SOVALDI

This brand name is authorized in Brazil, Canada, Cyprus, Estonia, Spain, Finland, France, Hong Kong, Ireland, Lithuania, Netherlands, Poland, Romania, Singapore, Tunisia, Turkey, United Kingdom, United States

Active ingredients

The drug SOVALDI contains one active pharmaceutical ingredient (API):

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

Medication package inserts

Below package inserts are available for further reading:

Title	Information Source	Document Type
SOVALDI 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
J05AP08		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 J05AP08

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): 546815090000001
Country: CA	Health Products and Food Branch	Identifier(s): 02418355
Country: EE	Ravimiamet	Identifier(s): 1637995, 1638008, 1821978, 1821990, 1822003
Country: ES	Centro de información online de medicamentos de la AEMPS	Identifier(s): 113894001
Country: FI	Lääkealan turvallisuus- ja kehittämiskeskus	Identifier(s): 062575
Country: FR	Base de données publique des médicaments	Identifier(s): 61206641
Country: GB	Medicines & Healthcare Products Regulatory Agency	Identifier(s): 245695
Country: HK	Department of Health Drug Office	Identifier(s): 63501
Country: LT	Valstybinė vaistų kontrolės tarnyba	Identifier(s): 1072554, 1072555, 1090797, 1090798, 1090799
Country: NL	Z-Index G-Standaard, PRK	Identifier(s): 112690
Country: PL	Rejestru Produktów Leczniczych	Identifier(s): 100288446, 100443020, 100443036, 100443042
Country: RO	Agenția Națională a Medicamentului și a Dispozitivelor Medicale	Identifier(s): W64758001, W64758002
Country: SG	Health Sciences Authority	Identifier(s): 14771P
Country: TN	Direction de la Pharmacie et du Médicament	Identifier(s): 11353021H
Country: TR	İlaç ve Tıbbi Cihaz Kurumu	Identifier(s): 8698760090106, 8698760090113
Country: US	FDA, National Drug Code	Identifier(s): 61958-1501, 61958-1503, 61958-1504, 61958-1505