STR-DULOXETINE CAPSULE (DELAYED RELEASE)

البلد: كندا

اللغة: الإنجليزية

المصدر: Health Canada

العنصر النشط:

DULOXETINE (DULOXETINE HYDROCHLORIDE)

متاح من:

STAR - PHARMA PAN - AMERICA INC

ATC رمز:

N06AX21

INN (الاسم الدولي):

DULOXETINE

جرعة:

30MG

الشكل الصيدلاني:

CAPSULE (DELAYED RELEASE)

تركيب:

DULOXETINE (DULOXETINE HYDROCHLORIDE) 30MG

طريقة التعاطي:

ORAL

الوحدات في الحزمة:

100

نوع الوصفة الطبية :

Prescription

المجال العلاجي:

SELECTIVE SEROTONIN AND NOREPINEPHRINE-REUPTAKE INHIBITORS

ملخص المنتج:

Active ingredient group (AIG) number: 0152350001; AHFS:

الوضع إذن:

CANCELLED PRE MARKET

تاريخ الترخيص:

2021-12-13

خصائص المنتج

1
PRODUCT MONOGRAPH
PR
STR-DULOXETINE
Duloxetine Delayed-Release Capsules
Duloxetine (as duloxetine hydrochloride)
30 mg and 60 mg
USP
ANALGESIC / ANTIDEPRESSANT / ANXIOLYTIC
Star-Pharma Pan-America Inc.
Date of Preparation:
2985 Drew Rd., Suite 216
06 March 2017
Mississauga, Ontario
L4T 0A4
Control No.: 198169
2
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
..............................................................................
37
OVERDOSAGE
.................................................................................................................
40
ACTION AND CLINICAL PHARMACOLOGY
............................................................. 41
STORAGE AND STABILITY
..........................................................................................
44
DOSAGE FORMS, COMPOSITION AND PACKAGING
.............................................. 44
PART II: SCIENTIFIC INFORMATION
................................................................................
46
PHARMACEUTICAL INFORMATION
..........................................................................
46
CLINICAL TRIALS
..........................................................................................................
47
DETAILED PHARMACOLOGY
..............................