APO-EFAVIRENZ-EMTRICITABINE-TENOFOVIR TABLET

Country: Canada

Language: English

Source: Health Canada

Active ingredient:

EFAVIRENZ; EMTRICITABINE; TENOFOVIR DISOPROXIL FUMARATE

Available from:

APOTEX INC

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:

30/90

Prescription type:

Prescription

Therapeutic area:

NONNUCLEOSIDE REVERSE TRANSCRIPTASE INHIBITORS

Product summary:

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

Authorization status:

APPROVED

Authorization date:

2017-09-14

Summary of Product characteristics

Page 1 of 77
PRODUCT MONOGRAPH
PR
APO-EFAVIRENZ-EMTRICITABINE-TENOFOVIR
EFAVIRENZ, EMTRICITABINE
AND
TENOFOVIR TABLETS
APOTEX STANDARD
600 MG EFAVIRENZ
200 MG EMTRICITABINE
300 MG TENOFOVIR DISOPROXIL FUMARATE
ANTIRETROVIRAL AGENT
APOTEX INC.
Date of Revision:
150 Signet Drive
June 24, 2020.
Toronto, Ontario
M9L 1T9
Submission Control No.: 239967
Page 2 of 77
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
.........................................................................................................
16
DRUG INTERACTIONS
.........................................................................................................
25
DOSAGE AND ADMINISTRATION
.....................................................................................
42
OVERDOSAGE
.......................................................................................................................
43
ACTION AND CLINICAL PHARMACOLOGY
....................................................................
44
STORAGE AND STABILITY
.................................................................................................
48
SPECIAL HANDLING INSTRUCTIONS
..............................................................................
48
DOSAGE FORMS, COMPOSITION AND
PACKAGING..................................................... 48
PART II.
SCIENTIFIC INFORMATION
...................................................................................
49
PHARMACEUTICAL INFORMATION
..........