VOSEVI

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

Active ingredients

The drug VOSEVI 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

3 Voxilaprevir UNII 0570F37359 - VOXILAPREVIR

Voxilaprevir is a pan-genotypic inhibitor of the HCV NS3/4A protease. Voxilaprevir acts as a noncovalent, reversible inhibitor of the NS3/4A protease. Read about Voxilaprevir

Medication package inserts

Below package inserts are available for further reading:

Title	Information Source	Document Type
VOSEVI 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
J05AP56		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 J05AP56

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): 11658N, 11659P, 11665Y
Country: BR	Câmara de Regulação do Mercado de Medicamentos	Identifier(s): 546820090000907
Country: CA	Health Products and Food Branch	Identifier(s): 02467542
Country: EE	Ravimiamet	Identifier(s): 1751015, 1862456
Country: ES	Centro de información online de medicamentos de la AEMPS	Identifier(s): 1171223001
Country: FI	Lääkealan turvallisuus- ja kehittämiskeskus	Identifier(s): 138505
Country: FR	Base de données publique des médicaments	Identifier(s): 61932485
Country: GB	Medicines & Healthcare Products Regulatory Agency	Identifier(s): 348215
Country: HK	Department of Health Drug Office	Identifier(s): 65775
Country: IL	מִשְׂרַד הַבְּרִיאוּת	Identifier(s): 8203
Country: IT	Agenzia del Farmaco	Identifier(s): 045494010, 045494022
Country: LT	Valstybinė vaistų kontrolės tarnyba	Identifier(s): 1083657, 1093372
Country: NL	Z-Index G-Standaard, PRK	Identifier(s): 151319
Country: NZ	Medicines and Medical Devices Safety Authority	Identifier(s): 19933
Country: PL	Rejestru Produktów Leczniczych	Identifier(s): 100392362, 100461459
Country: RO	Agenția Națională a Medicamentului și a Dispozitivelor Medicale	Identifier(s): W64760001
Country: SG	Health Sciences Authority	Identifier(s): 15705P
Country: TR	İlaç ve Tıbbi Cihaz Kurumu	Identifier(s): 8698760090243
Country: US	FDA, National Drug Code	Identifier(s): 61958-2401