AURO-EFAVIRENZ TABLET

Land: Kanada

Sprache: Englisch

Quelle: Health Canada

Wirkstoff:

EFAVIRENZ

Verfügbar ab:

AURO PHARMA INC

ATC-Code:

J05AG03

INN (Internationale Bezeichnung):

EFAVIRENZ

Dosierung:

600MG

Darreichungsform:

TABLET

Zusammensetzung:

EFAVIRENZ 600MG

Verabreichungsweg:

ORAL

Einheiten im Paket:

10/30/90/500

Verschreibungstyp:

Prescription

Therapiebereich:

NONNUCLEOSIDE REVERSE TRANSCRIPTASE INHIBITORS

Produktbesonderheiten:

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

Berechtigungsstatus:

APPROVED

Berechtigungsdatum:

2013-12-17

Fachinformation

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....................…�