TEVA-DESVENLAFAXINE TABLET (EXTENDED-RELEASE)
국가: 캐나다
언어: 영어
출처: Health Canada
제품 특성 요약
(SPC)
18-10-2021
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유효 성분:
DESVENLAFAXINE (DESVENLAFAXINE SUCCINATE)
제공처:
TEVA CANADA LIMITED
ATC 코드:
N06AX23
INN (국제 이름):
DESVENLAFAXINE
복용량:
50MG
약제 형태:
TABLET (EXTENDED-RELEASE)
구성:
DESVENLAFAXINE (DESVENLAFAXINE SUCCINATE) 50MG
관리 경로:
ORAL
패키지 단위:
30/100
처방전 유형:
Prescription
제품 요약:
Active ingredient group (AIG) number: 0152509001; AHFS:
승인 상태:
APPROVED
승인 날짜:
2022-02-14
제품 특성 요약
PRODUCT MONOGRAPH
Pr
TEVA-DESVENLAFAXINE
Desvenlafaxine Extended-Release Tablets
50 mg and 100 mg desvenlafaxine (as desvenlafaxine succinate)
Antidepressant
Teva Canada Limited
Date of Revision:
30 Novopharm Court
October 18, 2021
Toronto, Ontario
M1B 2K9
Control No.: 256177
2
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
........................................................................................................
20
DOSAGE AND ADMINISTRATION
.....................................................................................
23
OVERDOSAGE
.....................................................................................................................
25
ACTION AND CLINICAL
PHARMACOLOGY.....................................................................
26
STORAGE AND STABILITY
................................................................................................
29
SPECIAL HANDLING INSTRUCTIONS
...............................................................................
29
DOSAGE FORMS, COMPOSITION AND
PACKAGING....................................................... 30
PART II: SCIENTIFIC INFORMATION
.............................................................................
31
PHARMACEUTICAL INFORMATION
.................................................................................
31
CLINICAL TRIALS
.......
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