HARVONI

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

Active ingredients

The drug HARVONI contains a combination of these active pharmaceutical ingredients (APIs):

1	Ledipasvir UNII 013TE6E4WV - LEDIPASVIR
	Read more about Ledipasvir
2	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

Medication package inserts

Below package inserts are available for further reading:

Document	Type	Information Source
HARVONI 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
J05AP51		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 J05AP51

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	10628J, 10653Q, 10661D, 10667K, 10668L, 10669M, 10670N, 10672Q, 10679C
BR	Câmara de Regulação do Mercado de Medicamentos	546818020000102
CA	Health Products and Food Branch	02432226
EC	Agencia Nacional de Regulación, Control y Vigilancia Sanitaria	5756-MEE-1220
EE	Ravimiamet	1668955, 1668966, 1823510, 1823521, 1823532, 1823543
ES	Centro de información online de medicamentos de la AEMPS	114958001
FI	Lääkealan turvallisuus- ja kehittämiskeskus	461465, 488991, 573382
FR	Base de données publique des médicaments	64426906
GB	Medicines & Healthcare Products Regulatory Agency	283205, 398152
HK	Department of Health Drug Office	63886
IL	מִשְׂרַד הַבְּרִיאוּת	7822
JP	医薬品医療機器総合機構	6250107F1026
LT	Valstybinė vaistų kontrolės tarnyba	1074960, 1074961, 1090844, 1090845, 1090846
NL	Z-Index G-Standaard, PRK	127094
NZ	Medicines and Medical Devices Safety Authority	16741
PL	Rejestru Produktów Leczniczych	100332851, 100442396, 100442404, 100442410
RO	Agenția Națională a Medicamentului și a Dispozitivelor Medicale	W64756001
SG	Health Sciences Authority	14920P
TN	Direction de la Pharmacie et du Médicament	11353031H
TR	İlaç ve Tıbbi Cihaz Kurumu	8698760090120, 8698760090137
US	FDA, National Drug Code	61958-1801, 61958-1803, 61958-1804, 61958-1805