SOVALDI

This brand name is authorized in United States. It is also authorized in Brazil, Canada, Cyprus, Estonia, Finland, France, Hong Kong SAR China, Ireland, Lithuania, Netherlands, Poland, Romania, Singapore, Spain, Tunisia, Turkey, UK.

Active ingredients

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

1
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

Medication package inserts

Below package inserts are available for further reading:

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

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