SANDOZ EMTRICITABINE-TENOFOVIR TABLET
Country: Canada
Language: English
Source: Health Canada
Summary of Product characteristics
(SPC)
24-04-2019
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Active ingredient:
TENOFOVIR DISOPROXIL FUMARATE; EMTRICITABINE
Available from:
SANDOZ CANADA INCORPORATED
ATC code:
J05AR03
INN (International Name):
TENOFOVIR DISOPROXIL AND EMTRICITABINE
Dosage:
300MG; 200MG
Pharmaceutical form:
TABLET
Composition:
TENOFOVIR DISOPROXIL FUMARATE 300MG; EMTRICITABINE 200MG
Administration route:
ORAL
Units in package:
100
Prescription type:
Prescription
Therapeutic area:
NUCLEOSIDE AND NUCLEOTIDE REVERSE TRANSCRIPTASE INHIBITORS
Product summary:
Active ingredient group (AIG) number: 0251568001; AHFS:
Authorization status:
CANCELLED PRE MARKET
Authorization date:
2022-05-11
Summary of Product characteristics
Page 1 of 66
PRODUCT MONOGRAPH
Pr
SANDOZ EMTRICITABINE-TENOFOVIR
Emtricitabine and Tenofovir Tablets
200 mg/300 mg
(emtricitabine and tenofovir disoproxil fumarate)
Manufacturer’s Standard
Antiretroviral Agent
Sandoz Canada Inc.
110, de Lauzon Street
Boucherville, QC, Canada
J4B 1E6
Date of Preparation:
April 24, 2019
Submission Control No: 211963
Page 2 of 66
TABLE OF CONTENTS
PART I.
HEALTH PROFESSIONAL INFORMATION
............................................................. 3
SUMMARY PRODUCT INFORMATION
.........................................................................
3
INDICATIONS AND CLINICAL USE
...............................................................................
3
CONTRAINDICATIONS
....................................................................................................
5
WARNINGS AND PRECAUTIONS
...................................................................................
5
ADVERSE REACTIONS
...................................................................................................
14
DRUG INTERACTIONS
...................................................................................................
21
DOSAGE AND ADMINISTRATION
...............................................................................
34
OVERDOSAGE
.................................................................................................................
36
ACTION AND CLINICAL PHARMACOLOGY
.............................................................. 36
STORAGE AND STABILITY
...........................................................................................
39
SPECIAL HANDLING INSTRUCTIONS
.........................................................................
39
DOSAGE FORMS, COMPOSITION AND PACKAGING
............................................... 39
PART II.
SCIENTIFIC INFORMATION
...................................................................................
40
PHARMACEUTICAL INFORMATION
...........................................................................
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