MYLAN-EFAVIRENZ TABLET

Land: Canada

Taal: Engels

Bron: Health Canada

Werkstoffen:

EFAVIRENZ

Beschikbaar vanaf:

MYLAN PHARMACEUTICALS ULC

ATC-code:

J05AG03

INN (Algemene Internationale Benaming):

EFAVIRENZ

Dosering:

600MG

farmaceutische vorm:

TABLET

Samenstelling:

EFAVIRENZ 600MG

Toedieningsweg:

ORAL

Eenheden in pakket:

30/100

Prescription-type:

Prescription

Therapeutisch gebied:

NONNUCLEOSIDE REVERSE TRANSCRIPTASE INHIBITORS

Product samenvatting:

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

Autorisatie-status:

APPROVED

Autorisatie datum:

2013-07-30

Productkenmerken

_ _
PRODUCT MONOGRAPH
Pr MYLAN-EFAVIRENZ
(efavirenz tablets)
600 mg
Antiretroviral Agent
Mylan Pharmaceuticals ULC
85 Advance Road
Etobicoke, ON
M8Z 2S6
Date of Revision:
February 15, 2021
Submission Control No. 248541
Page 2 of 54
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TABLE OF CONTENTS
PART I: HEALTH PROFESSIONAL INFORMATION
................................................... 3
SUMMARY PRODUCT INFORMATION
.............................................................................
3
INDICATIONS AND CLINICAL USE
..................................................................................
3
CONTRAINDICATIONS
.......................................................................................................
3
WARNINGS AND PRECAUTIONS
......................................................................................
4
ADVERSE REACTIONS
.....................................................................................................
11
DRUG INTERACTIONS
......................................................................................................
17
DOSAGE AND ADMINISTRATION
..................................................................................
23
OVERDOSAGE....................................................................................................................
24
ACTION AND CLINICAL PHARMACOLOGY
................................................................. 24
STORAGE AND STABILITY
..............................................................................................
31
DOSAGE FORMS, COMPOSITION AND PACKAGING
................................................... 31
PART II: SCIENTIFIC INFORMATION
.........................................................................
33
PHARMACEUTICAL INFORMATION
..............................................................................
33
CLINICAL TRIALS
.............................................................................................................
34
DETAILED PHARMACOLOGY
.................................................................