulação do Mercado de Medicamentos	Identifier(s): 546818070000207
Country: CA	Health Products and Food Branch	Identifier(s): 02456370
Country: EE	Ravimiamet	Identifier(s): 1725825, 1826287, 1873201, 1884168
Country: ES	Centro de información online de medicamentos de la AEMPS	Identifier(s): 1161116001
Country: FI	Lääkealan turvallisuus- ja kehittämiskeskus	Identifier(s): 131873, 491230
Country: FR	Base de données publique des médicaments	Identifier(s): 63434686
Country: GB	Medicines & Healthcare Products Regulatory Agency	Identifier(s): 336165, 392963
Country: HK	Department of Health Drug Office	Identifier(s): 65046
Country: IL	מִשְׂרַד הַבְּרִיאוּת	Identifier(s): 7976
Country: JP	医薬品医療機器総合機構	Identifier(s): 6250116F1025
Country: LT	Valstybinė vaistų kontrolės tarnyba	Identifier(s): 1080783, 1091058
Country: NG	Registered Drug Product Database	Identifier(s): C4-1333
Country: NL	Z-Index G-Standaard, PRK	Identifier(s): 142026
Country: NZ	Medicines and Medical Devices Safety Authority	Identifier(s): 18118
Country: PL	Rejestru Produktów Leczniczych	Identifier(s): 100376860, 100447620
Country: RO	Agenția Națională a Medicamentului și a Dispozitivelor Medicale	Identifier(s): W64754001, W68904001, W68905001, W68915001
Country: SG	Health Sciences Authority	Identifier(s): 15351P
Country: US	FDA, National Drug Code	Identifier(s): 61958-2201, 61958-2203