EPCLUSA

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

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 more 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 more about Velpatasvir

Medication package inserts

Below package inserts are available for further reading:

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