ATRIPLA TABLET
Country: Canada
Language: English
Source: Health Canada
Summary of Product characteristics
(SPC)
12-02-2020
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Active ingredient:
EFAVIRENZ; EMTRICITABINE; TENOFOVIR DISOPROXIL FUMARATE
Available from:
GILEAD SCIENCES, LLC
ATC code:
J05AR06
INN (International Name):
EMTRICITABINE, TENOFOVIR DISOPROXIL AND EFAVIRENZ
Dosage:
600MG; 200MG; 300MG
Pharmaceutical form:
TABLET
Composition:
EFAVIRENZ 600MG; EMTRICITABINE 200MG; TENOFOVIR DISOPROXIL FUMARATE 300MG
Administration route:
ORAL
Units in package:
30
Prescription type:
Prescription
Therapeutic area:
NONNUCLEOSIDE REVERSE TRANSCRIPTASE INHIBITORS
Product summary:
Active ingredient group (AIG) number: 0352327001; AHFS:
Authorization status:
CANCELLED POST MARKET
Authorization date:
2021-12-22
Summary of Product characteristics
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........
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