EPCLUSA TABLET

Pays: Canada

Langue: anglais

Source: Health Canada

Ingrédients actifs:

SOFOSBUVIR; VELPATASVIR

Disponible depuis:

GILEAD SCIENCES CANADA INC

Code ATC:

J05AP55

DCI (Dénomination commune internationale):

SOFOSBUVIR AND VELPATASVIR

Dosage:

400MG; 100MG

forme pharmaceutique:

TABLET

Composition:

SOFOSBUVIR 400MG; VELPATASVIR 100MG

Mode d'administration:

ORAL

Unités en paquet:

28

Type d'ordonnance:

Prescription

Domaine thérapeutique:

HCV Polymerase Inhibitors

Descriptif du produit:

Active ingredient group (AIG) number: 0258270001; AHFS:

Statut de autorisation:

APPROVED

Date de l'autorisation:

2016-07-11

Résumé des caractéristiques du produit

_Product Monograph _
_ _
_Epclusa (sofosbuvir/velpatasvir) tablets _
_Page 1 of 70_
PRODUCT MONOGRAPH
INCLUDING PATIENT MEDICATION INFORMATION
PR
EPCLUSA
®
sofosbuvir/velpatasvir tablets
400 mg/100 mg, Oral
Antiviral Agent
Gilead Sciences Canada, Inc.
Mississauga, ON L5N 2W3
www.gilead.ca
Date of Initial Authorization:
July 11, 2016
Date of Revision:
August 8, 2022
Submission Control Number: 256301
_ _
_Product Monograph _
_ _
_Epclusa (sofosbuvir/velpatasvir) tablets _
_Page 2 of 70_
RECENT MAJOR LABEL CHANGES
1 Indications
11/2020
7 Warnings and Precautions, Hepatic/Biliary/Pancreatic
11/2020
7 Warnings and Precautions, 7.1 Special Populations, 7.1.3
Pediatrics (< 18 years of age)
11/2020
7 Warnings and Precautions, 7.1 Special Populations, 7.1.5
Others, HCV/HIV-1 Co-infection
11/2020
TABLE OF CONTENTS
SECTIONS OR SUBSECTIONS THAT ARE NOT APPLICABLE AT THE TIME OF
AUTHORIZATION ARE NOT
LISTED.
RECENT MAJOR LABEL CHANGES
....................................................................................
2
TABLE OF CONTENTS
.........................................................................................................
2
PART I: HEALTH PROFESSIONAL
INFORMATION..............................................................
4
1
INDICATIONS.............................................................................................................
4
1.1
Pediatrics (<18 years of
age)........................................................................
4
1.2
Geriatrics (≥ 65 years of age)
.......................................................................
4
2
CONTRAINDICATIONS
..............................................................................................
4
3
SERIOUS WARNINGS AND PRECAUTIONS
BOX..................................................... 5
4
DOSAGE AND ADMINISTRATION
.............................................................................
5
4.2
Recommended Dose and Dosage
Adjustment.............................................. 5
4.5
Missed Dose
........................