TEVA-EFAVIRENZ/EMTRICITABINE/TENOFOVIR TABLET

Country: Canada

Language: English

Source: Health Canada

Active ingredient:

EFAVIRENZ; EMTRICITABINE; TENOFOVIR DISOPROXIL FUMARATE

Available from:

TEVA CANADA LIMITED

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:

APPROVED

Authorization date:

2017-07-26

Summary of Product characteristics

PRODUCT MONOGRAPH
PR
TEVA-EFAVIRENZ/EMTRICITABINE/TENOFOVIR
Efavirenz, Emtricitabine and Tenofovir Tablets
Teva Standard
600 mg/200 mg/300 mg
(efavirenz/emtricitabine/tenofovir disoproxil fumarate)
Antiretroviral Agent
Teva Canada Limited
Date of Revision:
30 Novopharm Court
June 1, 2020
Toronto, Ontario
Canada M1B 2K9
www.tevacanada.com
Control No.: 238915
_TEVA-EFAVIRENZ/EMTRICITABINE/TENOFOVIR Product Monograph _
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TABLE OF CONTENTS
PART I: HEALTH PROFESSIONAL INFORMATION
.......................................................... 3
SUMMARY PRODUCT INFORMATION
.................................................................................3
INDICATIONS AND CLINICAL USE
.......................................................................................3
CONTRAINDICATIONS
............................................................................................................3
WARNINGS AND PRECAUTIONS
...........................................................................................4
ADVERSE REACTIONS
...........................................................................................................15
DRUG INTERACTIONS
...........................................................................................................23
DOSAGE AND ADMINISTRATION
.......................................................................................39
OVERDOSAGE
.........................................................................................................................39
ACTION AND CLINICAL PHARMACOLOGY
.....................................................................40
STORAGE AND STABILITY
...................................................................................................44
SPECIAL HANDLING INSTRUCTIONS
................................................................................44
DOSAGE FORMS, COMPOSITION AND PACKAGING
......................................................44
PART II: SCIENTIFIC INFORMATION
..................................