MYLAN-EFAVIRENZ TABLET

Country: Kanada

Lingwa: Ingliż

Sors: Health Canada

Ingredjent attiv:

EFAVIRENZ

Disponibbli minn:

MYLAN PHARMACEUTICALS ULC

Kodiċi ATC:

J05AG03

INN (Isem Internazzjonali):

EFAVIRENZ

Dożaġġ:

600MG

Għamla farmaċewtika:

TABLET

Kompożizzjoni:

EFAVIRENZ 600MG

Rotta amministrattiva:

ORAL

Unitajiet fil-pakkett:

30/100

Tip ta 'preskrizzjoni:

Prescription

Żona terapewtika:

NONNUCLEOSIDE REVERSE TRANSCRIPTASE INHIBITORS

Sommarju tal-prodott:

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

L-istatus ta 'awtorizzazzjoni:

APPROVED

Data ta 'l-awtorizzazzjoni:

2013-07-30

Karatteristiċi tal-prodott

_ _
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
_ _
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
.................................................................