TEVA-ESCITALOPRAM TABLET

국가: 캐나다

언어: 영어

출처: Health Canada

유효 성분:

ESCITALOPRAM (ESCITALOPRAM OXALATE)

제공처:

TEVA CANADA LIMITED

ATC 코드:

N06AB10

INN (국제 이름):

ESCITALOPRAM

복용량:

5MG

약제 형태:

TABLET

구성:

ESCITALOPRAM (ESCITALOPRAM OXALATE) 5MG

관리 경로:

ORAL

패키지 단위:

30/100

처방전 유형:

Prescription

치료 영역:

SELECTIVE-SEROTONIN REUPTAKE INHIBITORS

제품 요약:

Active ingredient group (AIG) number: 0150435001; AHFS:

승인 상태:

CANCELLED PRE MARKET

승인 날짜:

2015-10-16

제품 특성 요약

PRODUCT MONOGRAPH
PR
TEVA-ESCITALOPRAM
(escitalopram oxalate)
Tablets 5 mg, 10 mg, 15 mg and 20 mg escitalopram (as escitalopram
oxalate)
Antidepressant
Teva Canada Limited
30 Novopharm Court
Toronto, Ontario
M1B 2K9
Submission Control No. 119039, 138252
Date of Preparation:
September 23, 2010
2
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...........................................................................................
10
DRUG INTERACTIONS
...........................................................................................
20
DOSAGE AND
ADMINISTRATION.......................................................................
26
OVERDOSAGE
.........................................................................................................
28
ACTION AND CLINICAL PHARMACOLOGY
..................................................... 29
STORAGE AND
STABILITY...................................................................................
30
DOSAGE FORMS, COMPOSITION AND PACKAGING
...................................... 31
PART II: SCIENTIFIC INFORMATION
........................................................................
32
PHARMACEUTICAL
INFORMATION...................................................................
32
CLINICAL
TRIALS...................................................................................................
34
DETAILED
PHARMACOLOGY..............................................................................
35
TOXICOLOGY
..................................................................