MYLAN-VENLAFAXINE XR CAPSULE (EXTENDED RELEASE)

Country: Կանադա

language: անգլերեն

source: Health Canada

active_ingredient:

VENLAFAXINE (VENLAFAXINE HYDROCHLORIDE)

MAH:

MYLAN PHARMACEUTICALS ULC

ATC_code:

N06AX16

INN:

VENLAFAXINE

dosage:

37.5MG

pharmaceutical_form:

CAPSULE (EXTENDED RELEASE)

composition:

VENLAFAXINE (VENLAFAXINE HYDROCHLORIDE) 37.5MG

administration_route:

ORAL

units_in_package:

100/500

prescription_type:

Prescription

therapeutic_area:

SELECTIVE SEROTONIN AND NOREPINEPHRINE-REUPTAKE INHIBITORS

leaflet_short:

Active ingredient group (AIG) number: 0131294002; AHFS:

authorization_status:

CANCELLED POST MARKET

authorization_date:

2018-02-07

SPC

PAGE 1 OF 62
PRODUCT MONOGRAPH
PR
MYLAN-VENLAFAXINE XR CAPSULES
(VENLAFAXINE HYDROCHLORIDE)
EXTENDED RELEASE CAPSULES
(37.5 MG, 75 MG, AND 150 MG VENLAFAXINE AS VENLAFAXINE HYDROCHLORIDE)
ANTIDEPRESSANT
Mylan Pharmaceuticals ULC
Date of Revision:
85 Advance Rd.
May 17, 2018
Etobicoke, Ontario
M8Z 2S6
Submission Control No.: 215657
PAGE 2 OF 62
TABLE OF CONTENTS
PART I: HEALTH PROFESSIONAL
INFORMATION...............................................................
3
SUMMARY PRODUCT INFORMATION
...............................................................................
3
INDICATIONS AND CLINICAL USE
.....................................................................................
3
CONTRAINDICATIONS
..........................................................................................................
4
WARNINGS AND PRECAUTIONS
.........................................................................................
4
ADVERSE REACTIONS
.........................................................................................................
16
DRUG INTERACTIONS
.........................................................................................................
29
DOSAGE AND ADMINISTRATION
.....................................................................................
36
OVERDOSAGE
.......................................................................................................................
39
ACTION AND CLINICAL PHARMACOLOGY
................................................................... 41
STORAGE AND STABILITY
.................................................................................................
45
SPECIAL HANDLING INSTRUCTIONS
..............................................................................
45
DOSAGE FORMS, COMPOSITION AND PACKAGING
.................................................... 45
PART II: SCIENTIFIC INFORMATION
....................................................................................
47
PHARMACEUTICAL INFORMATION
.......................