AURO-EFAVIRENZ TABLET

Država: Kanada

Jezik: angleščina

Source: Health Canada

Aktivna sestavina:

EFAVIRENZ

Dostopno od:

AURO PHARMA INC

Koda artikla:

J05AG03

INN (mednarodno ime):

EFAVIRENZ

Odmerek:

600MG

Farmacevtska oblika:

TABLET

Sestava:

EFAVIRENZ 600MG

Pot uporabe:

ORAL

Enote v paketu:

10/30/90/500

Tip zastaranja:

Prescription

Terapevtsko območje:

NONNUCLEOSIDE REVERSE TRANSCRIPTASE INHIBITORS

Povzetek izdelek:

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

Status dovoljenje:

APPROVED

Datum dovoljenje:

2013-12-17

Lastnosti izdelka

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....................…�