AURO-EFAVIRENZ TABLET
Country: Canada
Language: English
Source: Health Canada
Summary of Product characteristics
(SPC)
11-02-2020
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Active ingredient:
EFAVIRENZ
Available from:
AURO PHARMA INC
ATC code:
J05AG03
INN (International Name):
EFAVIRENZ
Dosage:
600MG
Pharmaceutical form:
TABLET
Composition:
EFAVIRENZ 600MG
Administration route:
ORAL
Units in package:
10/30/90/500
Prescription type:
Prescription
Therapeutic area:
NONNUCLEOSIDE REVERSE TRANSCRIPTASE INHIBITORS
Product summary:
Active ingredient group (AIG) number: 0137031005; AHFS:
Authorization status:
APPROVED
Authorization date:
2013-12-17
Summary of Product characteristics
Page 1 of 53
PRODUCT MONOGRAPH
Pr
AURO-EFAVIRENZ
Efavirenz Tablets, 600 mg
House Standard
Antiretroviral Agent
AURO PHARMA INC.
3700 Steeles Avenue West, Suite # 402
Woodbridge, Ontario, L4L 8K8
CANADA
Date of Revision:
February 11, 2020
Control Number:
235726
Page 2 of 53
TABLE OF CONTENTS
_ _
PRODUCT MONOGRAPH
............................................................................................1
TABLE OF CONTENTS
................................................................................................
2
PART I:
HEALTH PROFESSIONAL INFORMATION.......………..............
3
SUMMARY PRODUCT INFORMATION .....................….............
3
INDICATIONS AND CLINICAL USE .....................……...........
3
CONTRAINDICATIONS
.........................................………........... 3
WARNINGS AND PRECAUTIONS
..........................…….............. 4
ADVERSE
REACTIONS.....................................………….............
10
DRUG INTERACTIONS
..............................……………................ 16
DOSAGE AND ADMINISTRATION .............…............................
22
OVERDOSAGE
......................................………….........................
23
ACTION AND CLINICAL PHARMACOLOGY….........................
23
STORAGE AND STABILITY
........................................…….......... 30
DOSAGE FORMS, COMPOSITION AND PACKAGING….......
30
PART II:
SCIENTIFIC
INFORMATION..........................…………….….......
31
PHARMACEUTICAL INFORMATION.........................….............
31
CLINICAL TRIALS
...............................................……………......
32
DETAILED PHARMACOLOGY ..............................……………..
39
VIROLOGY
.............................…………………………............
40
TOXICOLOGY
............................…………………………............
42
REFERENCES
....................................………………………….....
48
PART III:
CONSUMER
INFORMATION....................…
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