VENLAFAXINE HYDROCHLORIDE EXTENDED-RELEASE CAPSULES CAPSULE (EXTENDED RELEASE)

국가: 캐나다

언어: 영어

출처: Health Canada

유효 성분:

VENLAFAXINE (VENLAFAXINE HYDROCHLORIDE)

제공처:

DR. REDDY'S LABORATORIES INC

ATC 코드:

N06AX16

INN (국제 이름):

VENLAFAXINE

복용량:

75MG

약제 형태:

CAPSULE (EXTENDED RELEASE)

구성:

VENLAFAXINE (VENLAFAXINE HYDROCHLORIDE) 75MG

관리 경로:

ORAL

패키지 단위:

100

처방전 유형:

Prescription

치료 영역:

SELECTIVE SEROTONIN AND NOREPINEPHRINE-REUPTAKE INHIBITORS

제품 요약:

Active ingredient group (AIG) number: 0131294001; AHFS:

승인 상태:

CANCELLED PRE MARKET

승인 날짜:

2022-07-13

제품 특성 요약

Page
1
of
68
PRODUCT MONOGRAPH
PR
VENLAFAXINE HYDROCHLORIDE
EXTENDED-RELEASE CAPSULES
(37.5 MG, 75 MG, 150 MG VENLAFAXINE HYDROCHLORIDE EXTENDED RELEASE
CAPSULES)
ANTIDEPRESSANT/ANXIOLYTIC
MANUFACTURED BY:
DR.REDDYS LABORATORIES INC.
,
DATE OF PREPARATION:
200 Somerset Corporate BLVD
SEPTEMBER 20, 2011
Floor 7, Bridgewater,
New Jersey 08807
DISTRIBUTED BY:
UPS - SCS INC.
4071 North Service Road
Burlington, ON L7L 4X6
905-315-1575
SUBMISSION CONTROL NO: 124517
Page
2
of
68
TABLE OF CONTENTS
PART I: HEALTH PROFESSIONAL
INFORMATION...............................................3
SUMMARY PRODUCT INFORMATION
........................................................................3
INDICATIONS AND CLINICAL
USE..............................................................................3
CONTRAINDICATIONS
.................................................................................................4
WARNINGS AND
PRECAUTIONS..................................................................................5
ADVERSE
REACTIONS..................................................................................................17
DRUG
INTERACTIONS..................................................................................................34
DOSAGE AND
ADMINISTRATION...............................................................................40
OVERDOSAGE
...............................................................................................................44
ACTION AND CLINICAL PHARMACOLOGY
..............................................................46
STORAGE AND
STABILITY...........................................................................................49
SPECIAL HANDLING INSTRUCTIONS
........................................................................49
DOSAGE FORMS, COMPOSITION AND PACKAGING
................................................49
PART II: SCIENTIFIC
INFORMATION......................................................................51
PHARMACEUTICAL
INFORMATION.......................