VOSEVI

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, Italy, Lithuania, Netherlands, New Zealand, Poland, Romania, Singapore, Spain, Turkey, UK.

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 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
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 more about Voxilaprevir

Medication package inserts

Below package inserts are available for further reading:

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