ZEPATIER

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

Active ingredients

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

1
UNII 632L571YDK - ELBASVIR
 
Read more about Elbasvir
2
UNII 8YE81R1X1J - GRAZOPREVIR ANHYDROUS
 
Read more about Grazoprevir

Medication package inserts

Below package inserts are available for further reading:

Document Type Information Source  
 ZEPATIER 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
J05AP54 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 J05AP54

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 525518010020302
CA Health Products and Food Branch 02451131
EE Ravimiamet 1725870
ES Centro de información online de medicamentos de la AEMPS 1161119001
FI Lääkealan turvallisuus- ja kehittämiskeskus 050068
FR Base de données publique des médicaments 66198173
GB Medicines & Healthcare Products Regulatory Agency 334084, 369093
HK Department of Health Drug Office 65571, 66768
IL מִשְׂרַד הַבְּרִיאוּת 7989
IT Agenzia del Farmaco 044929014
LT Valstybinė vaistų kontrolės tarnyba 1080792
NL Z-Index G-Standaard, PRK 137545
PL Rejestru Produktów Leczniczych 100376883
RO Agenția Națională a Medicamentului și a Dispozitivelor Medicale W64591001
SG Health Sciences Authority 15404P
US FDA, National Drug Code 0006-3074

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