AURO-EFAVIRENZ TABLET

Land: Canada

Språk: engelsk

Kilde: Health Canada

Aktiv ingrediens:

EFAVIRENZ

Tilgjengelig fra:

AURO PHARMA INC

ATC-kode:

J05AG03

INN (International Name):

EFAVIRENZ

Dosering :

600MG

Legemiddelform:

TABLET

Sammensetning:

EFAVIRENZ 600MG

Administreringsrute:

ORAL

Enheter i pakken:

10/30/90/500

Resept typen:

Prescription

Terapeutisk område:

NONNUCLEOSIDE REVERSE TRANSCRIPTASE INHIBITORS

Produkt oppsummering:

Active ingredient group (AIG) number: 0137031005; AHFS:

Autorisasjon status:

APPROVED

Autorisasjon dato:

2013-12-17

Preparatomtale

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....................…�