MYLAN-EFAVIRENZ TABLET
Country: Canada
Language: English
Source: Health Canada
Summary of Product characteristics
(SPC)
15-02-2021
Some documents for this product are not currently available, you can send a request to our customer service and we will notify you as soon as we are able to obtain them.
Send request.
Send request.
Active ingredient:
EFAVIRENZ
Available from:
MYLAN PHARMACEUTICALS ULC
ATC code:
J05AG03
INN (International Name):
EFAVIRENZ
Dosage:
600MG
Pharmaceutical form:
TABLET
Composition:
EFAVIRENZ 600MG
Administration route:
ORAL
Units in package:
30/100
Prescription type:
Prescription
Therapeutic area:
NONNUCLEOSIDE REVERSE TRANSCRIPTASE INHIBITORS
Product summary:
Active ingredient group (AIG) number: 0137031005; AHFS:
Authorization status:
APPROVED
Authorization date:
2013-07-30
Summary of Product characteristics
_ _
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
.................................................................
Read the complete document
