ATRIPLA TABLET

Pays: Canada

Langue: anglais

Source: Health Canada

Ingrédients actifs:

EFAVIRENZ; EMTRICITABINE; TENOFOVIR DISOPROXIL FUMARATE

Disponible depuis:

GILEAD SCIENCES, LLC

Code ATC:

J05AR06

DCI (Dénomination commune internationale):

EMTRICITABINE, TENOFOVIR DISOPROXIL AND EFAVIRENZ

Dosage:

600MG; 200MG; 300MG

forme pharmaceutique:

TABLET

Composition:

EFAVIRENZ 600MG; EMTRICITABINE 200MG; TENOFOVIR DISOPROXIL FUMARATE 300MG

Mode d'administration:

ORAL

Unités en paquet:

30

Type d'ordonnance:

Prescription

Domaine thérapeutique:

NONNUCLEOSIDE REVERSE TRANSCRIPTASE INHIBITORS

Descriptif du produit:

Active ingredient group (AIG) number: 0352327001; AHFS:

Statut de autorisation:

CANCELLED POST MARKET

Date de l'autorisation:

2021-12-22

Résumé des caractéristiques du produit

PRODUCT MONOGRAPH
PR
ATRIPLA
®
(EFAVIRENZ/EMTRICITABINE/
TENOFOVIR DISOPROXIL FUMARATE) TABLETS
600 MG EFAVIRENZ
200 MG EMTRICITABINE
300 MG TENOFOVIR DISOPROXIL FUMARATE
ANTIRETROVIRAL AGENT
Gilead Sciences, LLC.
Foster City, CA 94404
USA
Gilead Sciences Canada, Inc.
Mississauga, ON L5N 2W3
www.gilead.ca
Submission Control No.: 235076_ _
Date of Revision:
February 12, 2020
ATRIPLA
®
(efavirenz/emtricitabine/tenofovir disoproxil fumarate) tablets
Product Monograph
Page 2
TABLE OF CONTENTS
PART I.
HEALTH PROFESSIONAL INFORMATION
................................................................................
3
SUMMARY PRODUCT INFORMATION
..................................................................................................
3
INDICATIONS AND CLINICAL USE
........................................................................................................
3
CONTRAINDICATIONS
.............................................................................................................................
3
WARNINGS AND PRECAUTIONS
............................................................................................................
5
ADVERSE REACTIONS
............................................................................................................................
15
DRUG INTERACTIONS
............................................................................................................................
25
DOSAGE AND ADMINISTRATION
........................................................................................................
44
OVERDOSAGE
..........................................................................................................................................
45
ACTION AND CLINICAL PHARMACOLOGY
.......................................................................................
46
STORAGE AND STABILITY
....................................................................................................................
50
SPECIAL HANDLING
INSTRUCTIONS........